Heidi Splete

The incidence of esophageal adenocarcinoma in adults aged younger than 50 years increased threefold between 1975 and 2015, based on data from more than 34,000 cases.

Esophageal carcinoma rates overall have risen in the United States over the past 4 decades, but the average patient is in their 60s, wrote Don C. Codipilly, MD, of the Mayo Clinic, Rochester, Minn., and colleagues. Therefore, “data on the incidence, stage distribution, and outcomes of this segment of patients [younger than 50 years] with esophageal adenocarcinoma are relatively limited.”

In a study published in Cancer Epidemiology, Biomarkers & Prevention, the researchers identified 34,443 cases of esophageal adenocarcinoma using the Surveillance, Epidemiology, and End Results (SEER) database for the periods of 1975-1989, 1990-1999, and 2000-2015. The cases were limited to histologically confirmed cases and were stratified according to age at diagnosis: younger than 50 years, 50-69 years, and 70 years and older

Overall, the annual incidence of esophageal adenocarcinoma among individuals younger than 50 years increased from 0.08 per 100,000 persons in 1975 to 0.27 per 100,000 persons in 2015.
 

Younger patients show more advanced illness

Although the incidence rose across all three age groups during the study period, the largest increase was seen in those aged 70 years and older. However, the younger group was significantly more likely to present at more-advanced stages, the researchers pointed out: Between 2000 and 2015, localized disease represented only 15.1% of cases in those younger than 50 years, compared with 22.4% in patients aged 50-69 years and 32.2% in those 70 years and older. The incidence of regional/distant disease among younger patients has increased over time, with 81.8% in 1975-1989, 75.5% in 1990-1999, and 84.9% in 2000-2015 (P < .01), and this increase has been faster than among older groups, the researches noted. For comparison, during 2000-2015 only 77.6% of patients aged 50-69 years and 67.8% of patients 70 years and older had regional/distant disease.

In addition, the majority of cases of young-onset esophageal adenocarcinoma occurred in men in a trend that persisted across the study periods; 90% of patients younger than 50 years were male in 1975, and 86% of the younger patients in 2015 were male.

“There is no clear explanation for the higher proportion of advanced disease in younger patients, and further study is required to identify biologic, genetic, and environmental factors that may underlie this observation,” the researchers wrote. “A potential hypothesis is that ‘young-onset esophageal adenocarcinoma’ may involve rapid transition from intestinal metaplasia to esophageal adenocarcinoma, driven by an increase in signaling molecules that are active in the intestine,” they suggested.

The study findings were limited by several factors including the inability to review individual case records to confirm disease stage and to compare outcomes across ethnicities, and the lack of data on comorbidities in the SEER database, the researchers noted.

However, the results were strengthened by overall quality of the SEER database and use of multivariate analysis, they added. The evidence of increased incidence and increased odds of advanced disease in younger adults suggest that “reevaluation of our diagnostic and treatment strategies in this age group might need to be considered.”
 

Reasons for increase remain unclear

“While esophageal adenocarcinoma is uncommon overall in younger patients, this study importantly highlights that not only has the incidence of esophageal adenocarcinoma increased more than threefold in patients under the age of 50 over the last 4 decades, but that younger patients are presenting with more advanced disease and have overall poorer survival, compared to older patients,” Rahul A. Shimpi, MD, of Duke University, Durham, N.C., said in an interview.

“The reasons for these findings are unclear, but the authors propose a number of potential factors that could explain them. These include differences in tumor biology, rising rates of obesity and [gastroesophageal reflux disease] in younger patients, decreased endoscopic screening for and surveillance of Barrett’s esophagus in this age group, and differing therapeutic approaches to management,” Dr. Shimpi said.

“The findings from this study underscore that, while uncommon, clinicians need to be aware of the rising incidence of esophageal cancer in younger patients. It is important that even younger patients presenting with esophageal symptoms, such as dysphagia, undergo investigation,” he emphasized.

“I would like to see further study into the potential factors driving the findings in this study, including whether trends in differential treatment modalities account for some of the survival differences found in different age groups,” Dr. Shimpi added. “Finally, further research will ideally clarify optimal Barrett’s screening and surveillance approaches in patients younger than age 50 in order to determine whether new strategies might impact esophageal adenocarcinoma incidence and outcomes in this group.”

The study was funded in part by the National Cancer Institute and the National Center for Advancing Translational Sciences. Two authors disclosed relationships outside the submitted work, but Dr. Codipilly and the remaining authors had no financial conflicts to disclose. Dr. Shimpi had no financial conflicts to disclose.

SOURCE: Codipilly DC et al. Cancer Epidemiol Biomarkers Prev. 2020 Dec 11. doi: 10.1158/1055-9965.EPI-20-0944.

The incidence of esophageal adenocarcinoma in adults aged younger than 50 years increased threefold between 1975 and 2015, based on data from more than 34,000 cases.

Esophageal carcinoma rates overall have risen in the United States over the past 4 decades, but the average patient is in their 60s, wrote Don C. Codipilly, MD, of the Mayo Clinic, Rochester, Minn., and colleagues. Therefore, “data on the incidence, stage distribution, and outcomes of this segment of patients [younger than 50 years] with esophageal adenocarcinoma are relatively limited.”

In a study published in Cancer Epidemiology, Biomarkers & Prevention, the researchers identified 34,443 cases of esophageal adenocarcinoma using the Surveillance, Epidemiology, and End Results (SEER) database for the periods of 1975-1989, 1990-1999, and 2000-2015. The cases were limited to histologically confirmed cases and were stratified according to age at diagnosis: younger than 50 years, 50-69 years, and 70 years and older

Overall, the annual incidence of esophageal adenocarcinoma among individuals younger than 50 years increased from 0.08 per 100,000 persons in 1975 to 0.27 per 100,000 persons in 2015.
 

Younger patients show more advanced illness

Although the incidence rose across all three age groups during the study period, the largest increase was seen in those aged 70 years and older. However, the younger group was significantly more likely to present at more-advanced stages, the researchers pointed out: Between 2000 and 2015, localized disease represented only 15.1% of cases in those younger than 50 years, compared with 22.4% in patients aged 50-69 years and 32.2% in those 70 years and older. The incidence of regional/distant disease among younger patients has increased over time, with 81.8% in 1975-1989, 75.5% in 1990-1999, and 84.9% in 2000-2015 (P < .01), and this increase has been faster than among older groups, the researches noted. For comparison, during 2000-2015 only 77.6% of patients aged 50-69 years and 67.8% of patients 70 years and older had regional/distant disease.

In addition, the majority of cases of young-onset esophageal adenocarcinoma occurred in men in a trend that persisted across the study periods; 90% of patients younger than 50 years were male in 1975, and 86% of the younger patients in 2015 were male.

“There is no clear explanation for the higher proportion of advanced disease in younger patients, and further study is required to identify biologic, genetic, and environmental factors that may underlie this observation,” the researchers wrote. “A potential hypothesis is that ‘young-onset esophageal adenocarcinoma’ may involve rapid transition from intestinal metaplasia to esophageal adenocarcinoma, driven by an increase in signaling molecules that are active in the intestine,” they suggested.

The study findings were limited by several factors including the inability to review individual case records to confirm disease stage and to compare outcomes across ethnicities, and the lack of data on comorbidities in the SEER database, the researchers noted.

However, the results were strengthened by overall quality of the SEER database and use of multivariate analysis, they added. The evidence of increased incidence and increased odds of advanced disease in younger adults suggest that “reevaluation of our diagnostic and treatment strategies in this age group might need to be considered.”
 

Reasons for increase remain unclear

“While esophageal adenocarcinoma is uncommon overall in younger patients, this study importantly highlights that not only has the incidence of esophageal adenocarcinoma increased more than threefold in patients under the age of 50 over the last 4 decades, but that younger patients are presenting with more advanced disease and have overall poorer survival, compared to older patients,” Rahul A. Shimpi, MD, of Duke University, Durham, N.C., said in an interview.

“The reasons for these findings are unclear, but the authors propose a number of potential factors that could explain them. These include differences in tumor biology, rising rates of obesity and [gastroesophageal reflux disease] in younger patients, decreased endoscopic screening for and surveillance of Barrett’s esophagus in this age group, and differing therapeutic approaches to management,” Dr. Shimpi said.

“The findings from this study underscore that, while uncommon, clinicians need to be aware of the rising incidence of esophageal cancer in younger patients. It is important that even younger patients presenting with esophageal symptoms, such as dysphagia, undergo investigation,” he emphasized.

“I would like to see further study into the potential factors driving the findings in this study, including whether trends in differential treatment modalities account for some of the survival differences found in different age groups,” Dr. Shimpi added. “Finally, further research will ideally clarify optimal Barrett’s screening and surveillance approaches in patients younger than age 50 in order to determine whether new strategies might impact esophageal adenocarcinoma incidence and outcomes in this group.”

The study was funded in part by the National Cancer Institute and the National Center for Advancing Translational Sciences. Two authors disclosed relationships outside the submitted work, but Dr. Codipilly and the remaining authors had no financial conflicts to disclose. Dr. Shimpi had no financial conflicts to disclose.

SOURCE: Codipilly DC et al. Cancer Epidemiol Biomarkers Prev. 2020 Dec 11. doi: 10.1158/1055-9965.EPI-20-0944.

The incidence of esophageal adenocarcinoma in adults aged younger than 50 years increased threefold between 1975 and 2015, based on data from more than 34,000 cases.

Esophageal carcinoma rates overall have risen in the United States over the past 4 decades, but the average patient is in their 60s, wrote Don C. Codipilly, MD, of the Mayo Clinic, Rochester, Minn., and colleagues. Therefore, “data on the incidence, stage distribution, and outcomes of this segment of patients [younger than 50 years] with esophageal adenocarcinoma are relatively limited.”

In a study published in Cancer Epidemiology, Biomarkers & Prevention, the researchers identified 34,443 cases of esophageal adenocarcinoma using the Surveillance, Epidemiology, and End Results (SEER) database for the periods of 1975-1989, 1990-1999, and 2000-2015. The cases were limited to histologically confirmed cases and were stratified according to age at diagnosis: younger than 50 years, 50-69 years, and 70 years and older

Overall, the annual incidence of esophageal adenocarcinoma among individuals younger than 50 years increased from 0.08 per 100,000 persons in 1975 to 0.27 per 100,000 persons in 2015.
 

Younger patients show more advanced illness

Although the incidence rose across all three age groups during the study period, the largest increase was seen in those aged 70 years and older. However, the younger group was significantly more likely to present at more-advanced stages, the researchers pointed out: Between 2000 and 2015, localized disease represented only 15.1% of cases in those younger than 50 years, compared with 22.4% in patients aged 50-69 years and 32.2% in those 70 years and older. The incidence of regional/distant disease among younger patients has increased over time, with 81.8% in 1975-1989, 75.5% in 1990-1999, and 84.9% in 2000-2015 (P < .01), and this increase has been faster than among older groups, the researches noted. For comparison, during 2000-2015 only 77.6% of patients aged 50-69 years and 67.8% of patients 70 years and older had regional/distant disease.

In addition, the majority of cases of young-onset esophageal adenocarcinoma occurred in men in a trend that persisted across the study periods; 90% of patients younger than 50 years were male in 1975, and 86% of the younger patients in 2015 were male.

“There is no clear explanation for the higher proportion of advanced disease in younger patients, and further study is required to identify biologic, genetic, and environmental factors that may underlie this observation,” the researchers wrote. “A potential hypothesis is that ‘young-onset esophageal adenocarcinoma’ may involve rapid transition from intestinal metaplasia to esophageal adenocarcinoma, driven by an increase in signaling molecules that are active in the intestine,” they suggested.

The study findings were limited by several factors including the inability to review individual case records to confirm disease stage and to compare outcomes across ethnicities, and the lack of data on comorbidities in the SEER database, the researchers noted.

However, the results were strengthened by overall quality of the SEER database and use of multivariate analysis, they added. The evidence of increased incidence and increased odds of advanced disease in younger adults suggest that “reevaluation of our diagnostic and treatment strategies in this age group might need to be considered.”
 

Reasons for increase remain unclear

“While esophageal adenocarcinoma is uncommon overall in younger patients, this study importantly highlights that not only has the incidence of esophageal adenocarcinoma increased more than threefold in patients under the age of 50 over the last 4 decades, but that younger patients are presenting with more advanced disease and have overall poorer survival, compared to older patients,” Rahul A. Shimpi, MD, of Duke University, Durham, N.C., said in an interview.

“The reasons for these findings are unclear, but the authors propose a number of potential factors that could explain them. These include differences in tumor biology, rising rates of obesity and [gastroesophageal reflux disease] in younger patients, decreased endoscopic screening for and surveillance of Barrett’s esophagus in this age group, and differing therapeutic approaches to management,” Dr. Shimpi said.

“The findings from this study underscore that, while uncommon, clinicians need to be aware of the rising incidence of esophageal cancer in younger patients. It is important that even younger patients presenting with esophageal symptoms, such as dysphagia, undergo investigation,” he emphasized.

“I would like to see further study into the potential factors driving the findings in this study, including whether trends in differential treatment modalities account for some of the survival differences found in different age groups,” Dr. Shimpi added. “Finally, further research will ideally clarify optimal Barrett’s screening and surveillance approaches in patients younger than age 50 in order to determine whether new strategies might impact esophageal adenocarcinoma incidence and outcomes in this group.”

The study was funded in part by the National Cancer Institute and the National Center for Advancing Translational Sciences. Two authors disclosed relationships outside the submitted work, but Dr. Codipilly and the remaining authors had no financial conflicts to disclose. Dr. Shimpi had no financial conflicts to disclose.

SOURCE: Codipilly DC et al. Cancer Epidemiol Biomarkers Prev. 2020 Dec 11. doi: 10.1158/1055-9965.EPI-20-0944.

Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m² or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m² or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

Obese women may benefit from a higher dose of magnesium sulfate to protect against preeclampsia, based on data from a randomized trial.

Pharmacokinetic models have shown that, “in women who received a 4-g intravenous loading dose followed by a 2-g/h IV maintenance dose, obese women took approximately twice as long as women of mean body weight in the sample to achieve these previously accepted therapeutic serum magnesium concentrations,” which suggests the need for alternate dosing based on body mass index, wrote Kathleen F. Brookfield, MD, of Oregon Health & Science University, Portland, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 37 women aged 15-45 years with a BMI of 35 kg/m² or higher who were at least 32 weeks’ gestation to receive the standard Zuspan regimen of magnesium sulfate (4 g intravenous loading dose, followed by a 1-g/hour infusion) or to higher dosing (6 g IV loading dose, followed by a 2-g/hour infusion).
 

Higher dose increases effectiveness

Serum magnesium concentrations were measured at baseline, and after administration of magnesium sulfate at 1 hour, 4 hours, and delivery; the primary outcome was the proportion of women with subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration.

After 4 hours, the average magnesium sulfate concentrations were significantly higher for women in the high-dose group vs. the standard group (4.41 mg/dL vs. 3.53 mg/dL). In addition, 100% of women in the standard group had subtherapeutic serum magnesium concentrations compared with 63% of the high-dose group.

No significant differences in maternal side effects or neonatal outcomes occurred between the groups. However, rates of nausea and flushing were higher in the higher dose group, compared with the standard group (10.5% vs. 5.5% and 5.2% vs. 0%, respectively).

The study findings were limited by several factors including the lack of statistical power to evaluate clinical outcomes and lack of generalizability to extremely obese patients, as well as to settings in which the higher-dose regimen is already the standard treatment, the researchers noted. However, the results were strengthened by the use of prospective pharmacokinetic data to determine dosing.

The researchers also noted that the study was not powered to examine preeclampsia as an outcome “and there is no evidence to date to suggest women in the United States with higher BMIs are more likely to experience eclampsia,” they said. “Therefore, we caution against universally applying the study findings to obese women without also considering the potential for increased toxicity with higher dosing regimens,” they added.

Current results may not affect practice

The study objectives are unclear, as they do not change the dosing for magnesium sulfate already in use, said Baha M. Sibai, MD, of the University of Texas Health Science Center at Houston, in an interview.

Dr. Sibai said he was not surprised by the findings. “This information has been known for almost 30 years as to serum levels with different dosing irrespective of BMI,” he said. Based on current evidence, Dr. Sibai advised clinicians “not to change your practice, since there are no therapeutic levels for preventing seizures.” In fact, “the largest trial that included 10,000 women showed no difference in the rate of eclampsia between 4 grams loading with 1 g/hour [magnesium sulfate] and 6 g loading and 2 g/hour,” he explained.

Future research should focus on different outcomes, said Dr. Sibai. “The outcome should be eclampsia and not serum levels. This requires studying over 6,000 women,” he emphasized.

The study was supported by the National Institutes of Health Loan Repayment Program and a Mission Support Award from Oregon Health & Science University to Dr. Brookfield and by the Oregon Clinical & Translational Research Institute grant. Dr. Brookfield also disclosed funding from the World Health Organization. Dr. Sibai had no financial conflicts to disclose.

SOURCE: Brookfield KF et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004137.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Maintaining an average hydroxychloroquine whole blood level above 1,068 ng/mL significantly reduced the risk of thrombosis in adults with systemic lupus erythematosus, based on data from 739 patients.

Marc Bruxelle/Getty Images

Hydroxychloroquine (HCQ) is a common treatment for systemic lupus erythematosus (SLE); studies suggest that it may protect against thrombosis, but the optimal dosing for this purpose remains unknown, wrote Michelle Petri, MD, of Johns Hopkins University, Baltimore, and colleagues. In a study published in Arthritis & Rheumatology, the researchers examined data on HCQ levels from 739 adults with SLE who were part of the Hopkins Lupus Cohort, a longitudinal study of outcomes in SLE patients. Of these, 38 (5.1%) developed thrombosis during 2,330 person-years of follow-up.

M. Alexander Otto/MDedge News

The average age of the patients at the time HCQ measurements began was 43 years, 93% were female, and 46% were White. Patients visited a clinic every 3 months, and HCQ levels were determined by liquid chromatography-tandem mass spectrometry.

“Between-person and within-person correlation coefficients were used to measure the strength of the linear association between HCQ blood levels and commonly prescribed HCQ doses from 4.5 to 6.5 mg/kg,” the researchers said.

Higher doses of HCQ have been associated with increased risk for retinopathy, and current guidelines recommend using less than 5 mg/kg of ideal body weight, the researchers said. “Importantly, there was no correlation between the prescribed dose and the hydroxychloroquine blood level over the range (4.5 to 6.5 mg/kg) used in clinical practice, highlighting the need for personalized hydroxychloroquine drug level-guided therapy and dose adjustment,” they emphasized.

The study findings were limited by several factors, including the observational design and potential confounding from variables not included in the model, as well as the small sample size, single site, and single rheumatologist involved in the study, the researchers noted.

The results suggest that aiming for a blood HCQ level of 1,068 ng/mL can be done safely to help prevent thrombosis in patients with SLE, the researchers said. “Routine clinical integration of hydroxychloroquine blood level measurement offers an opportunity for personalized drug dosing and risk management beyond rigid empirical dosing recommendations in patients with SLE,” they concluded.

The study was supported in part by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no relevant financial conflicts to disclose.

SOURCE: Petri M et al. Arthritis Rheumatol. 2021 Jan 6. doi: 10.1002/ART.41621.

Maintaining an average hydroxychloroquine whole blood level above 1,068 ng/mL significantly reduced the risk of thrombosis in adults with systemic lupus erythematosus, based on data from 739 patients.

Marc Bruxelle/Getty Images

Hydroxychloroquine (HCQ) is a common treatment for systemic lupus erythematosus (SLE); studies suggest that it may protect against thrombosis, but the optimal dosing for this purpose remains unknown, wrote Michelle Petri, MD, of Johns Hopkins University, Baltimore, and colleagues. In a study published in Arthritis & Rheumatology, the researchers examined data on HCQ levels from 739 adults with SLE who were part of the Hopkins Lupus Cohort, a longitudinal study of outcomes in SLE patients. Of these, 38 (5.1%) developed thrombosis during 2,330 person-years of follow-up.

M. Alexander Otto/MDedge News

The average age of the patients at the time HCQ measurements began was 43 years, 93% were female, and 46% were White. Patients visited a clinic every 3 months, and HCQ levels were determined by liquid chromatography-tandem mass spectrometry.

“Between-person and within-person correlation coefficients were used to measure the strength of the linear association between HCQ blood levels and commonly prescribed HCQ doses from 4.5 to 6.5 mg/kg,” the researchers said.

Higher doses of HCQ have been associated with increased risk for retinopathy, and current guidelines recommend using less than 5 mg/kg of ideal body weight, the researchers said. “Importantly, there was no correlation between the prescribed dose and the hydroxychloroquine blood level over the range (4.5 to 6.5 mg/kg) used in clinical practice, highlighting the need for personalized hydroxychloroquine drug level-guided therapy and dose adjustment,” they emphasized.

The study findings were limited by several factors, including the observational design and potential confounding from variables not included in the model, as well as the small sample size, single site, and single rheumatologist involved in the study, the researchers noted.

The results suggest that aiming for a blood HCQ level of 1,068 ng/mL can be done safely to help prevent thrombosis in patients with SLE, the researchers said. “Routine clinical integration of hydroxychloroquine blood level measurement offers an opportunity for personalized drug dosing and risk management beyond rigid empirical dosing recommendations in patients with SLE,” they concluded.

The study was supported in part by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no relevant financial conflicts to disclose.

SOURCE: Petri M et al. Arthritis Rheumatol. 2021 Jan 6. doi: 10.1002/ART.41621.

Maintaining an average hydroxychloroquine whole blood level above 1,068 ng/mL significantly reduced the risk of thrombosis in adults with systemic lupus erythematosus, based on data from 739 patients.

Marc Bruxelle/Getty Images

Hydroxychloroquine (HCQ) is a common treatment for systemic lupus erythematosus (SLE); studies suggest that it may protect against thrombosis, but the optimal dosing for this purpose remains unknown, wrote Michelle Petri, MD, of Johns Hopkins University, Baltimore, and colleagues. In a study published in Arthritis & Rheumatology, the researchers examined data on HCQ levels from 739 adults with SLE who were part of the Hopkins Lupus Cohort, a longitudinal study of outcomes in SLE patients. Of these, 38 (5.1%) developed thrombosis during 2,330 person-years of follow-up.

M. Alexander Otto/MDedge News

The average age of the patients at the time HCQ measurements began was 43 years, 93% were female, and 46% were White. Patients visited a clinic every 3 months, and HCQ levels were determined by liquid chromatography-tandem mass spectrometry.

“Between-person and within-person correlation coefficients were used to measure the strength of the linear association between HCQ blood levels and commonly prescribed HCQ doses from 4.5 to 6.5 mg/kg,” the researchers said.

Higher doses of HCQ have been associated with increased risk for retinopathy, and current guidelines recommend using less than 5 mg/kg of ideal body weight, the researchers said. “Importantly, there was no correlation between the prescribed dose and the hydroxychloroquine blood level over the range (4.5 to 6.5 mg/kg) used in clinical practice, highlighting the need for personalized hydroxychloroquine drug level-guided therapy and dose adjustment,” they emphasized.

The study findings were limited by several factors, including the observational design and potential confounding from variables not included in the model, as well as the small sample size, single site, and single rheumatologist involved in the study, the researchers noted.

The results suggest that aiming for a blood HCQ level of 1,068 ng/mL can be done safely to help prevent thrombosis in patients with SLE, the researchers said. “Routine clinical integration of hydroxychloroquine blood level measurement offers an opportunity for personalized drug dosing and risk management beyond rigid empirical dosing recommendations in patients with SLE,” they concluded.

The study was supported in part by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers had no relevant financial conflicts to disclose.

SOURCE: Petri M et al. Arthritis Rheumatol. 2021 Jan 6. doi: 10.1002/ART.41621.

Researchers in Italy have identified microplastic (MP) fragments in four human placentas that were donated for study after delivery.

curtoicurto/Getty Images

“The presence of MPs in the placenta tissue requires the reconsideration of the immunological mechanism of self-tolerance,” wrote Antonio Ragusa, MD, of San Giovanni Calibita Fatebenefratelli Hospital, Rome, and colleagues. “Placenta represents the interface between the fetus and the environment.”

In a pilot observational study published in Environment International, the researchers used Raman microspectroscopy to analyze placentas from six women with physiological pregnancies for the presence of MPs. MPs were defined as particles smaller than 5 mm resulting from the degradation of plastic in the environment, such as plastic objects, coatings, adhesives, paints, and personal care products. Data from previous studies have shown that MPs can move into living organisms, but this study is the first to identify MPs in human placentas, the researchers said.
 

Polypropylene and pigments identified

A total of 12 microplastic fragments were identified in tissue from the placentas of four women; 5 in the fetal side, 4 in the maternal side, and 3 in the chorioamniotic membranes, which suggests that MPs can reach all levels of placental tissue, the researchers said. Most of the MPs were approximately 10 mcm in size, but two were roughly 5 mcm.

All 12 of the MPs were pigmented; of these, 3 were identified as stained polypropylene and the other 9 contained pigments used in a variety of items including coatings, paints, adhesives, plasters, finger paints, polymers and cosmetics, and personal care products. The researchers used a software program to analyze the pigments and matched them with information from the European Chemical Agency for identification of the commercial name, chemical formula, International Union of Pure and Applied Chemistry name, and Color Index Constitution Number.

The mechanism by which MPs may enter the bloodstream and access the placenta remains unclear, the researchers said. “The most probable transport route for MPs is a mechanism of particle uptake and translocation, already described for the internalization from the gastrointestinal tract. Once MPs have reached the maternal surface of the placenta, as other exogenous materials, they can invade the tissue in depth by several transport mechanisms, both active and passive, that are not clearly understood yet.”

The range in location and characteristics of the particles found in the study suggest that passage of MPs into the placenta may be affected by physiological conditions and genetics, as well as food and lifestyle habits of the patients, the researchers said.

The study findings were limited by several factors including the small sample size and observational study design.

However, the presence of MPs in the placenta could affect the pregnancy in various ways, including immunity, growth factor signaling, maternal-fetal communication, and trafficking of various cell types and macrophages, the researchers wrote. In addition, MPs could have a transgenerational effect on metabolism and reproduction.

“Further studies need to be performed to assess if the presence of MPs in human placenta may trigger immune responses or may lead to the release of toxic contaminants, resulting harmful for pregnancy,” they concluded.
 

Cause for concern, but research gaps remain

“Microplastics are ubiquitous in the environment and are detectable in tissues of humans and wildlife,” Andrea C. Gore, PhD, of the University of Texas, Austin, said in an interview. “To my knowledge, this was never previously shown in the placenta.

“There are two reasons why detection of microplastics in placenta would be concerning,” Dr. Gore explained. “First, microplastics may be endocrine-disrupting chemicals (EDCs), or they may concentrate other chemicals that are EDCs. Second, the developing fetus is exquisitely sensitive to natural hormones, and disruptions by EDCs may lead to both immediate as well as latent health problems.

“Clinicians should be concerned about particulate matter in the placenta, “although the number of particles was very small,” said Dr. Gore. “Out of six women, four had particles in their placentas (total of 12) of which one was confirmed to be a plastic (polypropylene). For the other 11 particles, only the pigments could be identified, so more work is needed to confirm whether they were plastics.

“If I were a clinician discussing this article with my patients, I would point out that, although it is concerning that microparticles are present in placenta, few of them were found, and it is not known whether any chemical is released from the particles or actually reaches the fetal circulation,” Dr. Gore said. “I would use it as a starting point for a conversation about lifestyle during pregnancy and encouraging pregnant women to avoid eating foods stored and/or prepared in plastics.”

The limitations of the study include not only the small sample size, but also that “the type of chemicals in the microplastics is for the most part unknown, making it difficult to assess which (if any) might be EDCs,” Dr. Gore emphasized. In addition, “lifestyle and diet can greatly affect exposures to chemicals, so this needs to be carefully factored into the analysis.” Also, “most of the detected particles are pigments, so connections to plastics (other than the one polypropylene particle) need to be strengthened,” she explained.

“The pathways by which microplastics might get into tissues are still rather speculative, and the mechanisms proposed by the authors (endocytosis, paracellular diffusion, entry via airways) need to be demonstrated,” Dr. Gore concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gore had no conflicts to disclose.

SOURCE: Ragusa A et al. Environ Int. 2020 Dec 2. doi: 10.1016/j.envint.2020.106274.

Researchers in Italy have identified microplastic (MP) fragments in four human placentas that were donated for study after delivery.

curtoicurto/Getty Images

“The presence of MPs in the placenta tissue requires the reconsideration of the immunological mechanism of self-tolerance,” wrote Antonio Ragusa, MD, of San Giovanni Calibita Fatebenefratelli Hospital, Rome, and colleagues. “Placenta represents the interface between the fetus and the environment.”

In a pilot observational study published in Environment International, the researchers used Raman microspectroscopy to analyze placentas from six women with physiological pregnancies for the presence of MPs. MPs were defined as particles smaller than 5 mm resulting from the degradation of plastic in the environment, such as plastic objects, coatings, adhesives, paints, and personal care products. Data from previous studies have shown that MPs can move into living organisms, but this study is the first to identify MPs in human placentas, the researchers said.
 

Polypropylene and pigments identified

A total of 12 microplastic fragments were identified in tissue from the placentas of four women; 5 in the fetal side, 4 in the maternal side, and 3 in the chorioamniotic membranes, which suggests that MPs can reach all levels of placental tissue, the researchers said. Most of the MPs were approximately 10 mcm in size, but two were roughly 5 mcm.

All 12 of the MPs were pigmented; of these, 3 were identified as stained polypropylene and the other 9 contained pigments used in a variety of items including coatings, paints, adhesives, plasters, finger paints, polymers and cosmetics, and personal care products. The researchers used a software program to analyze the pigments and matched them with information from the European Chemical Agency for identification of the commercial name, chemical formula, International Union of Pure and Applied Chemistry name, and Color Index Constitution Number.

The mechanism by which MPs may enter the bloodstream and access the placenta remains unclear, the researchers said. “The most probable transport route for MPs is a mechanism of particle uptake and translocation, already described for the internalization from the gastrointestinal tract. Once MPs have reached the maternal surface of the placenta, as other exogenous materials, they can invade the tissue in depth by several transport mechanisms, both active and passive, that are not clearly understood yet.”

The range in location and characteristics of the particles found in the study suggest that passage of MPs into the placenta may be affected by physiological conditions and genetics, as well as food and lifestyle habits of the patients, the researchers said.

The study findings were limited by several factors including the small sample size and observational study design.

However, the presence of MPs in the placenta could affect the pregnancy in various ways, including immunity, growth factor signaling, maternal-fetal communication, and trafficking of various cell types and macrophages, the researchers wrote. In addition, MPs could have a transgenerational effect on metabolism and reproduction.

“Further studies need to be performed to assess if the presence of MPs in human placenta may trigger immune responses or may lead to the release of toxic contaminants, resulting harmful for pregnancy,” they concluded.
 

Cause for concern, but research gaps remain

“Microplastics are ubiquitous in the environment and are detectable in tissues of humans and wildlife,” Andrea C. Gore, PhD, of the University of Texas, Austin, said in an interview. “To my knowledge, this was never previously shown in the placenta.

“There are two reasons why detection of microplastics in placenta would be concerning,” Dr. Gore explained. “First, microplastics may be endocrine-disrupting chemicals (EDCs), or they may concentrate other chemicals that are EDCs. Second, the developing fetus is exquisitely sensitive to natural hormones, and disruptions by EDCs may lead to both immediate as well as latent health problems.

“Clinicians should be concerned about particulate matter in the placenta, “although the number of particles was very small,” said Dr. Gore. “Out of six women, four had particles in their placentas (total of 12) of which one was confirmed to be a plastic (polypropylene). For the other 11 particles, only the pigments could be identified, so more work is needed to confirm whether they were plastics.

“If I were a clinician discussing this article with my patients, I would point out that, although it is concerning that microparticles are present in placenta, few of them were found, and it is not known whether any chemical is released from the particles or actually reaches the fetal circulation,” Dr. Gore said. “I would use it as a starting point for a conversation about lifestyle during pregnancy and encouraging pregnant women to avoid eating foods stored and/or prepared in plastics.”

The limitations of the study include not only the small sample size, but also that “the type of chemicals in the microplastics is for the most part unknown, making it difficult to assess which (if any) might be EDCs,” Dr. Gore emphasized. In addition, “lifestyle and diet can greatly affect exposures to chemicals, so this needs to be carefully factored into the analysis.” Also, “most of the detected particles are pigments, so connections to plastics (other than the one polypropylene particle) need to be strengthened,” she explained.

“The pathways by which microplastics might get into tissues are still rather speculative, and the mechanisms proposed by the authors (endocytosis, paracellular diffusion, entry via airways) need to be demonstrated,” Dr. Gore concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gore had no conflicts to disclose.

SOURCE: Ragusa A et al. Environ Int. 2020 Dec 2. doi: 10.1016/j.envint.2020.106274.

Researchers in Italy have identified microplastic (MP) fragments in four human placentas that were donated for study after delivery.

curtoicurto/Getty Images

“The presence of MPs in the placenta tissue requires the reconsideration of the immunological mechanism of self-tolerance,” wrote Antonio Ragusa, MD, of San Giovanni Calibita Fatebenefratelli Hospital, Rome, and colleagues. “Placenta represents the interface between the fetus and the environment.”

In a pilot observational study published in Environment International, the researchers used Raman microspectroscopy to analyze placentas from six women with physiological pregnancies for the presence of MPs. MPs were defined as particles smaller than 5 mm resulting from the degradation of plastic in the environment, such as plastic objects, coatings, adhesives, paints, and personal care products. Data from previous studies have shown that MPs can move into living organisms, but this study is the first to identify MPs in human placentas, the researchers said.
 

Polypropylene and pigments identified

A total of 12 microplastic fragments were identified in tissue from the placentas of four women; 5 in the fetal side, 4 in the maternal side, and 3 in the chorioamniotic membranes, which suggests that MPs can reach all levels of placental tissue, the researchers said. Most of the MPs were approximately 10 mcm in size, but two were roughly 5 mcm.

All 12 of the MPs were pigmented; of these, 3 were identified as stained polypropylene and the other 9 contained pigments used in a variety of items including coatings, paints, adhesives, plasters, finger paints, polymers and cosmetics, and personal care products. The researchers used a software program to analyze the pigments and matched them with information from the European Chemical Agency for identification of the commercial name, chemical formula, International Union of Pure and Applied Chemistry name, and Color Index Constitution Number.

The mechanism by which MPs may enter the bloodstream and access the placenta remains unclear, the researchers said. “The most probable transport route for MPs is a mechanism of particle uptake and translocation, already described for the internalization from the gastrointestinal tract. Once MPs have reached the maternal surface of the placenta, as other exogenous materials, they can invade the tissue in depth by several transport mechanisms, both active and passive, that are not clearly understood yet.”

The range in location and characteristics of the particles found in the study suggest that passage of MPs into the placenta may be affected by physiological conditions and genetics, as well as food and lifestyle habits of the patients, the researchers said.

The study findings were limited by several factors including the small sample size and observational study design.

However, the presence of MPs in the placenta could affect the pregnancy in various ways, including immunity, growth factor signaling, maternal-fetal communication, and trafficking of various cell types and macrophages, the researchers wrote. In addition, MPs could have a transgenerational effect on metabolism and reproduction.

“Further studies need to be performed to assess if the presence of MPs in human placenta may trigger immune responses or may lead to the release of toxic contaminants, resulting harmful for pregnancy,” they concluded.
 

Cause for concern, but research gaps remain

“Microplastics are ubiquitous in the environment and are detectable in tissues of humans and wildlife,” Andrea C. Gore, PhD, of the University of Texas, Austin, said in an interview. “To my knowledge, this was never previously shown in the placenta.

“There are two reasons why detection of microplastics in placenta would be concerning,” Dr. Gore explained. “First, microplastics may be endocrine-disrupting chemicals (EDCs), or they may concentrate other chemicals that are EDCs. Second, the developing fetus is exquisitely sensitive to natural hormones, and disruptions by EDCs may lead to both immediate as well as latent health problems.

“Clinicians should be concerned about particulate matter in the placenta, “although the number of particles was very small,” said Dr. Gore. “Out of six women, four had particles in their placentas (total of 12) of which one was confirmed to be a plastic (polypropylene). For the other 11 particles, only the pigments could be identified, so more work is needed to confirm whether they were plastics.

“If I were a clinician discussing this article with my patients, I would point out that, although it is concerning that microparticles are present in placenta, few of them were found, and it is not known whether any chemical is released from the particles or actually reaches the fetal circulation,” Dr. Gore said. “I would use it as a starting point for a conversation about lifestyle during pregnancy and encouraging pregnant women to avoid eating foods stored and/or prepared in plastics.”

The limitations of the study include not only the small sample size, but also that “the type of chemicals in the microplastics is for the most part unknown, making it difficult to assess which (if any) might be EDCs,” Dr. Gore emphasized. In addition, “lifestyle and diet can greatly affect exposures to chemicals, so this needs to be carefully factored into the analysis.” Also, “most of the detected particles are pigments, so connections to plastics (other than the one polypropylene particle) need to be strengthened,” she explained.

“The pathways by which microplastics might get into tissues are still rather speculative, and the mechanisms proposed by the authors (endocytosis, paracellular diffusion, entry via airways) need to be demonstrated,” Dr. Gore concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gore had no conflicts to disclose.

SOURCE: Ragusa A et al. Environ Int. 2020 Dec 2. doi: 10.1016/j.envint.2020.106274.

Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.

Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.

In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.

A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.

Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.

In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).

In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.

“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.

The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.

However, the study was strengthened by the large sample size and use of a real-world setting, they said.

“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
 

Comparisons inform choices

“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.

Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.

The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.

The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.  

The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.

SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323

Story updated Jan. 6, 2021.

Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.

Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.

In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.

A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.

Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.

In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).

In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.

“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.

The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.

However, the study was strengthened by the large sample size and use of a real-world setting, they said.

“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
 

Comparisons inform choices

“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.

Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.

The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.

The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.  

The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.

SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323

Story updated Jan. 6, 2021.

Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.

Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.

In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.

A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.

Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.

In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).

In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.

“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.

The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.

However, the study was strengthened by the large sample size and use of a real-world setting, they said.

“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
 

Comparisons inform choices

“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.

Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.

The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.

The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.  

The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.

SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323

Story updated Jan. 6, 2021.

Patients with severe COVID-19 were significantly more likely than those with milder cases to have GI symptoms of anorexia and diarrhea, as well as abnormal liver function, based on data from a meta-analysis of more than 4,500 patients.

Previous studies have shown that liver damage “was more likely to be observed in severe patients during the process of disease,” and other studies have shown varying degrees of liver insufficiency in COVID-19 patients, but gastrointestinal symptoms have not been well studied, wrote Zi-yuan Dong, MD, of China Medical University, Shenyang City, and colleagues.

In a study published in the Journal of Clinical Gastroenterology, the researchers identified 31 studies including 4,682 COVID-19 patients. Case collection was from Dec. 11, 2019, to Feb. 28, 2020. Median age among studies ranged from 36 to 62 years, and 55% of patients were male.

A total of 26 studies were analyzed for the prevalence of GI symptoms, specifically nausea, vomiting, diarrhea, abdominal pain, and anorexia. Of these, anorexia and diarrhea were significantly more common in COVID-19 patients, with prevalence of 17% and 8% respectively, (P < .0001 for both).

In addition, 14 of the studies included in the analysis assessed the prevalence of abnormal liver function based on increased levels of aspartate aminotransferase, alanine aminotransferase, and total bilirubin. Of these, increased alanine aminotransferase was the most common, occurring in 25% of patients, compared with increased AST (in 24%) and total bilirubin (in 13%).

When assessed by disease severity, patients with severe disease and those in the ICU were significantly more likely than general/non-ICU patients to have anorexia (odds ratio, 2.19), diarrhea (OR, 1.65), and abdominal pain (OR, 6.38). The severely ill patients were significantly more likely to have increased AST and ALT (OR, 2.98 and 2.66, respectively).

“However, there were no significant differences between severe/ICU group and general/non-ICU group for the prevalence of nausea and vomiting and liver disease,” the researchers said.

The study findings were limited by several factors including the unclear classification of digestive system disease and liver disease in many of the studies, the small sample sizes, and the lack of data on pathology of the liver or colon in COVID-19 patients, the researchers noted.

More research is needed, but the findings suggest that COVID-19 could contribute to liver damage because the most significant abnormal liver function was increased ALT, they said.
 

Check liver function in cases with GI symptoms

“COVID patients can present asymptomatically or with nonspecific symptoms, including GI symptoms,” said Ziad F. Gellad, MD, of Duke University Medical Center, Durham, N.C., in an interview. “While the focus of management naturally is directed to the pulmonary consequences of the disease, it is important to evaluate the patient holistically,” he said.

“I do not think these findings have profound clinical implications because they identify relatively nonspecific symptoms that are commonly seen in patients in a number of other conditions,” noted Dr. Gellad. “The management of COVID should not change, with the exception of perhaps making sure to check for abnormal liver function tests in patients that present with more typical COVID symptoms,” he said.

“Additional research is needed to understand the biologic mechanism by which COVID impacts systems outside of the lungs,” Dr. Gellad emphasized. “For example, there has been some very interesting work understanding the impact of COVID on the pancreas and risk for pancreatitis. That work is similarly needed to understand how COVID, outside of causing a general illness, specifically impacts the rest of the GI tract,” he said.

The study was supported by the Liaoning Science and Technology Foundation. The researchers had no financial conflicts to disclose. Dr. Gellad had no financial conflicts to disclose.

SOURCE: Dong Z-Y et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001424.

Patients with severe COVID-19 were significantly more likely than those with milder cases to have GI symptoms of anorexia and diarrhea, as well as abnormal liver function, based on data from a meta-analysis of more than 4,500 patients.

Previous studies have shown that liver damage “was more likely to be observed in severe patients during the process of disease,” and other studies have shown varying degrees of liver insufficiency in COVID-19 patients, but gastrointestinal symptoms have not been well studied, wrote Zi-yuan Dong, MD, of China Medical University, Shenyang City, and colleagues.

In a study published in the Journal of Clinical Gastroenterology, the researchers identified 31 studies including 4,682 COVID-19 patients. Case collection was from Dec. 11, 2019, to Feb. 28, 2020. Median age among studies ranged from 36 to 62 years, and 55% of patients were male.

A total of 26 studies were analyzed for the prevalence of GI symptoms, specifically nausea, vomiting, diarrhea, abdominal pain, and anorexia. Of these, anorexia and diarrhea were significantly more common in COVID-19 patients, with prevalence of 17% and 8% respectively, (P < .0001 for both).

In addition, 14 of the studies included in the analysis assessed the prevalence of abnormal liver function based on increased levels of aspartate aminotransferase, alanine aminotransferase, and total bilirubin. Of these, increased alanine aminotransferase was the most common, occurring in 25% of patients, compared with increased AST (in 24%) and total bilirubin (in 13%).

When assessed by disease severity, patients with severe disease and those in the ICU were significantly more likely than general/non-ICU patients to have anorexia (odds ratio, 2.19), diarrhea (OR, 1.65), and abdominal pain (OR, 6.38). The severely ill patients were significantly more likely to have increased AST and ALT (OR, 2.98 and 2.66, respectively).

“However, there were no significant differences between severe/ICU group and general/non-ICU group for the prevalence of nausea and vomiting and liver disease,” the researchers said.

The study findings were limited by several factors including the unclear classification of digestive system disease and liver disease in many of the studies, the small sample sizes, and the lack of data on pathology of the liver or colon in COVID-19 patients, the researchers noted.

More research is needed, but the findings suggest that COVID-19 could contribute to liver damage because the most significant abnormal liver function was increased ALT, they said.
 

Check liver function in cases with GI symptoms

“COVID patients can present asymptomatically or with nonspecific symptoms, including GI symptoms,” said Ziad F. Gellad, MD, of Duke University Medical Center, Durham, N.C., in an interview. “While the focus of management naturally is directed to the pulmonary consequences of the disease, it is important to evaluate the patient holistically,” he said.

“I do not think these findings have profound clinical implications because they identify relatively nonspecific symptoms that are commonly seen in patients in a number of other conditions,” noted Dr. Gellad. “The management of COVID should not change, with the exception of perhaps making sure to check for abnormal liver function tests in patients that present with more typical COVID symptoms,” he said.

“Additional research is needed to understand the biologic mechanism by which COVID impacts systems outside of the lungs,” Dr. Gellad emphasized. “For example, there has been some very interesting work understanding the impact of COVID on the pancreas and risk for pancreatitis. That work is similarly needed to understand how COVID, outside of causing a general illness, specifically impacts the rest of the GI tract,” he said.

The study was supported by the Liaoning Science and Technology Foundation. The researchers had no financial conflicts to disclose. Dr. Gellad had no financial conflicts to disclose.

SOURCE: Dong Z-Y et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001424.

Patients with severe COVID-19 were significantly more likely than those with milder cases to have GI symptoms of anorexia and diarrhea, as well as abnormal liver function, based on data from a meta-analysis of more than 4,500 patients.

Previous studies have shown that liver damage “was more likely to be observed in severe patients during the process of disease,” and other studies have shown varying degrees of liver insufficiency in COVID-19 patients, but gastrointestinal symptoms have not been well studied, wrote Zi-yuan Dong, MD, of China Medical University, Shenyang City, and colleagues.

In a study published in the Journal of Clinical Gastroenterology, the researchers identified 31 studies including 4,682 COVID-19 patients. Case collection was from Dec. 11, 2019, to Feb. 28, 2020. Median age among studies ranged from 36 to 62 years, and 55% of patients were male.

A total of 26 studies were analyzed for the prevalence of GI symptoms, specifically nausea, vomiting, diarrhea, abdominal pain, and anorexia. Of these, anorexia and diarrhea were significantly more common in COVID-19 patients, with prevalence of 17% and 8% respectively, (P < .0001 for both).

In addition, 14 of the studies included in the analysis assessed the prevalence of abnormal liver function based on increased levels of aspartate aminotransferase, alanine aminotransferase, and total bilirubin. Of these, increased alanine aminotransferase was the most common, occurring in 25% of patients, compared with increased AST (in 24%) and total bilirubin (in 13%).

When assessed by disease severity, patients with severe disease and those in the ICU were significantly more likely than general/non-ICU patients to have anorexia (odds ratio, 2.19), diarrhea (OR, 1.65), and abdominal pain (OR, 6.38). The severely ill patients were significantly more likely to have increased AST and ALT (OR, 2.98 and 2.66, respectively).

“However, there were no significant differences between severe/ICU group and general/non-ICU group for the prevalence of nausea and vomiting and liver disease,” the researchers said.

The study findings were limited by several factors including the unclear classification of digestive system disease and liver disease in many of the studies, the small sample sizes, and the lack of data on pathology of the liver or colon in COVID-19 patients, the researchers noted.

More research is needed, but the findings suggest that COVID-19 could contribute to liver damage because the most significant abnormal liver function was increased ALT, they said.
 

Check liver function in cases with GI symptoms

“COVID patients can present asymptomatically or with nonspecific symptoms, including GI symptoms,” said Ziad F. Gellad, MD, of Duke University Medical Center, Durham, N.C., in an interview. “While the focus of management naturally is directed to the pulmonary consequences of the disease, it is important to evaluate the patient holistically,” he said.

“I do not think these findings have profound clinical implications because they identify relatively nonspecific symptoms that are commonly seen in patients in a number of other conditions,” noted Dr. Gellad. “The management of COVID should not change, with the exception of perhaps making sure to check for abnormal liver function tests in patients that present with more typical COVID symptoms,” he said.

“Additional research is needed to understand the biologic mechanism by which COVID impacts systems outside of the lungs,” Dr. Gellad emphasized. “For example, there has been some very interesting work understanding the impact of COVID on the pancreas and risk for pancreatitis. That work is similarly needed to understand how COVID, outside of causing a general illness, specifically impacts the rest of the GI tract,” he said.

The study was supported by the Liaoning Science and Technology Foundation. The researchers had no financial conflicts to disclose. Dr. Gellad had no financial conflicts to disclose.

SOURCE: Dong Z-Y et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001424.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.

Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.

In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.

A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.

Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.

In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).

In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.

“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.

The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.

However, the study was strengthened by the large sample size and use of a real-world setting, they said.

“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
 

Comparisons inform choices

“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.

Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.

The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.

The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.  

The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323

Story updated Jan. 5, 2021.

Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.

Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.

In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.

A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.

Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.

In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).

In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.

“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.

The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.

However, the study was strengthened by the large sample size and use of a real-world setting, they said.

“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
 

Comparisons inform choices

“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.

Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.

The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.

The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.  

The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD. 

SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323

Story updated Jan. 5, 2021.

Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.

Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.

In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.

A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.

Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.

In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).

In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.

“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.

The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.

However, the study was strengthened by the large sample size and use of a real-world setting, they said.

“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
 

Comparisons inform choices

“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.

Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.

The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.

The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.  

The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.

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SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323

Story updated Jan. 5, 2021.