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Contact allergen of the year found in foam in shin guards, footwear
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The announcement was made by Donald V. Belsito, MD, professor of dermatology, Columbia University, New York, during a presentation at the annual meeting of the American Contact Dermatitis Society, held virtually this year. In his opinion, he said, the most exciting selections occur when international cooperation results in the identification of a new allergen that could become problematic, and acetophenone azine falls into this category.
The chemical formula of acetophenone azine is C16H16N2.
Acetophenone azine was highlighted as a contact allergen in a recent report in Dermatitis. The authors, Nadia Raison-Peyron, MD, from the department of dermatology at the University of Montpelier (France), and Denis Sasseville, MD, from the division of dermatology at McGill University Health Center, Quebec, described publications and reports of about 12 cases of severe allergic contact dermatitis secondary to shin pads or footwear, mainly in children and teens in Europe (one case was in Canada).
A common feature of these cases was the presence of a foam used for cushioning, made of ethyl vinyl acetate (EVA) used in the relevant products.
In one case, a 13-year-old boy who wore shin pads for soccer developed contact dermatitis on both shins that spread, and was described as severe. Patch testing revealed the EVA foam in the shin pads as the only positive reaction. Similar cases have been reported after exposure to EVA-containing products, including shin pads, sneakers, flip-flops, ski boots, insoles, swimming goggles, and bicycle seats, according to the authors.
In some reports, cases related to footwear presented as dyshidrosiform, vesiculobullous eczema, with or without palmar lesions, or presented as plantar hyperkeratotic dermatitis, they wrote. In other cases, patients experienced scarring and postinflammatory hypopigmentation.
The compound is likely not added to EVA intentionally, they added, but instead is thought to result from reactions between additives during the manufacturing process. The presence of acetophenone azine is not well explained, but the current theory is that it results from a combination of “the degradation of the initiator dicumylperoxide and hydrazine from the foaming agent azodicarbonamide,” the authors said.
In the paper, Dr. Raison-Peyron and Dr. Sasseville recommended a patch testing concentration of 0.1% in acetone or petrolatum, as acetophenone azine is not currently available from path test suppliers, although it can be obtained from chemical product distributors.
“Given the recent discovery of this allergen, it is presumed that cases of allergic contact dermatitis would have been missed and labeled irritant contact dermatitis or dyshidrosis,” they noted. To avoid missing more cases, acetophenone azine should be added to the patch testing shoe series, as well as plastics and glues series, they emphasized.
Although no cases of allergic reactions to acetophenone azine have been reported in the United States to date, it is an emerging allergen that should be on the radar for U.S. dermatologists, Amber Atwater, MD, outgoing ACDS president, said in an interview. The lack of reported cases may be in part attributed to the fact that acetophenone azine is not yet available to purchase for testing in the United States, and the allergen could be present in shin guards and other products identified in reported cases, added Dr. Atwater, associate professor of dermatology, Duke University, Durham, N.C.
.
The announcement was made by Donald V. Belsito, MD, professor of dermatology, Columbia University, New York, during a presentation at the annual meeting of the American Contact Dermatitis Society, held virtually this year. In his opinion, he said, the most exciting selections occur when international cooperation results in the identification of a new allergen that could become problematic, and acetophenone azine falls into this category.
The chemical formula of acetophenone azine is C16H16N2.
Acetophenone azine was highlighted as a contact allergen in a recent report in Dermatitis. The authors, Nadia Raison-Peyron, MD, from the department of dermatology at the University of Montpelier (France), and Denis Sasseville, MD, from the division of dermatology at McGill University Health Center, Quebec, described publications and reports of about 12 cases of severe allergic contact dermatitis secondary to shin pads or footwear, mainly in children and teens in Europe (one case was in Canada).
A common feature of these cases was the presence of a foam used for cushioning, made of ethyl vinyl acetate (EVA) used in the relevant products.
In one case, a 13-year-old boy who wore shin pads for soccer developed contact dermatitis on both shins that spread, and was described as severe. Patch testing revealed the EVA foam in the shin pads as the only positive reaction. Similar cases have been reported after exposure to EVA-containing products, including shin pads, sneakers, flip-flops, ski boots, insoles, swimming goggles, and bicycle seats, according to the authors.
In some reports, cases related to footwear presented as dyshidrosiform, vesiculobullous eczema, with or without palmar lesions, or presented as plantar hyperkeratotic dermatitis, they wrote. In other cases, patients experienced scarring and postinflammatory hypopigmentation.
The compound is likely not added to EVA intentionally, they added, but instead is thought to result from reactions between additives during the manufacturing process. The presence of acetophenone azine is not well explained, but the current theory is that it results from a combination of “the degradation of the initiator dicumylperoxide and hydrazine from the foaming agent azodicarbonamide,” the authors said.
In the paper, Dr. Raison-Peyron and Dr. Sasseville recommended a patch testing concentration of 0.1% in acetone or petrolatum, as acetophenone azine is not currently available from path test suppliers, although it can be obtained from chemical product distributors.
“Given the recent discovery of this allergen, it is presumed that cases of allergic contact dermatitis would have been missed and labeled irritant contact dermatitis or dyshidrosis,” they noted. To avoid missing more cases, acetophenone azine should be added to the patch testing shoe series, as well as plastics and glues series, they emphasized.
Although no cases of allergic reactions to acetophenone azine have been reported in the United States to date, it is an emerging allergen that should be on the radar for U.S. dermatologists, Amber Atwater, MD, outgoing ACDS president, said in an interview. The lack of reported cases may be in part attributed to the fact that acetophenone azine is not yet available to purchase for testing in the United States, and the allergen could be present in shin guards and other products identified in reported cases, added Dr. Atwater, associate professor of dermatology, Duke University, Durham, N.C.
.
The announcement was made by Donald V. Belsito, MD, professor of dermatology, Columbia University, New York, during a presentation at the annual meeting of the American Contact Dermatitis Society, held virtually this year. In his opinion, he said, the most exciting selections occur when international cooperation results in the identification of a new allergen that could become problematic, and acetophenone azine falls into this category.
The chemical formula of acetophenone azine is C16H16N2.
Acetophenone azine was highlighted as a contact allergen in a recent report in Dermatitis. The authors, Nadia Raison-Peyron, MD, from the department of dermatology at the University of Montpelier (France), and Denis Sasseville, MD, from the division of dermatology at McGill University Health Center, Quebec, described publications and reports of about 12 cases of severe allergic contact dermatitis secondary to shin pads or footwear, mainly in children and teens in Europe (one case was in Canada).
A common feature of these cases was the presence of a foam used for cushioning, made of ethyl vinyl acetate (EVA) used in the relevant products.
In one case, a 13-year-old boy who wore shin pads for soccer developed contact dermatitis on both shins that spread, and was described as severe. Patch testing revealed the EVA foam in the shin pads as the only positive reaction. Similar cases have been reported after exposure to EVA-containing products, including shin pads, sneakers, flip-flops, ski boots, insoles, swimming goggles, and bicycle seats, according to the authors.
In some reports, cases related to footwear presented as dyshidrosiform, vesiculobullous eczema, with or without palmar lesions, or presented as plantar hyperkeratotic dermatitis, they wrote. In other cases, patients experienced scarring and postinflammatory hypopigmentation.
The compound is likely not added to EVA intentionally, they added, but instead is thought to result from reactions between additives during the manufacturing process. The presence of acetophenone azine is not well explained, but the current theory is that it results from a combination of “the degradation of the initiator dicumylperoxide and hydrazine from the foaming agent azodicarbonamide,” the authors said.
In the paper, Dr. Raison-Peyron and Dr. Sasseville recommended a patch testing concentration of 0.1% in acetone or petrolatum, as acetophenone azine is not currently available from path test suppliers, although it can be obtained from chemical product distributors.
“Given the recent discovery of this allergen, it is presumed that cases of allergic contact dermatitis would have been missed and labeled irritant contact dermatitis or dyshidrosis,” they noted. To avoid missing more cases, acetophenone azine should be added to the patch testing shoe series, as well as plastics and glues series, they emphasized.
Although no cases of allergic reactions to acetophenone azine have been reported in the United States to date, it is an emerging allergen that should be on the radar for U.S. dermatologists, Amber Atwater, MD, outgoing ACDS president, said in an interview. The lack of reported cases may be in part attributed to the fact that acetophenone azine is not yet available to purchase for testing in the United States, and the allergen could be present in shin guards and other products identified in reported cases, added Dr. Atwater, associate professor of dermatology, Duke University, Durham, N.C.
FROM ACDS 2021
Infliximab weakens COVID-19 antibody response for IBD patients
Patients treated with infliximab for inflammatory bowel disease (IBD) showed significantly reduced response to COVID-19 antibodies, compared with those treated with vedolizumab, according to data from nearly 7,000 patients.
Although anti–tumor necrosis factor (anti-TNF) drugs are routinely used for patients with IBD, the impact of their immune-suppressing properties on protective immunity to COVID-19 is unknown, wrote Nicholas A. Kennedy, MD, of the University of Exeter (England) and colleagues. These drugs have been reported to impair protective immunity following vaccines for other diseases, such as those for influenza and viral hepatitis.
“By suppressing immune responses, biological and immunosuppression therapies may lead to chronic SARS-CoV-2 infection and have recently been implicated in the evolution and emergence of novel variants,” they noted, citing a study published in Cell.
In the current study, published in Gut, the researchers used data from the CLARITY IBD study to identify 6,935 patients with IBD aged 5 years and older seen at 92 hospitals in the United Kingdom between Sept. 22, 2020, and Dec. 23, 2020. Of these, 4,685 were treated with infliximab, and 2,250 received vedolizumab. The proportion of study participants with a positive anti–SARS-CoV-2 antibody test was the primary outcome, with secondary outcomes including proportion with positive antibodies following positive polymerase chain reaction test for SARS-CoV-2 and the magnitude of antibody reactivity.
Substantial seroprevalence differences seen
Overall, rates of symptomatic and proven SARS-CoV-2 infection and hospitalization were similar between infliximab-treated and vedolizumab-treated patients with IBD. However, seroprevalence was significantly lower in the infliximab group, compared with the vedolizumab group (3.4% vs. 6.0%; P < .0001). In addition, infliximab and immunomodulator use were each independently associated with lower seropositivity, compared with vedolizumab (odds ratio, 0.66 for infliximab and OR, 0.70 for immunomodulators) in a multivariate analysis.
In a sensitivity analysis, 39 of 81 infliximab-treated patients with polymerase chain reaction–confirmed COVID-19 infection seroconverted (48%), compared with 30 of 36 vedolizumab-treated patients (83%) (P < .00044). Infliximab-treated patients with confirmed infections also showed a lower magnitude of anti–SARS-CoV-2 reactivity, compared with vedolizumab-treated patients (P < .0001).
From a clinical perspective, the lower seroconversion rates and reduced levels of anti–SARS-CoV-2 antibody reactivity might increase susceptibility to recurrent COVID-19 infections in infliximab-treated IBD patients, the researchers noted. In addition, the impaired serological responses might promote chronic nasopharyngeal colonization and consequently promote the development of COVID-19 variants and drive persistent transmission, the researchers said.
The study findings were limited by several factors including lack of knowledge on the impact of attenuated immune response on infection risk, the potential for recall bias associated with patient reports, and the focus on infliximab only, the researchers pointed out. However, the key findings are likely apply to other anti-TNF monoclonal antibodies including adalimumab, certolizumab and golimumab, they suggested.
The study was strengthened by the recruitment of a large number of patients in a narrow time frame and comprehensive collection of data on patient-reported outcomes, COVID-19 testing, and serological assay results, the researchers said. Overall, the findings support the public health value of serological testing and virus surveillance to identify suboptimal vaccine response and to consider implications for practice, they added. “If attenuated serological responses following vaccination are also observed, then modified immunization strategies will need to be designed for millions of patients worldwide,” they emphasized.
Findings inform clinical practice and public health
The study is very important for many reasons, said Kim L. Isaacs, MD, PhD, AGAF, of the University of North Carolina at Chapel Hill in an interview. “It is known that there is decreased responsiveness to a number of routine vaccinations in IBD patients on immune active therapy. In terms of SARS-CoV-2, development of an immune response with infection is important in terms of severity of infection, reinfection, and possibly limiting spread of infection in this patient population,” she said. “Looking at both serum seroconversion and reactivity of immune response in patients with known SARS-CoV-2 infection will help to define clinical and public health guidance, and also may be predictive as to what might happen with SARS-CoV-2 immunization based on background biologic or immunosuppressant therapy,” she noted.
Dr. Isaacs said that she was not surprised by the study findings. “Anti-TNF, thiopurine, and methotrexate therapy are all thought to be systemically active and likely to suppress the immune response to infection and vaccination,” she said. Vedolizumab, on the other hand, is thought to be less systemically active and clinically is associated with fewer serious infections.
Data will drive patient counseling
“These results affect counseling of IBD patients on immune active therapy who have had a SARS-CoV-2 infection,” said Dr. Isaacs. “They should be made aware that infection does not indicate protection for further infection. Although the issues that are raised in this study are of concern, patients should not have clinically beneficial therapy discontinued or switched based on these results,” she said.
“Additional research is needed to determine what the seroconversion rate is with the currently available immunizations for SARS-CoV-2,” said Dr. Isaacs. More questions to address include whether there are differences in the different products available, whether immunization after SARS-CoV-2 infection improves both seroconversion and immune reactivity, and whether there is any benefit to transiently stopping dual immune active therapy during the time of immunization, she said.
Further studies can fill knowledge gaps
“There is a knowledge gap in our understanding of susceptibility to SARS-CoV-2 infections among patients with IBD who have previously been infected,” Shirley Cohen-Mekelburg, MD, MS, staff physician and research scientist in the inflammatory bowel disease program at the Veterans Affairs Ann Arbor (Mich.) Healthcare System, said in an interview. ”This is a first step in beginning to narrow this gap – to provide patients and providers with data to drive recommendations during this COVID-19 pandemic.”
She added that, while further work needs to be done, the study findings do support potential benefit for ongoing vigilance among patients receiving infliximab for IBD. “The study findings also drive us to seek answers to more questions: For example, should we consider serological testing for patients on infliximab? How does the presence or absence of anti–SARS-CoV-2 antibodies associate with susceptibility to infection for patients with infliximab?
“Further studies examining anti–SARS-CoV-2 reactivity are necessary to better understand antibody responses between patients with IBD to the general population, or between patients on immunosuppressive therapy and the general population,” she said. “Observational studies are also not designed to examine the causal relationship between infections, medications, and antibody responses. There may be some inherent differences to patients who receive infliximab as compared to vedolizumab for IBD.”
The study was supported by Biogen (Switzerland), Celltrion Healthcare, Galapagos, F. Hoffmann-La Roche, Hull University Teaching Hospital NHS Trust, and the Royal Devon and Exeter NHS Foundation Trust. The study authors disclosed financial and nonfinancial relationships with numerous companies, including AbbVie, Biogen, Celltrion Healthcare, Galapagos, F. Hoffmann-La Roche, and Immundiagnostik, as well as Janssen, who markets infliximab, and Takeda, who markets vedolizumab. Dr. Isaacs and Dr. Cohen-Mekelburg had no relevant financial conflicts to disclose.
This article was updated 3/31/21.
Patients treated with infliximab for inflammatory bowel disease (IBD) showed significantly reduced response to COVID-19 antibodies, compared with those treated with vedolizumab, according to data from nearly 7,000 patients.
Although anti–tumor necrosis factor (anti-TNF) drugs are routinely used for patients with IBD, the impact of their immune-suppressing properties on protective immunity to COVID-19 is unknown, wrote Nicholas A. Kennedy, MD, of the University of Exeter (England) and colleagues. These drugs have been reported to impair protective immunity following vaccines for other diseases, such as those for influenza and viral hepatitis.
“By suppressing immune responses, biological and immunosuppression therapies may lead to chronic SARS-CoV-2 infection and have recently been implicated in the evolution and emergence of novel variants,” they noted, citing a study published in Cell.
In the current study, published in Gut, the researchers used data from the CLARITY IBD study to identify 6,935 patients with IBD aged 5 years and older seen at 92 hospitals in the United Kingdom between Sept. 22, 2020, and Dec. 23, 2020. Of these, 4,685 were treated with infliximab, and 2,250 received vedolizumab. The proportion of study participants with a positive anti–SARS-CoV-2 antibody test was the primary outcome, with secondary outcomes including proportion with positive antibodies following positive polymerase chain reaction test for SARS-CoV-2 and the magnitude of antibody reactivity.
Substantial seroprevalence differences seen
Overall, rates of symptomatic and proven SARS-CoV-2 infection and hospitalization were similar between infliximab-treated and vedolizumab-treated patients with IBD. However, seroprevalence was significantly lower in the infliximab group, compared with the vedolizumab group (3.4% vs. 6.0%; P < .0001). In addition, infliximab and immunomodulator use were each independently associated with lower seropositivity, compared with vedolizumab (odds ratio, 0.66 for infliximab and OR, 0.70 for immunomodulators) in a multivariate analysis.
In a sensitivity analysis, 39 of 81 infliximab-treated patients with polymerase chain reaction–confirmed COVID-19 infection seroconverted (48%), compared with 30 of 36 vedolizumab-treated patients (83%) (P < .00044). Infliximab-treated patients with confirmed infections also showed a lower magnitude of anti–SARS-CoV-2 reactivity, compared with vedolizumab-treated patients (P < .0001).
From a clinical perspective, the lower seroconversion rates and reduced levels of anti–SARS-CoV-2 antibody reactivity might increase susceptibility to recurrent COVID-19 infections in infliximab-treated IBD patients, the researchers noted. In addition, the impaired serological responses might promote chronic nasopharyngeal colonization and consequently promote the development of COVID-19 variants and drive persistent transmission, the researchers said.
The study findings were limited by several factors including lack of knowledge on the impact of attenuated immune response on infection risk, the potential for recall bias associated with patient reports, and the focus on infliximab only, the researchers pointed out. However, the key findings are likely apply to other anti-TNF monoclonal antibodies including adalimumab, certolizumab and golimumab, they suggested.
The study was strengthened by the recruitment of a large number of patients in a narrow time frame and comprehensive collection of data on patient-reported outcomes, COVID-19 testing, and serological assay results, the researchers said. Overall, the findings support the public health value of serological testing and virus surveillance to identify suboptimal vaccine response and to consider implications for practice, they added. “If attenuated serological responses following vaccination are also observed, then modified immunization strategies will need to be designed for millions of patients worldwide,” they emphasized.
Findings inform clinical practice and public health
The study is very important for many reasons, said Kim L. Isaacs, MD, PhD, AGAF, of the University of North Carolina at Chapel Hill in an interview. “It is known that there is decreased responsiveness to a number of routine vaccinations in IBD patients on immune active therapy. In terms of SARS-CoV-2, development of an immune response with infection is important in terms of severity of infection, reinfection, and possibly limiting spread of infection in this patient population,” she said. “Looking at both serum seroconversion and reactivity of immune response in patients with known SARS-CoV-2 infection will help to define clinical and public health guidance, and also may be predictive as to what might happen with SARS-CoV-2 immunization based on background biologic or immunosuppressant therapy,” she noted.
Dr. Isaacs said that she was not surprised by the study findings. “Anti-TNF, thiopurine, and methotrexate therapy are all thought to be systemically active and likely to suppress the immune response to infection and vaccination,” she said. Vedolizumab, on the other hand, is thought to be less systemically active and clinically is associated with fewer serious infections.
Data will drive patient counseling
“These results affect counseling of IBD patients on immune active therapy who have had a SARS-CoV-2 infection,” said Dr. Isaacs. “They should be made aware that infection does not indicate protection for further infection. Although the issues that are raised in this study are of concern, patients should not have clinically beneficial therapy discontinued or switched based on these results,” she said.
“Additional research is needed to determine what the seroconversion rate is with the currently available immunizations for SARS-CoV-2,” said Dr. Isaacs. More questions to address include whether there are differences in the different products available, whether immunization after SARS-CoV-2 infection improves both seroconversion and immune reactivity, and whether there is any benefit to transiently stopping dual immune active therapy during the time of immunization, she said.
Further studies can fill knowledge gaps
“There is a knowledge gap in our understanding of susceptibility to SARS-CoV-2 infections among patients with IBD who have previously been infected,” Shirley Cohen-Mekelburg, MD, MS, staff physician and research scientist in the inflammatory bowel disease program at the Veterans Affairs Ann Arbor (Mich.) Healthcare System, said in an interview. ”This is a first step in beginning to narrow this gap – to provide patients and providers with data to drive recommendations during this COVID-19 pandemic.”
She added that, while further work needs to be done, the study findings do support potential benefit for ongoing vigilance among patients receiving infliximab for IBD. “The study findings also drive us to seek answers to more questions: For example, should we consider serological testing for patients on infliximab? How does the presence or absence of anti–SARS-CoV-2 antibodies associate with susceptibility to infection for patients with infliximab?
“Further studies examining anti–SARS-CoV-2 reactivity are necessary to better understand antibody responses between patients with IBD to the general population, or between patients on immunosuppressive therapy and the general population,” she said. “Observational studies are also not designed to examine the causal relationship between infections, medications, and antibody responses. There may be some inherent differences to patients who receive infliximab as compared to vedolizumab for IBD.”
The study was supported by Biogen (Switzerland), Celltrion Healthcare, Galapagos, F. Hoffmann-La Roche, Hull University Teaching Hospital NHS Trust, and the Royal Devon and Exeter NHS Foundation Trust. The study authors disclosed financial and nonfinancial relationships with numerous companies, including AbbVie, Biogen, Celltrion Healthcare, Galapagos, F. Hoffmann-La Roche, and Immundiagnostik, as well as Janssen, who markets infliximab, and Takeda, who markets vedolizumab. Dr. Isaacs and Dr. Cohen-Mekelburg had no relevant financial conflicts to disclose.
This article was updated 3/31/21.
Patients treated with infliximab for inflammatory bowel disease (IBD) showed significantly reduced response to COVID-19 antibodies, compared with those treated with vedolizumab, according to data from nearly 7,000 patients.
Although anti–tumor necrosis factor (anti-TNF) drugs are routinely used for patients with IBD, the impact of their immune-suppressing properties on protective immunity to COVID-19 is unknown, wrote Nicholas A. Kennedy, MD, of the University of Exeter (England) and colleagues. These drugs have been reported to impair protective immunity following vaccines for other diseases, such as those for influenza and viral hepatitis.
“By suppressing immune responses, biological and immunosuppression therapies may lead to chronic SARS-CoV-2 infection and have recently been implicated in the evolution and emergence of novel variants,” they noted, citing a study published in Cell.
In the current study, published in Gut, the researchers used data from the CLARITY IBD study to identify 6,935 patients with IBD aged 5 years and older seen at 92 hospitals in the United Kingdom between Sept. 22, 2020, and Dec. 23, 2020. Of these, 4,685 were treated with infliximab, and 2,250 received vedolizumab. The proportion of study participants with a positive anti–SARS-CoV-2 antibody test was the primary outcome, with secondary outcomes including proportion with positive antibodies following positive polymerase chain reaction test for SARS-CoV-2 and the magnitude of antibody reactivity.
Substantial seroprevalence differences seen
Overall, rates of symptomatic and proven SARS-CoV-2 infection and hospitalization were similar between infliximab-treated and vedolizumab-treated patients with IBD. However, seroprevalence was significantly lower in the infliximab group, compared with the vedolizumab group (3.4% vs. 6.0%; P < .0001). In addition, infliximab and immunomodulator use were each independently associated with lower seropositivity, compared with vedolizumab (odds ratio, 0.66 for infliximab and OR, 0.70 for immunomodulators) in a multivariate analysis.
In a sensitivity analysis, 39 of 81 infliximab-treated patients with polymerase chain reaction–confirmed COVID-19 infection seroconverted (48%), compared with 30 of 36 vedolizumab-treated patients (83%) (P < .00044). Infliximab-treated patients with confirmed infections also showed a lower magnitude of anti–SARS-CoV-2 reactivity, compared with vedolizumab-treated patients (P < .0001).
From a clinical perspective, the lower seroconversion rates and reduced levels of anti–SARS-CoV-2 antibody reactivity might increase susceptibility to recurrent COVID-19 infections in infliximab-treated IBD patients, the researchers noted. In addition, the impaired serological responses might promote chronic nasopharyngeal colonization and consequently promote the development of COVID-19 variants and drive persistent transmission, the researchers said.
The study findings were limited by several factors including lack of knowledge on the impact of attenuated immune response on infection risk, the potential for recall bias associated with patient reports, and the focus on infliximab only, the researchers pointed out. However, the key findings are likely apply to other anti-TNF monoclonal antibodies including adalimumab, certolizumab and golimumab, they suggested.
The study was strengthened by the recruitment of a large number of patients in a narrow time frame and comprehensive collection of data on patient-reported outcomes, COVID-19 testing, and serological assay results, the researchers said. Overall, the findings support the public health value of serological testing and virus surveillance to identify suboptimal vaccine response and to consider implications for practice, they added. “If attenuated serological responses following vaccination are also observed, then modified immunization strategies will need to be designed for millions of patients worldwide,” they emphasized.
Findings inform clinical practice and public health
The study is very important for many reasons, said Kim L. Isaacs, MD, PhD, AGAF, of the University of North Carolina at Chapel Hill in an interview. “It is known that there is decreased responsiveness to a number of routine vaccinations in IBD patients on immune active therapy. In terms of SARS-CoV-2, development of an immune response with infection is important in terms of severity of infection, reinfection, and possibly limiting spread of infection in this patient population,” she said. “Looking at both serum seroconversion and reactivity of immune response in patients with known SARS-CoV-2 infection will help to define clinical and public health guidance, and also may be predictive as to what might happen with SARS-CoV-2 immunization based on background biologic or immunosuppressant therapy,” she noted.
Dr. Isaacs said that she was not surprised by the study findings. “Anti-TNF, thiopurine, and methotrexate therapy are all thought to be systemically active and likely to suppress the immune response to infection and vaccination,” she said. Vedolizumab, on the other hand, is thought to be less systemically active and clinically is associated with fewer serious infections.
Data will drive patient counseling
“These results affect counseling of IBD patients on immune active therapy who have had a SARS-CoV-2 infection,” said Dr. Isaacs. “They should be made aware that infection does not indicate protection for further infection. Although the issues that are raised in this study are of concern, patients should not have clinically beneficial therapy discontinued or switched based on these results,” she said.
“Additional research is needed to determine what the seroconversion rate is with the currently available immunizations for SARS-CoV-2,” said Dr. Isaacs. More questions to address include whether there are differences in the different products available, whether immunization after SARS-CoV-2 infection improves both seroconversion and immune reactivity, and whether there is any benefit to transiently stopping dual immune active therapy during the time of immunization, she said.
Further studies can fill knowledge gaps
“There is a knowledge gap in our understanding of susceptibility to SARS-CoV-2 infections among patients with IBD who have previously been infected,” Shirley Cohen-Mekelburg, MD, MS, staff physician and research scientist in the inflammatory bowel disease program at the Veterans Affairs Ann Arbor (Mich.) Healthcare System, said in an interview. ”This is a first step in beginning to narrow this gap – to provide patients and providers with data to drive recommendations during this COVID-19 pandemic.”
She added that, while further work needs to be done, the study findings do support potential benefit for ongoing vigilance among patients receiving infliximab for IBD. “The study findings also drive us to seek answers to more questions: For example, should we consider serological testing for patients on infliximab? How does the presence or absence of anti–SARS-CoV-2 antibodies associate with susceptibility to infection for patients with infliximab?
“Further studies examining anti–SARS-CoV-2 reactivity are necessary to better understand antibody responses between patients with IBD to the general population, or between patients on immunosuppressive therapy and the general population,” she said. “Observational studies are also not designed to examine the causal relationship between infections, medications, and antibody responses. There may be some inherent differences to patients who receive infliximab as compared to vedolizumab for IBD.”
The study was supported by Biogen (Switzerland), Celltrion Healthcare, Galapagos, F. Hoffmann-La Roche, Hull University Teaching Hospital NHS Trust, and the Royal Devon and Exeter NHS Foundation Trust. The study authors disclosed financial and nonfinancial relationships with numerous companies, including AbbVie, Biogen, Celltrion Healthcare, Galapagos, F. Hoffmann-La Roche, and Immundiagnostik, as well as Janssen, who markets infliximab, and Takeda, who markets vedolizumab. Dr. Isaacs and Dr. Cohen-Mekelburg had no relevant financial conflicts to disclose.
This article was updated 3/31/21.
FROM GUT
COVID-19’s impact on lupus inpatients examined in study
Severe COVID-19 infection was more likely in hospitalized patients with systemic lupus erythematosus (SLE) who had comorbidities and risk factors associated with severe infection in the general population, notably older age, male gender, and hypertension, based on data from a nationwide epidemiologic study of inpatients in France.
“Recently, anti-interferon antibodies have been implicated in severe SARS-CoV-2 infection while it has been known for decades that patients with SLE may produce such autoantibodies,” but large-scale data on the risk of severe COVID-19 infection in SLE patients are limited, Arthur Mageau, MD, of Bichat–Claude Bernard Hospital in Paris, and colleagues wrote.
In a research letter published in Annals of the Rheumatic Diseases, the researchers used the French health care database Programme de Médicalisation des Systèmes d’Information to identify 11,055 adult SLE patients who had at least one hospital stay between March 1, 2020, and Oct.31, 2020. Of these, 1,411 (12.8%) also were diagnosed with COVID-19, and these patients had a total of 1,721 hospital stays.
Overall, in-hospital mortality was approximately four times higher among SLE patients with COVID-19 infection, compared with SLE patients without COVID-19 infection (9.5% vs. 2.4%, P < .001), and 293 (17%) of the COVID-19 hospital stays involved an intensive care unit. In the ICU, 78 (26.7%) of the COVID-19 patients required invasive ventilation, and 71 (24.7%) required noninvasive mechanical ventilation.
The SLE patients with COVID-19 who died were significantly more likely than the SLE patients with COVID-19 who recovered to be older and male, and to have conditions including chronic kidney disease, high blood pressure, chronic pulmonary disease, and a history of cardiovascular events or lupus nephritis. The study findings were limited by the focus on hospitalized patients only, so the results cannot be generalized to all lupus patients, the researchers said.
“Interestingly, while the overall mortality rate was lower in SLE/COVID-19–positive inpatients as compared with the total population admitted for SARS-CoV-2 infection in France during the same period (9.5% vs 15.7%, P < .0001), the mortality rate at a younger age tended to be higher in patients with SLE,” the researchers wrote, but the difference for these younger patients was not statistically significant. This disparity may be caused by the reduced need for immunosuppressive drugs in SLE patients as they age, and the observed increased mortality in younger SLE patients, compared with the general population, suggests that SLE may promote poor outcomes from COVID-19 infection.
Dr. Mageau received PhD fellowship support from the Agence Nationale pour la recherche. He and the other researchers had no financial conflicts to disclose. The study received no outside funding.
Severe COVID-19 infection was more likely in hospitalized patients with systemic lupus erythematosus (SLE) who had comorbidities and risk factors associated with severe infection in the general population, notably older age, male gender, and hypertension, based on data from a nationwide epidemiologic study of inpatients in France.
“Recently, anti-interferon antibodies have been implicated in severe SARS-CoV-2 infection while it has been known for decades that patients with SLE may produce such autoantibodies,” but large-scale data on the risk of severe COVID-19 infection in SLE patients are limited, Arthur Mageau, MD, of Bichat–Claude Bernard Hospital in Paris, and colleagues wrote.
In a research letter published in Annals of the Rheumatic Diseases, the researchers used the French health care database Programme de Médicalisation des Systèmes d’Information to identify 11,055 adult SLE patients who had at least one hospital stay between March 1, 2020, and Oct.31, 2020. Of these, 1,411 (12.8%) also were diagnosed with COVID-19, and these patients had a total of 1,721 hospital stays.
Overall, in-hospital mortality was approximately four times higher among SLE patients with COVID-19 infection, compared with SLE patients without COVID-19 infection (9.5% vs. 2.4%, P < .001), and 293 (17%) of the COVID-19 hospital stays involved an intensive care unit. In the ICU, 78 (26.7%) of the COVID-19 patients required invasive ventilation, and 71 (24.7%) required noninvasive mechanical ventilation.
The SLE patients with COVID-19 who died were significantly more likely than the SLE patients with COVID-19 who recovered to be older and male, and to have conditions including chronic kidney disease, high blood pressure, chronic pulmonary disease, and a history of cardiovascular events or lupus nephritis. The study findings were limited by the focus on hospitalized patients only, so the results cannot be generalized to all lupus patients, the researchers said.
“Interestingly, while the overall mortality rate was lower in SLE/COVID-19–positive inpatients as compared with the total population admitted for SARS-CoV-2 infection in France during the same period (9.5% vs 15.7%, P < .0001), the mortality rate at a younger age tended to be higher in patients with SLE,” the researchers wrote, but the difference for these younger patients was not statistically significant. This disparity may be caused by the reduced need for immunosuppressive drugs in SLE patients as they age, and the observed increased mortality in younger SLE patients, compared with the general population, suggests that SLE may promote poor outcomes from COVID-19 infection.
Dr. Mageau received PhD fellowship support from the Agence Nationale pour la recherche. He and the other researchers had no financial conflicts to disclose. The study received no outside funding.
Severe COVID-19 infection was more likely in hospitalized patients with systemic lupus erythematosus (SLE) who had comorbidities and risk factors associated with severe infection in the general population, notably older age, male gender, and hypertension, based on data from a nationwide epidemiologic study of inpatients in France.
“Recently, anti-interferon antibodies have been implicated in severe SARS-CoV-2 infection while it has been known for decades that patients with SLE may produce such autoantibodies,” but large-scale data on the risk of severe COVID-19 infection in SLE patients are limited, Arthur Mageau, MD, of Bichat–Claude Bernard Hospital in Paris, and colleagues wrote.
In a research letter published in Annals of the Rheumatic Diseases, the researchers used the French health care database Programme de Médicalisation des Systèmes d’Information to identify 11,055 adult SLE patients who had at least one hospital stay between March 1, 2020, and Oct.31, 2020. Of these, 1,411 (12.8%) also were diagnosed with COVID-19, and these patients had a total of 1,721 hospital stays.
Overall, in-hospital mortality was approximately four times higher among SLE patients with COVID-19 infection, compared with SLE patients without COVID-19 infection (9.5% vs. 2.4%, P < .001), and 293 (17%) of the COVID-19 hospital stays involved an intensive care unit. In the ICU, 78 (26.7%) of the COVID-19 patients required invasive ventilation, and 71 (24.7%) required noninvasive mechanical ventilation.
The SLE patients with COVID-19 who died were significantly more likely than the SLE patients with COVID-19 who recovered to be older and male, and to have conditions including chronic kidney disease, high blood pressure, chronic pulmonary disease, and a history of cardiovascular events or lupus nephritis. The study findings were limited by the focus on hospitalized patients only, so the results cannot be generalized to all lupus patients, the researchers said.
“Interestingly, while the overall mortality rate was lower in SLE/COVID-19–positive inpatients as compared with the total population admitted for SARS-CoV-2 infection in France during the same period (9.5% vs 15.7%, P < .0001), the mortality rate at a younger age tended to be higher in patients with SLE,” the researchers wrote, but the difference for these younger patients was not statistically significant. This disparity may be caused by the reduced need for immunosuppressive drugs in SLE patients as they age, and the observed increased mortality in younger SLE patients, compared with the general population, suggests that SLE may promote poor outcomes from COVID-19 infection.
Dr. Mageau received PhD fellowship support from the Agence Nationale pour la recherche. He and the other researchers had no financial conflicts to disclose. The study received no outside funding.
FROM ANNALS OF THE RHEUMATIC DISEASES
Cannabinoids may pose death risk for older patients with COPD
, compared with nonusers, findings from a large study have shown.
Synthetic cannabinoids drugs, such as nabilone and dronabinol, have been approved by the Food and Drug Administration for nausea and vomiting caused by chemotherapy. But their off-label use by adults with COPD to help manage chronic musculoskeletal pain, insomnia, and refractory dyspnea is on the rise, wrote Nicholas T. Vozoris, MD, of the University of Toronto and colleagues.
Cannabinoids may actually contribute to negative respiratory outcomes among individuals with COPD through several possible mechanisms including causing sedation, inducing anxiety, and provoking respiratory muscle weakness, they said.
“Possible adverse respiratory effects of cannabinoids may occur with greater likelihood among older adults (in whom COPD is more prevalent), as this group is known to less efficiently metabolise drugs,” they noted.
In a retrospective, population-based cohort study published in Thorax the researchers identified 185,876 adults aged 66 years and older with COPD using health administrative database information from 2006 to 2016. New cannabinoid users (those starting nabilone or dronabinol) were matched with control nonusers (defined as new users of noncannabinoid drugs). Individuals receiving palliative care, or having a diagnosis of cancer or HIV, were excluded because these are settings where synthetic cannabinoids may be prescribed for nausea or vomiting, and these patients are more likely to be in a poorer state of health.
Overall, new cannabinoid users had significantly higher all-cause mortality rates, compared with nonusers (hazard ratio, 1.64). The effects was greater in high-dose users.
Daniel R. Ouellette, MD, associate professor of medicine at Wayne State University and a senior staff physician at Henry Ford Hospital, both in Detroit, commented that this study has value for clinicians. “Many states are liberalizing cannabinoid use, and it is important to know the health effects of this type of drug on patients with chronic respiratory disease,” he noted. “The study is somewhat surprising. While one might have expected adverse consequences in patients with COPD who inhaled smoke from cannabinoids, it is somewhat unexpected that oral use would be associated with adverse consequences.” He added, “Pain in older adults is a complex problem. Cannabinoids are often recommended for pain in the general community, but pain per se is not a primary symptom for most patients with COPD from their respiratory problems. Physicians treating patients with COPD should diagnose the cause of the pain and provide appropriate treatment.”
Dose makes a difference
All-cause mortality increased by 231% and hospitalization for COPD or pneumonia increased by 178% among new users of higher-dose cannabinoids, compared with nonusers. Higher dose was defined in this study as more than 1.5mg/day of nabilone. No significant differences appeared in new users vs. nonusers in hospitalization for COPD or pneumonia at lower doses, and no significant differences appeared overall in outpatient respiratory exacerbations, emergency department visits for COPD or pneumonia, or COPD- or pneumonia-related mortality.
Potential limitations and implications
“The fact that COPD- or pneumonia-related mortality was not observed to occur with significantly greater rates among cannabinoid users with COPD may suggest that the increased all-cause mortality finding was not being driven by adverse respiratory-related drug effects, as we hypothesized, and instead was possibly a result of unresolved confounding,” the researchers noted.
The study findings were limited by several factors including the inability to prove causation in an observational study, and the potential for confounding based on unmeasured differences between cannabinoid users and nonusers, the researchers said. “Our findings may not be generalizable to all individuals with COPD, as our study included only those aged 66 years and older, and our COPD identification algorithm, while highly specific, had modest sensitivity,” they added. However, the results were strengthened by the large study population and suggest that cannabinoids are not contraindicated for older adults with COPD, the researchers said. “There can be legitimate reasons for using cannabinoids in this population, such as to help treat chemotherapy-related nausea and vomiting, and possibly for end-of-life care,” they emphasized.
The study findings serve to inform clinicians of the significantly increased mortality risk when older adults with COPD initiate cannabinoids, and “this information should be discussed with patients and incorporated in prescribing decision-making and management plans,” along with consideration of using lower doses when possible to minimize adverse events, they concluded.
The study was supported by The Lung Association – Ontario Grant Review/Grant-In-Aid. The researchers had no financial conflicts to disclose.
, compared with nonusers, findings from a large study have shown.
Synthetic cannabinoids drugs, such as nabilone and dronabinol, have been approved by the Food and Drug Administration for nausea and vomiting caused by chemotherapy. But their off-label use by adults with COPD to help manage chronic musculoskeletal pain, insomnia, and refractory dyspnea is on the rise, wrote Nicholas T. Vozoris, MD, of the University of Toronto and colleagues.
Cannabinoids may actually contribute to negative respiratory outcomes among individuals with COPD through several possible mechanisms including causing sedation, inducing anxiety, and provoking respiratory muscle weakness, they said.
“Possible adverse respiratory effects of cannabinoids may occur with greater likelihood among older adults (in whom COPD is more prevalent), as this group is known to less efficiently metabolise drugs,” they noted.
In a retrospective, population-based cohort study published in Thorax the researchers identified 185,876 adults aged 66 years and older with COPD using health administrative database information from 2006 to 2016. New cannabinoid users (those starting nabilone or dronabinol) were matched with control nonusers (defined as new users of noncannabinoid drugs). Individuals receiving palliative care, or having a diagnosis of cancer or HIV, were excluded because these are settings where synthetic cannabinoids may be prescribed for nausea or vomiting, and these patients are more likely to be in a poorer state of health.
Overall, new cannabinoid users had significantly higher all-cause mortality rates, compared with nonusers (hazard ratio, 1.64). The effects was greater in high-dose users.
Daniel R. Ouellette, MD, associate professor of medicine at Wayne State University and a senior staff physician at Henry Ford Hospital, both in Detroit, commented that this study has value for clinicians. “Many states are liberalizing cannabinoid use, and it is important to know the health effects of this type of drug on patients with chronic respiratory disease,” he noted. “The study is somewhat surprising. While one might have expected adverse consequences in patients with COPD who inhaled smoke from cannabinoids, it is somewhat unexpected that oral use would be associated with adverse consequences.” He added, “Pain in older adults is a complex problem. Cannabinoids are often recommended for pain in the general community, but pain per se is not a primary symptom for most patients with COPD from their respiratory problems. Physicians treating patients with COPD should diagnose the cause of the pain and provide appropriate treatment.”
Dose makes a difference
All-cause mortality increased by 231% and hospitalization for COPD or pneumonia increased by 178% among new users of higher-dose cannabinoids, compared with nonusers. Higher dose was defined in this study as more than 1.5mg/day of nabilone. No significant differences appeared in new users vs. nonusers in hospitalization for COPD or pneumonia at lower doses, and no significant differences appeared overall in outpatient respiratory exacerbations, emergency department visits for COPD or pneumonia, or COPD- or pneumonia-related mortality.
Potential limitations and implications
“The fact that COPD- or pneumonia-related mortality was not observed to occur with significantly greater rates among cannabinoid users with COPD may suggest that the increased all-cause mortality finding was not being driven by adverse respiratory-related drug effects, as we hypothesized, and instead was possibly a result of unresolved confounding,” the researchers noted.
The study findings were limited by several factors including the inability to prove causation in an observational study, and the potential for confounding based on unmeasured differences between cannabinoid users and nonusers, the researchers said. “Our findings may not be generalizable to all individuals with COPD, as our study included only those aged 66 years and older, and our COPD identification algorithm, while highly specific, had modest sensitivity,” they added. However, the results were strengthened by the large study population and suggest that cannabinoids are not contraindicated for older adults with COPD, the researchers said. “There can be legitimate reasons for using cannabinoids in this population, such as to help treat chemotherapy-related nausea and vomiting, and possibly for end-of-life care,” they emphasized.
The study findings serve to inform clinicians of the significantly increased mortality risk when older adults with COPD initiate cannabinoids, and “this information should be discussed with patients and incorporated in prescribing decision-making and management plans,” along with consideration of using lower doses when possible to minimize adverse events, they concluded.
The study was supported by The Lung Association – Ontario Grant Review/Grant-In-Aid. The researchers had no financial conflicts to disclose.
, compared with nonusers, findings from a large study have shown.
Synthetic cannabinoids drugs, such as nabilone and dronabinol, have been approved by the Food and Drug Administration for nausea and vomiting caused by chemotherapy. But their off-label use by adults with COPD to help manage chronic musculoskeletal pain, insomnia, and refractory dyspnea is on the rise, wrote Nicholas T. Vozoris, MD, of the University of Toronto and colleagues.
Cannabinoids may actually contribute to negative respiratory outcomes among individuals with COPD through several possible mechanisms including causing sedation, inducing anxiety, and provoking respiratory muscle weakness, they said.
“Possible adverse respiratory effects of cannabinoids may occur with greater likelihood among older adults (in whom COPD is more prevalent), as this group is known to less efficiently metabolise drugs,” they noted.
In a retrospective, population-based cohort study published in Thorax the researchers identified 185,876 adults aged 66 years and older with COPD using health administrative database information from 2006 to 2016. New cannabinoid users (those starting nabilone or dronabinol) were matched with control nonusers (defined as new users of noncannabinoid drugs). Individuals receiving palliative care, or having a diagnosis of cancer or HIV, were excluded because these are settings where synthetic cannabinoids may be prescribed for nausea or vomiting, and these patients are more likely to be in a poorer state of health.
Overall, new cannabinoid users had significantly higher all-cause mortality rates, compared with nonusers (hazard ratio, 1.64). The effects was greater in high-dose users.
Daniel R. Ouellette, MD, associate professor of medicine at Wayne State University and a senior staff physician at Henry Ford Hospital, both in Detroit, commented that this study has value for clinicians. “Many states are liberalizing cannabinoid use, and it is important to know the health effects of this type of drug on patients with chronic respiratory disease,” he noted. “The study is somewhat surprising. While one might have expected adverse consequences in patients with COPD who inhaled smoke from cannabinoids, it is somewhat unexpected that oral use would be associated with adverse consequences.” He added, “Pain in older adults is a complex problem. Cannabinoids are often recommended for pain in the general community, but pain per se is not a primary symptom for most patients with COPD from their respiratory problems. Physicians treating patients with COPD should diagnose the cause of the pain and provide appropriate treatment.”
Dose makes a difference
All-cause mortality increased by 231% and hospitalization for COPD or pneumonia increased by 178% among new users of higher-dose cannabinoids, compared with nonusers. Higher dose was defined in this study as more than 1.5mg/day of nabilone. No significant differences appeared in new users vs. nonusers in hospitalization for COPD or pneumonia at lower doses, and no significant differences appeared overall in outpatient respiratory exacerbations, emergency department visits for COPD or pneumonia, or COPD- or pneumonia-related mortality.
Potential limitations and implications
“The fact that COPD- or pneumonia-related mortality was not observed to occur with significantly greater rates among cannabinoid users with COPD may suggest that the increased all-cause mortality finding was not being driven by adverse respiratory-related drug effects, as we hypothesized, and instead was possibly a result of unresolved confounding,” the researchers noted.
The study findings were limited by several factors including the inability to prove causation in an observational study, and the potential for confounding based on unmeasured differences between cannabinoid users and nonusers, the researchers said. “Our findings may not be generalizable to all individuals with COPD, as our study included only those aged 66 years and older, and our COPD identification algorithm, while highly specific, had modest sensitivity,” they added. However, the results were strengthened by the large study population and suggest that cannabinoids are not contraindicated for older adults with COPD, the researchers said. “There can be legitimate reasons for using cannabinoids in this population, such as to help treat chemotherapy-related nausea and vomiting, and possibly for end-of-life care,” they emphasized.
The study findings serve to inform clinicians of the significantly increased mortality risk when older adults with COPD initiate cannabinoids, and “this information should be discussed with patients and incorporated in prescribing decision-making and management plans,” along with consideration of using lower doses when possible to minimize adverse events, they concluded.
The study was supported by The Lung Association – Ontario Grant Review/Grant-In-Aid. The researchers had no financial conflicts to disclose.
FROM THORAX
Psychological difficulties persist among patients with IBD
Psychological issues in patients with inflammatory bowel disease should be addressed at both personal and systemic levels, according to a review of current literature.
In a review published in the Journal of Clinical Gastroenterology, researchers highlighted data on the burden of mental disorders in inflammatory bowel disease (IBD) patients and presented several strategies for addressing them.
“From a systems perspective, underrecognized and/or suboptimally treated mental health problems in patients with IBD are associated with increased disability, poorer adherence, and more admissions and surgeries, driving increased health care utilization and costs,” Maia S. Kredentser, PhD, of the University of Manitoba, Winnipeg, and colleagues wrote, citing a 2018 study’s findings.
“There is ample evidence for a higher prevalence of mental disorders in IBD, in particular depression and anxiety, compared with the general population,” the authors wrote.
They cited a recent population-based study in which the incident rate ratios were significantly higher for IBD patients, compared with matched controls for depression (IRR, 1.58), anxiety disorder (IRR, 1.39), bipolar disorder (IRR, 1.82), and schizophrenia (IRR, 1.64).
Mental disorders associated with IBD also include issues of body image and sexuality. Although research on the impact of disease activity on sexual function is inconsistent, one study suggested that body image “may be an important target of treatment in women reporting poor quality of life and psychological distress,” the researchers noted. A French study from 2017 published in the Journal of Crohn’s and Colitis showed that approximately half of men and women reported problems with erectile or sexual dysfunction.
Issues related to environmental stressors may contribute to IBD by promoting chronic inflammation, the researchers wrote. For example, data from longitudinal, population-based research suggest that adverse childhood experiences can promote proinflammatory states across inflammatory illnesses. Research has also suggested that people with IBD have higher rates of these adverse childhood experiences than the general population. However, data also show that many are able to cope and adapt: “Many patients with IBD are resilient, experience growth, and in fact, thrive,” the researchers added. One longitudinal study suggested that patients with IBD who identified with “thriving” had “stronger coping efficacy (the perceived ability to meet illness demands), illness acceptance, and social support and lower depression” and that this was associated with life satisfaction 6 months later.
Fatigue also has been shown to be a factor for patients with IBD. The researchers cited one population-based study showing fatigue in 57%-72% of IBD patients with active disease. IBD patients with quiescent disease also report fatigue. The psychological and behavioral factors driving fatigue could be related to mental disorders or other factors such as suboptimal sleep, stress, and use of caffeine and alcohol, they noted. Management strategies include improving sleep hygiene and evaluation of mental health concerns.
Seek complete picture before treatment
“Addressing psychological comorbidity in IBD requires individual and systemic approaches focused on both the prevention and treatment of mental health concerns,” the researchers wrote. “Because of the pervasiveness of psychological comorbidities in IBD, and recent evidence that they may be part of the disease process itself, assessment of psychological functioning in IBD is considered an essential aspect of disease management.”
Evidence-based psychological interventions include cognitive-behavioral therapy, which includes training in relaxation; treatment with clinical hypnosis; and encouraging mindfulness through acceptance and commitment therapy, which focuses on developing psychological flexibility to cope with suffering. In addition, a small but evolving body of research shows some benefit to motivational interviewing (a strategy focused on behavior change) for IBD patients. Notably, one review of four studies showed benefits of motivational interviewing for improving medication adherence and advice seeking, the researchers reported.
Although several psychological treatment options exist for addressing mental health issues in IBD, randomized trials are needed. “To facilitate this important research and optimize patient care, the integration of psychologists and other mental health providers into IBD care is considered best practice and provides exciting opportunities for improving patient care and outcomes,” the researchers concluded.
Address mental health to ease disease burden
“There is a large burden of mental health issues in patients with inflammatory bowel disease, with depression and anxiety leading the way,” Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.
“There are multiple reasons for this, including dealing with chronic pain, social concerns around using the bathroom, body-image issues due to surgery, and drug side effects. There is increasing evidence that the inflammatory process in IBD may be driving some of the changes in the brain which lead to further mental health dysfunction,” she noted.
“Addressing depression, anxiety, [and] sleep disturbance in patients will not only improve quality of life from a mental health perspective but has been shown to improve control of disease,” Dr. Isaacs emphasized.
“Small things like increased medication compliance have a large impact on disease management and decreased need for hospitalization and hospitalization,” said Dr. Isaacs. “As gastroenterologists we need to expand our focus beyond the gut and address the emotional needs of our patients – identifying those patients who need increased mental health support.”
Barriers to better care
The greatest barriers to treating mental health issues in IBD patients are time and knowledge, said Dr. Isaacs. “Many gastroenterologists have limited time in the office to do more than address the acute issues of the patients such as rectal bleeding and worsening diarrhea. It takes time and trust to explore what is going on in a patient’s life. Is the patient anxious and depressed? How are they coping with their current disease manifestations? Simple screening tools may help with this, but then there need to be resources to support interventions.”
Some IBD practices, especially academic ones, have a psychologist in the IBD center or one that’s readily available for consultation. “This is an investment for the practice that may reduce significantly disease burden. The IBD specialty home model includes resources for management of psychiatric issues and nutritional concerns as well as disease management,” she added.
More research in several areas can help reduce the mental health burden of IBD. “On the immunology/biology side, understanding how the microbiome affects the brain/gut may allow for more directed mental health treatment. On the disease management side, larger trials directed at psychiatric interventions may help to determine which therapy is best for each patient,” Dr. Isaacs said. “Further work developing health care systems, such as the medical home, that allow for maximum disease management and decreased system costs will go far in implementation of models of care that address the needs of the entire patient with inflammatory bowel disease.”
The review received no outside funding. The researchers had no financial conflicts to disclose. Dr. Isaacs disclosed consulting on the data safety monitoring board for Janssen.
Psychological issues in patients with inflammatory bowel disease should be addressed at both personal and systemic levels, according to a review of current literature.
In a review published in the Journal of Clinical Gastroenterology, researchers highlighted data on the burden of mental disorders in inflammatory bowel disease (IBD) patients and presented several strategies for addressing them.
“From a systems perspective, underrecognized and/or suboptimally treated mental health problems in patients with IBD are associated with increased disability, poorer adherence, and more admissions and surgeries, driving increased health care utilization and costs,” Maia S. Kredentser, PhD, of the University of Manitoba, Winnipeg, and colleagues wrote, citing a 2018 study’s findings.
“There is ample evidence for a higher prevalence of mental disorders in IBD, in particular depression and anxiety, compared with the general population,” the authors wrote.
They cited a recent population-based study in which the incident rate ratios were significantly higher for IBD patients, compared with matched controls for depression (IRR, 1.58), anxiety disorder (IRR, 1.39), bipolar disorder (IRR, 1.82), and schizophrenia (IRR, 1.64).
Mental disorders associated with IBD also include issues of body image and sexuality. Although research on the impact of disease activity on sexual function is inconsistent, one study suggested that body image “may be an important target of treatment in women reporting poor quality of life and psychological distress,” the researchers noted. A French study from 2017 published in the Journal of Crohn’s and Colitis showed that approximately half of men and women reported problems with erectile or sexual dysfunction.
Issues related to environmental stressors may contribute to IBD by promoting chronic inflammation, the researchers wrote. For example, data from longitudinal, population-based research suggest that adverse childhood experiences can promote proinflammatory states across inflammatory illnesses. Research has also suggested that people with IBD have higher rates of these adverse childhood experiences than the general population. However, data also show that many are able to cope and adapt: “Many patients with IBD are resilient, experience growth, and in fact, thrive,” the researchers added. One longitudinal study suggested that patients with IBD who identified with “thriving” had “stronger coping efficacy (the perceived ability to meet illness demands), illness acceptance, and social support and lower depression” and that this was associated with life satisfaction 6 months later.
Fatigue also has been shown to be a factor for patients with IBD. The researchers cited one population-based study showing fatigue in 57%-72% of IBD patients with active disease. IBD patients with quiescent disease also report fatigue. The psychological and behavioral factors driving fatigue could be related to mental disorders or other factors such as suboptimal sleep, stress, and use of caffeine and alcohol, they noted. Management strategies include improving sleep hygiene and evaluation of mental health concerns.
Seek complete picture before treatment
“Addressing psychological comorbidity in IBD requires individual and systemic approaches focused on both the prevention and treatment of mental health concerns,” the researchers wrote. “Because of the pervasiveness of psychological comorbidities in IBD, and recent evidence that they may be part of the disease process itself, assessment of psychological functioning in IBD is considered an essential aspect of disease management.”
Evidence-based psychological interventions include cognitive-behavioral therapy, which includes training in relaxation; treatment with clinical hypnosis; and encouraging mindfulness through acceptance and commitment therapy, which focuses on developing psychological flexibility to cope with suffering. In addition, a small but evolving body of research shows some benefit to motivational interviewing (a strategy focused on behavior change) for IBD patients. Notably, one review of four studies showed benefits of motivational interviewing for improving medication adherence and advice seeking, the researchers reported.
Although several psychological treatment options exist for addressing mental health issues in IBD, randomized trials are needed. “To facilitate this important research and optimize patient care, the integration of psychologists and other mental health providers into IBD care is considered best practice and provides exciting opportunities for improving patient care and outcomes,” the researchers concluded.
Address mental health to ease disease burden
“There is a large burden of mental health issues in patients with inflammatory bowel disease, with depression and anxiety leading the way,” Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.
“There are multiple reasons for this, including dealing with chronic pain, social concerns around using the bathroom, body-image issues due to surgery, and drug side effects. There is increasing evidence that the inflammatory process in IBD may be driving some of the changes in the brain which lead to further mental health dysfunction,” she noted.
“Addressing depression, anxiety, [and] sleep disturbance in patients will not only improve quality of life from a mental health perspective but has been shown to improve control of disease,” Dr. Isaacs emphasized.
“Small things like increased medication compliance have a large impact on disease management and decreased need for hospitalization and hospitalization,” said Dr. Isaacs. “As gastroenterologists we need to expand our focus beyond the gut and address the emotional needs of our patients – identifying those patients who need increased mental health support.”
Barriers to better care
The greatest barriers to treating mental health issues in IBD patients are time and knowledge, said Dr. Isaacs. “Many gastroenterologists have limited time in the office to do more than address the acute issues of the patients such as rectal bleeding and worsening diarrhea. It takes time and trust to explore what is going on in a patient’s life. Is the patient anxious and depressed? How are they coping with their current disease manifestations? Simple screening tools may help with this, but then there need to be resources to support interventions.”
Some IBD practices, especially academic ones, have a psychologist in the IBD center or one that’s readily available for consultation. “This is an investment for the practice that may reduce significantly disease burden. The IBD specialty home model includes resources for management of psychiatric issues and nutritional concerns as well as disease management,” she added.
More research in several areas can help reduce the mental health burden of IBD. “On the immunology/biology side, understanding how the microbiome affects the brain/gut may allow for more directed mental health treatment. On the disease management side, larger trials directed at psychiatric interventions may help to determine which therapy is best for each patient,” Dr. Isaacs said. “Further work developing health care systems, such as the medical home, that allow for maximum disease management and decreased system costs will go far in implementation of models of care that address the needs of the entire patient with inflammatory bowel disease.”
The review received no outside funding. The researchers had no financial conflicts to disclose. Dr. Isaacs disclosed consulting on the data safety monitoring board for Janssen.
Psychological issues in patients with inflammatory bowel disease should be addressed at both personal and systemic levels, according to a review of current literature.
In a review published in the Journal of Clinical Gastroenterology, researchers highlighted data on the burden of mental disorders in inflammatory bowel disease (IBD) patients and presented several strategies for addressing them.
“From a systems perspective, underrecognized and/or suboptimally treated mental health problems in patients with IBD are associated with increased disability, poorer adherence, and more admissions and surgeries, driving increased health care utilization and costs,” Maia S. Kredentser, PhD, of the University of Manitoba, Winnipeg, and colleagues wrote, citing a 2018 study’s findings.
“There is ample evidence for a higher prevalence of mental disorders in IBD, in particular depression and anxiety, compared with the general population,” the authors wrote.
They cited a recent population-based study in which the incident rate ratios were significantly higher for IBD patients, compared with matched controls for depression (IRR, 1.58), anxiety disorder (IRR, 1.39), bipolar disorder (IRR, 1.82), and schizophrenia (IRR, 1.64).
Mental disorders associated with IBD also include issues of body image and sexuality. Although research on the impact of disease activity on sexual function is inconsistent, one study suggested that body image “may be an important target of treatment in women reporting poor quality of life and psychological distress,” the researchers noted. A French study from 2017 published in the Journal of Crohn’s and Colitis showed that approximately half of men and women reported problems with erectile or sexual dysfunction.
Issues related to environmental stressors may contribute to IBD by promoting chronic inflammation, the researchers wrote. For example, data from longitudinal, population-based research suggest that adverse childhood experiences can promote proinflammatory states across inflammatory illnesses. Research has also suggested that people with IBD have higher rates of these adverse childhood experiences than the general population. However, data also show that many are able to cope and adapt: “Many patients with IBD are resilient, experience growth, and in fact, thrive,” the researchers added. One longitudinal study suggested that patients with IBD who identified with “thriving” had “stronger coping efficacy (the perceived ability to meet illness demands), illness acceptance, and social support and lower depression” and that this was associated with life satisfaction 6 months later.
Fatigue also has been shown to be a factor for patients with IBD. The researchers cited one population-based study showing fatigue in 57%-72% of IBD patients with active disease. IBD patients with quiescent disease also report fatigue. The psychological and behavioral factors driving fatigue could be related to mental disorders or other factors such as suboptimal sleep, stress, and use of caffeine and alcohol, they noted. Management strategies include improving sleep hygiene and evaluation of mental health concerns.
Seek complete picture before treatment
“Addressing psychological comorbidity in IBD requires individual and systemic approaches focused on both the prevention and treatment of mental health concerns,” the researchers wrote. “Because of the pervasiveness of psychological comorbidities in IBD, and recent evidence that they may be part of the disease process itself, assessment of psychological functioning in IBD is considered an essential aspect of disease management.”
Evidence-based psychological interventions include cognitive-behavioral therapy, which includes training in relaxation; treatment with clinical hypnosis; and encouraging mindfulness through acceptance and commitment therapy, which focuses on developing psychological flexibility to cope with suffering. In addition, a small but evolving body of research shows some benefit to motivational interviewing (a strategy focused on behavior change) for IBD patients. Notably, one review of four studies showed benefits of motivational interviewing for improving medication adherence and advice seeking, the researchers reported.
Although several psychological treatment options exist for addressing mental health issues in IBD, randomized trials are needed. “To facilitate this important research and optimize patient care, the integration of psychologists and other mental health providers into IBD care is considered best practice and provides exciting opportunities for improving patient care and outcomes,” the researchers concluded.
Address mental health to ease disease burden
“There is a large burden of mental health issues in patients with inflammatory bowel disease, with depression and anxiety leading the way,” Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, said in an interview.
“There are multiple reasons for this, including dealing with chronic pain, social concerns around using the bathroom, body-image issues due to surgery, and drug side effects. There is increasing evidence that the inflammatory process in IBD may be driving some of the changes in the brain which lead to further mental health dysfunction,” she noted.
“Addressing depression, anxiety, [and] sleep disturbance in patients will not only improve quality of life from a mental health perspective but has been shown to improve control of disease,” Dr. Isaacs emphasized.
“Small things like increased medication compliance have a large impact on disease management and decreased need for hospitalization and hospitalization,” said Dr. Isaacs. “As gastroenterologists we need to expand our focus beyond the gut and address the emotional needs of our patients – identifying those patients who need increased mental health support.”
Barriers to better care
The greatest barriers to treating mental health issues in IBD patients are time and knowledge, said Dr. Isaacs. “Many gastroenterologists have limited time in the office to do more than address the acute issues of the patients such as rectal bleeding and worsening diarrhea. It takes time and trust to explore what is going on in a patient’s life. Is the patient anxious and depressed? How are they coping with their current disease manifestations? Simple screening tools may help with this, but then there need to be resources to support interventions.”
Some IBD practices, especially academic ones, have a psychologist in the IBD center or one that’s readily available for consultation. “This is an investment for the practice that may reduce significantly disease burden. The IBD specialty home model includes resources for management of psychiatric issues and nutritional concerns as well as disease management,” she added.
More research in several areas can help reduce the mental health burden of IBD. “On the immunology/biology side, understanding how the microbiome affects the brain/gut may allow for more directed mental health treatment. On the disease management side, larger trials directed at psychiatric interventions may help to determine which therapy is best for each patient,” Dr. Isaacs said. “Further work developing health care systems, such as the medical home, that allow for maximum disease management and decreased system costs will go far in implementation of models of care that address the needs of the entire patient with inflammatory bowel disease.”
The review received no outside funding. The researchers had no financial conflicts to disclose. Dr. Isaacs disclosed consulting on the data safety monitoring board for Janssen.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Nearly 20% of lupus patients have severe infection in first decade after diagnosis
People with systemic lupus erythematosus (SLE) experienced significantly higher rates of first severe infections, a higher number of severe infections overall, and greater infection-related mortality, compared with controls, based on data from a population-based cohort study of more than 30,000 individuals.
Infections remain a leading cause of morbidity and early mortality in patients with SLE, wrote Kai Zhao, MSc, of Arthritis Research Canada, Richmond, and colleagues. However, “limitations from existing studies including selected samples, small sizes, and prevalent cohorts can negatively affect the accuracy of both the absolute and relative risk estimates of infections in SLE at the population level,” they said.
In a study published in Rheumatology, the researchers identified 5,169 people newly diagnosed with SLE between Jan. 1, 1997, and March 31, 2015, and matched them with 25,845 non-SLE controls using an administrative health database of all health care services funded in British Columbia during the time period. The investigators said the study is the first “to evaluate the risk of severe infections in a large population-based and incident SLE cohort.”
The average age of the patients was 46.9 at the time of their index SLE diagnosis, and 86% were women. The average follow-up period was approximately 10 years.
The primary outcome was the first severe infection after the onset of SLE that required hospitalization or occurred in the hospital setting. A total of 955 (18.5%) first severe infections occurred in the SLE group, compared with 1,988 (7.7%) in the controls, for incidence rates of 19.7 events per 1,000 person-years and 7.6 events per 1,000 person-years, respectively, yielding an 82% increased risk of severe infection for SLE patients after adjustment for confounding baseline factors.
Secondary outcomes of the total number of severe infections and infection-related mortality both showed significant increases in SLE patients, compared with controls. The total number of severe infections in the SLE and control groups was 1,898 and 3,114, respectively, with an adjusted risk ratio of 2.07.
As for mortality, a total of 539 deaths occurred in SLE patients during the study period, and 114 (21%) were related to severe infection. A total of 1,495 deaths occurred in the control group, including 269 (18%) related to severe infection. The adjusted hazard ratio was 1.61 after adjustment for confounding baseline variables.
The risks for first severe infection, total number of severe infections, and infection-related mortality were “independent of traditional risk factors for infection and the results remain robust in the presence of an unmeasured confounder (smoking) and competing risk of death,” the researchers said. Reasons for the increased risk are uncertain, but likely result from intrinsic factors such as immune system dysfunction and extrinsic factors such as the impact of immunosuppressive medications. “Future research can focus on quantifying the relative contributions of these intrinsic and extrinsic factors on the increased infection risk in SLE patients,” they added.
The study findings were limited by several factors linked to the observational design, including possible misdiagnosis of SLE and inaccurate measure of SLE onset, the researchers noted. In addition, no data were available for certain confounders such as smoking and nonhospitalized infections, they said.
However, the results were strengthened by the large size and general population and the use of sensitivity analyses, they noted. For SLE patients, “increased awareness of the risk of infections can identify their early signs and potentially prevent hospitalizations,” and clinicians can promote infection prevention strategies, including vaccinations when appropriate, they added.
Based on their findings, “we recommend a closer surveillance for severe infections in SLE patients and risk assessment for severe infections for SLE patients after diagnosis,” the researchers emphasized. “Further studies are warranted to further identify risk factors for infections in SLE patients to develop personalized treatment regimens and to select treatment in practice by synthesizing patient information,” they concluded.
The study was supported by the Canadian Institutes for Health Research. The researchers had no financial conflicts to disclose.
People with systemic lupus erythematosus (SLE) experienced significantly higher rates of first severe infections, a higher number of severe infections overall, and greater infection-related mortality, compared with controls, based on data from a population-based cohort study of more than 30,000 individuals.
Infections remain a leading cause of morbidity and early mortality in patients with SLE, wrote Kai Zhao, MSc, of Arthritis Research Canada, Richmond, and colleagues. However, “limitations from existing studies including selected samples, small sizes, and prevalent cohorts can negatively affect the accuracy of both the absolute and relative risk estimates of infections in SLE at the population level,” they said.
In a study published in Rheumatology, the researchers identified 5,169 people newly diagnosed with SLE between Jan. 1, 1997, and March 31, 2015, and matched them with 25,845 non-SLE controls using an administrative health database of all health care services funded in British Columbia during the time period. The investigators said the study is the first “to evaluate the risk of severe infections in a large population-based and incident SLE cohort.”
The average age of the patients was 46.9 at the time of their index SLE diagnosis, and 86% were women. The average follow-up period was approximately 10 years.
The primary outcome was the first severe infection after the onset of SLE that required hospitalization or occurred in the hospital setting. A total of 955 (18.5%) first severe infections occurred in the SLE group, compared with 1,988 (7.7%) in the controls, for incidence rates of 19.7 events per 1,000 person-years and 7.6 events per 1,000 person-years, respectively, yielding an 82% increased risk of severe infection for SLE patients after adjustment for confounding baseline factors.
Secondary outcomes of the total number of severe infections and infection-related mortality both showed significant increases in SLE patients, compared with controls. The total number of severe infections in the SLE and control groups was 1,898 and 3,114, respectively, with an adjusted risk ratio of 2.07.
As for mortality, a total of 539 deaths occurred in SLE patients during the study period, and 114 (21%) were related to severe infection. A total of 1,495 deaths occurred in the control group, including 269 (18%) related to severe infection. The adjusted hazard ratio was 1.61 after adjustment for confounding baseline variables.
The risks for first severe infection, total number of severe infections, and infection-related mortality were “independent of traditional risk factors for infection and the results remain robust in the presence of an unmeasured confounder (smoking) and competing risk of death,” the researchers said. Reasons for the increased risk are uncertain, but likely result from intrinsic factors such as immune system dysfunction and extrinsic factors such as the impact of immunosuppressive medications. “Future research can focus on quantifying the relative contributions of these intrinsic and extrinsic factors on the increased infection risk in SLE patients,” they added.
The study findings were limited by several factors linked to the observational design, including possible misdiagnosis of SLE and inaccurate measure of SLE onset, the researchers noted. In addition, no data were available for certain confounders such as smoking and nonhospitalized infections, they said.
However, the results were strengthened by the large size and general population and the use of sensitivity analyses, they noted. For SLE patients, “increased awareness of the risk of infections can identify their early signs and potentially prevent hospitalizations,” and clinicians can promote infection prevention strategies, including vaccinations when appropriate, they added.
Based on their findings, “we recommend a closer surveillance for severe infections in SLE patients and risk assessment for severe infections for SLE patients after diagnosis,” the researchers emphasized. “Further studies are warranted to further identify risk factors for infections in SLE patients to develop personalized treatment regimens and to select treatment in practice by synthesizing patient information,” they concluded.
The study was supported by the Canadian Institutes for Health Research. The researchers had no financial conflicts to disclose.
People with systemic lupus erythematosus (SLE) experienced significantly higher rates of first severe infections, a higher number of severe infections overall, and greater infection-related mortality, compared with controls, based on data from a population-based cohort study of more than 30,000 individuals.
Infections remain a leading cause of morbidity and early mortality in patients with SLE, wrote Kai Zhao, MSc, of Arthritis Research Canada, Richmond, and colleagues. However, “limitations from existing studies including selected samples, small sizes, and prevalent cohorts can negatively affect the accuracy of both the absolute and relative risk estimates of infections in SLE at the population level,” they said.
In a study published in Rheumatology, the researchers identified 5,169 people newly diagnosed with SLE between Jan. 1, 1997, and March 31, 2015, and matched them with 25,845 non-SLE controls using an administrative health database of all health care services funded in British Columbia during the time period. The investigators said the study is the first “to evaluate the risk of severe infections in a large population-based and incident SLE cohort.”
The average age of the patients was 46.9 at the time of their index SLE diagnosis, and 86% were women. The average follow-up period was approximately 10 years.
The primary outcome was the first severe infection after the onset of SLE that required hospitalization or occurred in the hospital setting. A total of 955 (18.5%) first severe infections occurred in the SLE group, compared with 1,988 (7.7%) in the controls, for incidence rates of 19.7 events per 1,000 person-years and 7.6 events per 1,000 person-years, respectively, yielding an 82% increased risk of severe infection for SLE patients after adjustment for confounding baseline factors.
Secondary outcomes of the total number of severe infections and infection-related mortality both showed significant increases in SLE patients, compared with controls. The total number of severe infections in the SLE and control groups was 1,898 and 3,114, respectively, with an adjusted risk ratio of 2.07.
As for mortality, a total of 539 deaths occurred in SLE patients during the study period, and 114 (21%) were related to severe infection. A total of 1,495 deaths occurred in the control group, including 269 (18%) related to severe infection. The adjusted hazard ratio was 1.61 after adjustment for confounding baseline variables.
The risks for first severe infection, total number of severe infections, and infection-related mortality were “independent of traditional risk factors for infection and the results remain robust in the presence of an unmeasured confounder (smoking) and competing risk of death,” the researchers said. Reasons for the increased risk are uncertain, but likely result from intrinsic factors such as immune system dysfunction and extrinsic factors such as the impact of immunosuppressive medications. “Future research can focus on quantifying the relative contributions of these intrinsic and extrinsic factors on the increased infection risk in SLE patients,” they added.
The study findings were limited by several factors linked to the observational design, including possible misdiagnosis of SLE and inaccurate measure of SLE onset, the researchers noted. In addition, no data were available for certain confounders such as smoking and nonhospitalized infections, they said.
However, the results were strengthened by the large size and general population and the use of sensitivity analyses, they noted. For SLE patients, “increased awareness of the risk of infections can identify their early signs and potentially prevent hospitalizations,” and clinicians can promote infection prevention strategies, including vaccinations when appropriate, they added.
Based on their findings, “we recommend a closer surveillance for severe infections in SLE patients and risk assessment for severe infections for SLE patients after diagnosis,” the researchers emphasized. “Further studies are warranted to further identify risk factors for infections in SLE patients to develop personalized treatment regimens and to select treatment in practice by synthesizing patient information,” they concluded.
The study was supported by the Canadian Institutes for Health Research. The researchers had no financial conflicts to disclose.
FROM RHEUMATOLOGY
Cannabis vaping triggers respiratory symptoms in teens
, according to findings of a study based on a national sample of teens.
Most studies of electronic nicotine delivery systems (ENDS) use in teens have not addressed cannabis vaping, although e-cigarette– or vaping product use–associated lung injury (EVALI) has been predominately associated with cannabis products, wrote Carol J. Boyd, PhD, of the University of Michigan School of Nursing, Ann Arbor, and colleagues.
“At this time, relatively little is known about the population-level health consequences of adolescents’ use of ENDS, including use with cannabis and controlling for a history of asthma,” they said.
In a study published in the Journal of Adolescent Health, the researchers identified 14,798 adolescents aged 12-17 years using Wave 4 data from the Population Assessment of Tobacco and Health Study. Of these, 17.6% had a baseline asthma diagnosis, 8.9% reported ever using cannabis in ENDS, and 4.7% reported any cannabis use. In addition, 4.2% reported current e-cigarette use, 3.1% reported current cigarette use, 51% were male, and 69.2% were white.
Any cannabis vaping makes impact
In a fully-adjusted model, teens who had ever vaped cannabis had higher odds of five respiratory symptoms in the past year, compared with those with no history of cannabis vaping: wheezing or whistling in the chest (adjusted odds ratio, 1.81); sleep disturbed by wheezing or whistling (AOR, 1.71); speech limited because of wheezing (AOR, 1.96); wheezy during and after exercise (AOR, 1.33), and a dry cough at night independent of a cold or chest infection (AOR, 1.26).
Neither e-cigarettes nor cigarettes were significantly associated with any of these five respiratory symptoms in the fully adjusted models. In addition, “past 30-day use of cigarettes, e-cigarettes and cannabis use were associated with some respiratory symptoms in bivariate analyses but not in the adjusted models,” the researchers noted. In addition, the associations of an asthma diagnosis and respiratory symptoms had greater magnitudes than either cigarette, e-cigarette, and cannabis use or vaping cannabis with ENDS.
The study findings were limited by several factors including the inherent limitations of secondary database analysis, the researchers noted. “Another limitation is that co-use of cannabis and tobacco/nicotine was not assessed and, in the future, should be examined: Researchers have found that co-use is related to EVALI symptoms among young adults,” they said.
However, the study is the first known to include ENDS product use and respiratory symptoms while accounting for baseline asthma, and an asthma diagnosis was even more strongly associated with all five respiratory symptoms, the researchers said.
The results suggest that “the inhalation of cannabis via vaping is associated with some pulmonary irritation and symptoms of lung diseases (both known and unknown),” that may be predictive of later EVALI, they concluded.
Product details aid in diagnosis
“As we continue to see patients presenting with EVALI in pediatric hospitals, it is important for us to identify if there are specific products (or categories) that are more likely to cause it,” said Brandon Seay, MD, FCCP, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta, in an interview. “When we are trying to diagnose EVALI, we should be asking appropriate questions about exposures to specific products to get the best answers. If we simply ask ‘Are you smoking e-cigarettes?’ the patient may not [equate] e-cigarette smoking to vaping cannabis products,” he said.
Dr. Seay said he was not surprised by the study findings. “A lot of the patients I see with EVALI have reported vaping THC products, and most of them also report that the products were mixed by a friend or an individual instead of being a commercially produced product,” he noted. “This is not surprising, as THC is still illegal in most states and there would not be any commercially available products,” he said. “The mixing of these products by individuals increases the risk of ingredients being more toxic or irritating to the lungs,” Dr. Seay added. “This does highlight the need for more regulation of vaping products. As more states legalize marijuana, more of these products will become available, which will provide an opportunity for increased regulation, he said.
The take-home message for clinicians is to seek specific details from their young patients, Dr. Seay emphasized. “When we are educating our patients on the dangers of vaping/e-cigarettes, we need to make sure we are asking specifically which products they are using and know the terminology,” he said. “The use of THC-containing products will be increasing across the country with more legalization, so we need to keep ourselves apprised of the different risks between THC- and nicotine-containing devices,” he added.
As for additional research, it would be interesting to know whether patients were asked where they had gotten their products (commercially available products vs. those mixed by individuals) and explore any difference between the two, said Dr. Seay. “Also, as these products are relatively new to the market, compared to cigarettes, data on the longitudinal effects of vaping (nicotine and THC) over a long period of time, compared to traditional combustible cigarettes, will be needed,” he said.
The study was funded by grants from the National Institutes of Health, National Institute on Drug Abuse, and National Cancer Institute. The researchers had no financial conflicts to disclose.
Dr. Seay had no financial disclosures, but serves as a member of the CHEST Physician editorial board.
, according to findings of a study based on a national sample of teens.
Most studies of electronic nicotine delivery systems (ENDS) use in teens have not addressed cannabis vaping, although e-cigarette– or vaping product use–associated lung injury (EVALI) has been predominately associated with cannabis products, wrote Carol J. Boyd, PhD, of the University of Michigan School of Nursing, Ann Arbor, and colleagues.
“At this time, relatively little is known about the population-level health consequences of adolescents’ use of ENDS, including use with cannabis and controlling for a history of asthma,” they said.
In a study published in the Journal of Adolescent Health, the researchers identified 14,798 adolescents aged 12-17 years using Wave 4 data from the Population Assessment of Tobacco and Health Study. Of these, 17.6% had a baseline asthma diagnosis, 8.9% reported ever using cannabis in ENDS, and 4.7% reported any cannabis use. In addition, 4.2% reported current e-cigarette use, 3.1% reported current cigarette use, 51% were male, and 69.2% were white.
Any cannabis vaping makes impact
In a fully-adjusted model, teens who had ever vaped cannabis had higher odds of five respiratory symptoms in the past year, compared with those with no history of cannabis vaping: wheezing or whistling in the chest (adjusted odds ratio, 1.81); sleep disturbed by wheezing or whistling (AOR, 1.71); speech limited because of wheezing (AOR, 1.96); wheezy during and after exercise (AOR, 1.33), and a dry cough at night independent of a cold or chest infection (AOR, 1.26).
Neither e-cigarettes nor cigarettes were significantly associated with any of these five respiratory symptoms in the fully adjusted models. In addition, “past 30-day use of cigarettes, e-cigarettes and cannabis use were associated with some respiratory symptoms in bivariate analyses but not in the adjusted models,” the researchers noted. In addition, the associations of an asthma diagnosis and respiratory symptoms had greater magnitudes than either cigarette, e-cigarette, and cannabis use or vaping cannabis with ENDS.
The study findings were limited by several factors including the inherent limitations of secondary database analysis, the researchers noted. “Another limitation is that co-use of cannabis and tobacco/nicotine was not assessed and, in the future, should be examined: Researchers have found that co-use is related to EVALI symptoms among young adults,” they said.
However, the study is the first known to include ENDS product use and respiratory symptoms while accounting for baseline asthma, and an asthma diagnosis was even more strongly associated with all five respiratory symptoms, the researchers said.
The results suggest that “the inhalation of cannabis via vaping is associated with some pulmonary irritation and symptoms of lung diseases (both known and unknown),” that may be predictive of later EVALI, they concluded.
Product details aid in diagnosis
“As we continue to see patients presenting with EVALI in pediatric hospitals, it is important for us to identify if there are specific products (or categories) that are more likely to cause it,” said Brandon Seay, MD, FCCP, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta, in an interview. “When we are trying to diagnose EVALI, we should be asking appropriate questions about exposures to specific products to get the best answers. If we simply ask ‘Are you smoking e-cigarettes?’ the patient may not [equate] e-cigarette smoking to vaping cannabis products,” he said.
Dr. Seay said he was not surprised by the study findings. “A lot of the patients I see with EVALI have reported vaping THC products, and most of them also report that the products were mixed by a friend or an individual instead of being a commercially produced product,” he noted. “This is not surprising, as THC is still illegal in most states and there would not be any commercially available products,” he said. “The mixing of these products by individuals increases the risk of ingredients being more toxic or irritating to the lungs,” Dr. Seay added. “This does highlight the need for more regulation of vaping products. As more states legalize marijuana, more of these products will become available, which will provide an opportunity for increased regulation, he said.
The take-home message for clinicians is to seek specific details from their young patients, Dr. Seay emphasized. “When we are educating our patients on the dangers of vaping/e-cigarettes, we need to make sure we are asking specifically which products they are using and know the terminology,” he said. “The use of THC-containing products will be increasing across the country with more legalization, so we need to keep ourselves apprised of the different risks between THC- and nicotine-containing devices,” he added.
As for additional research, it would be interesting to know whether patients were asked where they had gotten their products (commercially available products vs. those mixed by individuals) and explore any difference between the two, said Dr. Seay. “Also, as these products are relatively new to the market, compared to cigarettes, data on the longitudinal effects of vaping (nicotine and THC) over a long period of time, compared to traditional combustible cigarettes, will be needed,” he said.
The study was funded by grants from the National Institutes of Health, National Institute on Drug Abuse, and National Cancer Institute. The researchers had no financial conflicts to disclose.
Dr. Seay had no financial disclosures, but serves as a member of the CHEST Physician editorial board.
, according to findings of a study based on a national sample of teens.
Most studies of electronic nicotine delivery systems (ENDS) use in teens have not addressed cannabis vaping, although e-cigarette– or vaping product use–associated lung injury (EVALI) has been predominately associated with cannabis products, wrote Carol J. Boyd, PhD, of the University of Michigan School of Nursing, Ann Arbor, and colleagues.
“At this time, relatively little is known about the population-level health consequences of adolescents’ use of ENDS, including use with cannabis and controlling for a history of asthma,” they said.
In a study published in the Journal of Adolescent Health, the researchers identified 14,798 adolescents aged 12-17 years using Wave 4 data from the Population Assessment of Tobacco and Health Study. Of these, 17.6% had a baseline asthma diagnosis, 8.9% reported ever using cannabis in ENDS, and 4.7% reported any cannabis use. In addition, 4.2% reported current e-cigarette use, 3.1% reported current cigarette use, 51% were male, and 69.2% were white.
Any cannabis vaping makes impact
In a fully-adjusted model, teens who had ever vaped cannabis had higher odds of five respiratory symptoms in the past year, compared with those with no history of cannabis vaping: wheezing or whistling in the chest (adjusted odds ratio, 1.81); sleep disturbed by wheezing or whistling (AOR, 1.71); speech limited because of wheezing (AOR, 1.96); wheezy during and after exercise (AOR, 1.33), and a dry cough at night independent of a cold or chest infection (AOR, 1.26).
Neither e-cigarettes nor cigarettes were significantly associated with any of these five respiratory symptoms in the fully adjusted models. In addition, “past 30-day use of cigarettes, e-cigarettes and cannabis use were associated with some respiratory symptoms in bivariate analyses but not in the adjusted models,” the researchers noted. In addition, the associations of an asthma diagnosis and respiratory symptoms had greater magnitudes than either cigarette, e-cigarette, and cannabis use or vaping cannabis with ENDS.
The study findings were limited by several factors including the inherent limitations of secondary database analysis, the researchers noted. “Another limitation is that co-use of cannabis and tobacco/nicotine was not assessed and, in the future, should be examined: Researchers have found that co-use is related to EVALI symptoms among young adults,” they said.
However, the study is the first known to include ENDS product use and respiratory symptoms while accounting for baseline asthma, and an asthma diagnosis was even more strongly associated with all five respiratory symptoms, the researchers said.
The results suggest that “the inhalation of cannabis via vaping is associated with some pulmonary irritation and symptoms of lung diseases (both known and unknown),” that may be predictive of later EVALI, they concluded.
Product details aid in diagnosis
“As we continue to see patients presenting with EVALI in pediatric hospitals, it is important for us to identify if there are specific products (or categories) that are more likely to cause it,” said Brandon Seay, MD, FCCP, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta, in an interview. “When we are trying to diagnose EVALI, we should be asking appropriate questions about exposures to specific products to get the best answers. If we simply ask ‘Are you smoking e-cigarettes?’ the patient may not [equate] e-cigarette smoking to vaping cannabis products,” he said.
Dr. Seay said he was not surprised by the study findings. “A lot of the patients I see with EVALI have reported vaping THC products, and most of them also report that the products were mixed by a friend or an individual instead of being a commercially produced product,” he noted. “This is not surprising, as THC is still illegal in most states and there would not be any commercially available products,” he said. “The mixing of these products by individuals increases the risk of ingredients being more toxic or irritating to the lungs,” Dr. Seay added. “This does highlight the need for more regulation of vaping products. As more states legalize marijuana, more of these products will become available, which will provide an opportunity for increased regulation, he said.
The take-home message for clinicians is to seek specific details from their young patients, Dr. Seay emphasized. “When we are educating our patients on the dangers of vaping/e-cigarettes, we need to make sure we are asking specifically which products they are using and know the terminology,” he said. “The use of THC-containing products will be increasing across the country with more legalization, so we need to keep ourselves apprised of the different risks between THC- and nicotine-containing devices,” he added.
As for additional research, it would be interesting to know whether patients were asked where they had gotten their products (commercially available products vs. those mixed by individuals) and explore any difference between the two, said Dr. Seay. “Also, as these products are relatively new to the market, compared to cigarettes, data on the longitudinal effects of vaping (nicotine and THC) over a long period of time, compared to traditional combustible cigarettes, will be needed,” he said.
The study was funded by grants from the National Institutes of Health, National Institute on Drug Abuse, and National Cancer Institute. The researchers had no financial conflicts to disclose.
Dr. Seay had no financial disclosures, but serves as a member of the CHEST Physician editorial board.
FROM THE JOURNAL OF ADOLESCENT HEALTH
Tocilizumab (Actemra) scores FDA approval for systemic sclerosis–associated interstitial lung disease
The Food and Drug Administration has approved subcutaneously-injected tocilizumab (Actemra) to reduce the rate of pulmonary function decline in systemic sclerosis–associated interstitial lung disease (SSc-ILD) patients, according to a press release from manufacturer Genentech.
Tocilizumab is the first biologic to be approved by the agency for adults with SSc-ILD, a rare and potentially life-threatening condition that may affect up to 80% of SSc patients and lead to lung inflammation and scarring.
The approval was based primarily on data from a phase 3 randomized, double-blind, placebo-controlled clinical trial (the focuSSced trial) that included 212 adults with SSc. Although that study failed to meet its primary endpoint of change from baseline to 48 weeks in the modified Rodnan Skin Score, the researchers observed a significantly reduced lung function decline as measured by forced vital capacity (FVC) and percent predicted forced vital capacity (ppFVC) among tocilizumab-treated patients, compared with those who received placebo. A total of 68 patients (65%) in the tocilizumab group and 68 patients (64%) in the placebo group had SSc-ILD at baseline.
In a subgroup analysis, patients taking tocilizumab had a smaller decline in mean ppFVC, compared with placebo patients (0.07% vs. –6.4%; mean difference, 6.47%), and a smaller decline in FVC (mean change –14 mL vs. –255 mL with placebo; mean difference, 241 mL).
The mean change from baseline to week 48 in modified Rodnan Skin Score was –5.88 for patients on tocilizumab and –3.77 with placebo.
Safety data were similar between tocilizumab and placebo groups through 48 weeks, and similar for patients with and without SSc-ILD. In general, tocilizumab side effects include increased susceptibility to infections, and serious side effects may include stomach tears, hepatotoxicity, and increased risk of cancer and hepatitis B, according to the prescribing information. However, the most common side effects are upper respiratory tract infections, headache, hypertension, and injection-site reactions.
Tocilizumab, an interleukin-6 receptor antagonist, is already approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis, as well as for adult patients with giant cell arteritis; patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis; and adults and pediatric patients 2 years of age and older with chimeric antigen receptor T-cell–induced severe or life-threatening cytokine release syndrome.
Prescribing information is available here.
The Food and Drug Administration has approved subcutaneously-injected tocilizumab (Actemra) to reduce the rate of pulmonary function decline in systemic sclerosis–associated interstitial lung disease (SSc-ILD) patients, according to a press release from manufacturer Genentech.
Tocilizumab is the first biologic to be approved by the agency for adults with SSc-ILD, a rare and potentially life-threatening condition that may affect up to 80% of SSc patients and lead to lung inflammation and scarring.
The approval was based primarily on data from a phase 3 randomized, double-blind, placebo-controlled clinical trial (the focuSSced trial) that included 212 adults with SSc. Although that study failed to meet its primary endpoint of change from baseline to 48 weeks in the modified Rodnan Skin Score, the researchers observed a significantly reduced lung function decline as measured by forced vital capacity (FVC) and percent predicted forced vital capacity (ppFVC) among tocilizumab-treated patients, compared with those who received placebo. A total of 68 patients (65%) in the tocilizumab group and 68 patients (64%) in the placebo group had SSc-ILD at baseline.
In a subgroup analysis, patients taking tocilizumab had a smaller decline in mean ppFVC, compared with placebo patients (0.07% vs. –6.4%; mean difference, 6.47%), and a smaller decline in FVC (mean change –14 mL vs. –255 mL with placebo; mean difference, 241 mL).
The mean change from baseline to week 48 in modified Rodnan Skin Score was –5.88 for patients on tocilizumab and –3.77 with placebo.
Safety data were similar between tocilizumab and placebo groups through 48 weeks, and similar for patients with and without SSc-ILD. In general, tocilizumab side effects include increased susceptibility to infections, and serious side effects may include stomach tears, hepatotoxicity, and increased risk of cancer and hepatitis B, according to the prescribing information. However, the most common side effects are upper respiratory tract infections, headache, hypertension, and injection-site reactions.
Tocilizumab, an interleukin-6 receptor antagonist, is already approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis, as well as for adult patients with giant cell arteritis; patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis; and adults and pediatric patients 2 years of age and older with chimeric antigen receptor T-cell–induced severe or life-threatening cytokine release syndrome.
Prescribing information is available here.
The Food and Drug Administration has approved subcutaneously-injected tocilizumab (Actemra) to reduce the rate of pulmonary function decline in systemic sclerosis–associated interstitial lung disease (SSc-ILD) patients, according to a press release from manufacturer Genentech.
Tocilizumab is the first biologic to be approved by the agency for adults with SSc-ILD, a rare and potentially life-threatening condition that may affect up to 80% of SSc patients and lead to lung inflammation and scarring.
The approval was based primarily on data from a phase 3 randomized, double-blind, placebo-controlled clinical trial (the focuSSced trial) that included 212 adults with SSc. Although that study failed to meet its primary endpoint of change from baseline to 48 weeks in the modified Rodnan Skin Score, the researchers observed a significantly reduced lung function decline as measured by forced vital capacity (FVC) and percent predicted forced vital capacity (ppFVC) among tocilizumab-treated patients, compared with those who received placebo. A total of 68 patients (65%) in the tocilizumab group and 68 patients (64%) in the placebo group had SSc-ILD at baseline.
In a subgroup analysis, patients taking tocilizumab had a smaller decline in mean ppFVC, compared with placebo patients (0.07% vs. –6.4%; mean difference, 6.47%), and a smaller decline in FVC (mean change –14 mL vs. –255 mL with placebo; mean difference, 241 mL).
The mean change from baseline to week 48 in modified Rodnan Skin Score was –5.88 for patients on tocilizumab and –3.77 with placebo.
Safety data were similar between tocilizumab and placebo groups through 48 weeks, and similar for patients with and without SSc-ILD. In general, tocilizumab side effects include increased susceptibility to infections, and serious side effects may include stomach tears, hepatotoxicity, and increased risk of cancer and hepatitis B, according to the prescribing information. However, the most common side effects are upper respiratory tract infections, headache, hypertension, and injection-site reactions.
Tocilizumab, an interleukin-6 receptor antagonist, is already approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis, as well as for adult patients with giant cell arteritis; patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis; and adults and pediatric patients 2 years of age and older with chimeric antigen receptor T-cell–induced severe or life-threatening cytokine release syndrome.
Prescribing information is available here.
FDA supports robotic device as hysterectomy helper
Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.
The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.
The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.
RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.
“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.
The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.
The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.
“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.
The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.
Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.
Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.
The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.
The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.
RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.
“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.
The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.
The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.
“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.
The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.
Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.
Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.
The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.
The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.
RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.
“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.
The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.
The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.
“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.
The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.
Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.
Rural women receive antibiotics for longer than necessary for UTIs
Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.
Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.
“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.
Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.
In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.
Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.
Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.
The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
More rural women receive long-duration antibiotics
In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).
However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).
The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.
From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.
The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.
However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.
“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
Data support need for education and stewardship
“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.
“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.
To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.
The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.
Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.
Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.
“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.
Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.
In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.
Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.
Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.
The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
More rural women receive long-duration antibiotics
In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).
However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).
The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.
From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.
The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.
However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.
“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
Data support need for education and stewardship
“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.
“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.
To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.
The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.
Women living in rural areas were significantly more likely than were those in urban areas to receive inappropriate antibiotic prescriptions for urinary tract infections, based on data from an observational cohort study of more than 600,000 women.
Uncomplicated urinary tract infections (UTIs) are common among otherwise healthy women in the United States, and certain antibiotics are recommended as first-line therapy, wrote Abbye W. Clark, MD, of Washington University, St. Louis, and colleagues.
“However, the majority of antibiotic prescriptions for uncomplicated UTI are suboptimal because they are written for nonrecommended agents and durations,” they said.
Addressing rural health disparities has become a focus in the United States, and previous studies of respiratory tract infections have shown differences in antibiotic prescribing based on geographic region; “however, no large-scale studies have evaluated rural-urban differences in inappropriate outpatient prescribing for UTI,” they added.
In a study published in Infection Control & Hospital Epidemiology, the researchers identified 670,450 women aged 18-44 years who received oral antibiotics for uncomplicated UTIs between 2010 to 2015, using a commercial insurance database to determine diagnosis and antibiotic prescription information. Women were defined as urban if they lived in a metropolitan statistical area of at least 50,000 inhabitants (86.2%); all other women were defined as rural (13.8%). The median age was 30 years for both groups.
Overall, 46.7% of the women received prescriptions for inappropriate antibiotics, and 76.1% received antibiotics for inappropriate durations.
Antibiotics and durations were defined as appropriate or inappropriate based on current clinical guidelines. “We classified first-line agents (nitrofurantoin, TMP-SMX, fosfomycin) as appropriate and non–first-line agents (fluoroquinolones, beta-lactams) as inappropriate,” the researchers said.
The regimens classified as appropriate duration were “nitrofurantoin 5-day regimen, TMP-SMX (including TMP monotherapy) 3-day regimen, fosfomycin 1-day regimen, fluoroquinolones 3-day regimen, and beta-lactams 3- to 7-day regimen. All other regimens were classified as inappropriate duration,” they noted.
More rural women receive long-duration antibiotics
In a multivariate analysis, similar percentages of antibiotics for rural and urban women consisted of inappropriate agents (45.9% vs. 46.9%) including use of fluoroquinolones (41.0% vs. 41.7%) and beta-lactams (4.8% vs. 5.0%).
However, across all antibiotics, women in rural areas were more likely than were women in urban areas to receive prescriptions for inappropriately long durations (83.9% vs. 75.9%, adjusted risk ratio 1.10).
The percentage of women who received inappropriate antibiotic agents was not significantly different based on geographic region of the country.
From 2011 to 2015, the quarterly proportion of women overall who received inappropriate agents and antibiotics for inappropriate durations decreased slightly (48.5% to 43.7% and 78.3% to 73.4%, respectively), the researchers noted.
The study findings were limited by several factors including the potentially lenient definition of antibiotic duration, a study population that disproportionately oversampled from the South and undersampled from the West, use of ZIP codes to determine rural vs. urban status, lack of data on race and income, and lack of access to urine culture results, the researchers noted.
However, “our study identified rural-urban differences in antibiotic prescribing, including an actionable disparity in the duration of antibiotics that disproportionately affects women who live in rural locations,” they said.
“Given the large quantity of inappropriate prescriptions annually in the U.S., as well as the negative patient- and society-level consequences of unnecessary exposure to antibiotics, antimicrobial stewardship interventions are needed to improve outpatient UTI antibiotic prescribing, particularly in rural settings,” they concluded.
Data support need for education and stewardship
“This manuscript provides valuable information to all women’s health providers regarding the importance of antibiotic stewardship,” David M. Jaspan, DO, and Natasha Abdullah, MD, Einstein Medical Center, Philadelphia, said in an interview. Whether urban or rural, over 45% of the patients received inappropriate non–first-line treatment and 76% of the prescriptions were for an inappropriate duration (98.8% for longer than recommended), they emphasized.
“The potential negative impact of antibiotic resistance, coupled with the potential for increased side effects, should prompt providers to ensure that when treating uncomplicated UTIs in women, that the choice of treatment and the duration of treatment is tailored to the patient’s needs,” the Dr. Jaspan and Dr. Abdullah said.
To improve antibiotic prescribing, especially at the local and regional level, “We encourage providers to familiarize themselves with local information as it pertains to known resistance when prescribing empiric treatment regimens for uncomplicated UTIs,” they said.
The study was supported by the National Center for Advancing Translational Sciences at the National Institutes of Health. Lead author Dr. Clark, as well as Dr. Jaspan and Dr. Abdullah, had no financial conflicts to disclose.
FROM INFECTION CONTROL & HOSPITAL EPIDEMIOLOGY