Jim Kling

SAN FRANCISCO – In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.

The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.

Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.

The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.

“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.

In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).

Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).

The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.

The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.

Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.

Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”

The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.

SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.

SAN FRANCISCO – In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.

The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.

Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.

The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.

“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.

In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).

Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).

The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.

The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.

Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.

Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”

The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.

SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.

SAN FRANCISCO – In locally advanced rectal cancer, fragmentation of radiotherapy and surgery comes at a cost, even at academic medical centers, according to a new analysis of data from the National Cancer Center Database. Researchers found that survival was higher when care was integrated – that is, both the surgery and the radiotherapy were performed at the same location.

The study paints a complex picture. Academic settings had a higher frequency of fragmented care than comprehensive community and community hospitals, but treatment in them was associated with better overall survival. However, patients who received fragmented care at academic hospitals had no survival advantage over the other institutions, according to Kyle Freischlag, MD, an intern at the University of Iowa, Iowa City, who presented the study at the annual clinical congress of the American College of Surgeons. The study was conducted at Duke University, Durham, N.C., during Dr. Freischlag’s time there.

Cancer care is becoming more centralized, with the expectation that patients will travel to specialty centers for treatment. But this isn’t possible for all patients, so some may get surgery at one locale, and radiation therapy at a closer, more convenient center.

The push for centralization of cancer care is embodied by the National Accreditation Program for Rectal Cancer, which accredits hospitals to be centers of excellence for rectal cancer surgery. “It’s a great program, it’s very comprehensive. But it is resource intensive to become accredited, so realistically, I think it will be mostly larger-volume hospitals that will apply for accreditation,” said Elise Lawson, MD, in an interview. Dr. Lawson is assistant professor of surgery at University of Wisconsin–Madison, and moderated the session where the research was presented.

“It is a great first step to improving the quality of rectal cancer care, but this study highlights that accreditation of large-volume centers may not be enough, and that we have to be careful that we aren’t going to exacerbate existing disparities in access and quality of care for patients who live in rural settings,” Dr. Lawson added.

In an analysis of 28,227 patients between 2006 and 2015, 17,663 of whom had integrated care, the researchers found that integrated care patients had a lower likelihood of 30-day unplanned readmissions (6.2% vs. 7.0%; P =.01), and those with fragmented care experienced higher mortality (hazard ratio, 1.07; 95% confidence interval, 1.01-1.12). Treatment in an academic center was associated with lower mortality overall than treatment in community centers (HR, 0.881; P =.005).

Fragmented care was more common in academic centers (40% vs. 36% in comprehensive community centers vs. 37% in community centers, P less than .001). Within academic centers, 5-year overall survival was worse with fragmented versus integrated care (70% vs. 74%; P =.00016).

The researchers found that performance of surgery at an academic center was itself a predictor of better survival (odd ratio, 0.88; 95% CI, 0.81-0.96). Integrated care at an academic center was associated with lower 30-day mortality (0.5% vs. 0.6% in integrated comprehensive community centers vs. 1.1% in integrated community centers; P = .038) and better 5-year overall survival (73% vs. 71% vs. 66%; HR, 0.85; 95% CI, 0.75-0.98; P less than .0001). “However, that survival benefit seen in academic hospitals disappeared when they had fragmented care,” Dr. Freischlag noted.

The study is limited by its retrospective nature, though the researchers did adjust for clinical and demographic characteristics, and selection bias for fragmented care should be generalizable across hospital types.

Dr. Freischlag believes that centralization has created additional financial and emotional burdens on patients, reduced the chances of patients receiving adjuvant therapy and completing radiation therapy, and led to increased stage at diagnosis, all factors that might explain the survival difference. He called for efforts to reduce fragmentation, and to conduct surgery at academic centers whenever possible, since that is associated with a survival advantage.

Dr. Lawson agreed, and called for a greater focus on improving care across centers. “It’s a problem if we’re only improving the large volume centers and not thinking about the burden that travel places on patients that live far away from these centers. This study is further showing that it matters not just where you get surgery, but also chemotherapy and radiation – so we need to think about how to coordinate comprehensive care for patients with rectal cancer better.”

The study received no external funding. Dr. Freischlag and Dr. Lawson reported no relevant conflicts of interest.

SOURCE: Freischlag K et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S52.

A significant portion of the increased cardiovascular disease risk seen in black adults may stem from hypertension, according to a prospective cohort study published by a team led by Donald Clark III, MD, of the University of Mississippi in Jackson.

The analysis showed that about one-third of cardiovascular disease can be traced to hypertension in black adults, and the influence was much stronger in individuals under 60, suggesting that early interventions to maintain normal blood pressure have the potential to reduce risk in this population.

Hypertension is already known to be the leading contributor to cardiovascular disease (CVD) in the United States, and non-Hispanic black adults experience it at a rate of 55%, higher than any other group.

The researchers used data from the Jackson Heart Study (JHS) and the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study to determine the association between CVD and hypertension, and NHANES 2011-2014 to examine the rate of hypertension among non-Hispanic black adults in the United States.

At baseline, among 12,497 participants In the JHS and REGARDS studies, 33% had normal blood pressure, 41% had elevated BP, and 36% had hypertension. In the NHANES cohort, 35% had normal BP, 12% had elevated BP, and 53% had hypertension.

In the combined JHS and REGARDS cohorts, subjects with elevated BP and hypertension had greater odds of taking cholesterol-lowering medication compared to those with normal BP: 8.5% of normotensive patients and 9.9% of those with elevated BP were on medication, compared with 26.0% of hypertensive patient, emphasizing the importance of effective hypertension management, the investigators noted.

Similarly, 9.9% of patients with normal BP and 14.7% of those with elevated BP had diabetes, compared with 26.0% of hypertensive patients. Hypertensive patients were also less likely to have graduated from high school (81%) than were those with elevated BP (84.5%) and normal BP (89.9%), and they had a higher mean body mass index (31.4 kg/m2) than their counterparts with elevated (29.6) and normal (28.8) BP.

After a maximum of 14.3 years of follow-up, 9.9% of participants experienced a CVD event. The researchers calculated the population attributable risk (PAR) using the prevalence of hypertension from the NHANES dataset and the multivariable-adjusted association between elevated versus normal BP and hypertension versus normal BP in the JHS and REGARDS data.

“Hypertension was independently associated with incident [coronary heart disease], heart failure, and stroke,” the investigators wrote. The PARs associated with hypertension were 32.5% (95% CI, 20.5-43.6%) for CVD, 42.7% (95% CI, 24.0-58.4%) for coronary heart disease, 21.6% (95% CI, 0.6-40.8%) for heart failure, and 38.9% (95% CI, 19.4-55.6%) for stroke.

Men and women had similar PAR values for CVD (33.9% vs. 31.1%). Participants younger than 60 had a higher value of PAR associated with hypertension than older participants (54.6% [95% CI, 37.2-68.7%] vs. 32.0% [95% CI, 11.9-48.1%]). Dr. Clark and his coinvestigators noted that the “most substantial finding” of the study was PAR of 69% for stroke associated with hypertension found in patients younger than 60 years. “These data suggest that interventions to maintain normal BP across the life course may reduce the incidence of CVD in this population,” they concluded.

The REGARDS study was funded by NIH and the American Heart Association. The JHS study was funded by Jackson State University, Tougaloo College, the Mississippi State Department of Health, and the University of Mississippi Medical Center. The authors have extensive financial ties to pharmaceutical companies.

SOURCE: JAMA Card. 2019. October 23, 2019. doi:10.1001/jamacardio.2019.3773.

A significant portion of the increased cardiovascular disease risk seen in black adults may stem from hypertension, according to a prospective cohort study published by a team led by Donald Clark III, MD, of the University of Mississippi in Jackson.

The analysis showed that about one-third of cardiovascular disease can be traced to hypertension in black adults, and the influence was much stronger in individuals under 60, suggesting that early interventions to maintain normal blood pressure have the potential to reduce risk in this population.

Hypertension is already known to be the leading contributor to cardiovascular disease (CVD) in the United States, and non-Hispanic black adults experience it at a rate of 55%, higher than any other group.

The researchers used data from the Jackson Heart Study (JHS) and the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study to determine the association between CVD and hypertension, and NHANES 2011-2014 to examine the rate of hypertension among non-Hispanic black adults in the United States.

At baseline, among 12,497 participants In the JHS and REGARDS studies, 33% had normal blood pressure, 41% had elevated BP, and 36% had hypertension. In the NHANES cohort, 35% had normal BP, 12% had elevated BP, and 53% had hypertension.

In the combined JHS and REGARDS cohorts, subjects with elevated BP and hypertension had greater odds of taking cholesterol-lowering medication compared to those with normal BP: 8.5% of normotensive patients and 9.9% of those with elevated BP were on medication, compared with 26.0% of hypertensive patient, emphasizing the importance of effective hypertension management, the investigators noted.

Similarly, 9.9% of patients with normal BP and 14.7% of those with elevated BP had diabetes, compared with 26.0% of hypertensive patients. Hypertensive patients were also less likely to have graduated from high school (81%) than were those with elevated BP (84.5%) and normal BP (89.9%), and they had a higher mean body mass index (31.4 kg/m2) than their counterparts with elevated (29.6) and normal (28.8) BP.

After a maximum of 14.3 years of follow-up, 9.9% of participants experienced a CVD event. The researchers calculated the population attributable risk (PAR) using the prevalence of hypertension from the NHANES dataset and the multivariable-adjusted association between elevated versus normal BP and hypertension versus normal BP in the JHS and REGARDS data.

“Hypertension was independently associated with incident [coronary heart disease], heart failure, and stroke,” the investigators wrote. The PARs associated with hypertension were 32.5% (95% CI, 20.5-43.6%) for CVD, 42.7% (95% CI, 24.0-58.4%) for coronary heart disease, 21.6% (95% CI, 0.6-40.8%) for heart failure, and 38.9% (95% CI, 19.4-55.6%) for stroke.

Men and women had similar PAR values for CVD (33.9% vs. 31.1%). Participants younger than 60 had a higher value of PAR associated with hypertension than older participants (54.6% [95% CI, 37.2-68.7%] vs. 32.0% [95% CI, 11.9-48.1%]). Dr. Clark and his coinvestigators noted that the “most substantial finding” of the study was PAR of 69% for stroke associated with hypertension found in patients younger than 60 years. “These data suggest that interventions to maintain normal BP across the life course may reduce the incidence of CVD in this population,” they concluded.

The REGARDS study was funded by NIH and the American Heart Association. The JHS study was funded by Jackson State University, Tougaloo College, the Mississippi State Department of Health, and the University of Mississippi Medical Center. The authors have extensive financial ties to pharmaceutical companies.

SOURCE: JAMA Card. 2019. October 23, 2019. doi:10.1001/jamacardio.2019.3773.

A significant portion of the increased cardiovascular disease risk seen in black adults may stem from hypertension, according to a prospective cohort study published by a team led by Donald Clark III, MD, of the University of Mississippi in Jackson.

The analysis showed that about one-third of cardiovascular disease can be traced to hypertension in black adults, and the influence was much stronger in individuals under 60, suggesting that early interventions to maintain normal blood pressure have the potential to reduce risk in this population.

Hypertension is already known to be the leading contributor to cardiovascular disease (CVD) in the United States, and non-Hispanic black adults experience it at a rate of 55%, higher than any other group.

The researchers used data from the Jackson Heart Study (JHS) and the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study to determine the association between CVD and hypertension, and NHANES 2011-2014 to examine the rate of hypertension among non-Hispanic black adults in the United States.

At baseline, among 12,497 participants In the JHS and REGARDS studies, 33% had normal blood pressure, 41% had elevated BP, and 36% had hypertension. In the NHANES cohort, 35% had normal BP, 12% had elevated BP, and 53% had hypertension.

In the combined JHS and REGARDS cohorts, subjects with elevated BP and hypertension had greater odds of taking cholesterol-lowering medication compared to those with normal BP: 8.5% of normotensive patients and 9.9% of those with elevated BP were on medication, compared with 26.0% of hypertensive patient, emphasizing the importance of effective hypertension management, the investigators noted.

Similarly, 9.9% of patients with normal BP and 14.7% of those with elevated BP had diabetes, compared with 26.0% of hypertensive patients. Hypertensive patients were also less likely to have graduated from high school (81%) than were those with elevated BP (84.5%) and normal BP (89.9%), and they had a higher mean body mass index (31.4 kg/m2) than their counterparts with elevated (29.6) and normal (28.8) BP.

After a maximum of 14.3 years of follow-up, 9.9% of participants experienced a CVD event. The researchers calculated the population attributable risk (PAR) using the prevalence of hypertension from the NHANES dataset and the multivariable-adjusted association between elevated versus normal BP and hypertension versus normal BP in the JHS and REGARDS data.

“Hypertension was independently associated with incident [coronary heart disease], heart failure, and stroke,” the investigators wrote. The PARs associated with hypertension were 32.5% (95% CI, 20.5-43.6%) for CVD, 42.7% (95% CI, 24.0-58.4%) for coronary heart disease, 21.6% (95% CI, 0.6-40.8%) for heart failure, and 38.9% (95% CI, 19.4-55.6%) for stroke.

Men and women had similar PAR values for CVD (33.9% vs. 31.1%). Participants younger than 60 had a higher value of PAR associated with hypertension than older participants (54.6% [95% CI, 37.2-68.7%] vs. 32.0% [95% CI, 11.9-48.1%]). Dr. Clark and his coinvestigators noted that the “most substantial finding” of the study was PAR of 69% for stroke associated with hypertension found in patients younger than 60 years. “These data suggest that interventions to maintain normal BP across the life course may reduce the incidence of CVD in this population,” they concluded.

The REGARDS study was funded by NIH and the American Heart Association. The JHS study was funded by Jackson State University, Tougaloo College, the Mississippi State Department of Health, and the University of Mississippi Medical Center. The authors have extensive financial ties to pharmaceutical companies.

SOURCE: JAMA Card. 2019. October 23, 2019. doi:10.1001/jamacardio.2019.3773.

The novel drug bremelanotide shows promise in acquired female hypoactive sexual desire disorder, according to the results of two randomized, controlled trials and a 52-week open-label extension study published online in Obstetrics & Gynecology.

Bremelanotide, which received Food and Drug Administration approval for this indication in June 2019, is an analog of the endogenous neuropeptide alpha-melanocyte-stimulating hormone.

Two separate, identically designed phase 3 studies (RECONNECT) were performed by Sheryl Kingsburg, MD, of the Cleveland Medical Center, and associates. Combined, 1,267 premenopausal women in monogamous relationships with acquired hypoactive sexual desire disorder were randomized to bremelanotide or placebo. Women in the treatment arm had significant improvement in female sexual function index–desire domain (FSFI-D) scores from baseline to week 24 (integrated studies: 0.35; P less than .001; effect size, 0.39), compared with placebo. They also experienced significant improvement in the FSFI-desire/arousal/orgasm (FSFI-DAO) domain (integrated studies: –0.33; P less than .001; effect size, 0.27).

The most common adverse events were nausea (integrated: 40% versus 1% in placebo), flushing (20% versus 0.3%), and headache (11% versus 2%). Overall, 77% in the treatment group reported a treatment-emergent adverse event, compared with 58% in the placebo group.

The open-label follow-up study was led by James Simon, MD, of George Washington University and IntimMedicine Specialists, Washington. Of the 684 participants who opted to enter the extension study, 40% completed it. In those who received bremelanotide during the randomized trial, the change in FSFI-D scores from baseline to the end of the open-label study ranged from 1.25 to 1.30, while the change in FSFI-DAO ranged from –1.4 to –1.7. In patients originally on placebo, the changes were 0.70-0.77 and –0.9, respectively.

Both groups surpassed the minimally clinically important difference for the FSFI-D score, which is considered to be 0.6.

“Patients switching from placebo experienced a higher incidence of adverse events than those continuing on bremelanotide during the open-label extension (79% versus 63%, respectively),” Dr. Simon and associates said.

The treatment is subcutaneous and can be self-administered up to about 45 minutes before a sexual event, no more than once during a 24-hour period, and no more than 8 doses per month, according to an FDA press release. The drug is contraindicated for women with cardiovascular disease or uncontrolled hypertension due to observations of transiently, slightly increased blood pressure.

The trials were funded by Palatin Technologies and AMAG Pharmaceuticals. The authors and coauthors have extensive financial relationships with pharmaceutical companies. Dr. Carson reported no financial conflicts.

SOURCE: Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003500; Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003514.

The novel drug bremelanotide shows promise in acquired female hypoactive sexual desire disorder, according to the results of two randomized, controlled trials and a 52-week open-label extension study published online in Obstetrics & Gynecology.

Bremelanotide, which received Food and Drug Administration approval for this indication in June 2019, is an analog of the endogenous neuropeptide alpha-melanocyte-stimulating hormone.

Two separate, identically designed phase 3 studies (RECONNECT) were performed by Sheryl Kingsburg, MD, of the Cleveland Medical Center, and associates. Combined, 1,267 premenopausal women in monogamous relationships with acquired hypoactive sexual desire disorder were randomized to bremelanotide or placebo. Women in the treatment arm had significant improvement in female sexual function index–desire domain (FSFI-D) scores from baseline to week 24 (integrated studies: 0.35; P less than .001; effect size, 0.39), compared with placebo. They also experienced significant improvement in the FSFI-desire/arousal/orgasm (FSFI-DAO) domain (integrated studies: –0.33; P less than .001; effect size, 0.27).

The most common adverse events were nausea (integrated: 40% versus 1% in placebo), flushing (20% versus 0.3%), and headache (11% versus 2%). Overall, 77% in the treatment group reported a treatment-emergent adverse event, compared with 58% in the placebo group.

The open-label follow-up study was led by James Simon, MD, of George Washington University and IntimMedicine Specialists, Washington. Of the 684 participants who opted to enter the extension study, 40% completed it. In those who received bremelanotide during the randomized trial, the change in FSFI-D scores from baseline to the end of the open-label study ranged from 1.25 to 1.30, while the change in FSFI-DAO ranged from –1.4 to –1.7. In patients originally on placebo, the changes were 0.70-0.77 and –0.9, respectively.

Both groups surpassed the minimally clinically important difference for the FSFI-D score, which is considered to be 0.6.

“Patients switching from placebo experienced a higher incidence of adverse events than those continuing on bremelanotide during the open-label extension (79% versus 63%, respectively),” Dr. Simon and associates said.

The treatment is subcutaneous and can be self-administered up to about 45 minutes before a sexual event, no more than once during a 24-hour period, and no more than 8 doses per month, according to an FDA press release. The drug is contraindicated for women with cardiovascular disease or uncontrolled hypertension due to observations of transiently, slightly increased blood pressure.

The trials were funded by Palatin Technologies and AMAG Pharmaceuticals. The authors and coauthors have extensive financial relationships with pharmaceutical companies. Dr. Carson reported no financial conflicts.

SOURCE: Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003500; Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003514.

The novel drug bremelanotide shows promise in acquired female hypoactive sexual desire disorder, according to the results of two randomized, controlled trials and a 52-week open-label extension study published online in Obstetrics & Gynecology.

Bremelanotide, which received Food and Drug Administration approval for this indication in June 2019, is an analog of the endogenous neuropeptide alpha-melanocyte-stimulating hormone.

Two separate, identically designed phase 3 studies (RECONNECT) were performed by Sheryl Kingsburg, MD, of the Cleveland Medical Center, and associates. Combined, 1,267 premenopausal women in monogamous relationships with acquired hypoactive sexual desire disorder were randomized to bremelanotide or placebo. Women in the treatment arm had significant improvement in female sexual function index–desire domain (FSFI-D) scores from baseline to week 24 (integrated studies: 0.35; P less than .001; effect size, 0.39), compared with placebo. They also experienced significant improvement in the FSFI-desire/arousal/orgasm (FSFI-DAO) domain (integrated studies: –0.33; P less than .001; effect size, 0.27).

The most common adverse events were nausea (integrated: 40% versus 1% in placebo), flushing (20% versus 0.3%), and headache (11% versus 2%). Overall, 77% in the treatment group reported a treatment-emergent adverse event, compared with 58% in the placebo group.

The open-label follow-up study was led by James Simon, MD, of George Washington University and IntimMedicine Specialists, Washington. Of the 684 participants who opted to enter the extension study, 40% completed it. In those who received bremelanotide during the randomized trial, the change in FSFI-D scores from baseline to the end of the open-label study ranged from 1.25 to 1.30, while the change in FSFI-DAO ranged from –1.4 to –1.7. In patients originally on placebo, the changes were 0.70-0.77 and –0.9, respectively.

Both groups surpassed the minimally clinically important difference for the FSFI-D score, which is considered to be 0.6.

“Patients switching from placebo experienced a higher incidence of adverse events than those continuing on bremelanotide during the open-label extension (79% versus 63%, respectively),” Dr. Simon and associates said.

The treatment is subcutaneous and can be self-administered up to about 45 minutes before a sexual event, no more than once during a 24-hour period, and no more than 8 doses per month, according to an FDA press release. The drug is contraindicated for women with cardiovascular disease or uncontrolled hypertension due to observations of transiently, slightly increased blood pressure.

The trials were funded by Palatin Technologies and AMAG Pharmaceuticals. The authors and coauthors have extensive financial relationships with pharmaceutical companies. Dr. Carson reported no financial conflicts.

SOURCE: Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003500; Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003514.

Lung function appears to continue to decline even decades after smoking cessation, according to new data from the National Heart, Lung, and Blood Institute Pooled Cohort Study. Compared with never-smokers, former smokers had a decline in forced expiratory volume in 1 second (FEV₁) about 20% as severe as current smokers, but nevertheless higher than never-smokers. Low-intensity smokers also fared worse than never-smokers, suggesting that no amount of smoke exposure should be considered safe.

bilderbox/fotolia.com

The increased decline occurred even decades after smoking cessation, according to the study published in Lancet Respiratory Medicine, which was led by Elizabeth Oelsner, MD, MPH, of Columbia University, New York. Smoking prevalence has decreased from 42% to 16% in the past 50 years, and many smokers report that they smoke fewer cigarettes per day, from an average of 21 to 14, according to the authors. Despite those trends, the prevalence of chronic obstructive pulmonary disease has continued to increase, and is now the third-leading cause of death worldwide.

A meta-analysis of 47 studies and 88,887 adults found no association between smoking and FEV₁ decline, but many of the studies were small or focused on nonrepresentative populations, and they used variably standardized spirometry.

The study pooled data from nine individual U.S. cohorts, with 25,352 participants recruited during 1983-2016. Subjects included those who underwent at least two prebronchodilator spirometry tests following American Thoracic Society standards. After adjustment, former smokers had increased FEV₁ decline of 1.82 mL/year (P less than .0001), compared with never-smokers. Current smokers had an increased decline of 9.21 mL/year (P less than .0001).

Even after decades of abstinence, the effects of smoking appeared to linger: 20-30 years later, FEV₁ loss was accelerated by 2.50 mL/year (P less than .0001), and by 0.93 mL/year (P = .0104) after 30 years, compared with never-smokers.

Even low-intensity smokers (cumulative less than 10 pack-years) had an significantly accelerated FEV₁ decline (0.87 mL; P = .0153).

The researchers also found a relationship between FEV₁ decline and intensity of current smoking: Those smoking fewer than 5 cigarettes per day had a lower decline than those smoking 30 or more (7.65 mL; 95% confidence interval, 6.21-9.09 vs. 11.24 mL; 95% CI, 9.86-12.62).

The study is limited by the fact that smoking status and daily tobacco reporting were self-reported, which could result in information bias.

The study was funded by the National Institutes of Health, National Heart Lung and Blood Institute, and U.S. Environmental Protection Agency. The authors report personal fees, consultancy fees, or grants from a wide variety of pharmaceutical companies.
 

SOURCE: Oelsner EC et al. Lancet Respir Med. 2019 Oct 9. doi: 10.1016/S2213-2600(19)30276-0.

Lung function appears to continue to decline even decades after smoking cessation, according to new data from the National Heart, Lung, and Blood Institute Pooled Cohort Study. Compared with never-smokers, former smokers had a decline in forced expiratory volume in 1 second (FEV₁) about 20% as severe as current smokers, but nevertheless higher than never-smokers. Low-intensity smokers also fared worse than never-smokers, suggesting that no amount of smoke exposure should be considered safe.

bilderbox/fotolia.com

The increased decline occurred even decades after smoking cessation, according to the study published in Lancet Respiratory Medicine, which was led by Elizabeth Oelsner, MD, MPH, of Columbia University, New York. Smoking prevalence has decreased from 42% to 16% in the past 50 years, and many smokers report that they smoke fewer cigarettes per day, from an average of 21 to 14, according to the authors. Despite those trends, the prevalence of chronic obstructive pulmonary disease has continued to increase, and is now the third-leading cause of death worldwide.

A meta-analysis of 47 studies and 88,887 adults found no association between smoking and FEV₁ decline, but many of the studies were small or focused on nonrepresentative populations, and they used variably standardized spirometry.

The study pooled data from nine individual U.S. cohorts, with 25,352 participants recruited during 1983-2016. Subjects included those who underwent at least two prebronchodilator spirometry tests following American Thoracic Society standards. After adjustment, former smokers had increased FEV₁ decline of 1.82 mL/year (P less than .0001), compared with never-smokers. Current smokers had an increased decline of 9.21 mL/year (P less than .0001).

Even after decades of abstinence, the effects of smoking appeared to linger: 20-30 years later, FEV₁ loss was accelerated by 2.50 mL/year (P less than .0001), and by 0.93 mL/year (P = .0104) after 30 years, compared with never-smokers.

Even low-intensity smokers (cumulative less than 10 pack-years) had an significantly accelerated FEV₁ decline (0.87 mL; P = .0153).

The researchers also found a relationship between FEV₁ decline and intensity of current smoking: Those smoking fewer than 5 cigarettes per day had a lower decline than those smoking 30 or more (7.65 mL; 95% confidence interval, 6.21-9.09 vs. 11.24 mL; 95% CI, 9.86-12.62).

The study is limited by the fact that smoking status and daily tobacco reporting were self-reported, which could result in information bias.

The study was funded by the National Institutes of Health, National Heart Lung and Blood Institute, and U.S. Environmental Protection Agency. The authors report personal fees, consultancy fees, or grants from a wide variety of pharmaceutical companies.
 

SOURCE: Oelsner EC et al. Lancet Respir Med. 2019 Oct 9. doi: 10.1016/S2213-2600(19)30276-0.

Lung function appears to continue to decline even decades after smoking cessation, according to new data from the National Heart, Lung, and Blood Institute Pooled Cohort Study. Compared with never-smokers, former smokers had a decline in forced expiratory volume in 1 second (FEV₁) about 20% as severe as current smokers, but nevertheless higher than never-smokers. Low-intensity smokers also fared worse than never-smokers, suggesting that no amount of smoke exposure should be considered safe.

bilderbox/fotolia.com

The increased decline occurred even decades after smoking cessation, according to the study published in Lancet Respiratory Medicine, which was led by Elizabeth Oelsner, MD, MPH, of Columbia University, New York. Smoking prevalence has decreased from 42% to 16% in the past 50 years, and many smokers report that they smoke fewer cigarettes per day, from an average of 21 to 14, according to the authors. Despite those trends, the prevalence of chronic obstructive pulmonary disease has continued to increase, and is now the third-leading cause of death worldwide.

A meta-analysis of 47 studies and 88,887 adults found no association between smoking and FEV₁ decline, but many of the studies were small or focused on nonrepresentative populations, and they used variably standardized spirometry.

The study pooled data from nine individual U.S. cohorts, with 25,352 participants recruited during 1983-2016. Subjects included those who underwent at least two prebronchodilator spirometry tests following American Thoracic Society standards. After adjustment, former smokers had increased FEV₁ decline of 1.82 mL/year (P less than .0001), compared with never-smokers. Current smokers had an increased decline of 9.21 mL/year (P less than .0001).

Even after decades of abstinence, the effects of smoking appeared to linger: 20-30 years later, FEV₁ loss was accelerated by 2.50 mL/year (P less than .0001), and by 0.93 mL/year (P = .0104) after 30 years, compared with never-smokers.

Even low-intensity smokers (cumulative less than 10 pack-years) had an significantly accelerated FEV₁ decline (0.87 mL; P = .0153).

The researchers also found a relationship between FEV₁ decline and intensity of current smoking: Those smoking fewer than 5 cigarettes per day had a lower decline than those smoking 30 or more (7.65 mL; 95% confidence interval, 6.21-9.09 vs. 11.24 mL; 95% CI, 9.86-12.62).

The study is limited by the fact that smoking status and daily tobacco reporting were self-reported, which could result in information bias.

The study was funded by the National Institutes of Health, National Heart Lung and Blood Institute, and U.S. Environmental Protection Agency. The authors report personal fees, consultancy fees, or grants from a wide variety of pharmaceutical companies.
 

SOURCE: Oelsner EC et al. Lancet Respir Med. 2019 Oct 9. doi: 10.1016/S2213-2600(19)30276-0.

SEATTLE – It used to be thought that acne begins with microcomedones, which go on to develop either inflammatory lesions or noninflammatory lesions, but more recent evidence has changed that perception, according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital, Detroit.

Biopsies of acne-prone areas have found that, before the development of microcomedones, “it appears that there is inflammation around the hair follicles,” Dr. Stein Gold said at the annual Coastal Dermatology Symposium. “All acne is inflammation acne,” and inflammation also persists, she added. Biopsies of scarred lesions, once considered postinflammatory, also have revealed persistent inflammation, she noted.

One study found that persistent scars can evolve from closed comedones, papules, and pustules, but the most common was a papule that turned into a postinflammatory lesion (J Drugs Dermatol 2017 Jun 1;16[6]:566-72). “So when patients come in and they have these red spots on their face, it’s not over. There’s still time to be aggressive because those inflammatory lesions are more likely to lead to scars than anything else,” Dr. Stein Gold said. “And we also know that papules that develop into scars do so because they’re there for a longer period of time. Those that develop scars are present about 10.5 days, compared with 6.6 days for those that don’t develop into scars.”

She went on to review some of the new treatments for acne that can be brought to bear in such cases. These include developments with topical retinoids that are aimed at improving delivery and reducing skin irritation.

A new topical retinoid, trifarotene cream, 0.005%, showed efficacy and tolerability for both the face and trunk in a recent phase 3 trial of patients with moderate facial and truncal acne and was recently approved for patients aged 9 years and older. In the study, about 30%-40% of people aged 9 years and older treated with once-daily trifarotene cream (Aklief) achieved clear or almost-clear status of the face at 12 weeks, vs. about 20% and 26%, of those on the vehicle cream (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9).

The drug can also treat papules and pustules, nearly as well as it treats blackheads and whiteheads, according to Dr. Stein Gold. Like other retinoids, it produces some redness and scaling and rather than letting these adverse events discourage patients, she leans in. “I tell patients they’re going to have some sloughing of the skin the first 2 weeks. I tell them that people pay money for that. It’s called a chemical peel,” said Dr. Stein Gold, noting that patients respond well to this information.

If patients find the treatments too irritating, she advises them to avoid applying it to wet skin. They can also apply it every other night, or even less frequently, and then work up to more frequent use, she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

Tazarotene is another topical retinoid that can be very irritating. A new lotion formulation of tazarotene 0.045% contains a lower dose than the 0.1% typically used in creams, and has similar efficacy but reduced irritation, Dr. Stein Gold said. In August, the manufacturer submitted an application for approval with the Food and Drug Administration for treatment of acne.

Dr. Stein Gold also talked about using retinoids to minimize scarring, referring to a study of patients with moderate and severe facial acne, and atrophic acne scars, comparing adapalene 0.3% plus benzoyl peroxide 2.5% gel on one side of the face and vehicle on the other side of the face for 24 weeks, followed by application of the active treatment to both sides of the face for 24 weeks. Treatment was associated with a reduction of atrophic acne scars at 24 weeks, which was maintained for up to 48 weeks (Am J Clin Dermatol. 2019 Oct[5];20:725-32).

“We can now say to patients, ‘Not only can I help you with your acne, but I can potentially even improve your atrophic scarring,’ ” she said.

Finally, she discussed clascoterone, a novel androgen receptor antagonist, which inhibits sebum production and prevents colonization by Cutibacterium acnes (formerly called Propionibacterium acnes) and subsequent inflammation. “It does a lot of good things in terms of the pathogenesis of acne, but more importantly, it is one of the first drugs that topically has been shown to decrease the production of sebum,” Dr. Stein Gold said. A 1% cream formulation is being studied for acne.

Dr. Stein Gold is a consultant, investigator, and/or speaker for Galderma, Ortho Derm, Sol Gel, Foamix, Cassiopea, and Almirall.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – It used to be thought that acne begins with microcomedones, which go on to develop either inflammatory lesions or noninflammatory lesions, but more recent evidence has changed that perception, according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital, Detroit.

Biopsies of acne-prone areas have found that, before the development of microcomedones, “it appears that there is inflammation around the hair follicles,” Dr. Stein Gold said at the annual Coastal Dermatology Symposium. “All acne is inflammation acne,” and inflammation also persists, she added. Biopsies of scarred lesions, once considered postinflammatory, also have revealed persistent inflammation, she noted.

One study found that persistent scars can evolve from closed comedones, papules, and pustules, but the most common was a papule that turned into a postinflammatory lesion (J Drugs Dermatol 2017 Jun 1;16[6]:566-72). “So when patients come in and they have these red spots on their face, it’s not over. There’s still time to be aggressive because those inflammatory lesions are more likely to lead to scars than anything else,” Dr. Stein Gold said. “And we also know that papules that develop into scars do so because they’re there for a longer period of time. Those that develop scars are present about 10.5 days, compared with 6.6 days for those that don’t develop into scars.”

She went on to review some of the new treatments for acne that can be brought to bear in such cases. These include developments with topical retinoids that are aimed at improving delivery and reducing skin irritation.

A new topical retinoid, trifarotene cream, 0.005%, showed efficacy and tolerability for both the face and trunk in a recent phase 3 trial of patients with moderate facial and truncal acne and was recently approved for patients aged 9 years and older. In the study, about 30%-40% of people aged 9 years and older treated with once-daily trifarotene cream (Aklief) achieved clear or almost-clear status of the face at 12 weeks, vs. about 20% and 26%, of those on the vehicle cream (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9).

The drug can also treat papules and pustules, nearly as well as it treats blackheads and whiteheads, according to Dr. Stein Gold. Like other retinoids, it produces some redness and scaling and rather than letting these adverse events discourage patients, she leans in. “I tell patients they’re going to have some sloughing of the skin the first 2 weeks. I tell them that people pay money for that. It’s called a chemical peel,” said Dr. Stein Gold, noting that patients respond well to this information.

If patients find the treatments too irritating, she advises them to avoid applying it to wet skin. They can also apply it every other night, or even less frequently, and then work up to more frequent use, she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

Tazarotene is another topical retinoid that can be very irritating. A new lotion formulation of tazarotene 0.045% contains a lower dose than the 0.1% typically used in creams, and has similar efficacy but reduced irritation, Dr. Stein Gold said. In August, the manufacturer submitted an application for approval with the Food and Drug Administration for treatment of acne.

Dr. Stein Gold also talked about using retinoids to minimize scarring, referring to a study of patients with moderate and severe facial acne, and atrophic acne scars, comparing adapalene 0.3% plus benzoyl peroxide 2.5% gel on one side of the face and vehicle on the other side of the face for 24 weeks, followed by application of the active treatment to both sides of the face for 24 weeks. Treatment was associated with a reduction of atrophic acne scars at 24 weeks, which was maintained for up to 48 weeks (Am J Clin Dermatol. 2019 Oct[5];20:725-32).

“We can now say to patients, ‘Not only can I help you with your acne, but I can potentially even improve your atrophic scarring,’ ” she said.

Finally, she discussed clascoterone, a novel androgen receptor antagonist, which inhibits sebum production and prevents colonization by Cutibacterium acnes (formerly called Propionibacterium acnes) and subsequent inflammation. “It does a lot of good things in terms of the pathogenesis of acne, but more importantly, it is one of the first drugs that topically has been shown to decrease the production of sebum,” Dr. Stein Gold said. A 1% cream formulation is being studied for acne.

Dr. Stein Gold is a consultant, investigator, and/or speaker for Galderma, Ortho Derm, Sol Gel, Foamix, Cassiopea, and Almirall.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – It used to be thought that acne begins with microcomedones, which go on to develop either inflammatory lesions or noninflammatory lesions, but more recent evidence has changed that perception, according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital, Detroit.

Biopsies of acne-prone areas have found that, before the development of microcomedones, “it appears that there is inflammation around the hair follicles,” Dr. Stein Gold said at the annual Coastal Dermatology Symposium. “All acne is inflammation acne,” and inflammation also persists, she added. Biopsies of scarred lesions, once considered postinflammatory, also have revealed persistent inflammation, she noted.

One study found that persistent scars can evolve from closed comedones, papules, and pustules, but the most common was a papule that turned into a postinflammatory lesion (J Drugs Dermatol 2017 Jun 1;16[6]:566-72). “So when patients come in and they have these red spots on their face, it’s not over. There’s still time to be aggressive because those inflammatory lesions are more likely to lead to scars than anything else,” Dr. Stein Gold said. “And we also know that papules that develop into scars do so because they’re there for a longer period of time. Those that develop scars are present about 10.5 days, compared with 6.6 days for those that don’t develop into scars.”

She went on to review some of the new treatments for acne that can be brought to bear in such cases. These include developments with topical retinoids that are aimed at improving delivery and reducing skin irritation.

A new topical retinoid, trifarotene cream, 0.005%, showed efficacy and tolerability for both the face and trunk in a recent phase 3 trial of patients with moderate facial and truncal acne and was recently approved for patients aged 9 years and older. In the study, about 30%-40% of people aged 9 years and older treated with once-daily trifarotene cream (Aklief) achieved clear or almost-clear status of the face at 12 weeks, vs. about 20% and 26%, of those on the vehicle cream (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9).

The drug can also treat papules and pustules, nearly as well as it treats blackheads and whiteheads, according to Dr. Stein Gold. Like other retinoids, it produces some redness and scaling and rather than letting these adverse events discourage patients, she leans in. “I tell patients they’re going to have some sloughing of the skin the first 2 weeks. I tell them that people pay money for that. It’s called a chemical peel,” said Dr. Stein Gold, noting that patients respond well to this information.

If patients find the treatments too irritating, she advises them to avoid applying it to wet skin. They can also apply it every other night, or even less frequently, and then work up to more frequent use, she said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

Tazarotene is another topical retinoid that can be very irritating. A new lotion formulation of tazarotene 0.045% contains a lower dose than the 0.1% typically used in creams, and has similar efficacy but reduced irritation, Dr. Stein Gold said. In August, the manufacturer submitted an application for approval with the Food and Drug Administration for treatment of acne.

Dr. Stein Gold also talked about using retinoids to minimize scarring, referring to a study of patients with moderate and severe facial acne, and atrophic acne scars, comparing adapalene 0.3% plus benzoyl peroxide 2.5% gel on one side of the face and vehicle on the other side of the face for 24 weeks, followed by application of the active treatment to both sides of the face for 24 weeks. Treatment was associated with a reduction of atrophic acne scars at 24 weeks, which was maintained for up to 48 weeks (Am J Clin Dermatol. 2019 Oct[5];20:725-32).

“We can now say to patients, ‘Not only can I help you with your acne, but I can potentially even improve your atrophic scarring,’ ” she said.

Finally, she discussed clascoterone, a novel androgen receptor antagonist, which inhibits sebum production and prevents colonization by Cutibacterium acnes (formerly called Propionibacterium acnes) and subsequent inflammation. “It does a lot of good things in terms of the pathogenesis of acne, but more importantly, it is one of the first drugs that topically has been shown to decrease the production of sebum,” Dr. Stein Gold said. A 1% cream formulation is being studied for acne.

Dr. Stein Gold is a consultant, investigator, and/or speaker for Galderma, Ortho Derm, Sol Gel, Foamix, Cassiopea, and Almirall.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Treatment of psoriasis has been profoundly impacted by the advent of biologic therapies, but “topical therapy is not dead,” Linda Stein Gold, MD, said at the annual Coastal Dermatology Symposium.

Jim Kling/MDedge News

“We have to remember when we think back to our practice, how many topical prescriptions do we write, compared to preventive prescriptions? Probably most are topical,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Hospital Center, Detroit.

Topical agents have a place when a patient is doing well on treatment with a biologic but is not responding completely, she noted. One open-label, single-arm study looked at adjunctive calcipotriene 0.005%/betamethasone dipropionate 0.064% (Enstilar) foam, applied once daily for 4 week, then twice a week on consecutive days for 12 weeks in 25 patients with psoriasis who had a mean body surface area (BSA) of less than 5% but significant remaining disease despite treatment with biologics.

At week 4, 76% achieved a BSA of 1% or less and Physician’s Global Assessment score of 1 or less at week 4, as did 68% at week 16. This was compared with 12% and 4%, respectively (J Drugs Dermatol. 2018 Aug 1;17[8]:845-50). “They found that a good potent topical on top of a biologic does really well. That can really kick up the last part of the efficacy to get the patients almost to clear,” she observed.

At the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education, Dr. Stein Gold also discussed tazarotene, a topical retinoid approved by the Food and Drug Administration for treating psoriasis and is available as a 0.1% and 0.05% cream and gel. About 10%-30% of patients experience side effects with tazarotene, such as pruritus, stinging, and burning. Topical corticosteroids can help, which prompted development of a combined product, she noted.

She referred to a phase 2 study of patients with moderate to severe plaque psoriasis, which compared the fixed combination lotion formulation of tazarotene plus halobetasol propionate to the two components alone. The investigators found almost a 9% rate of treatment success with tazarotene alone, versus about 23% with halobetasol propionate alone and about 43% with the combined product. The combined individual effect of the two drugs was about 32%, so the 43% efficacy of the combined product had an absolute synergistic effect of about 11%, Dr. Stein Gold pointed out.

Two phase 3 trials of adults with moderate to severe psoriasis supported the phase 2 results of the combined lotion formulation (halobetasol 0.01% with tazarotene 0.045%), said Dr. Stein Gold, the first author (J Am Acad Dermatol. 2018 Aug;79[2]:287-93). Treatment success was defined as at least a 2-grade Investigator’s Global Assessment score and improvement from baseline and a score of “clear” or “almost clear.” In one of the studies, 36% of those on the combination versus 7% of those on the vehicle met this endpoint at week 8, as did 45% versus 13%, respectively, in the second study (P less than .001 for both studies).

Patients also had less itching, drying, and stinging than typically seen with tazarotene alone, Dr. Stein Gold said. In the studies, contact dermatitis was the most common side effect associated with treatment, reported in 6.3%

Dr. Stein Gold has received research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, and Foamix. She has been a consultant for Sol-gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promis, Anacor, and Medimetriks. She has been on the speakers bureau of Galderma, Leo, Valeant, Novartis, Celgene, and Allergan. She has been a member of scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, and Promius.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Treatment of psoriasis has been profoundly impacted by the advent of biologic therapies, but “topical therapy is not dead,” Linda Stein Gold, MD, said at the annual Coastal Dermatology Symposium.

Jim Kling/MDedge News

“We have to remember when we think back to our practice, how many topical prescriptions do we write, compared to preventive prescriptions? Probably most are topical,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Hospital Center, Detroit.

Topical agents have a place when a patient is doing well on treatment with a biologic but is not responding completely, she noted. One open-label, single-arm study looked at adjunctive calcipotriene 0.005%/betamethasone dipropionate 0.064% (Enstilar) foam, applied once daily for 4 week, then twice a week on consecutive days for 12 weeks in 25 patients with psoriasis who had a mean body surface area (BSA) of less than 5% but significant remaining disease despite treatment with biologics.

At week 4, 76% achieved a BSA of 1% or less and Physician’s Global Assessment score of 1 or less at week 4, as did 68% at week 16. This was compared with 12% and 4%, respectively (J Drugs Dermatol. 2018 Aug 1;17[8]:845-50). “They found that a good potent topical on top of a biologic does really well. That can really kick up the last part of the efficacy to get the patients almost to clear,” she observed.

At the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education, Dr. Stein Gold also discussed tazarotene, a topical retinoid approved by the Food and Drug Administration for treating psoriasis and is available as a 0.1% and 0.05% cream and gel. About 10%-30% of patients experience side effects with tazarotene, such as pruritus, stinging, and burning. Topical corticosteroids can help, which prompted development of a combined product, she noted.

She referred to a phase 2 study of patients with moderate to severe plaque psoriasis, which compared the fixed combination lotion formulation of tazarotene plus halobetasol propionate to the two components alone. The investigators found almost a 9% rate of treatment success with tazarotene alone, versus about 23% with halobetasol propionate alone and about 43% with the combined product. The combined individual effect of the two drugs was about 32%, so the 43% efficacy of the combined product had an absolute synergistic effect of about 11%, Dr. Stein Gold pointed out.

Two phase 3 trials of adults with moderate to severe psoriasis supported the phase 2 results of the combined lotion formulation (halobetasol 0.01% with tazarotene 0.045%), said Dr. Stein Gold, the first author (J Am Acad Dermatol. 2018 Aug;79[2]:287-93). Treatment success was defined as at least a 2-grade Investigator’s Global Assessment score and improvement from baseline and a score of “clear” or “almost clear.” In one of the studies, 36% of those on the combination versus 7% of those on the vehicle met this endpoint at week 8, as did 45% versus 13%, respectively, in the second study (P less than .001 for both studies).

Patients also had less itching, drying, and stinging than typically seen with tazarotene alone, Dr. Stein Gold said. In the studies, contact dermatitis was the most common side effect associated with treatment, reported in 6.3%

Dr. Stein Gold has received research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, and Foamix. She has been a consultant for Sol-gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promis, Anacor, and Medimetriks. She has been on the speakers bureau of Galderma, Leo, Valeant, Novartis, Celgene, and Allergan. She has been a member of scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, and Promius.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Treatment of psoriasis has been profoundly impacted by the advent of biologic therapies, but “topical therapy is not dead,” Linda Stein Gold, MD, said at the annual Coastal Dermatology Symposium.

Jim Kling/MDedge News

“We have to remember when we think back to our practice, how many topical prescriptions do we write, compared to preventive prescriptions? Probably most are topical,” said Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Hospital Center, Detroit.

Topical agents have a place when a patient is doing well on treatment with a biologic but is not responding completely, she noted. One open-label, single-arm study looked at adjunctive calcipotriene 0.005%/betamethasone dipropionate 0.064% (Enstilar) foam, applied once daily for 4 week, then twice a week on consecutive days for 12 weeks in 25 patients with psoriasis who had a mean body surface area (BSA) of less than 5% but significant remaining disease despite treatment with biologics.

At week 4, 76% achieved a BSA of 1% or less and Physician’s Global Assessment score of 1 or less at week 4, as did 68% at week 16. This was compared with 12% and 4%, respectively (J Drugs Dermatol. 2018 Aug 1;17[8]:845-50). “They found that a good potent topical on top of a biologic does really well. That can really kick up the last part of the efficacy to get the patients almost to clear,” she observed.

At the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education, Dr. Stein Gold also discussed tazarotene, a topical retinoid approved by the Food and Drug Administration for treating psoriasis and is available as a 0.1% and 0.05% cream and gel. About 10%-30% of patients experience side effects with tazarotene, such as pruritus, stinging, and burning. Topical corticosteroids can help, which prompted development of a combined product, she noted.

She referred to a phase 2 study of patients with moderate to severe plaque psoriasis, which compared the fixed combination lotion formulation of tazarotene plus halobetasol propionate to the two components alone. The investigators found almost a 9% rate of treatment success with tazarotene alone, versus about 23% with halobetasol propionate alone and about 43% with the combined product. The combined individual effect of the two drugs was about 32%, so the 43% efficacy of the combined product had an absolute synergistic effect of about 11%, Dr. Stein Gold pointed out.

Two phase 3 trials of adults with moderate to severe psoriasis supported the phase 2 results of the combined lotion formulation (halobetasol 0.01% with tazarotene 0.045%), said Dr. Stein Gold, the first author (J Am Acad Dermatol. 2018 Aug;79[2]:287-93). Treatment success was defined as at least a 2-grade Investigator’s Global Assessment score and improvement from baseline and a score of “clear” or “almost clear.” In one of the studies, 36% of those on the combination versus 7% of those on the vehicle met this endpoint at week 8, as did 45% versus 13%, respectively, in the second study (P less than .001 for both studies).

Patients also had less itching, drying, and stinging than typically seen with tazarotene alone, Dr. Stein Gold said. In the studies, contact dermatitis was the most common side effect associated with treatment, reported in 6.3%

Dr. Stein Gold has received research support from Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, and Foamix. She has been a consultant for Sol-gel, Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, Promis, Anacor, and Medimetriks. She has been on the speakers bureau of Galderma, Leo, Valeant, Novartis, Celgene, and Allergan. She has been a member of scientific advisory boards for Galderma, Leo, Novan, Valeant, Dermira, Novartis, Celgene, Allergan, Foamix, and Promius.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – While current treatments for actinic keratosis include variations on light therapy and strategies such as field cancerization, the nitrogen tank in the corner of the office is likely to stay, David Pariser, MD, said during a presentation at the annual Coastal Dermatology Symposium.

“My personal view is that, no matter how good other treatments are eventually going to be, we’re never going to give that up,” Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

During the presentation, he emphasized that it isn’t always clear which actinic keratosis (AK) should be treated and which can be left alone, since most AKs don’t progress to squamous cell carcinoma (SCC). “We know that most squamous cell carcinomas arise near AKs, and many of them have histologic evidence” of AK/SCC continuum at the periphery, he said. Sun protection reduces the incidence of AKs and the incidence of nonmelanoma skin cancer, “so it’s a logical conclusion that treating AKs reduces the development of SCCs, but there are no data to show that.”

Generally, treatment decisions are made based on the presence of symptoms, location, or appearance; if the area is irritated; or there is a progressive or unusual appearance, especially if hyperkeratotic. Physician or patient concerns about cancer can prompt treatment, as should a history of multiple skin cancers or the presence of immunosuppression, he said.

Treatment options include cryosurgery, surgery, topical agents, and photodynamic therapy (PDT); Dr. Pariser focused on the latter because it is a special interest of his.

Field cancerization is based on the idea that a broad area of cells may be at risk for developing into SCC, rather than just individual AKs. Treatment with methyl 5-aminolevulinate (MAL) can reveal the extent of a problem. In some patients, “you can see a lot of fluorescence in areas that look reasonably clinically normal. So this is a piece of evidence of this field cancerization, that maybe we shouldn’t be treating individual AKs, but larger areas,” Dr. Pariser said.

With PDT, there has been some debate about how long to leave the photosensitizer on the skin before applying the light. The longer it remains, the more it spreads to nerves, which can lead to pain during the procedure. A clinical trial comparing 1-, 2-, and 3-hour wait times showed no difference in efficacy. “So 1 hour is what I do for AKs, that’s it,” Dr. Pariser said.

There are two Food and Drug Administration–approved PDT systems, a blue-light system combined with aminolevulinic acid (ALA) and a newer red-light system combined with a nanoemulsion of ALA 7.8% and a proprietary 635-nm red LED light. The nanoemulsion has the theoretical advantage in that it can penetrate more deeply into the epidermis, though this isn’t really an issue when treating AKs, according to Dr. Pariser.

A study comparing nanoemulsion of ALA, compared with a MAL cream, found the nanoemulsion to be superior in achieving complete clearance of all lesions at 12 weeks (78.2% vs. 64.2%; P less than .05). Both treatments achieved best efficacy with LED lamps, and the proprietary red light may reduce pain by allowing use of lower light intensity (Br J Dermatol. 2012 Jan; 166[1]:137-46).

Another study, Dr. Pariser said, looked at whether occlusion during drug incubation improves outcomes of blue light ALA-PDT (J Drugs Dermatol. 2012;11[12]:1483-9). Patients underwent split occlusion on the upper extremities before undergoing blue-light treatment. The median clearance rate of AKs at 8 weeks was higher with occlusion, compared with the nonoccluded areas (75% vs. 47%; P = .006), and at 12 weeks, after a second treatment (89% vs. 70%; P = .00029). There was a higher efficacy with a 3-hour incubation period, compared with studies using a 2-hour incubation period.

Application of heat can also boost success rates by increasing the synthesis of the photoactive agent, Dr. Pariser said. One study found that a simple heating pad applied to the area treated with ALA-PDT and blue light led to an 88% reduction in lesions at 8 and 24 weeks, compared with a reduction of 71% at 8 weeks and 68% at 24 weeks without heat (P less than .0001). “So if you want to give PDT a little extra oomph, add occlusion and heat,” he commented.

He also pointed out the availability of a new 4% 5-fluorouracil cream that contains peanut oil, which has similar efficacy to 5% 5-fluorouracil cream but has been associated with less pruritus, stinging/burning, edema, crusting, scaling/dryness, erosion, and erythema (J Drugs Dermatol. 2016 Oct 1;15[10]: 1218-24).

Dr. Pariser is an investigator and consultant for DUSA/Sun Pharma, Photocure, LEO Pharma, and Biofrontera. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – While current treatments for actinic keratosis include variations on light therapy and strategies such as field cancerization, the nitrogen tank in the corner of the office is likely to stay, David Pariser, MD, said during a presentation at the annual Coastal Dermatology Symposium.

“My personal view is that, no matter how good other treatments are eventually going to be, we’re never going to give that up,” Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

During the presentation, he emphasized that it isn’t always clear which actinic keratosis (AK) should be treated and which can be left alone, since most AKs don’t progress to squamous cell carcinoma (SCC). “We know that most squamous cell carcinomas arise near AKs, and many of them have histologic evidence” of AK/SCC continuum at the periphery, he said. Sun protection reduces the incidence of AKs and the incidence of nonmelanoma skin cancer, “so it’s a logical conclusion that treating AKs reduces the development of SCCs, but there are no data to show that.”

Generally, treatment decisions are made based on the presence of symptoms, location, or appearance; if the area is irritated; or there is a progressive or unusual appearance, especially if hyperkeratotic. Physician or patient concerns about cancer can prompt treatment, as should a history of multiple skin cancers or the presence of immunosuppression, he said.

Treatment options include cryosurgery, surgery, topical agents, and photodynamic therapy (PDT); Dr. Pariser focused on the latter because it is a special interest of his.

Field cancerization is based on the idea that a broad area of cells may be at risk for developing into SCC, rather than just individual AKs. Treatment with methyl 5-aminolevulinate (MAL) can reveal the extent of a problem. In some patients, “you can see a lot of fluorescence in areas that look reasonably clinically normal. So this is a piece of evidence of this field cancerization, that maybe we shouldn’t be treating individual AKs, but larger areas,” Dr. Pariser said.

With PDT, there has been some debate about how long to leave the photosensitizer on the skin before applying the light. The longer it remains, the more it spreads to nerves, which can lead to pain during the procedure. A clinical trial comparing 1-, 2-, and 3-hour wait times showed no difference in efficacy. “So 1 hour is what I do for AKs, that’s it,” Dr. Pariser said.

There are two Food and Drug Administration–approved PDT systems, a blue-light system combined with aminolevulinic acid (ALA) and a newer red-light system combined with a nanoemulsion of ALA 7.8% and a proprietary 635-nm red LED light. The nanoemulsion has the theoretical advantage in that it can penetrate more deeply into the epidermis, though this isn’t really an issue when treating AKs, according to Dr. Pariser.

A study comparing nanoemulsion of ALA, compared with a MAL cream, found the nanoemulsion to be superior in achieving complete clearance of all lesions at 12 weeks (78.2% vs. 64.2%; P less than .05). Both treatments achieved best efficacy with LED lamps, and the proprietary red light may reduce pain by allowing use of lower light intensity (Br J Dermatol. 2012 Jan; 166[1]:137-46).

Another study, Dr. Pariser said, looked at whether occlusion during drug incubation improves outcomes of blue light ALA-PDT (J Drugs Dermatol. 2012;11[12]:1483-9). Patients underwent split occlusion on the upper extremities before undergoing blue-light treatment. The median clearance rate of AKs at 8 weeks was higher with occlusion, compared with the nonoccluded areas (75% vs. 47%; P = .006), and at 12 weeks, after a second treatment (89% vs. 70%; P = .00029). There was a higher efficacy with a 3-hour incubation period, compared with studies using a 2-hour incubation period.

Application of heat can also boost success rates by increasing the synthesis of the photoactive agent, Dr. Pariser said. One study found that a simple heating pad applied to the area treated with ALA-PDT and blue light led to an 88% reduction in lesions at 8 and 24 weeks, compared with a reduction of 71% at 8 weeks and 68% at 24 weeks without heat (P less than .0001). “So if you want to give PDT a little extra oomph, add occlusion and heat,” he commented.

He also pointed out the availability of a new 4% 5-fluorouracil cream that contains peanut oil, which has similar efficacy to 5% 5-fluorouracil cream but has been associated with less pruritus, stinging/burning, edema, crusting, scaling/dryness, erosion, and erythema (J Drugs Dermatol. 2016 Oct 1;15[10]: 1218-24).

Dr. Pariser is an investigator and consultant for DUSA/Sun Pharma, Photocure, LEO Pharma, and Biofrontera. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – While current treatments for actinic keratosis include variations on light therapy and strategies such as field cancerization, the nitrogen tank in the corner of the office is likely to stay, David Pariser, MD, said during a presentation at the annual Coastal Dermatology Symposium.

“My personal view is that, no matter how good other treatments are eventually going to be, we’re never going to give that up,” Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk, said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

During the presentation, he emphasized that it isn’t always clear which actinic keratosis (AK) should be treated and which can be left alone, since most AKs don’t progress to squamous cell carcinoma (SCC). “We know that most squamous cell carcinomas arise near AKs, and many of them have histologic evidence” of AK/SCC continuum at the periphery, he said. Sun protection reduces the incidence of AKs and the incidence of nonmelanoma skin cancer, “so it’s a logical conclusion that treating AKs reduces the development of SCCs, but there are no data to show that.”

Generally, treatment decisions are made based on the presence of symptoms, location, or appearance; if the area is irritated; or there is a progressive or unusual appearance, especially if hyperkeratotic. Physician or patient concerns about cancer can prompt treatment, as should a history of multiple skin cancers or the presence of immunosuppression, he said.

Treatment options include cryosurgery, surgery, topical agents, and photodynamic therapy (PDT); Dr. Pariser focused on the latter because it is a special interest of his.

Field cancerization is based on the idea that a broad area of cells may be at risk for developing into SCC, rather than just individual AKs. Treatment with methyl 5-aminolevulinate (MAL) can reveal the extent of a problem. In some patients, “you can see a lot of fluorescence in areas that look reasonably clinically normal. So this is a piece of evidence of this field cancerization, that maybe we shouldn’t be treating individual AKs, but larger areas,” Dr. Pariser said.

With PDT, there has been some debate about how long to leave the photosensitizer on the skin before applying the light. The longer it remains, the more it spreads to nerves, which can lead to pain during the procedure. A clinical trial comparing 1-, 2-, and 3-hour wait times showed no difference in efficacy. “So 1 hour is what I do for AKs, that’s it,” Dr. Pariser said.

There are two Food and Drug Administration–approved PDT systems, a blue-light system combined with aminolevulinic acid (ALA) and a newer red-light system combined with a nanoemulsion of ALA 7.8% and a proprietary 635-nm red LED light. The nanoemulsion has the theoretical advantage in that it can penetrate more deeply into the epidermis, though this isn’t really an issue when treating AKs, according to Dr. Pariser.

A study comparing nanoemulsion of ALA, compared with a MAL cream, found the nanoemulsion to be superior in achieving complete clearance of all lesions at 12 weeks (78.2% vs. 64.2%; P less than .05). Both treatments achieved best efficacy with LED lamps, and the proprietary red light may reduce pain by allowing use of lower light intensity (Br J Dermatol. 2012 Jan; 166[1]:137-46).

Another study, Dr. Pariser said, looked at whether occlusion during drug incubation improves outcomes of blue light ALA-PDT (J Drugs Dermatol. 2012;11[12]:1483-9). Patients underwent split occlusion on the upper extremities before undergoing blue-light treatment. The median clearance rate of AKs at 8 weeks was higher with occlusion, compared with the nonoccluded areas (75% vs. 47%; P = .006), and at 12 weeks, after a second treatment (89% vs. 70%; P = .00029). There was a higher efficacy with a 3-hour incubation period, compared with studies using a 2-hour incubation period.

Application of heat can also boost success rates by increasing the synthesis of the photoactive agent, Dr. Pariser said. One study found that a simple heating pad applied to the area treated with ALA-PDT and blue light led to an 88% reduction in lesions at 8 and 24 weeks, compared with a reduction of 71% at 8 weeks and 68% at 24 weeks without heat (P less than .0001). “So if you want to give PDT a little extra oomph, add occlusion and heat,” he commented.

He also pointed out the availability of a new 4% 5-fluorouracil cream that contains peanut oil, which has similar efficacy to 5% 5-fluorouracil cream but has been associated with less pruritus, stinging/burning, edema, crusting, scaling/dryness, erosion, and erythema (J Drugs Dermatol. 2016 Oct 1;15[10]: 1218-24).

Dr. Pariser is an investigator and consultant for DUSA/Sun Pharma, Photocure, LEO Pharma, and Biofrontera. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Immunodeficiency in children can look much like eczematous dermatitis. Be aware of this potential diagnosis.

Jim Kling/MDedge News

“Although it is important to know these are extremely rare conditions, you don’t want to miss them because you can literally change that child’s life,” Markus Boos, MD, an assistant professor of pediatrics at the University of Washington, Seattle, said in an interview at the annual Coastal Dermatology Symposium.

He outlined some key clinical features and patient history that can raise a potential red flag.

“Many primary immunodeficiencies present with a scaly red rash, but these can often be distinguished if you take a thoughtful history, and you really spend time looking at the morphology and distribution of the rash,” Dr. Boos said.

The distribution of the rash also can be distinctive. For example, hyper-IgE syndrome shows up as little red pus bumps that are widespread, but specifically occur on the face and other areas that usually aren’t affected eczematous dermatitis. “You should really focus on that, and not just assume that because something [like eczematous dermatitis] is common, everything has to be that,” Dr. Boos said at the meeting, which was jointly presented by the University of Louisville and Global Academy for Medical Education.

He also warned about a false positive. You may be alerted to high eosinophil and high IgE levels determined by a primary care physician’s tests, but these aren’t necessarily a strong indicator of hyper-IgE syndrome, he said. “Many inflammatory conditions in children have high levels of both those, so they aren’t a distinguishing feature of any one of them. You can reassure a family that the child doesn’t necessarily have hyper-IgE syndrome. There’s this leap [people take] because it sounds like the name, but it’s not a very specific marker of that particular condition.”

Patient history of an immunodeficiency patient in general obviously can include a history of infections, although a high rate of ear infections is pretty typical among children. The key is to ask yourself: “At what point does it seem like something that is beyond normal?” Dr. Boos said. Infections that required hospitalizations or were invasive or required antibiotics all are potential clues. Other factors to consider include growth and development issues such as frequent diarrhea or failure to thrive, or family members with frequent infections or who died prematurely.

Hyper-IgE patients also may have a prominent forehead and chin, deep-set eyes, broad nose, thickened facial skin, or a high arched palate. These physical features become more prominent by adolescence. For a reference for physical features go to https://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-types/hyper-ige-syndrome.

Clinical features of various immunodeficiencies include the following:

• Papulopustular eruption with frequent infections and musculoskeletal changes. This presentation is suggestive of autosomal dominant hyper-IgE syndrome. These children have a “heterozygous mutation in the gene encoding the transcription factor STAT3,” according to the Immune Deficiency Foundation.
• Severe atopy with extensive warts/molluscum/herpes simplex virus. This presentation is suggestive of autosomal recessive hyper-IgE syndrome. These children have “mutations and deletions in the DOCK8 gene,” the Immune Deficiency Foundation asserts.
• Diffusely red baby. Consider immunodeficiency if the patient also has experienced failure to thrive and/or diarrhea, or has a history of infection. High IgE levels are not a strong signal of hyper-IgE syndrome.
• Severe eczematous (or psoriasiform) dermatitis with chronic diarrhea, failure to thrive, and diabetes or hypothyroidism. This presentation is suggestive of IPEX syndrome (immune dysregulation, polyendocrinopathy, enteropathy, X-linked).
• Atopic dermatitis with bloody diarrhea, thrombocytopenia, recurrent ear infections. This presentation is indicative of Wiskott-Aldrich syndrome.

Dr. Boos is personally familiar with primary immunodeficiencies because he works closely with an immunology clinic, which also means he has a lot of support. Most clinicians diagnosing these patients don’t. If you find yourself with a case, “call in the troops,” he advised. You should be connected to a rheumatologist when there’s evidence of autoimmune disease, and hematologists or oncologists for the treatment, which requires a bone marrow transplant in the case of autosomal recessive hyper-IgE syndrome. Otherwise treatment is largely supportive for this immunodeficiency.

Having that network can be invaluable in managing what can be a very complicated patient. “If you ever feel uncomfortable making a decision about their care, discussing it with those other providers can give you some peace of mind,” he said.

Dr. Boos disclosed that he is a clinical researcher for Regeneron. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Immunodeficiency in children can look much like eczematous dermatitis. Be aware of this potential diagnosis.

Jim Kling/MDedge News

“Although it is important to know these are extremely rare conditions, you don’t want to miss them because you can literally change that child’s life,” Markus Boos, MD, an assistant professor of pediatrics at the University of Washington, Seattle, said in an interview at the annual Coastal Dermatology Symposium.

He outlined some key clinical features and patient history that can raise a potential red flag.

“Many primary immunodeficiencies present with a scaly red rash, but these can often be distinguished if you take a thoughtful history, and you really spend time looking at the morphology and distribution of the rash,” Dr. Boos said.

The distribution of the rash also can be distinctive. For example, hyper-IgE syndrome shows up as little red pus bumps that are widespread, but specifically occur on the face and other areas that usually aren’t affected eczematous dermatitis. “You should really focus on that, and not just assume that because something [like eczematous dermatitis] is common, everything has to be that,” Dr. Boos said at the meeting, which was jointly presented by the University of Louisville and Global Academy for Medical Education.

He also warned about a false positive. You may be alerted to high eosinophil and high IgE levels determined by a primary care physician’s tests, but these aren’t necessarily a strong indicator of hyper-IgE syndrome, he said. “Many inflammatory conditions in children have high levels of both those, so they aren’t a distinguishing feature of any one of them. You can reassure a family that the child doesn’t necessarily have hyper-IgE syndrome. There’s this leap [people take] because it sounds like the name, but it’s not a very specific marker of that particular condition.”

Patient history of an immunodeficiency patient in general obviously can include a history of infections, although a high rate of ear infections is pretty typical among children. The key is to ask yourself: “At what point does it seem like something that is beyond normal?” Dr. Boos said. Infections that required hospitalizations or were invasive or required antibiotics all are potential clues. Other factors to consider include growth and development issues such as frequent diarrhea or failure to thrive, or family members with frequent infections or who died prematurely.

Hyper-IgE patients also may have a prominent forehead and chin, deep-set eyes, broad nose, thickened facial skin, or a high arched palate. These physical features become more prominent by adolescence. For a reference for physical features go to https://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-types/hyper-ige-syndrome.

Clinical features of various immunodeficiencies include the following:

• Papulopustular eruption with frequent infections and musculoskeletal changes. This presentation is suggestive of autosomal dominant hyper-IgE syndrome. These children have a “heterozygous mutation in the gene encoding the transcription factor STAT3,” according to the Immune Deficiency Foundation.
• Severe atopy with extensive warts/molluscum/herpes simplex virus. This presentation is suggestive of autosomal recessive hyper-IgE syndrome. These children have “mutations and deletions in the DOCK8 gene,” the Immune Deficiency Foundation asserts.
• Diffusely red baby. Consider immunodeficiency if the patient also has experienced failure to thrive and/or diarrhea, or has a history of infection. High IgE levels are not a strong signal of hyper-IgE syndrome.
• Severe eczematous (or psoriasiform) dermatitis with chronic diarrhea, failure to thrive, and diabetes or hypothyroidism. This presentation is suggestive of IPEX syndrome (immune dysregulation, polyendocrinopathy, enteropathy, X-linked).
• Atopic dermatitis with bloody diarrhea, thrombocytopenia, recurrent ear infections. This presentation is indicative of Wiskott-Aldrich syndrome.

Dr. Boos is personally familiar with primary immunodeficiencies because he works closely with an immunology clinic, which also means he has a lot of support. Most clinicians diagnosing these patients don’t. If you find yourself with a case, “call in the troops,” he advised. You should be connected to a rheumatologist when there’s evidence of autoimmune disease, and hematologists or oncologists for the treatment, which requires a bone marrow transplant in the case of autosomal recessive hyper-IgE syndrome. Otherwise treatment is largely supportive for this immunodeficiency.

Having that network can be invaluable in managing what can be a very complicated patient. “If you ever feel uncomfortable making a decision about their care, discussing it with those other providers can give you some peace of mind,” he said.

Dr. Boos disclosed that he is a clinical researcher for Regeneron. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Immunodeficiency in children can look much like eczematous dermatitis. Be aware of this potential diagnosis.

Jim Kling/MDedge News

“Although it is important to know these are extremely rare conditions, you don’t want to miss them because you can literally change that child’s life,” Markus Boos, MD, an assistant professor of pediatrics at the University of Washington, Seattle, said in an interview at the annual Coastal Dermatology Symposium.

He outlined some key clinical features and patient history that can raise a potential red flag.

“Many primary immunodeficiencies present with a scaly red rash, but these can often be distinguished if you take a thoughtful history, and you really spend time looking at the morphology and distribution of the rash,” Dr. Boos said.

The distribution of the rash also can be distinctive. For example, hyper-IgE syndrome shows up as little red pus bumps that are widespread, but specifically occur on the face and other areas that usually aren’t affected eczematous dermatitis. “You should really focus on that, and not just assume that because something [like eczematous dermatitis] is common, everything has to be that,” Dr. Boos said at the meeting, which was jointly presented by the University of Louisville and Global Academy for Medical Education.

He also warned about a false positive. You may be alerted to high eosinophil and high IgE levels determined by a primary care physician’s tests, but these aren’t necessarily a strong indicator of hyper-IgE syndrome, he said. “Many inflammatory conditions in children have high levels of both those, so they aren’t a distinguishing feature of any one of them. You can reassure a family that the child doesn’t necessarily have hyper-IgE syndrome. There’s this leap [people take] because it sounds like the name, but it’s not a very specific marker of that particular condition.”

Patient history of an immunodeficiency patient in general obviously can include a history of infections, although a high rate of ear infections is pretty typical among children. The key is to ask yourself: “At what point does it seem like something that is beyond normal?” Dr. Boos said. Infections that required hospitalizations or were invasive or required antibiotics all are potential clues. Other factors to consider include growth and development issues such as frequent diarrhea or failure to thrive, or family members with frequent infections or who died prematurely.

Hyper-IgE patients also may have a prominent forehead and chin, deep-set eyes, broad nose, thickened facial skin, or a high arched palate. These physical features become more prominent by adolescence. For a reference for physical features go to https://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-types/hyper-ige-syndrome.

Clinical features of various immunodeficiencies include the following:

• Papulopustular eruption with frequent infections and musculoskeletal changes. This presentation is suggestive of autosomal dominant hyper-IgE syndrome. These children have a “heterozygous mutation in the gene encoding the transcription factor STAT3,” according to the Immune Deficiency Foundation.
• Severe atopy with extensive warts/molluscum/herpes simplex virus. This presentation is suggestive of autosomal recessive hyper-IgE syndrome. These children have “mutations and deletions in the DOCK8 gene,” the Immune Deficiency Foundation asserts.
• Diffusely red baby. Consider immunodeficiency if the patient also has experienced failure to thrive and/or diarrhea, or has a history of infection. High IgE levels are not a strong signal of hyper-IgE syndrome.
• Severe eczematous (or psoriasiform) dermatitis with chronic diarrhea, failure to thrive, and diabetes or hypothyroidism. This presentation is suggestive of IPEX syndrome (immune dysregulation, polyendocrinopathy, enteropathy, X-linked).
• Atopic dermatitis with bloody diarrhea, thrombocytopenia, recurrent ear infections. This presentation is indicative of Wiskott-Aldrich syndrome.

Dr. Boos is personally familiar with primary immunodeficiencies because he works closely with an immunology clinic, which also means he has a lot of support. Most clinicians diagnosing these patients don’t. If you find yourself with a case, “call in the troops,” he advised. You should be connected to a rheumatologist when there’s evidence of autoimmune disease, and hematologists or oncologists for the treatment, which requires a bone marrow transplant in the case of autosomal recessive hyper-IgE syndrome. Otherwise treatment is largely supportive for this immunodeficiency.

Having that network can be invaluable in managing what can be a very complicated patient. “If you ever feel uncomfortable making a decision about their care, discussing it with those other providers can give you some peace of mind,” he said.

Dr. Boos disclosed that he is a clinical researcher for Regeneron. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – After years of relying on oral anticholinergics for treating hyperhidrosis, more options have recently become available, David Pariser, MD, said at the annual Coastal Dermatology Symposium.

Koldunov/Thinkstock

Hyperhidrosis is among the dermatological conditions that have the greatest impact on quality of life, and it can be particularly concerning to teens, said Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk. He referred to some new developments for an old, often misunderstood, standby: antiperspirants. “I am amazed that many people do not know the difference between an antiperspirant and a deodorant,” he said, pointing out that antiperspirants contain active ingredients – aluminum and zirconium salts – that block sweat glands, while deodorants contain a masking fragrance.

There are new-generation topical antiperspirants available over the counter, with descriptions that include “clinical strength” or “clinical protection” on the labels; they come in a box and cost about twice as much as standard products. “But they are better, and they work just as well as some of the commercial preparations,” Dr. Pariser said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

One issue he highlighted was that antiperspirants are often misapplied. They shouldn’t be applied on wet skin because they react with water to create hydrochloric acid, which can irritate the skin, he said. The best time to apply an antiperspirant is right before bedtime, since it gives the salts time to clog sweat pores before sweat or water can interfere. “The plugs last for a couple of days,” so there’s no need to worry about rinsing the product off during a morning shower, he noted.

Additional therapeutic options include agents like oral glycopyrrolate, starting at a low dose (1 mg twice per day), increasing by 1 mg/day weekly until efficacy is achieved or limited by adverse events. There is also a glycopyrrolate oral solution 1mg/5ml (Cuvposa) that can be used in children.

A topical version of the anticholinergic glycopyrronium tosylate, applied using an infused cloth, was approved for treating axillary hyperhidrosis in June2018 and offers the potential for an enhanced local anticholinergic effect. Dr. Pariser, one of the authors, discussed the recently published results of two pivotal studies that found good improvement in a specially-designed quality of life endpoint (J Am Acad Derm. 2019; Jan;80[1]:128-138.e2).

Efficacy in a subanalysis of 44 pediatric subjects (ages 9-16 years) was similar as those reported in adults, and the rate of those reporting dry mouth (24% in both age groups) was similar. Of concern was a 16% rate of mydriasis in the pediatric group, compared with 6% in the older group. One patient even wound up in the emergency room for a stroke work-up as a result, said Dr. Pariser, who is confident that the problem was caused by inadvertent exposure to the eye during application. He advises patients to avoid contact with the eyes.

Other approaches to treatment of hyperhidrosis include oxybutynin, iontophoresis, an microwave thermolysis (which may also reduce odor and hair). Endoscopic thoracic sympathectomy is effective but is the most invasive option; botulinum toxin is a minimally invasive alternative to surgery.

For those who sweat when they experience anxiety, propranolol 5-10 mg taken about 1 hour before an event that could cause hyperhydrosis can be effective, said Dr. Pariser, who recommends a test dose. “I don’t normally tell patients to try something at home. But they should try this at home” before using it prior to an important event, he added.

Dr. Pariser is a consultant and/or investigator for Dermira, Brickell Biotech, TheraVida, Atacama, TDI Surgitech, Dermavant, and Revance Therapeutics. He has not done commercial speaking, has not been on speaker’s bureaus, and has no stock or options in any company.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – After years of relying on oral anticholinergics for treating hyperhidrosis, more options have recently become available, David Pariser, MD, said at the annual Coastal Dermatology Symposium.

Koldunov/Thinkstock

Hyperhidrosis is among the dermatological conditions that have the greatest impact on quality of life, and it can be particularly concerning to teens, said Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk. He referred to some new developments for an old, often misunderstood, standby: antiperspirants. “I am amazed that many people do not know the difference between an antiperspirant and a deodorant,” he said, pointing out that antiperspirants contain active ingredients – aluminum and zirconium salts – that block sweat glands, while deodorants contain a masking fragrance.

There are new-generation topical antiperspirants available over the counter, with descriptions that include “clinical strength” or “clinical protection” on the labels; they come in a box and cost about twice as much as standard products. “But they are better, and they work just as well as some of the commercial preparations,” Dr. Pariser said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

One issue he highlighted was that antiperspirants are often misapplied. They shouldn’t be applied on wet skin because they react with water to create hydrochloric acid, which can irritate the skin, he said. The best time to apply an antiperspirant is right before bedtime, since it gives the salts time to clog sweat pores before sweat or water can interfere. “The plugs last for a couple of days,” so there’s no need to worry about rinsing the product off during a morning shower, he noted.

Additional therapeutic options include agents like oral glycopyrrolate, starting at a low dose (1 mg twice per day), increasing by 1 mg/day weekly until efficacy is achieved or limited by adverse events. There is also a glycopyrrolate oral solution 1mg/5ml (Cuvposa) that can be used in children.

A topical version of the anticholinergic glycopyrronium tosylate, applied using an infused cloth, was approved for treating axillary hyperhidrosis in June2018 and offers the potential for an enhanced local anticholinergic effect. Dr. Pariser, one of the authors, discussed the recently published results of two pivotal studies that found good improvement in a specially-designed quality of life endpoint (J Am Acad Derm. 2019; Jan;80[1]:128-138.e2).

Efficacy in a subanalysis of 44 pediatric subjects (ages 9-16 years) was similar as those reported in adults, and the rate of those reporting dry mouth (24% in both age groups) was similar. Of concern was a 16% rate of mydriasis in the pediatric group, compared with 6% in the older group. One patient even wound up in the emergency room for a stroke work-up as a result, said Dr. Pariser, who is confident that the problem was caused by inadvertent exposure to the eye during application. He advises patients to avoid contact with the eyes.

Other approaches to treatment of hyperhidrosis include oxybutynin, iontophoresis, an microwave thermolysis (which may also reduce odor and hair). Endoscopic thoracic sympathectomy is effective but is the most invasive option; botulinum toxin is a minimally invasive alternative to surgery.

For those who sweat when they experience anxiety, propranolol 5-10 mg taken about 1 hour before an event that could cause hyperhydrosis can be effective, said Dr. Pariser, who recommends a test dose. “I don’t normally tell patients to try something at home. But they should try this at home” before using it prior to an important event, he added.

Dr. Pariser is a consultant and/or investigator for Dermira, Brickell Biotech, TheraVida, Atacama, TDI Surgitech, Dermavant, and Revance Therapeutics. He has not done commercial speaking, has not been on speaker’s bureaus, and has no stock or options in any company.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – After years of relying on oral anticholinergics for treating hyperhidrosis, more options have recently become available, David Pariser, MD, said at the annual Coastal Dermatology Symposium.

Koldunov/Thinkstock

Hyperhidrosis is among the dermatological conditions that have the greatest impact on quality of life, and it can be particularly concerning to teens, said Dr. Pariser, professor of dermatology at Eastern Virginia Medical School, Norfolk. He referred to some new developments for an old, often misunderstood, standby: antiperspirants. “I am amazed that many people do not know the difference between an antiperspirant and a deodorant,” he said, pointing out that antiperspirants contain active ingredients – aluminum and zirconium salts – that block sweat glands, while deodorants contain a masking fragrance.

There are new-generation topical antiperspirants available over the counter, with descriptions that include “clinical strength” or “clinical protection” on the labels; they come in a box and cost about twice as much as standard products. “But they are better, and they work just as well as some of the commercial preparations,” Dr. Pariser said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.

One issue he highlighted was that antiperspirants are often misapplied. They shouldn’t be applied on wet skin because they react with water to create hydrochloric acid, which can irritate the skin, he said. The best time to apply an antiperspirant is right before bedtime, since it gives the salts time to clog sweat pores before sweat or water can interfere. “The plugs last for a couple of days,” so there’s no need to worry about rinsing the product off during a morning shower, he noted.

Additional therapeutic options include agents like oral glycopyrrolate, starting at a low dose (1 mg twice per day), increasing by 1 mg/day weekly until efficacy is achieved or limited by adverse events. There is also a glycopyrrolate oral solution 1mg/5ml (Cuvposa) that can be used in children.

A topical version of the anticholinergic glycopyrronium tosylate, applied using an infused cloth, was approved for treating axillary hyperhidrosis in June2018 and offers the potential for an enhanced local anticholinergic effect. Dr. Pariser, one of the authors, discussed the recently published results of two pivotal studies that found good improvement in a specially-designed quality of life endpoint (J Am Acad Derm. 2019; Jan;80[1]:128-138.e2).

Efficacy in a subanalysis of 44 pediatric subjects (ages 9-16 years) was similar as those reported in adults, and the rate of those reporting dry mouth (24% in both age groups) was similar. Of concern was a 16% rate of mydriasis in the pediatric group, compared with 6% in the older group. One patient even wound up in the emergency room for a stroke work-up as a result, said Dr. Pariser, who is confident that the problem was caused by inadvertent exposure to the eye during application. He advises patients to avoid contact with the eyes.

Other approaches to treatment of hyperhidrosis include oxybutynin, iontophoresis, an microwave thermolysis (which may also reduce odor and hair). Endoscopic thoracic sympathectomy is effective but is the most invasive option; botulinum toxin is a minimally invasive alternative to surgery.

For those who sweat when they experience anxiety, propranolol 5-10 mg taken about 1 hour before an event that could cause hyperhydrosis can be effective, said Dr. Pariser, who recommends a test dose. “I don’t normally tell patients to try something at home. But they should try this at home” before using it prior to an important event, he added.

Dr. Pariser is a consultant and/or investigator for Dermira, Brickell Biotech, TheraVida, Atacama, TDI Surgitech, Dermavant, and Revance Therapeutics. He has not done commercial speaking, has not been on speaker’s bureaus, and has no stock or options in any company.

This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Psoriasis is a complex condition, made more difficult by comorbidities. Psoriatic arthritis is the most common and is frequently discussed. But mental health issues and cardiovascular events also co-occur and can present major complications, according to Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, who discussed psoriasis comorbidities at the annual Coastal Dermatology Symposium.

Mental health–related issues associated with psoriasis (Psychiatr Danub. 2017 Dec;29[4]:401-6) include sleep disorders (prevalence, 62%), sexual dysfunction (46%), personality disorder (35%), anxiety (30%), adjustment (29%), and depressive disorders (28%); 25% of patients have an accompanying substance abuse disorder. Suicidal ideation and suicidal depression are particularly concerning, and a meta-analysis (J Am Acad Dermatol. 2017 Sep;77[3]:425-40.e2) showed a 44% increased risk of suicidal ideation associated with psoriasis.

Such problems aren’t surprising, since psoriasis is a lifelong disease, and many patients’ symptoms aren’t adequately controlled. “A lot of these patients get topical therapies, which is probably not enough, especially if they have severe disease,” said Dr. Wu in an interview.

Dermatologists can sometimes be nervous about biologics because of concerns over increased risk of infection or cancer. That can lead to conservative, topical treatment. Dr. Wu feels that rare side effects shouldn’t deter from aggressive treatment, when appropriate. “It’s better to treat the patient to make sure they’re clear, which may improve their comorbidities as well. In general, if you’re worried, you can send them to other specialists to do monitoring,” Dr. Wu said in the interview.

Different treatment methods may influence mental health outcomes, according to the PSOLAR study (J Am Acad Dermatol. 2018 Jan;78[1]:70-80). It examined the issue prospectively with over 12,000 psoriasis patients, and found a depression incidence of 3.01 per 100-patient years when treated with biologics, compared with 5.85 for phototherapy and 5.70 for conventional therapy. Put another way, exposure to biologics was associated with a reduced risk of depression, compared with conventional therapies (hazard ratio, 0.76; P = .0367). “It seems to show that biologics have a better improvement of depression symptoms, compared to phototherapy or oral therapy,” said Dr. Wu.

Those results suggest that dermatologists should be on the lookout for mental health issues, though that is a challenge for someone not trained in the field. Dr. Wu takes a simple approach. “I like just asking open-ended questions, like how they’re doing, and if you get a sense that maybe they’re depressed, ask more specific questions about their mood, how they’re feeling, how things are at work, how things are at home.” When things aren’t right, “the key is to try to get them on something that’s going to clear them very quickly. If it’s severe disease, use a biologic that’s going to clear it very quickly,” he added.

Unfortunately, just being clear isn’t a complete guarantee of improved mental health. Dr. Wu had two patients who committed suicide despite significant skin improvement. Patients may have between-visit flare-ups, or regular injections may be a reminder that psoriasis is an ongoing health struggle. Or patients may have other psychological concerns. That underlines the importance of awareness of mental health issues. “You don’t need to refer everyone [to a mental health specialist], but you should have a rolodex where you have someone you can send a patient to if you’re worried,” said Dr. Wu.

As with mental health issues, psoriasis patients are also at elevated risk for a wide range of cardiovascular comorbidities, such as diabetes, dyslipidemia, and high blood pressure. “As a dermatologist, you may not want to screen for these things, but you can send them to their primary care doctor or a cardiologist,” Dr. Wu said in the interview.

Also like mental health issues, there is evidence that treatment with biologics may have an outsized protective effect. One study (J Eur Acad Dermatol Venereol. 2018 Mar 24. doi: 10.1111/jdv.14951) led by Dr. Wu showed that treatment with a tumor necrosis factor (TNF)–alpha inhibitor led to a significant reduction in major adverse cardiac events, compared with topical therapy (propensity score–adjusted HR, 0.80; 95% CI, 0.66-0.98), while phototherapy or oral therapy trended towards an increased risk (adjusted HR, 1.13; 95% CI, 1.00-1.28). Another analysis (J Am Acad Dermatol. 2017 Jan;76[1]:81-90) from Dr. Wu’s group that included about 380,000 psoriasis patients found that treatment with TNF-alpha inhibitors was associated with fewer major cardiovascular events, compared with treatment with methotrexate (adjusted HR, 0.55; P less than .0001). Individual analyses showed associated reductions in stroke or transient ischemic attack (aHR, 0.55; P less than .0001), unstable angina (aHR, 0.58; P = .0024), and MI (aHR, 0.49; P = .0002). TNF-alpha inhibitors also seem to beat out phototherapy with respect to major cardiovascular events (aHR, 0.77; P = .046. J Am Acad Dermatol. 2018 Jul;79[1]:60-6).

More direct evidence of the benefit of biologics comes from the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31), which randomized more than 10,000 patients with cryopyrin-associated periodic syndromes to receive the IL-1 beta-blocker canakinumab or placebo. Canakinumab was associated with significant reductions in nonfatal MI, nonfatal stroke, or cardiovascular death at 150 mg (HR, 0.85; P = .021) and 300 mg (HR, 0.86; P = .031), but not at 50 mg.

The bottom line, said Dr. Wu, is that psoriasis and psoriatic arthritis should be treated early with TNF-alpha inhibitors or IL-17 inhibitors in an effort to improve mental health, cardiovascular, and psoriatic arthritis outcomes.

Dr. Wu has been a consultant or speaker for, or done research on behalf of, AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Regeneron, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America.

The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Psoriasis is a complex condition, made more difficult by comorbidities. Psoriatic arthritis is the most common and is frequently discussed. But mental health issues and cardiovascular events also co-occur and can present major complications, according to Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, who discussed psoriasis comorbidities at the annual Coastal Dermatology Symposium.

Mental health–related issues associated with psoriasis (Psychiatr Danub. 2017 Dec;29[4]:401-6) include sleep disorders (prevalence, 62%), sexual dysfunction (46%), personality disorder (35%), anxiety (30%), adjustment (29%), and depressive disorders (28%); 25% of patients have an accompanying substance abuse disorder. Suicidal ideation and suicidal depression are particularly concerning, and a meta-analysis (J Am Acad Dermatol. 2017 Sep;77[3]:425-40.e2) showed a 44% increased risk of suicidal ideation associated with psoriasis.

Such problems aren’t surprising, since psoriasis is a lifelong disease, and many patients’ symptoms aren’t adequately controlled. “A lot of these patients get topical therapies, which is probably not enough, especially if they have severe disease,” said Dr. Wu in an interview.

Dermatologists can sometimes be nervous about biologics because of concerns over increased risk of infection or cancer. That can lead to conservative, topical treatment. Dr. Wu feels that rare side effects shouldn’t deter from aggressive treatment, when appropriate. “It’s better to treat the patient to make sure they’re clear, which may improve their comorbidities as well. In general, if you’re worried, you can send them to other specialists to do monitoring,” Dr. Wu said in the interview.

Different treatment methods may influence mental health outcomes, according to the PSOLAR study (J Am Acad Dermatol. 2018 Jan;78[1]:70-80). It examined the issue prospectively with over 12,000 psoriasis patients, and found a depression incidence of 3.01 per 100-patient years when treated with biologics, compared with 5.85 for phototherapy and 5.70 for conventional therapy. Put another way, exposure to biologics was associated with a reduced risk of depression, compared with conventional therapies (hazard ratio, 0.76; P = .0367). “It seems to show that biologics have a better improvement of depression symptoms, compared to phototherapy or oral therapy,” said Dr. Wu.

Those results suggest that dermatologists should be on the lookout for mental health issues, though that is a challenge for someone not trained in the field. Dr. Wu takes a simple approach. “I like just asking open-ended questions, like how they’re doing, and if you get a sense that maybe they’re depressed, ask more specific questions about their mood, how they’re feeling, how things are at work, how things are at home.” When things aren’t right, “the key is to try to get them on something that’s going to clear them very quickly. If it’s severe disease, use a biologic that’s going to clear it very quickly,” he added.

Unfortunately, just being clear isn’t a complete guarantee of improved mental health. Dr. Wu had two patients who committed suicide despite significant skin improvement. Patients may have between-visit flare-ups, or regular injections may be a reminder that psoriasis is an ongoing health struggle. Or patients may have other psychological concerns. That underlines the importance of awareness of mental health issues. “You don’t need to refer everyone [to a mental health specialist], but you should have a rolodex where you have someone you can send a patient to if you’re worried,” said Dr. Wu.

As with mental health issues, psoriasis patients are also at elevated risk for a wide range of cardiovascular comorbidities, such as diabetes, dyslipidemia, and high blood pressure. “As a dermatologist, you may not want to screen for these things, but you can send them to their primary care doctor or a cardiologist,” Dr. Wu said in the interview.

Also like mental health issues, there is evidence that treatment with biologics may have an outsized protective effect. One study (J Eur Acad Dermatol Venereol. 2018 Mar 24. doi: 10.1111/jdv.14951) led by Dr. Wu showed that treatment with a tumor necrosis factor (TNF)–alpha inhibitor led to a significant reduction in major adverse cardiac events, compared with topical therapy (propensity score–adjusted HR, 0.80; 95% CI, 0.66-0.98), while phototherapy or oral therapy trended towards an increased risk (adjusted HR, 1.13; 95% CI, 1.00-1.28). Another analysis (J Am Acad Dermatol. 2017 Jan;76[1]:81-90) from Dr. Wu’s group that included about 380,000 psoriasis patients found that treatment with TNF-alpha inhibitors was associated with fewer major cardiovascular events, compared with treatment with methotrexate (adjusted HR, 0.55; P less than .0001). Individual analyses showed associated reductions in stroke or transient ischemic attack (aHR, 0.55; P less than .0001), unstable angina (aHR, 0.58; P = .0024), and MI (aHR, 0.49; P = .0002). TNF-alpha inhibitors also seem to beat out phototherapy with respect to major cardiovascular events (aHR, 0.77; P = .046. J Am Acad Dermatol. 2018 Jul;79[1]:60-6).

More direct evidence of the benefit of biologics comes from the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31), which randomized more than 10,000 patients with cryopyrin-associated periodic syndromes to receive the IL-1 beta-blocker canakinumab or placebo. Canakinumab was associated with significant reductions in nonfatal MI, nonfatal stroke, or cardiovascular death at 150 mg (HR, 0.85; P = .021) and 300 mg (HR, 0.86; P = .031), but not at 50 mg.

The bottom line, said Dr. Wu, is that psoriasis and psoriatic arthritis should be treated early with TNF-alpha inhibitors or IL-17 inhibitors in an effort to improve mental health, cardiovascular, and psoriatic arthritis outcomes.

Dr. Wu has been a consultant or speaker for, or done research on behalf of, AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Regeneron, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America.

The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.

SEATTLE – Psoriasis is a complex condition, made more difficult by comorbidities. Psoriatic arthritis is the most common and is frequently discussed. But mental health issues and cardiovascular events also co-occur and can present major complications, according to Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation, who discussed psoriasis comorbidities at the annual Coastal Dermatology Symposium.

Mental health–related issues associated with psoriasis (Psychiatr Danub. 2017 Dec;29[4]:401-6) include sleep disorders (prevalence, 62%), sexual dysfunction (46%), personality disorder (35%), anxiety (30%), adjustment (29%), and depressive disorders (28%); 25% of patients have an accompanying substance abuse disorder. Suicidal ideation and suicidal depression are particularly concerning, and a meta-analysis (J Am Acad Dermatol. 2017 Sep;77[3]:425-40.e2) showed a 44% increased risk of suicidal ideation associated with psoriasis.

Such problems aren’t surprising, since psoriasis is a lifelong disease, and many patients’ symptoms aren’t adequately controlled. “A lot of these patients get topical therapies, which is probably not enough, especially if they have severe disease,” said Dr. Wu in an interview.

Dermatologists can sometimes be nervous about biologics because of concerns over increased risk of infection or cancer. That can lead to conservative, topical treatment. Dr. Wu feels that rare side effects shouldn’t deter from aggressive treatment, when appropriate. “It’s better to treat the patient to make sure they’re clear, which may improve their comorbidities as well. In general, if you’re worried, you can send them to other specialists to do monitoring,” Dr. Wu said in the interview.

Different treatment methods may influence mental health outcomes, according to the PSOLAR study (J Am Acad Dermatol. 2018 Jan;78[1]:70-80). It examined the issue prospectively with over 12,000 psoriasis patients, and found a depression incidence of 3.01 per 100-patient years when treated with biologics, compared with 5.85 for phototherapy and 5.70 for conventional therapy. Put another way, exposure to biologics was associated with a reduced risk of depression, compared with conventional therapies (hazard ratio, 0.76; P = .0367). “It seems to show that biologics have a better improvement of depression symptoms, compared to phototherapy or oral therapy,” said Dr. Wu.

Those results suggest that dermatologists should be on the lookout for mental health issues, though that is a challenge for someone not trained in the field. Dr. Wu takes a simple approach. “I like just asking open-ended questions, like how they’re doing, and if you get a sense that maybe they’re depressed, ask more specific questions about their mood, how they’re feeling, how things are at work, how things are at home.” When things aren’t right, “the key is to try to get them on something that’s going to clear them very quickly. If it’s severe disease, use a biologic that’s going to clear it very quickly,” he added.

Unfortunately, just being clear isn’t a complete guarantee of improved mental health. Dr. Wu had two patients who committed suicide despite significant skin improvement. Patients may have between-visit flare-ups, or regular injections may be a reminder that psoriasis is an ongoing health struggle. Or patients may have other psychological concerns. That underlines the importance of awareness of mental health issues. “You don’t need to refer everyone [to a mental health specialist], but you should have a rolodex where you have someone you can send a patient to if you’re worried,” said Dr. Wu.

As with mental health issues, psoriasis patients are also at elevated risk for a wide range of cardiovascular comorbidities, such as diabetes, dyslipidemia, and high blood pressure. “As a dermatologist, you may not want to screen for these things, but you can send them to their primary care doctor or a cardiologist,” Dr. Wu said in the interview.

Also like mental health issues, there is evidence that treatment with biologics may have an outsized protective effect. One study (J Eur Acad Dermatol Venereol. 2018 Mar 24. doi: 10.1111/jdv.14951) led by Dr. Wu showed that treatment with a tumor necrosis factor (TNF)–alpha inhibitor led to a significant reduction in major adverse cardiac events, compared with topical therapy (propensity score–adjusted HR, 0.80; 95% CI, 0.66-0.98), while phototherapy or oral therapy trended towards an increased risk (adjusted HR, 1.13; 95% CI, 1.00-1.28). Another analysis (J Am Acad Dermatol. 2017 Jan;76[1]:81-90) from Dr. Wu’s group that included about 380,000 psoriasis patients found that treatment with TNF-alpha inhibitors was associated with fewer major cardiovascular events, compared with treatment with methotrexate (adjusted HR, 0.55; P less than .0001). Individual analyses showed associated reductions in stroke or transient ischemic attack (aHR, 0.55; P less than .0001), unstable angina (aHR, 0.58; P = .0024), and MI (aHR, 0.49; P = .0002). TNF-alpha inhibitors also seem to beat out phototherapy with respect to major cardiovascular events (aHR, 0.77; P = .046. J Am Acad Dermatol. 2018 Jul;79[1]:60-6).

More direct evidence of the benefit of biologics comes from the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31), which randomized more than 10,000 patients with cryopyrin-associated periodic syndromes to receive the IL-1 beta-blocker canakinumab or placebo. Canakinumab was associated with significant reductions in nonfatal MI, nonfatal stroke, or cardiovascular death at 150 mg (HR, 0.85; P = .021) and 300 mg (HR, 0.86; P = .031), but not at 50 mg.

The bottom line, said Dr. Wu, is that psoriasis and psoriatic arthritis should be treated early with TNF-alpha inhibitors or IL-17 inhibitors in an effort to improve mental health, cardiovascular, and psoriatic arthritis outcomes.

Dr. Wu has been a consultant or speaker for, or done research on behalf of, AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Regeneron, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America.

The meeting is jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.