Amy Karon

SAN FRANCISCO– Dupilumab met its safety endpoints and significantly outperformed placebo for adults with moderate to severe atopic dermatitis, according to final results of a multicenter, international phase IIb study.

At all five doses tested, the biologic significantly improved atopic dermatitis (AD) compared with placebo based on multiple clinical measures, Dr. Lisa A. Beck said at the annual meeting of the American Academy of Dermatology. The highest dose of 300 mg given either weekly or every two weeks provided the most consistent benefits, added Dr. Beck of the University of Rochester Medical Center, Rochester, New York.

Atopic dermatitis (eczema) is caused by immune dysregulation and altered skin barrier function, though the relative contribution of each process is still under debate, Dr. Beck said. Dupilumab is a monoclonal antibody designed to block intracellular signaling by the interleukin 4 and IL-13 cytokines, which are thought to mediate many features of AD.

The study included 380 patients in Europe, the United States, Canada, and Japan who had moderate to severe AD that was inadequately controlled by topical corticosteroids or calcineurin inhibitors. At baseline, patients had been living with AD for more than three years and at least 10% of their body surface area was affected. Patients were randomized to weekly, biweekly, or monthly subcutaneous injections of dupilumab at doses of 300 mg, 200 mg, or 100 mg, or to placebo. The groups were demographically similar.

After 16 weeks of treatment, a linear regression model of Eczema Area and Severity Index (EASI) scores strongly favored dupilumab over placebo and indicated a dose-response trend, Dr. Beck reported. Based on the model, EASI scores dropped by about 45% for the low-dose group, by 63% to 65% for the intermediate-dose groups, by 68% for the high-dose group treated every two weeks, and by almost 74% for patients treated with 300 mg weekly. In contrast, the placebo group improved by about 18% (all P-values < .0001).

About 80% of patients who received the most intensive regimen (300 mg dupilumab weekly) achieved EASI-50, while about 60% achieved EASI-75 and close to 40% achieved EASI-90 (all P-values < .0001 compared with placebo). Responses for the lower-dose cohorts again indicated a dose-response trend. “Even the lowest dose showed an improvement, but it tended to lose that effect through the treatment phase,” Dr. Beck said.

Dupilumab also beat placebo on the Scoring Atopic Dermatitis (SCORAD) assessment, with estimated improvements in AD ranging from 26% for the low-dose group to the 57% for the high-dose group treated weekly, compared with about 14% for placebo (P < .05). Analyses of body surface area (BSA) ranged from about a 26% improvement for the low-dose group to more than 65% for the highest-dose, compared with about 8% for placebo (P < .05).

“We saw really significant drops in BSA with the highest dose group, and the BSA response was very much in line with the response in terms of signs of the disease,” Dr. Beck said. During every week of treatment, patients on dupilumab also reported significant improvements in pruritus compared with placebo based on a numerical rating scale.

Researchers assessed dupilumab’s safety through week 32, and found no dose-limiting adverse events. The dupilumab groups had slightly greater rates of headache, injection site reactions, and conjunctivitis. “We did see a trend of slightly greater herpes infections in the dupilumab-treated patients,” Dr. Beck said. “But if you look at other viral infections, there was no difference, and also herpes infections were highest in the lowest dose group. More studies need to be done to ferret out whether that’s real.”

Regeneron Pharmaceuticals is the maker of dupilumab. Dr. Beck reported having been the principal investigator at her site for the Regeneron trials of dupilumab in AD, and having consulted with the company on study design. She reported having no other relevant disclosures.

SAN FRANCISCO– Dupilumab met its safety endpoints and significantly outperformed placebo for adults with moderate to severe atopic dermatitis, according to final results of a multicenter, international phase IIb study.

At all five doses tested, the biologic significantly improved atopic dermatitis (AD) compared with placebo based on multiple clinical measures, Dr. Lisa A. Beck said at the annual meeting of the American Academy of Dermatology. The highest dose of 300 mg given either weekly or every two weeks provided the most consistent benefits, added Dr. Beck of the University of Rochester Medical Center, Rochester, New York.

Atopic dermatitis (eczema) is caused by immune dysregulation and altered skin barrier function, though the relative contribution of each process is still under debate, Dr. Beck said. Dupilumab is a monoclonal antibody designed to block intracellular signaling by the interleukin 4 and IL-13 cytokines, which are thought to mediate many features of AD.

The study included 380 patients in Europe, the United States, Canada, and Japan who had moderate to severe AD that was inadequately controlled by topical corticosteroids or calcineurin inhibitors. At baseline, patients had been living with AD for more than three years and at least 10% of their body surface area was affected. Patients were randomized to weekly, biweekly, or monthly subcutaneous injections of dupilumab at doses of 300 mg, 200 mg, or 100 mg, or to placebo. The groups were demographically similar.

After 16 weeks of treatment, a linear regression model of Eczema Area and Severity Index (EASI) scores strongly favored dupilumab over placebo and indicated a dose-response trend, Dr. Beck reported. Based on the model, EASI scores dropped by about 45% for the low-dose group, by 63% to 65% for the intermediate-dose groups, by 68% for the high-dose group treated every two weeks, and by almost 74% for patients treated with 300 mg weekly. In contrast, the placebo group improved by about 18% (all P-values < .0001).

About 80% of patients who received the most intensive regimen (300 mg dupilumab weekly) achieved EASI-50, while about 60% achieved EASI-75 and close to 40% achieved EASI-90 (all P-values < .0001 compared with placebo). Responses for the lower-dose cohorts again indicated a dose-response trend. “Even the lowest dose showed an improvement, but it tended to lose that effect through the treatment phase,” Dr. Beck said.

Dupilumab also beat placebo on the Scoring Atopic Dermatitis (SCORAD) assessment, with estimated improvements in AD ranging from 26% for the low-dose group to the 57% for the high-dose group treated weekly, compared with about 14% for placebo (P < .05). Analyses of body surface area (BSA) ranged from about a 26% improvement for the low-dose group to more than 65% for the highest-dose, compared with about 8% for placebo (P < .05).

“We saw really significant drops in BSA with the highest dose group, and the BSA response was very much in line with the response in terms of signs of the disease,” Dr. Beck said. During every week of treatment, patients on dupilumab also reported significant improvements in pruritus compared with placebo based on a numerical rating scale.

Researchers assessed dupilumab’s safety through week 32, and found no dose-limiting adverse events. The dupilumab groups had slightly greater rates of headache, injection site reactions, and conjunctivitis. “We did see a trend of slightly greater herpes infections in the dupilumab-treated patients,” Dr. Beck said. “But if you look at other viral infections, there was no difference, and also herpes infections were highest in the lowest dose group. More studies need to be done to ferret out whether that’s real.”

Regeneron Pharmaceuticals is the maker of dupilumab. Dr. Beck reported having been the principal investigator at her site for the Regeneron trials of dupilumab in AD, and having consulted with the company on study design. She reported having no other relevant disclosures.

SAN FRANCISCO– Dupilumab met its safety endpoints and significantly outperformed placebo for adults with moderate to severe atopic dermatitis, according to final results of a multicenter, international phase IIb study.

At all five doses tested, the biologic significantly improved atopic dermatitis (AD) compared with placebo based on multiple clinical measures, Dr. Lisa A. Beck said at the annual meeting of the American Academy of Dermatology. The highest dose of 300 mg given either weekly or every two weeks provided the most consistent benefits, added Dr. Beck of the University of Rochester Medical Center, Rochester, New York.

Atopic dermatitis (eczema) is caused by immune dysregulation and altered skin barrier function, though the relative contribution of each process is still under debate, Dr. Beck said. Dupilumab is a monoclonal antibody designed to block intracellular signaling by the interleukin 4 and IL-13 cytokines, which are thought to mediate many features of AD.

The study included 380 patients in Europe, the United States, Canada, and Japan who had moderate to severe AD that was inadequately controlled by topical corticosteroids or calcineurin inhibitors. At baseline, patients had been living with AD for more than three years and at least 10% of their body surface area was affected. Patients were randomized to weekly, biweekly, or monthly subcutaneous injections of dupilumab at doses of 300 mg, 200 mg, or 100 mg, or to placebo. The groups were demographically similar.

After 16 weeks of treatment, a linear regression model of Eczema Area and Severity Index (EASI) scores strongly favored dupilumab over placebo and indicated a dose-response trend, Dr. Beck reported. Based on the model, EASI scores dropped by about 45% for the low-dose group, by 63% to 65% for the intermediate-dose groups, by 68% for the high-dose group treated every two weeks, and by almost 74% for patients treated with 300 mg weekly. In contrast, the placebo group improved by about 18% (all P-values < .0001).

About 80% of patients who received the most intensive regimen (300 mg dupilumab weekly) achieved EASI-50, while about 60% achieved EASI-75 and close to 40% achieved EASI-90 (all P-values < .0001 compared with placebo). Responses for the lower-dose cohorts again indicated a dose-response trend. “Even the lowest dose showed an improvement, but it tended to lose that effect through the treatment phase,” Dr. Beck said.

Dupilumab also beat placebo on the Scoring Atopic Dermatitis (SCORAD) assessment, with estimated improvements in AD ranging from 26% for the low-dose group to the 57% for the high-dose group treated weekly, compared with about 14% for placebo (P < .05). Analyses of body surface area (BSA) ranged from about a 26% improvement for the low-dose group to more than 65% for the highest-dose, compared with about 8% for placebo (P < .05).

“We saw really significant drops in BSA with the highest dose group, and the BSA response was very much in line with the response in terms of signs of the disease,” Dr. Beck said. During every week of treatment, patients on dupilumab also reported significant improvements in pruritus compared with placebo based on a numerical rating scale.

Researchers assessed dupilumab’s safety through week 32, and found no dose-limiting adverse events. The dupilumab groups had slightly greater rates of headache, injection site reactions, and conjunctivitis. “We did see a trend of slightly greater herpes infections in the dupilumab-treated patients,” Dr. Beck said. “But if you look at other viral infections, there was no difference, and also herpes infections were highest in the lowest dose group. More studies need to be done to ferret out whether that’s real.”

Regeneron Pharmaceuticals is the maker of dupilumab. Dr. Beck reported having been the principal investigator at her site for the Regeneron trials of dupilumab in AD, and having consulted with the company on study design. She reported having no other relevant disclosures.

SAN FRANCISCO– An investigational topical ointment met its safety endpoints and showed signs of efficacy in children and adolescents with mild to moderate atopic dermatitis, according to a small phase II study.

Four weeks of twice-daily treatment with the AN2728 agent yielded an average 78% reduction in affected body surface area, reported Dr. Zoe Draelos at the annual meeting of the American Academy of Dermatology.

At day 29, 65% of patients had achieved Investigator’s Static Global Assessment (ISGA) scores of clear or almost clear, and 47% of patients had achieved those scores plus at least a two-grade improvement from baseline, said Dr. Draelos, a dermatologist in High Point, North Carolina.

The ointment is a 2% formulation of AN2728, a small-molecule compound based on elemental boron that works by suppressing phosphodiesterase type 4 activity, which in turn inhibits the release of cytokines such as TNF-alpha, IL-12, and IL-23. Investigators assessed its safety, pharmacokinetics, and effects on the signs and symptoms of atopic dermatitis (AD), as well as changes in the percentage of body surface area affected and disease severity based on the five-point IGSA scale, ranging from 0 (clear) to 4 (severe disease).

The study enrolled 34 patients aged two to 17 years who had AD affecting 25% to 35% of body surface area. The cream was applied twice daily for 28 days, which was done in the clinic for the first eight days to ensure maximum exposure to the agent.

Plasma levels of the agent measured on days 1 and 8 were low and resembled those previously observed for adults after adjusting for the percentage of body surface area treated. Twelve of the 34 patients had application site reactions, which included paresthesia, papules, itching, and burning, most of which were mild to moderate and resolved spontaneously. However, one patient withdrew from the study because of pain at the application site.

Patients had “marked” reductions in AD signs and symptoms, Dr. Draelos reported. Pruritus scores dropped an average of 60%, with improvements starting on about day 5 of treatment that leveled off at about day 15, she added. The investigators saw similar trends for erythema, lichenification, excoriation, and exudation.

Because patients were not allowed to use emollients during treatment, the adverse events observed were directly tied to twice-daily use of the product, Dr. Draelos noted.

Researchers are enrolling patients in phase III trials of AN2728, with data expected later in 2015, according to a press release from Anacor Pharmaceuticals, which makes the agent. Two carcinogenicity studies wrapped up earlier this year and yielded no evidence of malignancies, the company also reported.

Anacor sponsored the study. Dr. Draelos reported having served as a researcher for and receiving grant support from Anacor for the work.

SAN FRANCISCO– An investigational topical ointment met its safety endpoints and showed signs of efficacy in children and adolescents with mild to moderate atopic dermatitis, according to a small phase II study.

Four weeks of twice-daily treatment with the AN2728 agent yielded an average 78% reduction in affected body surface area, reported Dr. Zoe Draelos at the annual meeting of the American Academy of Dermatology.

At day 29, 65% of patients had achieved Investigator’s Static Global Assessment (ISGA) scores of clear or almost clear, and 47% of patients had achieved those scores plus at least a two-grade improvement from baseline, said Dr. Draelos, a dermatologist in High Point, North Carolina.

The ointment is a 2% formulation of AN2728, a small-molecule compound based on elemental boron that works by suppressing phosphodiesterase type 4 activity, which in turn inhibits the release of cytokines such as TNF-alpha, IL-12, and IL-23. Investigators assessed its safety, pharmacokinetics, and effects on the signs and symptoms of atopic dermatitis (AD), as well as changes in the percentage of body surface area affected and disease severity based on the five-point IGSA scale, ranging from 0 (clear) to 4 (severe disease).

The study enrolled 34 patients aged two to 17 years who had AD affecting 25% to 35% of body surface area. The cream was applied twice daily for 28 days, which was done in the clinic for the first eight days to ensure maximum exposure to the agent.

Plasma levels of the agent measured on days 1 and 8 were low and resembled those previously observed for adults after adjusting for the percentage of body surface area treated. Twelve of the 34 patients had application site reactions, which included paresthesia, papules, itching, and burning, most of which were mild to moderate and resolved spontaneously. However, one patient withdrew from the study because of pain at the application site.

Patients had “marked” reductions in AD signs and symptoms, Dr. Draelos reported. Pruritus scores dropped an average of 60%, with improvements starting on about day 5 of treatment that leveled off at about day 15, she added. The investigators saw similar trends for erythema, lichenification, excoriation, and exudation.

Because patients were not allowed to use emollients during treatment, the adverse events observed were directly tied to twice-daily use of the product, Dr. Draelos noted.

Researchers are enrolling patients in phase III trials of AN2728, with data expected later in 2015, according to a press release from Anacor Pharmaceuticals, which makes the agent. Two carcinogenicity studies wrapped up earlier this year and yielded no evidence of malignancies, the company also reported.

Anacor sponsored the study. Dr. Draelos reported having served as a researcher for and receiving grant support from Anacor for the work.

SAN FRANCISCO– An investigational topical ointment met its safety endpoints and showed signs of efficacy in children and adolescents with mild to moderate atopic dermatitis, according to a small phase II study.

Four weeks of twice-daily treatment with the AN2728 agent yielded an average 78% reduction in affected body surface area, reported Dr. Zoe Draelos at the annual meeting of the American Academy of Dermatology.

At day 29, 65% of patients had achieved Investigator’s Static Global Assessment (ISGA) scores of clear or almost clear, and 47% of patients had achieved those scores plus at least a two-grade improvement from baseline, said Dr. Draelos, a dermatologist in High Point, North Carolina.

The ointment is a 2% formulation of AN2728, a small-molecule compound based on elemental boron that works by suppressing phosphodiesterase type 4 activity, which in turn inhibits the release of cytokines such as TNF-alpha, IL-12, and IL-23. Investigators assessed its safety, pharmacokinetics, and effects on the signs and symptoms of atopic dermatitis (AD), as well as changes in the percentage of body surface area affected and disease severity based on the five-point IGSA scale, ranging from 0 (clear) to 4 (severe disease).

The study enrolled 34 patients aged two to 17 years who had AD affecting 25% to 35% of body surface area. The cream was applied twice daily for 28 days, which was done in the clinic for the first eight days to ensure maximum exposure to the agent.

Plasma levels of the agent measured on days 1 and 8 were low and resembled those previously observed for adults after adjusting for the percentage of body surface area treated. Twelve of the 34 patients had application site reactions, which included paresthesia, papules, itching, and burning, most of which were mild to moderate and resolved spontaneously. However, one patient withdrew from the study because of pain at the application site.

Patients had “marked” reductions in AD signs and symptoms, Dr. Draelos reported. Pruritus scores dropped an average of 60%, with improvements starting on about day 5 of treatment that leveled off at about day 15, she added. The investigators saw similar trends for erythema, lichenification, excoriation, and exudation.

Because patients were not allowed to use emollients during treatment, the adverse events observed were directly tied to twice-daily use of the product, Dr. Draelos noted.

Researchers are enrolling patients in phase III trials of AN2728, with data expected later in 2015, according to a press release from Anacor Pharmaceuticals, which makes the agent. Two carcinogenicity studies wrapped up earlier this year and yielded no evidence of malignancies, the company also reported.

Anacor sponsored the study. Dr. Draelos reported having served as a researcher for and receiving grant support from Anacor for the work.

SAN FRANCISCO– Secukinumab met its primary endpoint in a head-to-head trial, achieving 21% more PASI 90 responses than ustekinumab in patients with moderate to severe plaque psoriasis, according to interim, week 16 results from the phase IIIb CLEAR trial.

Patients’ responses to the two biologic agents had diverged by four weeks of treatment, when half the secukinumab group had achieved the secondary endpoint of PASI 75, compared with 20.6% of the ustekinumab group (P < .0001), Dr. Diamant Thaci said at the annual meeting of the American Academy of Dermatology.

“Secukinumab was superior to ustekinumab, even at early time points,” said Dr. Thaci of the Comprehensive Center for Inflammation Medicine at University Medical School Schleswig-Holstein, Lübeck, Germany. “This was very remarkable. Especially remarkable was the early difference for PASI 75.”

The biologic agents also showed similar safety profiles, and secukinumab yielded no new safety signals besides those observed in its pivotal phase III studies. “The most common adverse events were what we have seen in daily practice, including headache, nasopharyngitis, diarrhea, fatigue, and arthralgia,” Dr. Thaci said.

Secukinumab works by binding specifically to the interleukin-17A cytokine, thereby blocking its interaction with its receptor. The 52-week, phase IIIb CLEAR trial, which is underway at 134 sites in 24 countries, is comparing the safety and efficacy of secukinumab and ustekinumab in 679 patients with moderate to severe plaque psoriasis. Patients had baseline PASI scores of at least 12 and at least 10% body surface area involvement, no previous exposure to either biologic agent, and inadequate responses to topical treatments or phototherapy. Researchers randomized the patients to either 300 mg secukinumab given subcutaneously at baseline, at weeks one through four, and every four weeks thereafter, or to ustekinumab, dosed according to label.

The study cohorts resembled one another demographically at baseline. At week 16, 79% of patients given secukinumab had achieved a PASI 90 response, compared with 57.6% of the ustekinumab group (P < .0001). Furthermore, 44.3% of the secukinumab arm had achieved the secondary endpoint of completely clear skin (a PASI 100 response), compared with 28.4% of the ustekinumab group (P < .0001), Dr. Thaci reported.

After an average of 110 to 111 days of treatment, infections and infestations developed in 29.3% of the secukinumab group and 25.3% of ustekinumab group. Three percent of each group developed serious but non-fatal adverse events, with no deaths reported to date.

“Secukinumab treatment – even at early time points – has demonstrated superiority to ustekinumab in clearing the skin of subjects with moderate to severe psoriasis, with a comparable safety profile,” Dr. Thaci concluded. “It is very clear that we will be able to show and to observe that his agent is leading to improved quality of life.”

Dr. Thaci reported receiving research support from Dignity Sciences.

SAN FRANCISCO– Secukinumab met its primary endpoint in a head-to-head trial, achieving 21% more PASI 90 responses than ustekinumab in patients with moderate to severe plaque psoriasis, according to interim, week 16 results from the phase IIIb CLEAR trial.

Patients’ responses to the two biologic agents had diverged by four weeks of treatment, when half the secukinumab group had achieved the secondary endpoint of PASI 75, compared with 20.6% of the ustekinumab group (P < .0001), Dr. Diamant Thaci said at the annual meeting of the American Academy of Dermatology.

“Secukinumab was superior to ustekinumab, even at early time points,” said Dr. Thaci of the Comprehensive Center for Inflammation Medicine at University Medical School Schleswig-Holstein, Lübeck, Germany. “This was very remarkable. Especially remarkable was the early difference for PASI 75.”

The biologic agents also showed similar safety profiles, and secukinumab yielded no new safety signals besides those observed in its pivotal phase III studies. “The most common adverse events were what we have seen in daily practice, including headache, nasopharyngitis, diarrhea, fatigue, and arthralgia,” Dr. Thaci said.

Secukinumab works by binding specifically to the interleukin-17A cytokine, thereby blocking its interaction with its receptor. The 52-week, phase IIIb CLEAR trial, which is underway at 134 sites in 24 countries, is comparing the safety and efficacy of secukinumab and ustekinumab in 679 patients with moderate to severe plaque psoriasis. Patients had baseline PASI scores of at least 12 and at least 10% body surface area involvement, no previous exposure to either biologic agent, and inadequate responses to topical treatments or phototherapy. Researchers randomized the patients to either 300 mg secukinumab given subcutaneously at baseline, at weeks one through four, and every four weeks thereafter, or to ustekinumab, dosed according to label.

The study cohorts resembled one another demographically at baseline. At week 16, 79% of patients given secukinumab had achieved a PASI 90 response, compared with 57.6% of the ustekinumab group (P < .0001). Furthermore, 44.3% of the secukinumab arm had achieved the secondary endpoint of completely clear skin (a PASI 100 response), compared with 28.4% of the ustekinumab group (P < .0001), Dr. Thaci reported.

After an average of 110 to 111 days of treatment, infections and infestations developed in 29.3% of the secukinumab group and 25.3% of ustekinumab group. Three percent of each group developed serious but non-fatal adverse events, with no deaths reported to date.

“Secukinumab treatment – even at early time points – has demonstrated superiority to ustekinumab in clearing the skin of subjects with moderate to severe psoriasis, with a comparable safety profile,” Dr. Thaci concluded. “It is very clear that we will be able to show and to observe that his agent is leading to improved quality of life.”

Dr. Thaci reported receiving research support from Dignity Sciences.

SAN FRANCISCO– Secukinumab met its primary endpoint in a head-to-head trial, achieving 21% more PASI 90 responses than ustekinumab in patients with moderate to severe plaque psoriasis, according to interim, week 16 results from the phase IIIb CLEAR trial.

Patients’ responses to the two biologic agents had diverged by four weeks of treatment, when half the secukinumab group had achieved the secondary endpoint of PASI 75, compared with 20.6% of the ustekinumab group (P < .0001), Dr. Diamant Thaci said at the annual meeting of the American Academy of Dermatology.

“Secukinumab was superior to ustekinumab, even at early time points,” said Dr. Thaci of the Comprehensive Center for Inflammation Medicine at University Medical School Schleswig-Holstein, Lübeck, Germany. “This was very remarkable. Especially remarkable was the early difference for PASI 75.”

The biologic agents also showed similar safety profiles, and secukinumab yielded no new safety signals besides those observed in its pivotal phase III studies. “The most common adverse events were what we have seen in daily practice, including headache, nasopharyngitis, diarrhea, fatigue, and arthralgia,” Dr. Thaci said.

Secukinumab works by binding specifically to the interleukin-17A cytokine, thereby blocking its interaction with its receptor. The 52-week, phase IIIb CLEAR trial, which is underway at 134 sites in 24 countries, is comparing the safety and efficacy of secukinumab and ustekinumab in 679 patients with moderate to severe plaque psoriasis. Patients had baseline PASI scores of at least 12 and at least 10% body surface area involvement, no previous exposure to either biologic agent, and inadequate responses to topical treatments or phototherapy. Researchers randomized the patients to either 300 mg secukinumab given subcutaneously at baseline, at weeks one through four, and every four weeks thereafter, or to ustekinumab, dosed according to label.

The study cohorts resembled one another demographically at baseline. At week 16, 79% of patients given secukinumab had achieved a PASI 90 response, compared with 57.6% of the ustekinumab group (P < .0001). Furthermore, 44.3% of the secukinumab arm had achieved the secondary endpoint of completely clear skin (a PASI 100 response), compared with 28.4% of the ustekinumab group (P < .0001), Dr. Thaci reported.

After an average of 110 to 111 days of treatment, infections and infestations developed in 29.3% of the secukinumab group and 25.3% of ustekinumab group. Three percent of each group developed serious but non-fatal adverse events, with no deaths reported to date.

“Secukinumab treatment – even at early time points – has demonstrated superiority to ustekinumab in clearing the skin of subjects with moderate to severe psoriasis, with a comparable safety profile,” Dr. Thaci concluded. “It is very clear that we will be able to show and to observe that his agent is leading to improved quality of life.”

Dr. Thaci reported receiving research support from Dignity Sciences.

SAN FRANCISCO– Significantly more psoriasis patients who received the investigational biologic agent brodalumab achieved a PASI 100 response compared with those who received ustekinumab, and clinical responses persisted through 52 weeks, according to data from the pivotal phase III AMAGINE-2 trial.

Brodalumab also met its co-primary endpoints (PASI 75 and sPGA 0 or 1) compared with placebo at week 12 when given at doses of either 210 or 140 mg every two weeks, Dr. Mark Lebwohl said at the annual meeting of the American Academy of Dermatology.

But patients maintained the best responses at the higher brodalumab dose, Dr. Lebwohl, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York, reported. “Nearly 44% of patients in this group had not a dot of psoriasis left,” he said.

The interleukin-17 (IL-17) receptor and cytokine family play a key role  in the pathogenesis of plaque psoriasis. Brodalumab works by binding the IL-17 receptor, thereby blocking binding by the A, F, and A/F IL-17 cytokines. The AMAGINE-2 trial is the last of a trio of phase III studies to assess brodalumab’s safety and efficacy in patients with moderate to severe plaque psoriasis, Dr. Lebwohl and his associates noted. The findings are consistent with those from earlier trials, they said.

For the study, the researchers enrolled 1,831 patients with moderate to severe plaque psoriasis, of whom 1,776 completed the 12-week induction phase. During induction, patients received either 210 or 140 mg brodalumab, 45 mg of ustekinumab (or 90 mg if they weighed more than 100 kg), or placebo. At week 12, patients were re-randomized to one of the brodalumab or ustekinumab arms.

Fully 44% of patients who received 210 mg brodalumab achieved total clearance of skin disease, or Psoriasis Area Severity Index (PASI) 100 – twice the proportion of the ustekinumab group (22%; P < .001), Dr. Lebwohl said. The 210-mg brodalumab dose also achieved the highest PASI 75 response rate (86%, compared with 70% for ustekinumab, 67% for 140 mg brodalumab, and 8% for placebo), although the adjusted p-value comparing 210 mg brodalumab and ustekinumab did not reach statistical significance (P = .078), he noted. Finally, 79% of patients who received 210 mg brodalumab and 58% of those who received 140 mg brodalumab achieved clear or almost clear skin at week 12 according to the static Physician Global Assessment (sPGA), compared with only 4% of the placebo group (P < .001), he reported.

Brodalumab’s safety profile during the 12-week induction phase resembled that for previous trials, said Dr. Lebwohl. The most common adverse events were nasopharyngitis, upper respiratory tract infection, headache, and arthralgia. “But the punch line was Candida,” he said. Candidiasis affected 0.6% of patients in the placebo arm, compared with 1.4% for brodalumab-treated patients at week 12. By week 52, about 4% to 6.5% of treated patients had developed Candida infections.

Similarly small proportions of patients across all arms experienced serious side effects (1% to 2.6%) during the placebo-controlled period, noted Dr. Lebwohl. After adjusting for exposure time, rates of adverse events were similar for all groups, he said. “However, due to disparity in patient-years of exposure between treatment groups, we cannot draw conclusions about potential dose effects,” he added.

Dr. Lebwohl reported receiving research support from Amgen, which is developing brodalumab together with AstraZeneca/MedImmune.

SAN FRANCISCO– Significantly more psoriasis patients who received the investigational biologic agent brodalumab achieved a PASI 100 response compared with those who received ustekinumab, and clinical responses persisted through 52 weeks, according to data from the pivotal phase III AMAGINE-2 trial.

Brodalumab also met its co-primary endpoints (PASI 75 and sPGA 0 or 1) compared with placebo at week 12 when given at doses of either 210 or 140 mg every two weeks, Dr. Mark Lebwohl said at the annual meeting of the American Academy of Dermatology.

But patients maintained the best responses at the higher brodalumab dose, Dr. Lebwohl, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York, reported. “Nearly 44% of patients in this group had not a dot of psoriasis left,” he said.

The interleukin-17 (IL-17) receptor and cytokine family play a key role  in the pathogenesis of plaque psoriasis. Brodalumab works by binding the IL-17 receptor, thereby blocking binding by the A, F, and A/F IL-17 cytokines. The AMAGINE-2 trial is the last of a trio of phase III studies to assess brodalumab’s safety and efficacy in patients with moderate to severe plaque psoriasis, Dr. Lebwohl and his associates noted. The findings are consistent with those from earlier trials, they said.

For the study, the researchers enrolled 1,831 patients with moderate to severe plaque psoriasis, of whom 1,776 completed the 12-week induction phase. During induction, patients received either 210 or 140 mg brodalumab, 45 mg of ustekinumab (or 90 mg if they weighed more than 100 kg), or placebo. At week 12, patients were re-randomized to one of the brodalumab or ustekinumab arms.

Fully 44% of patients who received 210 mg brodalumab achieved total clearance of skin disease, or Psoriasis Area Severity Index (PASI) 100 – twice the proportion of the ustekinumab group (22%; P < .001), Dr. Lebwohl said. The 210-mg brodalumab dose also achieved the highest PASI 75 response rate (86%, compared with 70% for ustekinumab, 67% for 140 mg brodalumab, and 8% for placebo), although the adjusted p-value comparing 210 mg brodalumab and ustekinumab did not reach statistical significance (P = .078), he noted. Finally, 79% of patients who received 210 mg brodalumab and 58% of those who received 140 mg brodalumab achieved clear or almost clear skin at week 12 according to the static Physician Global Assessment (sPGA), compared with only 4% of the placebo group (P < .001), he reported.

Brodalumab’s safety profile during the 12-week induction phase resembled that for previous trials, said Dr. Lebwohl. The most common adverse events were nasopharyngitis, upper respiratory tract infection, headache, and arthralgia. “But the punch line was Candida,” he said. Candidiasis affected 0.6% of patients in the placebo arm, compared with 1.4% for brodalumab-treated patients at week 12. By week 52, about 4% to 6.5% of treated patients had developed Candida infections.

Similarly small proportions of patients across all arms experienced serious side effects (1% to 2.6%) during the placebo-controlled period, noted Dr. Lebwohl. After adjusting for exposure time, rates of adverse events were similar for all groups, he said. “However, due to disparity in patient-years of exposure between treatment groups, we cannot draw conclusions about potential dose effects,” he added.

Dr. Lebwohl reported receiving research support from Amgen, which is developing brodalumab together with AstraZeneca/MedImmune.

SAN FRANCISCO– Significantly more psoriasis patients who received the investigational biologic agent brodalumab achieved a PASI 100 response compared with those who received ustekinumab, and clinical responses persisted through 52 weeks, according to data from the pivotal phase III AMAGINE-2 trial.

Brodalumab also met its co-primary endpoints (PASI 75 and sPGA 0 or 1) compared with placebo at week 12 when given at doses of either 210 or 140 mg every two weeks, Dr. Mark Lebwohl said at the annual meeting of the American Academy of Dermatology.

But patients maintained the best responses at the higher brodalumab dose, Dr. Lebwohl, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York, reported. “Nearly 44% of patients in this group had not a dot of psoriasis left,” he said.

The interleukin-17 (IL-17) receptor and cytokine family play a key role  in the pathogenesis of plaque psoriasis. Brodalumab works by binding the IL-17 receptor, thereby blocking binding by the A, F, and A/F IL-17 cytokines. The AMAGINE-2 trial is the last of a trio of phase III studies to assess brodalumab’s safety and efficacy in patients with moderate to severe plaque psoriasis, Dr. Lebwohl and his associates noted. The findings are consistent with those from earlier trials, they said.

For the study, the researchers enrolled 1,831 patients with moderate to severe plaque psoriasis, of whom 1,776 completed the 12-week induction phase. During induction, patients received either 210 or 140 mg brodalumab, 45 mg of ustekinumab (or 90 mg if they weighed more than 100 kg), or placebo. At week 12, patients were re-randomized to one of the brodalumab or ustekinumab arms.

Fully 44% of patients who received 210 mg brodalumab achieved total clearance of skin disease, or Psoriasis Area Severity Index (PASI) 100 – twice the proportion of the ustekinumab group (22%; P < .001), Dr. Lebwohl said. The 210-mg brodalumab dose also achieved the highest PASI 75 response rate (86%, compared with 70% for ustekinumab, 67% for 140 mg brodalumab, and 8% for placebo), although the adjusted p-value comparing 210 mg brodalumab and ustekinumab did not reach statistical significance (P = .078), he noted. Finally, 79% of patients who received 210 mg brodalumab and 58% of those who received 140 mg brodalumab achieved clear or almost clear skin at week 12 according to the static Physician Global Assessment (sPGA), compared with only 4% of the placebo group (P < .001), he reported.

Brodalumab’s safety profile during the 12-week induction phase resembled that for previous trials, said Dr. Lebwohl. The most common adverse events were nasopharyngitis, upper respiratory tract infection, headache, and arthralgia. “But the punch line was Candida,” he said. Candidiasis affected 0.6% of patients in the placebo arm, compared with 1.4% for brodalumab-treated patients at week 12. By week 52, about 4% to 6.5% of treated patients had developed Candida infections.

Similarly small proportions of patients across all arms experienced serious side effects (1% to 2.6%) during the placebo-controlled period, noted Dr. Lebwohl. After adjusting for exposure time, rates of adverse events were similar for all groups, he said. “However, due to disparity in patient-years of exposure between treatment groups, we cannot draw conclusions about potential dose effects,” he added.

Dr. Lebwohl reported receiving research support from Amgen, which is developing brodalumab together with AstraZeneca/MedImmune.

Gastrointestinal dysfunction commonly affected patients with Parkinson’s disease, atypical parkinsonism, and vascular parkinsonism, and several GI symptoms correlated with specific motor and nonmotor signs, according to a cross-sectional survey published online in Parkinsonism and Related Disorders.

Regardless of which movement disorder they had, patients most frequently reported constipation, followed by appetite loss, weight loss, dysphagia, sialorrhea, and gastroesophageal reflux disease (GERD), said Dr. Hyeyoung Park at Seoul National University and her associates. “In general, the frequencies of GI dysfunctions were not markedly different among the three types of parkinsonian disorders, suggesting that GI symptoms may not be specific to Parkinson’s disease,” the researchers said (Parkinson Relat. Disord [doi:10.1016/j.parkreldis.2015.02.005]).

Gastrointestinal problems are frequent and debilitating in Parkinson’s disease (PD), and their etiology seems to be multifactorial, said the investigators. Affected patients experience weight loss, dysphagia, sialorrhea, and constipation 3-10 times more often than does the general population, they noted. However, less is known about associations between specific GI symptoms and nonmotor and motor disturbances in parkinsonian disorders, they said.

They carried out their study at two movement disorder clinics in Korea, where they surveyed 473 patients – 329 with PD, 62 with vascular parkinsonism, and 82 with atypical parkinsonism (including multiple symptom atrophy, progressive supranuclear palsy, corticobasal degeneration, or dementia with Lewy bodies). They excluded patients with drug-induced parkinsonism and those with an uncertain neurologic diagnosis.

Almost 65% of patients with PD reported constipation within the past 3 months, while 45% reported appetite loss, 35% reported weight loss, 19% reported dysphagia, 15% reported sialorrhea, and 9% reported GERD, the investigators said. Dysphagia and constipation were more prevalent in atypical, compared with vascular parkinsonism (P values .033 and .020, respectively), and scores on the Swallowing Disturbance Questionnaire averaged 8.3 for patients with atypical parkinsonism, compared with 6.0 (P = .015) for PD patients and 5.6 (P = .041) for those with vascular parkinsonism. All other GI symptoms were similarly prevalent among the three cohorts, the investigators added.

For the PD cohort, disease severity and specific motor and nonmotor signs and symptoms correlated with certain GI symptoms. For example, after controlling for age, gender, daily equivalent dose of levodopa, and disease duration, patients with motor fluctuation had more than twice the odds of weight loss (odds ratio, 2.47; 95% confidence interval, 1.08-5.65), compared with other PD patients, and patients with dyskinesia had more than three times the odds of sialorrhea (OR, 3.60; 95% CI, 1.28-10.12) and dysphagia (OR, 3.46; 95% CI, 1.30-9.23), compared with patients without dyskinesia. Also, the Movement Disorder Society Unified PD Rating Scale part 1 score was significantly linked with weight loss, appetite loss, and dysphagia, and the part 2 score was associated with dysphagia. Among nonmotor PD signs, cognitive dysfunction was associated with weight loss, autonomic dysfunction was associated with loss of weight and appetite, mood disturbance was associated with weight loss and dysphagia, and sleep disturbances were associated with appetite loss, said the researchers.

“Based on our results, GI dysfunction may be related to the broad spectrum of parkinsonian syndromes, and not necessarily confined to PD,” the investigators concluded. Use of amantadine and anticholinergics did not increase patients’ likelihood of GI symptoms, they noted.

The study lacked a control group, and its design excluded patients whose motor disabilities were so severe that they prevented them from visiting the movement disorder clinics, Dr. Park and colleagues added. They recommended further studies of correlations between GI dysfunction and specific motor and nonmotor PD symptoms, including in treatment-naive patients.

The Collaborative Clinical Research Fund of Boramae Medical Center partially funded the work. The authors declared no relevant conflicts of interest.

Gastrointestinal dysfunction commonly affected patients with Parkinson’s disease, atypical parkinsonism, and vascular parkinsonism, and several GI symptoms correlated with specific motor and nonmotor signs, according to a cross-sectional survey published online in Parkinsonism and Related Disorders.

Regardless of which movement disorder they had, patients most frequently reported constipation, followed by appetite loss, weight loss, dysphagia, sialorrhea, and gastroesophageal reflux disease (GERD), said Dr. Hyeyoung Park at Seoul National University and her associates. “In general, the frequencies of GI dysfunctions were not markedly different among the three types of parkinsonian disorders, suggesting that GI symptoms may not be specific to Parkinson’s disease,” the researchers said (Parkinson Relat. Disord [doi:10.1016/j.parkreldis.2015.02.005]).

Gastrointestinal problems are frequent and debilitating in Parkinson’s disease (PD), and their etiology seems to be multifactorial, said the investigators. Affected patients experience weight loss, dysphagia, sialorrhea, and constipation 3-10 times more often than does the general population, they noted. However, less is known about associations between specific GI symptoms and nonmotor and motor disturbances in parkinsonian disorders, they said.

They carried out their study at two movement disorder clinics in Korea, where they surveyed 473 patients – 329 with PD, 62 with vascular parkinsonism, and 82 with atypical parkinsonism (including multiple symptom atrophy, progressive supranuclear palsy, corticobasal degeneration, or dementia with Lewy bodies). They excluded patients with drug-induced parkinsonism and those with an uncertain neurologic diagnosis.

Almost 65% of patients with PD reported constipation within the past 3 months, while 45% reported appetite loss, 35% reported weight loss, 19% reported dysphagia, 15% reported sialorrhea, and 9% reported GERD, the investigators said. Dysphagia and constipation were more prevalent in atypical, compared with vascular parkinsonism (P values .033 and .020, respectively), and scores on the Swallowing Disturbance Questionnaire averaged 8.3 for patients with atypical parkinsonism, compared with 6.0 (P = .015) for PD patients and 5.6 (P = .041) for those with vascular parkinsonism. All other GI symptoms were similarly prevalent among the three cohorts, the investigators added.

For the PD cohort, disease severity and specific motor and nonmotor signs and symptoms correlated with certain GI symptoms. For example, after controlling for age, gender, daily equivalent dose of levodopa, and disease duration, patients with motor fluctuation had more than twice the odds of weight loss (odds ratio, 2.47; 95% confidence interval, 1.08-5.65), compared with other PD patients, and patients with dyskinesia had more than three times the odds of sialorrhea (OR, 3.60; 95% CI, 1.28-10.12) and dysphagia (OR, 3.46; 95% CI, 1.30-9.23), compared with patients without dyskinesia. Also, the Movement Disorder Society Unified PD Rating Scale part 1 score was significantly linked with weight loss, appetite loss, and dysphagia, and the part 2 score was associated with dysphagia. Among nonmotor PD signs, cognitive dysfunction was associated with weight loss, autonomic dysfunction was associated with loss of weight and appetite, mood disturbance was associated with weight loss and dysphagia, and sleep disturbances were associated with appetite loss, said the researchers.

“Based on our results, GI dysfunction may be related to the broad spectrum of parkinsonian syndromes, and not necessarily confined to PD,” the investigators concluded. Use of amantadine and anticholinergics did not increase patients’ likelihood of GI symptoms, they noted.

The study lacked a control group, and its design excluded patients whose motor disabilities were so severe that they prevented them from visiting the movement disorder clinics, Dr. Park and colleagues added. They recommended further studies of correlations between GI dysfunction and specific motor and nonmotor PD symptoms, including in treatment-naive patients.

The Collaborative Clinical Research Fund of Boramae Medical Center partially funded the work. The authors declared no relevant conflicts of interest.

Gastrointestinal dysfunction commonly affected patients with Parkinson’s disease, atypical parkinsonism, and vascular parkinsonism, and several GI symptoms correlated with specific motor and nonmotor signs, according to a cross-sectional survey published online in Parkinsonism and Related Disorders.

Regardless of which movement disorder they had, patients most frequently reported constipation, followed by appetite loss, weight loss, dysphagia, sialorrhea, and gastroesophageal reflux disease (GERD), said Dr. Hyeyoung Park at Seoul National University and her associates. “In general, the frequencies of GI dysfunctions were not markedly different among the three types of parkinsonian disorders, suggesting that GI symptoms may not be specific to Parkinson’s disease,” the researchers said (Parkinson Relat. Disord [doi:10.1016/j.parkreldis.2015.02.005]).

Gastrointestinal problems are frequent and debilitating in Parkinson’s disease (PD), and their etiology seems to be multifactorial, said the investigators. Affected patients experience weight loss, dysphagia, sialorrhea, and constipation 3-10 times more often than does the general population, they noted. However, less is known about associations between specific GI symptoms and nonmotor and motor disturbances in parkinsonian disorders, they said.

They carried out their study at two movement disorder clinics in Korea, where they surveyed 473 patients – 329 with PD, 62 with vascular parkinsonism, and 82 with atypical parkinsonism (including multiple symptom atrophy, progressive supranuclear palsy, corticobasal degeneration, or dementia with Lewy bodies). They excluded patients with drug-induced parkinsonism and those with an uncertain neurologic diagnosis.

Almost 65% of patients with PD reported constipation within the past 3 months, while 45% reported appetite loss, 35% reported weight loss, 19% reported dysphagia, 15% reported sialorrhea, and 9% reported GERD, the investigators said. Dysphagia and constipation were more prevalent in atypical, compared with vascular parkinsonism (P values .033 and .020, respectively), and scores on the Swallowing Disturbance Questionnaire averaged 8.3 for patients with atypical parkinsonism, compared with 6.0 (P = .015) for PD patients and 5.6 (P = .041) for those with vascular parkinsonism. All other GI symptoms were similarly prevalent among the three cohorts, the investigators added.

For the PD cohort, disease severity and specific motor and nonmotor signs and symptoms correlated with certain GI symptoms. For example, after controlling for age, gender, daily equivalent dose of levodopa, and disease duration, patients with motor fluctuation had more than twice the odds of weight loss (odds ratio, 2.47; 95% confidence interval, 1.08-5.65), compared with other PD patients, and patients with dyskinesia had more than three times the odds of sialorrhea (OR, 3.60; 95% CI, 1.28-10.12) and dysphagia (OR, 3.46; 95% CI, 1.30-9.23), compared with patients without dyskinesia. Also, the Movement Disorder Society Unified PD Rating Scale part 1 score was significantly linked with weight loss, appetite loss, and dysphagia, and the part 2 score was associated with dysphagia. Among nonmotor PD signs, cognitive dysfunction was associated with weight loss, autonomic dysfunction was associated with loss of weight and appetite, mood disturbance was associated with weight loss and dysphagia, and sleep disturbances were associated with appetite loss, said the researchers.

“Based on our results, GI dysfunction may be related to the broad spectrum of parkinsonian syndromes, and not necessarily confined to PD,” the investigators concluded. Use of amantadine and anticholinergics did not increase patients’ likelihood of GI symptoms, they noted.

The study lacked a control group, and its design excluded patients whose motor disabilities were so severe that they prevented them from visiting the movement disorder clinics, Dr. Park and colleagues added. They recommended further studies of correlations between GI dysfunction and specific motor and nonmotor PD symptoms, including in treatment-naive patients.

The Collaborative Clinical Research Fund of Boramae Medical Center partially funded the work. The authors declared no relevant conflicts of interest.

Inadequate vaccination coverage was to blame for the ongoing, multistate outbreak of measles linked to Disneyland Resort in California, according to a research letter published online in JAMA Pediatrics.

Rates of MMR vaccination in affected communities fell well short of the level needed for herd immunity, wrote Maimuna Majumder of Children’s Hospital Boston and the Massachusetts Institute of Technology, Cambridge, Mass., and associates. The ongoing outbreak “shines a glaring spotlight on our nation’s growing antivaccination movement and the prevalence of vaccination-hesitant parents.”

Measles is highly contagious, and adequate vaccine coverage is essential to prevent outbreaks. The current outbreak began at Disneyland Resort in December 2014, with secondary cases reported elsewhere in California and in Arizona, Colorado, Nebraska, Oregon, Utah, and Washington, according to the Centers for Disease Control and Prevention. The rapid rise in cases suggested that much of the exposed population was susceptible to measles, the investigators wrote (JAMA Pediatrics 2015 Mar. 16 [doi:10.1001/jamapediatrics.2015.0384]). To test that hypothesis, they used the IDEA (incidence decay and exponential adjustment) method to analyze publicly available outbreak data from the California Department of Public Health and Health Map media alerts. Based on their model, MMR vaccination rates in communities with secondary cases might have been as low as 50% and did not exceed 86%. “Given the highly contagious nature of measles, vaccination rates of 96%-99% are necessary to preserve herd immunity and prevent future outbreaks. Even the highest estimated vaccination rates from our model fall well below this threshold,” they wrote.

Estimating vaccination coverage among Disneyland visitors was challenging, not only because vaccination data are usually available only at the state and county level, but because the exposed population likely had diverse vaccination rates, the researchers said. Nonetheless, they concluded, “MMR vaccination rates in many of the communities that have been affected by this outbreak fall below the necessary threshold to sustain herd immunity, thus placing the greater population at risk as well.”

The National Library of Medicine funded the work. The authors declared no relevant conflicts of interest.

Inadequate vaccination coverage was to blame for the ongoing, multistate outbreak of measles linked to Disneyland Resort in California, according to a research letter published online in JAMA Pediatrics.

Rates of MMR vaccination in affected communities fell well short of the level needed for herd immunity, wrote Maimuna Majumder of Children’s Hospital Boston and the Massachusetts Institute of Technology, Cambridge, Mass., and associates. The ongoing outbreak “shines a glaring spotlight on our nation’s growing antivaccination movement and the prevalence of vaccination-hesitant parents.”

Measles is highly contagious, and adequate vaccine coverage is essential to prevent outbreaks. The current outbreak began at Disneyland Resort in December 2014, with secondary cases reported elsewhere in California and in Arizona, Colorado, Nebraska, Oregon, Utah, and Washington, according to the Centers for Disease Control and Prevention. The rapid rise in cases suggested that much of the exposed population was susceptible to measles, the investigators wrote (JAMA Pediatrics 2015 Mar. 16 [doi:10.1001/jamapediatrics.2015.0384]). To test that hypothesis, they used the IDEA (incidence decay and exponential adjustment) method to analyze publicly available outbreak data from the California Department of Public Health and Health Map media alerts. Based on their model, MMR vaccination rates in communities with secondary cases might have been as low as 50% and did not exceed 86%. “Given the highly contagious nature of measles, vaccination rates of 96%-99% are necessary to preserve herd immunity and prevent future outbreaks. Even the highest estimated vaccination rates from our model fall well below this threshold,” they wrote.

Estimating vaccination coverage among Disneyland visitors was challenging, not only because vaccination data are usually available only at the state and county level, but because the exposed population likely had diverse vaccination rates, the researchers said. Nonetheless, they concluded, “MMR vaccination rates in many of the communities that have been affected by this outbreak fall below the necessary threshold to sustain herd immunity, thus placing the greater population at risk as well.”

The National Library of Medicine funded the work. The authors declared no relevant conflicts of interest.

Inadequate vaccination coverage was to blame for the ongoing, multistate outbreak of measles linked to Disneyland Resort in California, according to a research letter published online in JAMA Pediatrics.

Rates of MMR vaccination in affected communities fell well short of the level needed for herd immunity, wrote Maimuna Majumder of Children’s Hospital Boston and the Massachusetts Institute of Technology, Cambridge, Mass., and associates. The ongoing outbreak “shines a glaring spotlight on our nation’s growing antivaccination movement and the prevalence of vaccination-hesitant parents.”

Measles is highly contagious, and adequate vaccine coverage is essential to prevent outbreaks. The current outbreak began at Disneyland Resort in December 2014, with secondary cases reported elsewhere in California and in Arizona, Colorado, Nebraska, Oregon, Utah, and Washington, according to the Centers for Disease Control and Prevention. The rapid rise in cases suggested that much of the exposed population was susceptible to measles, the investigators wrote (JAMA Pediatrics 2015 Mar. 16 [doi:10.1001/jamapediatrics.2015.0384]). To test that hypothesis, they used the IDEA (incidence decay and exponential adjustment) method to analyze publicly available outbreak data from the California Department of Public Health and Health Map media alerts. Based on their model, MMR vaccination rates in communities with secondary cases might have been as low as 50% and did not exceed 86%. “Given the highly contagious nature of measles, vaccination rates of 96%-99% are necessary to preserve herd immunity and prevent future outbreaks. Even the highest estimated vaccination rates from our model fall well below this threshold,” they wrote.

Estimating vaccination coverage among Disneyland visitors was challenging, not only because vaccination data are usually available only at the state and county level, but because the exposed population likely had diverse vaccination rates, the researchers said. Nonetheless, they concluded, “MMR vaccination rates in many of the communities that have been affected by this outbreak fall below the necessary threshold to sustain herd immunity, thus placing the greater population at risk as well.”

The National Library of Medicine funded the work. The authors declared no relevant conflicts of interest.

Inadequate vaccination coverage was to blame for the ongoing, multistate outbreak of measles linked to Disneyland Resort in California, according to a research letter published online in JAMA Pediatrics.

Rates of MMR vaccination in affected communities fell well short of the level needed for herd immunity, wrote Maimuna Majumder of Children’s Hospital Boston and the Massachusetts Institute of Technology, Cambridge, Mass., and associates. The ongoing outbreak “shines a glaring spotlight on our nation’s growing antivaccination movement and the prevalence of vaccination-hesitant parents.”

©luiscar/Thinkstockphotos.com

Measles is highly contagious, and adequate vaccine coverage is essential to prevent outbreaks. The current outbreak began at Disneyland Resort in December 2014, with secondary cases reported elsewhere in California and in Arizona, Colorado, Nebraska, Oregon, Utah, and Washington, according to the Centers for Disease Control and Prevention. The rapid rise in cases suggested that much of the exposed population was susceptible to measles, the investigators wrote (JAMA Pediatrics 2015 Mar. 16 [doi:10.1001/jamapediatrics.2015.0384]). To test that hypothesis, they used the IDEA (incidence decay and exponential adjustment) method to analyze publicly available outbreak data from the California Department of Public Health and Health Map media alerts. Based on their model, MMR vaccination rates in communities with secondary cases might have been as low as 50% and did not exceed 86%. “Given the highly contagious nature of measles, vaccination rates of 96%-99% are necessary to preserve herd immunity and prevent future outbreaks. Even the highest estimated vaccination rates from our model fall well below this threshold,” they wrote.

Estimating vaccination coverage among Disneyland visitors was challenging, not only because vaccination data are usually available only at the state and county level, but because the exposed population likely had diverse vaccination rates, the researchers said. Nonetheless, they concluded, “MMR vaccination rates in many of the communities that have been affected by this outbreak fall below the necessary threshold to sustain herd immunity, thus placing the greater population at risk as well.”

The National Library of Medicine funded the work. The authors declared no relevant conflicts of interest.

Inadequate vaccination coverage was to blame for the ongoing, multistate outbreak of measles linked to Disneyland Resort in California, according to a research letter published online in JAMA Pediatrics.

Rates of MMR vaccination in affected communities fell well short of the level needed for herd immunity, wrote Maimuna Majumder of Children’s Hospital Boston and the Massachusetts Institute of Technology, Cambridge, Mass., and associates. The ongoing outbreak “shines a glaring spotlight on our nation’s growing antivaccination movement and the prevalence of vaccination-hesitant parents.”

©luiscar/Thinkstockphotos.com

Measles is highly contagious, and adequate vaccine coverage is essential to prevent outbreaks. The current outbreak began at Disneyland Resort in December 2014, with secondary cases reported elsewhere in California and in Arizona, Colorado, Nebraska, Oregon, Utah, and Washington, according to the Centers for Disease Control and Prevention. The rapid rise in cases suggested that much of the exposed population was susceptible to measles, the investigators wrote (JAMA Pediatrics 2015 Mar. 16 [doi:10.1001/jamapediatrics.2015.0384]). To test that hypothesis, they used the IDEA (incidence decay and exponential adjustment) method to analyze publicly available outbreak data from the California Department of Public Health and Health Map media alerts. Based on their model, MMR vaccination rates in communities with secondary cases might have been as low as 50% and did not exceed 86%. “Given the highly contagious nature of measles, vaccination rates of 96%-99% are necessary to preserve herd immunity and prevent future outbreaks. Even the highest estimated vaccination rates from our model fall well below this threshold,” they wrote.

Estimating vaccination coverage among Disneyland visitors was challenging, not only because vaccination data are usually available only at the state and county level, but because the exposed population likely had diverse vaccination rates, the researchers said. Nonetheless, they concluded, “MMR vaccination rates in many of the communities that have been affected by this outbreak fall below the necessary threshold to sustain herd immunity, thus placing the greater population at risk as well.”

The National Library of Medicine funded the work. The authors declared no relevant conflicts of interest.

Inadequate vaccination coverage was to blame for the ongoing, multistate outbreak of measles linked to Disneyland Resort in California, according to a research letter published online in JAMA Pediatrics.

Rates of MMR vaccination in affected communities fell well short of the level needed for herd immunity, wrote Maimuna Majumder of Children’s Hospital Boston and the Massachusetts Institute of Technology, Cambridge, Mass., and associates. The ongoing outbreak “shines a glaring spotlight on our nation’s growing antivaccination movement and the prevalence of vaccination-hesitant parents.”

©luiscar/Thinkstockphotos.com

Measles is highly contagious, and adequate vaccine coverage is essential to prevent outbreaks. The current outbreak began at Disneyland Resort in December 2014, with secondary cases reported elsewhere in California and in Arizona, Colorado, Nebraska, Oregon, Utah, and Washington, according to the Centers for Disease Control and Prevention. The rapid rise in cases suggested that much of the exposed population was susceptible to measles, the investigators wrote (JAMA Pediatrics 2015 Mar. 16 [doi:10.1001/jamapediatrics.2015.0384]). To test that hypothesis, they used the IDEA (incidence decay and exponential adjustment) method to analyze publicly available outbreak data from the California Department of Public Health and Health Map media alerts. Based on their model, MMR vaccination rates in communities with secondary cases might have been as low as 50% and did not exceed 86%. “Given the highly contagious nature of measles, vaccination rates of 96%-99% are necessary to preserve herd immunity and prevent future outbreaks. Even the highest estimated vaccination rates from our model fall well below this threshold,” they wrote.

Estimating vaccination coverage among Disneyland visitors was challenging, not only because vaccination data are usually available only at the state and county level, but because the exposed population likely had diverse vaccination rates, the researchers said. Nonetheless, they concluded, “MMR vaccination rates in many of the communities that have been affected by this outbreak fall below the necessary threshold to sustain herd immunity, thus placing the greater population at risk as well.”

The National Library of Medicine funded the work. The authors declared no relevant conflicts of interest.

SAN DIEGO – Five years out, transcatheter aortic valve replacement beat standard therapy in patients with severe, inoperable aortic stenosis, and measured up to surgery in high-risk patients.

The final data from the PARTNER 1 data showed TAVR as an alternative to surgery for some high-risk surgical patients, Dr. Michael Mack reported at the annual scientific sessions of the American College of Cardiology. High-risk surgical patients had similar all-cause mortality, cardiovascular mortality, stroke, and hospital readmission rates, regardless of whether they underwent TAVR or surgical valve replacement, Dr. Mack of Baylor Scott & White Health in Plano, Texas, and his associates wrote in an article published online simultaneously with the presentation (Lancet 2015 Mar. 15 [doi: 10.1016/ S0140-6736(15)60308-7]). “Functional outcomes were also similar and preservation of valve hemodynamics was equivalent in both groups,” they wrote.

The trial also showed “a sustained benefit of TAVR” for inoperable aortic stenosis, “as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission, and functional status. Valves were durable, with no increase in transvalvular gradient, attrition of valve area, or worsening of aortic regurgitation,” Dr. Samir Kapadia at the Cleveland Clinic in Ohio and his associates reported in an related article that was not presented at the ACC meeting but was published at the same time as Dr. Mack’s presentation (Lancet 2015 Mar. 15 [doi: 10.1016/ S0140-6736(15)60290-2]). Based on the findings, “TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement,” the researchers added. “Appropriate selection of patients will help to maximize the benefit of TAVR and reduce mortality from coexisting severe comorbidities.”

The Placement of Aortic Transcatheter Valves (PARTNER 1) trial compared TAVR, standard nonsurgical treatment, and surgery in patients with severe, symptomatic aortic stenosis. The inoperable cohort included 358 patients who averaged 83 years of age. The high-risk cohort enrolled 699 patients whose overall average Society of Thoracic Surgeons (STS) Predicted Risk of Mortality Score was more than 11%. Inoperable patients were randomized to TAVR or standard treatment (usually including balloon aortic valvuloplasty), while high-risk patients were randomized to TAVR or surgical valve replacement.

Five years after treatment, almost 72% of TAVR patients in the inoperable cohort had died, compared with 94% of patients who received standard treatment (hazard ratio, 0.50; 95% confidence interval, 0.39-0.65; P < .0001), Dr. Kapadia and his associates reported. Notably, 86% (or 42 of 49) of surviving TAVR patients had New York Heart Association class 1 or 2 symptoms, compared with only 60% of patients who received standard treatment. Echocardiography did not reveal valve deterioration, the investigators said.

Patients in the high-risk group also faced substantial mortality – only about a third were alive 5 years after TAVR or surgery, Dr. Mack reported. Also, 14% of TAVR patients developed moderate to severe valvular regurgitation, compared with only 1% of the surgery group; P < .0001), and this complication was tied to lower survival, they wrote. “The clinical outcomes and valve performance in this trial might not reflect that of subsequent generations of balloon-expandable transcatheter valves, present operator expertise and experience, and more rigorous patient selection for TAVR,” he cautioned. “The patients selected for treatment in this trial, which started in 2007, are also representative of clinical practice at that time; clinicians have since refined patient selection, at least partly on the basis of early outcomes from this trial.”

Edwards Lifesciences funded the study. Several authors reported receiving travel reimbursements from Edwards Lifesciences and financial or consulting relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, Thubrikar Aortic Valve, St Jude Medical, Philips Healthcare, Sorin Medical, DirectFlow, Boston Scientific, Cardiosolutions, ValvXchange, and Posthorax.

SAN DIEGO – Five years out, transcatheter aortic valve replacement beat standard therapy in patients with severe, inoperable aortic stenosis, and measured up to surgery in high-risk patients.

The final data from the PARTNER 1 data showed TAVR as an alternative to surgery for some high-risk surgical patients, Dr. Michael Mack reported at the annual scientific sessions of the American College of Cardiology. High-risk surgical patients had similar all-cause mortality, cardiovascular mortality, stroke, and hospital readmission rates, regardless of whether they underwent TAVR or surgical valve replacement, Dr. Mack of Baylor Scott & White Health in Plano, Texas, and his associates wrote in an article published online simultaneously with the presentation (Lancet 2015 Mar. 15 [doi: 10.1016/ S0140-6736(15)60308-7]). “Functional outcomes were also similar and preservation of valve hemodynamics was equivalent in both groups,” they wrote.

The trial also showed “a sustained benefit of TAVR” for inoperable aortic stenosis, “as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission, and functional status. Valves were durable, with no increase in transvalvular gradient, attrition of valve area, or worsening of aortic regurgitation,” Dr. Samir Kapadia at the Cleveland Clinic in Ohio and his associates reported in an related article that was not presented at the ACC meeting but was published at the same time as Dr. Mack’s presentation (Lancet 2015 Mar. 15 [doi: 10.1016/ S0140-6736(15)60290-2]). Based on the findings, “TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement,” the researchers added. “Appropriate selection of patients will help to maximize the benefit of TAVR and reduce mortality from coexisting severe comorbidities.”

The Placement of Aortic Transcatheter Valves (PARTNER 1) trial compared TAVR, standard nonsurgical treatment, and surgery in patients with severe, symptomatic aortic stenosis. The inoperable cohort included 358 patients who averaged 83 years of age. The high-risk cohort enrolled 699 patients whose overall average Society of Thoracic Surgeons (STS) Predicted Risk of Mortality Score was more than 11%. Inoperable patients were randomized to TAVR or standard treatment (usually including balloon aortic valvuloplasty), while high-risk patients were randomized to TAVR or surgical valve replacement.

Five years after treatment, almost 72% of TAVR patients in the inoperable cohort had died, compared with 94% of patients who received standard treatment (hazard ratio, 0.50; 95% confidence interval, 0.39-0.65; P < .0001), Dr. Kapadia and his associates reported. Notably, 86% (or 42 of 49) of surviving TAVR patients had New York Heart Association class 1 or 2 symptoms, compared with only 60% of patients who received standard treatment. Echocardiography did not reveal valve deterioration, the investigators said.

Patients in the high-risk group also faced substantial mortality – only about a third were alive 5 years after TAVR or surgery, Dr. Mack reported. Also, 14% of TAVR patients developed moderate to severe valvular regurgitation, compared with only 1% of the surgery group; P < .0001), and this complication was tied to lower survival, they wrote. “The clinical outcomes and valve performance in this trial might not reflect that of subsequent generations of balloon-expandable transcatheter valves, present operator expertise and experience, and more rigorous patient selection for TAVR,” he cautioned. “The patients selected for treatment in this trial, which started in 2007, are also representative of clinical practice at that time; clinicians have since refined patient selection, at least partly on the basis of early outcomes from this trial.”

Edwards Lifesciences funded the study. Several authors reported receiving travel reimbursements from Edwards Lifesciences and financial or consulting relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, Thubrikar Aortic Valve, St Jude Medical, Philips Healthcare, Sorin Medical, DirectFlow, Boston Scientific, Cardiosolutions, ValvXchange, and Posthorax.

SAN DIEGO – Five years out, transcatheter aortic valve replacement beat standard therapy in patients with severe, inoperable aortic stenosis, and measured up to surgery in high-risk patients.

The final data from the PARTNER 1 data showed TAVR as an alternative to surgery for some high-risk surgical patients, Dr. Michael Mack reported at the annual scientific sessions of the American College of Cardiology. High-risk surgical patients had similar all-cause mortality, cardiovascular mortality, stroke, and hospital readmission rates, regardless of whether they underwent TAVR or surgical valve replacement, Dr. Mack of Baylor Scott & White Health in Plano, Texas, and his associates wrote in an article published online simultaneously with the presentation (Lancet 2015 Mar. 15 [doi: 10.1016/ S0140-6736(15)60308-7]). “Functional outcomes were also similar and preservation of valve hemodynamics was equivalent in both groups,” they wrote.

The trial also showed “a sustained benefit of TAVR” for inoperable aortic stenosis, “as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission, and functional status. Valves were durable, with no increase in transvalvular gradient, attrition of valve area, or worsening of aortic regurgitation,” Dr. Samir Kapadia at the Cleveland Clinic in Ohio and his associates reported in an related article that was not presented at the ACC meeting but was published at the same time as Dr. Mack’s presentation (Lancet 2015 Mar. 15 [doi: 10.1016/ S0140-6736(15)60290-2]). Based on the findings, “TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement,” the researchers added. “Appropriate selection of patients will help to maximize the benefit of TAVR and reduce mortality from coexisting severe comorbidities.”

The Placement of Aortic Transcatheter Valves (PARTNER 1) trial compared TAVR, standard nonsurgical treatment, and surgery in patients with severe, symptomatic aortic stenosis. The inoperable cohort included 358 patients who averaged 83 years of age. The high-risk cohort enrolled 699 patients whose overall average Society of Thoracic Surgeons (STS) Predicted Risk of Mortality Score was more than 11%. Inoperable patients were randomized to TAVR or standard treatment (usually including balloon aortic valvuloplasty), while high-risk patients were randomized to TAVR or surgical valve replacement.

Five years after treatment, almost 72% of TAVR patients in the inoperable cohort had died, compared with 94% of patients who received standard treatment (hazard ratio, 0.50; 95% confidence interval, 0.39-0.65; P < .0001), Dr. Kapadia and his associates reported. Notably, 86% (or 42 of 49) of surviving TAVR patients had New York Heart Association class 1 or 2 symptoms, compared with only 60% of patients who received standard treatment. Echocardiography did not reveal valve deterioration, the investigators said.

Patients in the high-risk group also faced substantial mortality – only about a third were alive 5 years after TAVR or surgery, Dr. Mack reported. Also, 14% of TAVR patients developed moderate to severe valvular regurgitation, compared with only 1% of the surgery group; P < .0001), and this complication was tied to lower survival, they wrote. “The clinical outcomes and valve performance in this trial might not reflect that of subsequent generations of balloon-expandable transcatheter valves, present operator expertise and experience, and more rigorous patient selection for TAVR,” he cautioned. “The patients selected for treatment in this trial, which started in 2007, are also representative of clinical practice at that time; clinicians have since refined patient selection, at least partly on the basis of early outcomes from this trial.”

Edwards Lifesciences funded the study. Several authors reported receiving travel reimbursements from Edwards Lifesciences and financial or consulting relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, Thubrikar Aortic Valve, St Jude Medical, Philips Healthcare, Sorin Medical, DirectFlow, Boston Scientific, Cardiosolutions, ValvXchange, and Posthorax.

Interrupting biologic therapy before surgery led to flares in psoriasis and psoriatic arthritis and did not appear to prevent postoperative complications in a small, retrospective cohort study.

“Our findings are in keeping with most of the existing literature on this topic,” said Dr. Waseem Bakkour and his associates at the University of Manchester (England). “However, it is important to acknowledge the deficiencies of our data, in particular the small data set and retrospective study design with numerous complexities associated with interpreting it” (J. Eur. Acad. Dermatol. Venereol. 2015 Mar. 2 [doi:10.1111/jdv.12997]).

The British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least four half-lives before surgery, but the guideline is based mostly on retrospective studies of rheumatoid arthritis and inflammatory bowel disease, the researchers said. For their study, they reviewed electronic health records from 42 patients with psoriasis and psoriatic arthritis who underwent 77 major and minor surgical procedures during a 6-year period. Discontinuing biologic therapy before surgery was linked to a significant risk of flare of psoriasis or psoriatic arthritis (40% with stoppage vs. 8.7% with continuation; P = .003). For three-quarters of procedures, patients continued biologic therapy (usually etanercept, but also adalimumab and infliximab), with no apparent effect on rates of postoperative infections or delayed wound healing. About 48% of procedures required general anesthesia, and most of the rest were skin surgeries.

The findings contradict those from a larger retrospective study (Arthritis Care Res. 2006;55:333-7)that linked biologic therapy before orthopedic surgery to a fourfold rise in the odds of postoperative infections, the investigators noted. “Whilst the current evidence, not surprisingly, suggests a link between stopping treatment and disease flare, it remains equivocal regarding the question of whether continuing biologic therapy perioperatively increases the risk of postsurgical complications,” they wrote.

The authors reported no funding sources. They disclosed financial and advisory relationships with many companies that manufacture biologic therapies.

Interrupting biologic therapy before surgery led to flares in psoriasis and psoriatic arthritis and did not appear to prevent postoperative complications in a small, retrospective cohort study.

“Our findings are in keeping with most of the existing literature on this topic,” said Dr. Waseem Bakkour and his associates at the University of Manchester (England). “However, it is important to acknowledge the deficiencies of our data, in particular the small data set and retrospective study design with numerous complexities associated with interpreting it” (J. Eur. Acad. Dermatol. Venereol. 2015 Mar. 2 [doi:10.1111/jdv.12997]).

The British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least four half-lives before surgery, but the guideline is based mostly on retrospective studies of rheumatoid arthritis and inflammatory bowel disease, the researchers said. For their study, they reviewed electronic health records from 42 patients with psoriasis and psoriatic arthritis who underwent 77 major and minor surgical procedures during a 6-year period. Discontinuing biologic therapy before surgery was linked to a significant risk of flare of psoriasis or psoriatic arthritis (40% with stoppage vs. 8.7% with continuation; P = .003). For three-quarters of procedures, patients continued biologic therapy (usually etanercept, but also adalimumab and infliximab), with no apparent effect on rates of postoperative infections or delayed wound healing. About 48% of procedures required general anesthesia, and most of the rest were skin surgeries.

The findings contradict those from a larger retrospective study (Arthritis Care Res. 2006;55:333-7)that linked biologic therapy before orthopedic surgery to a fourfold rise in the odds of postoperative infections, the investigators noted. “Whilst the current evidence, not surprisingly, suggests a link between stopping treatment and disease flare, it remains equivocal regarding the question of whether continuing biologic therapy perioperatively increases the risk of postsurgical complications,” they wrote.

The authors reported no funding sources. They disclosed financial and advisory relationships with many companies that manufacture biologic therapies.

Interrupting biologic therapy before surgery led to flares in psoriasis and psoriatic arthritis and did not appear to prevent postoperative complications in a small, retrospective cohort study.

“Our findings are in keeping with most of the existing literature on this topic,” said Dr. Waseem Bakkour and his associates at the University of Manchester (England). “However, it is important to acknowledge the deficiencies of our data, in particular the small data set and retrospective study design with numerous complexities associated with interpreting it” (J. Eur. Acad. Dermatol. Venereol. 2015 Mar. 2 [doi:10.1111/jdv.12997]).

The British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least four half-lives before surgery, but the guideline is based mostly on retrospective studies of rheumatoid arthritis and inflammatory bowel disease, the researchers said. For their study, they reviewed electronic health records from 42 patients with psoriasis and psoriatic arthritis who underwent 77 major and minor surgical procedures during a 6-year period. Discontinuing biologic therapy before surgery was linked to a significant risk of flare of psoriasis or psoriatic arthritis (40% with stoppage vs. 8.7% with continuation; P = .003). For three-quarters of procedures, patients continued biologic therapy (usually etanercept, but also adalimumab and infliximab), with no apparent effect on rates of postoperative infections or delayed wound healing. About 48% of procedures required general anesthesia, and most of the rest were skin surgeries.

The findings contradict those from a larger retrospective study (Arthritis Care Res. 2006;55:333-7)that linked biologic therapy before orthopedic surgery to a fourfold rise in the odds of postoperative infections, the investigators noted. “Whilst the current evidence, not surprisingly, suggests a link between stopping treatment and disease flare, it remains equivocal regarding the question of whether continuing biologic therapy perioperatively increases the risk of postsurgical complications,” they wrote.

The authors reported no funding sources. They disclosed financial and advisory relationships with many companies that manufacture biologic therapies.

Interrupting biologic therapy before surgery led to flares in psoriasis and psoriatic arthritis and did not appear to prevent postoperative complications in a small, retrospective cohort study.

“Our findings are in keeping with most of the existing literature on this topic,” said Dr. Waseem Bakkour and his associates at the University of Manchester (England). “However, it is important to acknowledge the deficiencies of our data, in particular the small data set and retrospective study design with numerous complexities associated with interpreting it” (J. Eur. Acad. Dermatol. Venereol. 2015 Mar. 2 [doi:10.1111/jdv.12997]).

The British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least four half-lives before surgery, but the guideline is based mostly on retrospective studies of rheumatoid arthritis and inflammatory bowel disease, the researchers said. For their study, they reviewed electronic health records from 42 patients with psoriasis and psoriatic arthritis who underwent 77 major and minor surgical procedures during a 6-year period. Discontinuing biologic therapy before surgery was linked to a significant risk of flare of psoriasis or psoriatic arthritis (40% with stoppage vs. 8.7% with continuation; P = .003). For three-quarters of procedures, patients continued biologic therapy (usually etanercept, but also adalimumab and infliximab), with no apparent effect on rates of postoperative infections or delayed wound healing. About 48% of procedures required general anesthesia, and most of the rest were skin surgeries.

The findings contradict those from a larger retrospective study (Arthritis Care Res. 2006;55:333-7) that linked biologic therapy before orthopedic surgery to a fourfold rise in the odds of postoperative infections, the investigators noted. “Whilst the current evidence, not surprisingly, suggests a link between stopping treatment and disease flare, it remains equivocal regarding the question of whether continuing biologic therapy perioperatively increases the risk of postsurgical complications,” they wrote.

The authors reported no funding sources. They disclosed financial and advisory relationships with many companies that manufacture biologic therapies.

Interrupting biologic therapy before surgery led to flares in psoriasis and psoriatic arthritis and did not appear to prevent postoperative complications in a small, retrospective cohort study.

“Our findings are in keeping with most of the existing literature on this topic,” said Dr. Waseem Bakkour and his associates at the University of Manchester (England). “However, it is important to acknowledge the deficiencies of our data, in particular the small data set and retrospective study design with numerous complexities associated with interpreting it” (J. Eur. Acad. Dermatol. Venereol. 2015 Mar. 2 [doi:10.1111/jdv.12997]).

The British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least four half-lives before surgery, but the guideline is based mostly on retrospective studies of rheumatoid arthritis and inflammatory bowel disease, the researchers said. For their study, they reviewed electronic health records from 42 patients with psoriasis and psoriatic arthritis who underwent 77 major and minor surgical procedures during a 6-year period. Discontinuing biologic therapy before surgery was linked to a significant risk of flare of psoriasis or psoriatic arthritis (40% with stoppage vs. 8.7% with continuation; P = .003). For three-quarters of procedures, patients continued biologic therapy (usually etanercept, but also adalimumab and infliximab), with no apparent effect on rates of postoperative infections or delayed wound healing. About 48% of procedures required general anesthesia, and most of the rest were skin surgeries.

The findings contradict those from a larger retrospective study (Arthritis Care Res. 2006;55:333-7) that linked biologic therapy before orthopedic surgery to a fourfold rise in the odds of postoperative infections, the investigators noted. “Whilst the current evidence, not surprisingly, suggests a link between stopping treatment and disease flare, it remains equivocal regarding the question of whether continuing biologic therapy perioperatively increases the risk of postsurgical complications,” they wrote.

The authors reported no funding sources. They disclosed financial and advisory relationships with many companies that manufacture biologic therapies.

Interrupting biologic therapy before surgery led to flares in psoriasis and psoriatic arthritis and did not appear to prevent postoperative complications in a small, retrospective cohort study.

“Our findings are in keeping with most of the existing literature on this topic,” said Dr. Waseem Bakkour and his associates at the University of Manchester (England). “However, it is important to acknowledge the deficiencies of our data, in particular the small data set and retrospective study design with numerous complexities associated with interpreting it” (J. Eur. Acad. Dermatol. Venereol. 2015 Mar. 2 [doi:10.1111/jdv.12997]).

The British Association of Dermatologists and the British Society for Rheumatology recommend stopping biologics for at least four half-lives before surgery, but the guideline is based mostly on retrospective studies of rheumatoid arthritis and inflammatory bowel disease, the researchers said. For their study, they reviewed electronic health records from 42 patients with psoriasis and psoriatic arthritis who underwent 77 major and minor surgical procedures during a 6-year period. Discontinuing biologic therapy before surgery was linked to a significant risk of flare of psoriasis or psoriatic arthritis (40% with stoppage vs. 8.7% with continuation; P = .003). For three-quarters of procedures, patients continued biologic therapy (usually etanercept, but also adalimumab and infliximab), with no apparent effect on rates of postoperative infections or delayed wound healing. About 48% of procedures required general anesthesia, and most of the rest were skin surgeries.

The findings contradict those from a larger retrospective study (Arthritis Care Res. 2006;55:333-7) that linked biologic therapy before orthopedic surgery to a fourfold rise in the odds of postoperative infections, the investigators noted. “Whilst the current evidence, not surprisingly, suggests a link between stopping treatment and disease flare, it remains equivocal regarding the question of whether continuing biologic therapy perioperatively increases the risk of postsurgical complications,” they wrote.

The authors reported no funding sources. They disclosed financial and advisory relationships with many companies that manufacture biologic therapies.