Psoriasis

Baseline radiographic damage and the presence of dactylitis at 5 years are independent predictors of further joint destruction in people with psoriatic arthritis, according to follow-up data from a psoriatic arthritis registry.

The analysis of hand and foot radiographic findings from 72 patients (29 men, 43 women) participating in the Swedish Early Psoriatic Arthritis Registry (SwePsA) registry found that radiographic progression in early PsA was generally slow but was substantial in men. At entry to the registry, the patients had a mean age of about 48 years and had symptoms for a median of 12 months. Most had polyarticular disease as a result of the registry’s protocol, and none had arthritis mutilans or axial disease only. Three men and none of the women had combined axial and peripheral disease, reported Dr. Mats Geijer of the Center for Medical Imaging and Physiology at Skåne University Hospital, Lund, Sweden, and his colleagues (J Rheumatol. 2015 Oct 15. doi: 10.3899/jrheum.150165).

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Only 4 (14%) of the men did not have radiographic changes at 5 years, compared with 17 (40%) women, making male sex a risk factor for structural abnormality (odds ratio, 4.09; 95% confidence interval, 1.2-13.8; P = .024). Most of the radiographic changes in men occurred in the feet. Baseline radiographic changes also were a significant predictor of additional radiographic damage at 5 years (OR, 3.4; 95% CI, 2.2-5.2; P less than .001).

In a multivariate linear regression analysis, only baseline radiographic score and the presence of dactylitis at 5 years were independent predictors of a high radiographic score at 5-year follow-up.

The findings suggested that men improve clinically but develop radiographic changes, whereas women show less clinical improvement but do not develop joint damage to the same extent as men. This gender-divergent behavior could be taken into consideration when planning treatment and care for patients, the authors said.

For example, women may require more interventions against functional deterioration and help coping with pain and men may need follow-up radiography, especially in the presence of dactylitis, high disease activity, and a known propensity for radiographic destruction, they suggested.

“Radiography and scoring the hands and feet at baseline are important and cannot be substituted with clinical signs, especially in men,” they concluded.

The study was supported by independent grants from the Swedish Psoriasis Foundation, Skåne University Hospital (SUS Fonder) and Pfizer.

Baseline radiographic damage and the presence of dactylitis at 5 years are independent predictors of further joint destruction in people with psoriatic arthritis, according to follow-up data from a psoriatic arthritis registry.

The analysis of hand and foot radiographic findings from 72 patients (29 men, 43 women) participating in the Swedish Early Psoriatic Arthritis Registry (SwePsA) registry found that radiographic progression in early PsA was generally slow but was substantial in men. At entry to the registry, the patients had a mean age of about 48 years and had symptoms for a median of 12 months. Most had polyarticular disease as a result of the registry’s protocol, and none had arthritis mutilans or axial disease only. Three men and none of the women had combined axial and peripheral disease, reported Dr. Mats Geijer of the Center for Medical Imaging and Physiology at Skåne University Hospital, Lund, Sweden, and his colleagues (J Rheumatol. 2015 Oct 15. doi: 10.3899/jrheum.150165).

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Only 4 (14%) of the men did not have radiographic changes at 5 years, compared with 17 (40%) women, making male sex a risk factor for structural abnormality (odds ratio, 4.09; 95% confidence interval, 1.2-13.8; P = .024). Most of the radiographic changes in men occurred in the feet. Baseline radiographic changes also were a significant predictor of additional radiographic damage at 5 years (OR, 3.4; 95% CI, 2.2-5.2; P less than .001).

In a multivariate linear regression analysis, only baseline radiographic score and the presence of dactylitis at 5 years were independent predictors of a high radiographic score at 5-year follow-up.

The findings suggested that men improve clinically but develop radiographic changes, whereas women show less clinical improvement but do not develop joint damage to the same extent as men. This gender-divergent behavior could be taken into consideration when planning treatment and care for patients, the authors said.

For example, women may require more interventions against functional deterioration and help coping with pain and men may need follow-up radiography, especially in the presence of dactylitis, high disease activity, and a known propensity for radiographic destruction, they suggested.

“Radiography and scoring the hands and feet at baseline are important and cannot be substituted with clinical signs, especially in men,” they concluded.

The study was supported by independent grants from the Swedish Psoriasis Foundation, Skåne University Hospital (SUS Fonder) and Pfizer.

Baseline radiographic damage and the presence of dactylitis at 5 years are independent predictors of further joint destruction in people with psoriatic arthritis, according to follow-up data from a psoriatic arthritis registry.

The analysis of hand and foot radiographic findings from 72 patients (29 men, 43 women) participating in the Swedish Early Psoriatic Arthritis Registry (SwePsA) registry found that radiographic progression in early PsA was generally slow but was substantial in men. At entry to the registry, the patients had a mean age of about 48 years and had symptoms for a median of 12 months. Most had polyarticular disease as a result of the registry’s protocol, and none had arthritis mutilans or axial disease only. Three men and none of the women had combined axial and peripheral disease, reported Dr. Mats Geijer of the Center for Medical Imaging and Physiology at Skåne University Hospital, Lund, Sweden, and his colleagues (J Rheumatol. 2015 Oct 15. doi: 10.3899/jrheum.150165).

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Only 4 (14%) of the men did not have radiographic changes at 5 years, compared with 17 (40%) women, making male sex a risk factor for structural abnormality (odds ratio, 4.09; 95% confidence interval, 1.2-13.8; P = .024). Most of the radiographic changes in men occurred in the feet. Baseline radiographic changes also were a significant predictor of additional radiographic damage at 5 years (OR, 3.4; 95% CI, 2.2-5.2; P less than .001).

In a multivariate linear regression analysis, only baseline radiographic score and the presence of dactylitis at 5 years were independent predictors of a high radiographic score at 5-year follow-up.

The findings suggested that men improve clinically but develop radiographic changes, whereas women show less clinical improvement but do not develop joint damage to the same extent as men. This gender-divergent behavior could be taken into consideration when planning treatment and care for patients, the authors said.

For example, women may require more interventions against functional deterioration and help coping with pain and men may need follow-up radiography, especially in the presence of dactylitis, high disease activity, and a known propensity for radiographic destruction, they suggested.

“Radiography and scoring the hands and feet at baseline are important and cannot be substituted with clinical signs, especially in men,” they concluded.

The study was supported by independent grants from the Swedish Psoriasis Foundation, Skåne University Hospital (SUS Fonder) and Pfizer.

COPENHAGEN – Severe psoriasis is an independent risk factor for serious renal disease – and psoriatic arthritis multiplies that risk even further, according to a Taiwanese national study.

“We think this might be related to the higher inflammatory status associated with psoriatic arthritis. For those with mild psoriasis without psoriatic arthritis, the risk was not increased,” Dr. Ching-Chi Chi said at the annual congress of the European Academy of Dermatology and Venereology.

The past decade has brought a mountain of data documenting that psoriasis, a chronic inflammatory dermatosis, is associated with increased risks of cardiovascular disease, diabetes, and other metabolic abnormalities, noted Dr. Chi, professor of dermatology at Chang Gung University in Taoyuan.

He presented a nationwide retrospective cohort study utilizing Taiwan’s national health insurance system, which covers more than 99% of the population. The study included 4,633 patients with psoriasis diagnosed by a dermatologist or rheumatologist since 2005 and 922,534 controls. A total of 453 patients were classified as having severe psoriasis based upon ever having received systemic treatment or phototherapy; the other 4,180 were classified as having mild psoriasis.

Among the controls there were 36,615 incident cases of chronic kidney disease (CKD) and 9,493 new cases of end-stage renal disease (ESRD) during the study period, translating to rates of 676 per 1,000,000 person-years and 172 per 1,000,000 person-years, respectively. In contrast, patients with severe psoriasis had an incident CKD rate of 2,160 per 1,000,000 person-years and an ESRD rate of 876 per 1,000,000 person-years.

In a Cox regression analysis adjusted for potential confounders including age, gender, comorbid cardiovascular disease, gout, hypertension, dyslipidemia, and use of NSAIDs, severe psoriasis was independently associated with a 1.9-fold increased risk of new-onset CKD and a 3-fold increased risk of ESRD.

Although mild psoriasis alone wasn’t associated with increased risk of renal disease, the 254 patients with mild psoriasis and psoriatic arthritis were at 1.3-fold increased risk of CKD and 2.5-fold increased risk of incident ESRD, compared with controls. Moreover, among the 93 patients with severe psoriasis plus psoriatic arthritis, the risks of incident CKD and ESRD were increased by 2.6- and 6.7-fold over the control subjects.

The new Taiwanese national study confirms earlier work by Dr. Joel M. Gelfand and his coinvestigators at the University of Pennsylvania, Philadelphia. Their population-based cohort study and nested cross-sectional study utilizing a huge U.K. electronic medical records database analyzed 136,529 patients with mild psoriasis, 7,354 with severe psoriasis, and nearly 690,000 matched controls and concluded that moderate to severe psoriasis is associated with an increased risk of stage 3-5 chronic kidney disease (BMJ. 2013 Oct 15;347:f5961).

He reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

This article was updated October 29, 2015.

COPENHAGEN – Severe psoriasis is an independent risk factor for serious renal disease – and psoriatic arthritis multiplies that risk even further, according to a Taiwanese national study.

“We think this might be related to the higher inflammatory status associated with psoriatic arthritis. For those with mild psoriasis without psoriatic arthritis, the risk was not increased,” Dr. Ching-Chi Chi said at the annual congress of the European Academy of Dermatology and Venereology.

The past decade has brought a mountain of data documenting that psoriasis, a chronic inflammatory dermatosis, is associated with increased risks of cardiovascular disease, diabetes, and other metabolic abnormalities, noted Dr. Chi, professor of dermatology at Chang Gung University in Taoyuan.

He presented a nationwide retrospective cohort study utilizing Taiwan’s national health insurance system, which covers more than 99% of the population. The study included 4,633 patients with psoriasis diagnosed by a dermatologist or rheumatologist since 2005 and 922,534 controls. A total of 453 patients were classified as having severe psoriasis based upon ever having received systemic treatment or phototherapy; the other 4,180 were classified as having mild psoriasis.

Among the controls there were 36,615 incident cases of chronic kidney disease (CKD) and 9,493 new cases of end-stage renal disease (ESRD) during the study period, translating to rates of 676 per 1,000,000 person-years and 172 per 1,000,000 person-years, respectively. In contrast, patients with severe psoriasis had an incident CKD rate of 2,160 per 1,000,000 person-years and an ESRD rate of 876 per 1,000,000 person-years.

In a Cox regression analysis adjusted for potential confounders including age, gender, comorbid cardiovascular disease, gout, hypertension, dyslipidemia, and use of NSAIDs, severe psoriasis was independently associated with a 1.9-fold increased risk of new-onset CKD and a 3-fold increased risk of ESRD.

Although mild psoriasis alone wasn’t associated with increased risk of renal disease, the 254 patients with mild psoriasis and psoriatic arthritis were at 1.3-fold increased risk of CKD and 2.5-fold increased risk of incident ESRD, compared with controls. Moreover, among the 93 patients with severe psoriasis plus psoriatic arthritis, the risks of incident CKD and ESRD were increased by 2.6- and 6.7-fold over the control subjects.

The new Taiwanese national study confirms earlier work by Dr. Joel M. Gelfand and his coinvestigators at the University of Pennsylvania, Philadelphia. Their population-based cohort study and nested cross-sectional study utilizing a huge U.K. electronic medical records database analyzed 136,529 patients with mild psoriasis, 7,354 with severe psoriasis, and nearly 690,000 matched controls and concluded that moderate to severe psoriasis is associated with an increased risk of stage 3-5 chronic kidney disease (BMJ. 2013 Oct 15;347:f5961).

He reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

This article was updated October 29, 2015.

COPENHAGEN – Severe psoriasis is an independent risk factor for serious renal disease – and psoriatic arthritis multiplies that risk even further, according to a Taiwanese national study.

“We think this might be related to the higher inflammatory status associated with psoriatic arthritis. For those with mild psoriasis without psoriatic arthritis, the risk was not increased,” Dr. Ching-Chi Chi said at the annual congress of the European Academy of Dermatology and Venereology.

The past decade has brought a mountain of data documenting that psoriasis, a chronic inflammatory dermatosis, is associated with increased risks of cardiovascular disease, diabetes, and other metabolic abnormalities, noted Dr. Chi, professor of dermatology at Chang Gung University in Taoyuan.

He presented a nationwide retrospective cohort study utilizing Taiwan’s national health insurance system, which covers more than 99% of the population. The study included 4,633 patients with psoriasis diagnosed by a dermatologist or rheumatologist since 2005 and 922,534 controls. A total of 453 patients were classified as having severe psoriasis based upon ever having received systemic treatment or phototherapy; the other 4,180 were classified as having mild psoriasis.

Among the controls there were 36,615 incident cases of chronic kidney disease (CKD) and 9,493 new cases of end-stage renal disease (ESRD) during the study period, translating to rates of 676 per 1,000,000 person-years and 172 per 1,000,000 person-years, respectively. In contrast, patients with severe psoriasis had an incident CKD rate of 2,160 per 1,000,000 person-years and an ESRD rate of 876 per 1,000,000 person-years.

In a Cox regression analysis adjusted for potential confounders including age, gender, comorbid cardiovascular disease, gout, hypertension, dyslipidemia, and use of NSAIDs, severe psoriasis was independently associated with a 1.9-fold increased risk of new-onset CKD and a 3-fold increased risk of ESRD.

Although mild psoriasis alone wasn’t associated with increased risk of renal disease, the 254 patients with mild psoriasis and psoriatic arthritis were at 1.3-fold increased risk of CKD and 2.5-fold increased risk of incident ESRD, compared with controls. Moreover, among the 93 patients with severe psoriasis plus psoriatic arthritis, the risks of incident CKD and ESRD were increased by 2.6- and 6.7-fold over the control subjects.

The new Taiwanese national study confirms earlier work by Dr. Joel M. Gelfand and his coinvestigators at the University of Pennsylvania, Philadelphia. Their population-based cohort study and nested cross-sectional study utilizing a huge U.K. electronic medical records database analyzed 136,529 patients with mild psoriasis, 7,354 with severe psoriasis, and nearly 690,000 matched controls and concluded that moderate to severe psoriasis is associated with an increased risk of stage 3-5 chronic kidney disease (BMJ. 2013 Oct 15;347:f5961).

He reported having no financial conflicts regarding this study.

bjancin@frontlinemedcom.com

This article was updated October 29, 2015.

COPENHAGEN – Long-term weight loss achieved by obese patients with psoriasis provides long-lasting reductions in psoriasis severity, Dr. Peter Jensen reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a prospective 64-week observational study that was a follow-up to his earlier 16-week randomized, controlled clinical trial. The earlier study (JAMA Dermatol. 2013 Jul;149[7]:795-801) generated enormous interest because it provided the first level I evidence that weight loss by obese psoriasis patients brings clinically meaningful improvement in their skin disease as well as achieving well-established metabolic and cardiovascular risk reduction benefits.

Bruce Jancin/Frontline Medical News

In the randomized trial, 60 consecutive obese patients with psoriasis and a mean baseline Psoriasis Area and Severity Index (PASI) of 5.4 and a body mass index of 34.4 kg/m² were assigned to a dietary intervention or given general advice to eat healthy foods. The intervention entailed 8 weeks of a low-energy liquid diet featuring a daily total nutrition intake of 800-1,000 kcal in the form of fortified drinks and soups. This was followed by 8 weeks in which regular foods were reintroduced at 1,200 kcal/day. At week 16, the intervention group had lost an average of 15.4 kg more body weight than controls. Their mean PASI was 2.0 points lower as well, according to Dr. Jensen, a dermatologist at the University of Copenhagen.

In the observational follow-up study, the original control group was offered the opportunity to participate in the 16-week weight loss intervention. All patients were then prospectively followed for 48 weeks after completing the dietary intervention. Psoriasis medications weren’t changed during the study period. The questions Dr. Jensen and coinvestigators sought to answer through the follow-up study were, first, can patients keep the weight off long term without a structured maintenance program and, if so, do their PASI scores stay low or do they creep back up?

Only 32 of the original 60 patients completed the full 64-week study. Among the completers, as is typical in weight loss studies, there was a gradual weight regain. Nonetheless, at 64 weeks, patients still maintained a mean 10-kg weight loss, compared with baseline, or two-thirds of the weight loss achieved during the 16-week dietary intervention.

Most importantly from a dermatologic perspective, the positive effect upon disease severity was maintained despite the regain of one-third of the initial weight loss, with patients showing a clinically important mean 3-point reduction in PASI, compared with baseline, Dr. Jensen noted.

Audience members were enthusiastic about the study findings but asked if the results are widely applicable. In other words, was this an unusually highly motivated group of patients?

“Our experience is that people really would like to try this. It was no problem to get participation,” according to Dr. Jensen.

Study limitations included the small sample size and the fact that this was a patient cohort with relatively mild psoriasis. In the future, it would be informative to study the effects of weight loss in obese patients with higher baseline PASI scores, the dermatologist said.

The study was funded by the Danish Academy of Dermatology and various research foundations. Dr. Jensen reported having no financial conflicts.

bjancin@frontlinemedcom.com

COPENHAGEN – Long-term weight loss achieved by obese patients with psoriasis provides long-lasting reductions in psoriasis severity, Dr. Peter Jensen reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a prospective 64-week observational study that was a follow-up to his earlier 16-week randomized, controlled clinical trial. The earlier study (JAMA Dermatol. 2013 Jul;149[7]:795-801) generated enormous interest because it provided the first level I evidence that weight loss by obese psoriasis patients brings clinically meaningful improvement in their skin disease as well as achieving well-established metabolic and cardiovascular risk reduction benefits.

Bruce Jancin/Frontline Medical News

In the randomized trial, 60 consecutive obese patients with psoriasis and a mean baseline Psoriasis Area and Severity Index (PASI) of 5.4 and a body mass index of 34.4 kg/m² were assigned to a dietary intervention or given general advice to eat healthy foods. The intervention entailed 8 weeks of a low-energy liquid diet featuring a daily total nutrition intake of 800-1,000 kcal in the form of fortified drinks and soups. This was followed by 8 weeks in which regular foods were reintroduced at 1,200 kcal/day. At week 16, the intervention group had lost an average of 15.4 kg more body weight than controls. Their mean PASI was 2.0 points lower as well, according to Dr. Jensen, a dermatologist at the University of Copenhagen.

In the observational follow-up study, the original control group was offered the opportunity to participate in the 16-week weight loss intervention. All patients were then prospectively followed for 48 weeks after completing the dietary intervention. Psoriasis medications weren’t changed during the study period. The questions Dr. Jensen and coinvestigators sought to answer through the follow-up study were, first, can patients keep the weight off long term without a structured maintenance program and, if so, do their PASI scores stay low or do they creep back up?

Only 32 of the original 60 patients completed the full 64-week study. Among the completers, as is typical in weight loss studies, there was a gradual weight regain. Nonetheless, at 64 weeks, patients still maintained a mean 10-kg weight loss, compared with baseline, or two-thirds of the weight loss achieved during the 16-week dietary intervention.

Most importantly from a dermatologic perspective, the positive effect upon disease severity was maintained despite the regain of one-third of the initial weight loss, with patients showing a clinically important mean 3-point reduction in PASI, compared with baseline, Dr. Jensen noted.

Audience members were enthusiastic about the study findings but asked if the results are widely applicable. In other words, was this an unusually highly motivated group of patients?

“Our experience is that people really would like to try this. It was no problem to get participation,” according to Dr. Jensen.

Study limitations included the small sample size and the fact that this was a patient cohort with relatively mild psoriasis. In the future, it would be informative to study the effects of weight loss in obese patients with higher baseline PASI scores, the dermatologist said.

The study was funded by the Danish Academy of Dermatology and various research foundations. Dr. Jensen reported having no financial conflicts.

bjancin@frontlinemedcom.com

COPENHAGEN – Long-term weight loss achieved by obese patients with psoriasis provides long-lasting reductions in psoriasis severity, Dr. Peter Jensen reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a prospective 64-week observational study that was a follow-up to his earlier 16-week randomized, controlled clinical trial. The earlier study (JAMA Dermatol. 2013 Jul;149[7]:795-801) generated enormous interest because it provided the first level I evidence that weight loss by obese psoriasis patients brings clinically meaningful improvement in their skin disease as well as achieving well-established metabolic and cardiovascular risk reduction benefits.

Bruce Jancin/Frontline Medical News

In the randomized trial, 60 consecutive obese patients with psoriasis and a mean baseline Psoriasis Area and Severity Index (PASI) of 5.4 and a body mass index of 34.4 kg/m² were assigned to a dietary intervention or given general advice to eat healthy foods. The intervention entailed 8 weeks of a low-energy liquid diet featuring a daily total nutrition intake of 800-1,000 kcal in the form of fortified drinks and soups. This was followed by 8 weeks in which regular foods were reintroduced at 1,200 kcal/day. At week 16, the intervention group had lost an average of 15.4 kg more body weight than controls. Their mean PASI was 2.0 points lower as well, according to Dr. Jensen, a dermatologist at the University of Copenhagen.

In the observational follow-up study, the original control group was offered the opportunity to participate in the 16-week weight loss intervention. All patients were then prospectively followed for 48 weeks after completing the dietary intervention. Psoriasis medications weren’t changed during the study period. The questions Dr. Jensen and coinvestigators sought to answer through the follow-up study were, first, can patients keep the weight off long term without a structured maintenance program and, if so, do their PASI scores stay low or do they creep back up?

Only 32 of the original 60 patients completed the full 64-week study. Among the completers, as is typical in weight loss studies, there was a gradual weight regain. Nonetheless, at 64 weeks, patients still maintained a mean 10-kg weight loss, compared with baseline, or two-thirds of the weight loss achieved during the 16-week dietary intervention.

Most importantly from a dermatologic perspective, the positive effect upon disease severity was maintained despite the regain of one-third of the initial weight loss, with patients showing a clinically important mean 3-point reduction in PASI, compared with baseline, Dr. Jensen noted.

Audience members were enthusiastic about the study findings but asked if the results are widely applicable. In other words, was this an unusually highly motivated group of patients?

“Our experience is that people really would like to try this. It was no problem to get participation,” according to Dr. Jensen.

Study limitations included the small sample size and the fact that this was a patient cohort with relatively mild psoriasis. In the future, it would be informative to study the effects of weight loss in obese patients with higher baseline PASI scores, the dermatologist said.

The study was funded by the Danish Academy of Dermatology and various research foundations. Dr. Jensen reported having no financial conflicts.

bjancin@frontlinemedcom.com

At the Rheumatic Skin Disease Clinic in Manhasset, N.Y., dermatologist Dr. Amit Garg regularly discusses patient cases and develops care plans alongside rheumatologists after each specialist separately visits the same patient. The dual dermatology-rheumatology clinic has led to countless benefits, including improved quality of care for patients and multi-discipline training for new and veteran physicians, said Dr. Garg, clinic codirector and chair of the dermatology department at North Shore–Long Island Jewish Health System in New York.

Perhaps the greatest advantage of the combined clinic, however, is the research inspiration generated by the collaboration. “Working closely with colleagues in another discipline makes the environment really ripe for new ideas based on observations we may see in the patients we’re treating,” Dr. Garg said in an interview. “It’s amazing how when you’re thinking through a patient’s care together, how quickly you appreciate where the gaps are in our understanding of disease and evaluation and management of disease. From there, you take it to the next step of planning research projects or protocols to essentially fill those gaps in knowledge.”

Dr. Garg’s clinic is one of a growing number at U.S. academic medical centers that combine dermatologic and rheumatologic care for the management of psoriatic arthritis (PsA) and other interrelated skin and musculoskeletal diseases. Clinic operations vary from virtual consults, to simultaneous assessments, to sequential patient visits, but all focus on collaborative care and disease management. The institutions using such models recently united to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network, a national organization that develops research initiatives and assists other centers in creating similar programs. At least 10 institutions are now participating in the network, including NYU Langone Medical Center, New York; Harvard University’s Brigham and Women’s Hospital, Boston; and the National Psoriasis Foundation, Portland, Ore.

Combining dermatology and rheumatology care through a dual clinic follows an ongoing trend by academic medical centers to integrate specialties that treat overlapping conditions, said Dr. Alexis R. Ogdie-Beatty, a rheumatologist at the University of Pennsylvania Health System in Philadelphia and director of the Penn Psoriatic Arthritis Program.

“It was kind of a natural thing for rheumatic disease because our diseases are multisystem in nature in most cases,” Dr. Ogdie-Beatty said in an interview. “I think the increasing knowledge of the need for communication [between specialists] drove this.”

Dr. Ogdie-Beatty leads a virtual rheumatology-dermatology clinic at the University of Pennsylvania where she meets weekly with two dermatologists to discuss research studies, shared patients, and case management. The physicians primarily see patients separately, but occasionally will visit patients at the same time, she said. In addition, dermatologists on the team immediately contact Dr. Ogdie-Beatty if they are seeing a patient who might benefit from an assessment by the rheumatologist and vice versa, she said.

“One of our favorite parts is learning from each other,” Dr. Ogdie-Beatty said in an interview. “I’ve learned a lot about skin disease and psoriasis, and they’ve learned about inflammatory arthritis and management. The ultimate impact for the patient is to have more well rounded care so that both the skin disease and the arthritis are being taken care of in a comprehensive way.”

©Jay Omobono

Dermatology and rheumatology medical students and residents exposed to such clinics have the unique opportunity to learn about disease overlap and strengthen their understanding of the other’s specialty, added Dr. Joseph F. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. Dr. Merola’s center also has created a fellowship program in which either a dermatologist or rheumatologist can spend 1 year training at the clinic.

Research opportunities abound at the combined clinics, physicians said. At the Center for Skin and Related Musculoskeletal Diseases for example, physicians have developed new outcome metrics for measuring psoriasis and screening for PsA, Dr. Merola said. Physicians also commonly refer clinic patients for clinical trials, he said.

“It’s a great place for patients who have been through many other therapies,” said Dr. Merola, who practices dermatology and rheumatology. “If they are at the end of the line, we have a number of clinical trials that we can offer them. Because it tends to be a referral center, these are patients who have more complex disease, so being able to offer them clinical trials and multiple opinions has been really key.”

Dr. Ogdie-Beatty’s clinic is participating in a variety of research studies, including an analysis of vascular inflammation in psoriasis patients. The study is examining markers of early joint inflammation among psoriasis patients who don’t have symptoms of joint pain. Another initiative focuses on how to implement psoriasis and PsA disease activity measures into the medical record, Dr. Ogdie-Beatty said.

At a combined dermatology-rheumatology clinic within the University Health Network, Toronto, doctors are studying the incidence of arthritis and comorbidities in patients with psoriasis, said Dr. Vinod Chandran, a rheumatologist at the University of Toronto. Another ongoing study focuses on identifying risk factors for PsA in patients with psoriasis. The Toronto clinic is participating in the studies as part of the International Psoriasis and Arthritis Research Team.

“There are a number of research opportunities in the combined clinic since a detailed clinical evaluation is extremely important in biomarker and translational studies,” said Dr. Chandran, who codirects the psoriatic arthritis program at the Centre for Prognosis Studies in the Rheumatic Diseases, Toronto. “The clinic also provides an opportunity to participate in phase II and III clinical trials.”

Managing the combined derm-rheum clinics does come with challenges, doctors said. The obstacles are primarily logistical, and include identifying the space, time, and scheduling for the clinic, Dr. Garg said. Other challenges revolve around reimbursement, such as figuring out the best payment structure and ensuring that insurers will cover the simultaneous care, Dr. Merola said. Generally, it also takes longer to see the patient, and physicians may not be able to see as many patients together per day as they could alone, he added. However, physicians stress that the benefits of the combined clinics far outweigh the negatives.

“We’ve always felt the value has been there because we feel the patients really appreciate the service,” he said. “And we think the quality of care around what we do is better.”

agallegos@frontlinemedcom.com

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At the Rheumatic Skin Disease Clinic in Manhasset, N.Y., dermatologist Dr. Amit Garg regularly discusses patient cases and develops care plans alongside rheumatologists after each specialist separately visits the same patient. The dual dermatology-rheumatology clinic has led to countless benefits, including improved quality of care for patients and multi-discipline training for new and veteran physicians, said Dr. Garg, clinic codirector and chair of the dermatology department at North Shore–Long Island Jewish Health System in New York.

Perhaps the greatest advantage of the combined clinic, however, is the research inspiration generated by the collaboration. “Working closely with colleagues in another discipline makes the environment really ripe for new ideas based on observations we may see in the patients we’re treating,” Dr. Garg said in an interview. “It’s amazing how when you’re thinking through a patient’s care together, how quickly you appreciate where the gaps are in our understanding of disease and evaluation and management of disease. From there, you take it to the next step of planning research projects or protocols to essentially fill those gaps in knowledge.”

Dr. Garg’s clinic is one of a growing number at U.S. academic medical centers that combine dermatologic and rheumatologic care for the management of psoriatic arthritis (PsA) and other interrelated skin and musculoskeletal diseases. Clinic operations vary from virtual consults, to simultaneous assessments, to sequential patient visits, but all focus on collaborative care and disease management. The institutions using such models recently united to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network, a national organization that develops research initiatives and assists other centers in creating similar programs. At least 10 institutions are now participating in the network, including NYU Langone Medical Center, New York; Harvard University’s Brigham and Women’s Hospital, Boston; and the National Psoriasis Foundation, Portland, Ore.

Combining dermatology and rheumatology care through a dual clinic follows an ongoing trend by academic medical centers to integrate specialties that treat overlapping conditions, said Dr. Alexis R. Ogdie-Beatty, a rheumatologist at the University of Pennsylvania Health System in Philadelphia and director of the Penn Psoriatic Arthritis Program.

“It was kind of a natural thing for rheumatic disease because our diseases are multisystem in nature in most cases,” Dr. Ogdie-Beatty said in an interview. “I think the increasing knowledge of the need for communication [between specialists] drove this.”

Dr. Ogdie-Beatty leads a virtual rheumatology-dermatology clinic at the University of Pennsylvania where she meets weekly with two dermatologists to discuss research studies, shared patients, and case management. The physicians primarily see patients separately, but occasionally will visit patients at the same time, she said. In addition, dermatologists on the team immediately contact Dr. Ogdie-Beatty if they are seeing a patient who might benefit from an assessment by the rheumatologist and vice versa, she said.

“One of our favorite parts is learning from each other,” Dr. Ogdie-Beatty said in an interview. “I’ve learned a lot about skin disease and psoriasis, and they’ve learned about inflammatory arthritis and management. The ultimate impact for the patient is to have more well rounded care so that both the skin disease and the arthritis are being taken care of in a comprehensive way.”

©Jay Omobono

Dermatology and rheumatology medical students and residents exposed to such clinics have the unique opportunity to learn about disease overlap and strengthen their understanding of the other’s specialty, added Dr. Joseph F. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. Dr. Merola’s center also has created a fellowship program in which either a dermatologist or rheumatologist can spend 1 year training at the clinic.

Research opportunities abound at the combined clinics, physicians said. At the Center for Skin and Related Musculoskeletal Diseases for example, physicians have developed new outcome metrics for measuring psoriasis and screening for PsA, Dr. Merola said. Physicians also commonly refer clinic patients for clinical trials, he said.

“It’s a great place for patients who have been through many other therapies,” said Dr. Merola, who practices dermatology and rheumatology. “If they are at the end of the line, we have a number of clinical trials that we can offer them. Because it tends to be a referral center, these are patients who have more complex disease, so being able to offer them clinical trials and multiple opinions has been really key.”

Dr. Ogdie-Beatty’s clinic is participating in a variety of research studies, including an analysis of vascular inflammation in psoriasis patients. The study is examining markers of early joint inflammation among psoriasis patients who don’t have symptoms of joint pain. Another initiative focuses on how to implement psoriasis and PsA disease activity measures into the medical record, Dr. Ogdie-Beatty said.

At a combined dermatology-rheumatology clinic within the University Health Network, Toronto, doctors are studying the incidence of arthritis and comorbidities in patients with psoriasis, said Dr. Vinod Chandran, a rheumatologist at the University of Toronto. Another ongoing study focuses on identifying risk factors for PsA in patients with psoriasis. The Toronto clinic is participating in the studies as part of the International Psoriasis and Arthritis Research Team.

“There are a number of research opportunities in the combined clinic since a detailed clinical evaluation is extremely important in biomarker and translational studies,” said Dr. Chandran, who codirects the psoriatic arthritis program at the Centre for Prognosis Studies in the Rheumatic Diseases, Toronto. “The clinic also provides an opportunity to participate in phase II and III clinical trials.”

Managing the combined derm-rheum clinics does come with challenges, doctors said. The obstacles are primarily logistical, and include identifying the space, time, and scheduling for the clinic, Dr. Garg said. Other challenges revolve around reimbursement, such as figuring out the best payment structure and ensuring that insurers will cover the simultaneous care, Dr. Merola said. Generally, it also takes longer to see the patient, and physicians may not be able to see as many patients together per day as they could alone, he added. However, physicians stress that the benefits of the combined clinics far outweigh the negatives.

“We’ve always felt the value has been there because we feel the patients really appreciate the service,” he said. “And we think the quality of care around what we do is better.”

agallegos@frontlinemedcom.com

On Twitter@legal_med

At the Rheumatic Skin Disease Clinic in Manhasset, N.Y., dermatologist Dr. Amit Garg regularly discusses patient cases and develops care plans alongside rheumatologists after each specialist separately visits the same patient. The dual dermatology-rheumatology clinic has led to countless benefits, including improved quality of care for patients and multi-discipline training for new and veteran physicians, said Dr. Garg, clinic codirector and chair of the dermatology department at North Shore–Long Island Jewish Health System in New York.

Perhaps the greatest advantage of the combined clinic, however, is the research inspiration generated by the collaboration. “Working closely with colleagues in another discipline makes the environment really ripe for new ideas based on observations we may see in the patients we’re treating,” Dr. Garg said in an interview. “It’s amazing how when you’re thinking through a patient’s care together, how quickly you appreciate where the gaps are in our understanding of disease and evaluation and management of disease. From there, you take it to the next step of planning research projects or protocols to essentially fill those gaps in knowledge.”

Dr. Garg’s clinic is one of a growing number at U.S. academic medical centers that combine dermatologic and rheumatologic care for the management of psoriatic arthritis (PsA) and other interrelated skin and musculoskeletal diseases. Clinic operations vary from virtual consults, to simultaneous assessments, to sequential patient visits, but all focus on collaborative care and disease management. The institutions using such models recently united to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network, a national organization that develops research initiatives and assists other centers in creating similar programs. At least 10 institutions are now participating in the network, including NYU Langone Medical Center, New York; Harvard University’s Brigham and Women’s Hospital, Boston; and the National Psoriasis Foundation, Portland, Ore.

Combining dermatology and rheumatology care through a dual clinic follows an ongoing trend by academic medical centers to integrate specialties that treat overlapping conditions, said Dr. Alexis R. Ogdie-Beatty, a rheumatologist at the University of Pennsylvania Health System in Philadelphia and director of the Penn Psoriatic Arthritis Program.

“It was kind of a natural thing for rheumatic disease because our diseases are multisystem in nature in most cases,” Dr. Ogdie-Beatty said in an interview. “I think the increasing knowledge of the need for communication [between specialists] drove this.”

Dr. Ogdie-Beatty leads a virtual rheumatology-dermatology clinic at the University of Pennsylvania where she meets weekly with two dermatologists to discuss research studies, shared patients, and case management. The physicians primarily see patients separately, but occasionally will visit patients at the same time, she said. In addition, dermatologists on the team immediately contact Dr. Ogdie-Beatty if they are seeing a patient who might benefit from an assessment by the rheumatologist and vice versa, she said.

“One of our favorite parts is learning from each other,” Dr. Ogdie-Beatty said in an interview. “I’ve learned a lot about skin disease and psoriasis, and they’ve learned about inflammatory arthritis and management. The ultimate impact for the patient is to have more well rounded care so that both the skin disease and the arthritis are being taken care of in a comprehensive way.”

©Jay Omobono

Dermatology and rheumatology medical students and residents exposed to such clinics have the unique opportunity to learn about disease overlap and strengthen their understanding of the other’s specialty, added Dr. Joseph F. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. Dr. Merola’s center also has created a fellowship program in which either a dermatologist or rheumatologist can spend 1 year training at the clinic.

Research opportunities abound at the combined clinics, physicians said. At the Center for Skin and Related Musculoskeletal Diseases for example, physicians have developed new outcome metrics for measuring psoriasis and screening for PsA, Dr. Merola said. Physicians also commonly refer clinic patients for clinical trials, he said.

“It’s a great place for patients who have been through many other therapies,” said Dr. Merola, who practices dermatology and rheumatology. “If they are at the end of the line, we have a number of clinical trials that we can offer them. Because it tends to be a referral center, these are patients who have more complex disease, so being able to offer them clinical trials and multiple opinions has been really key.”

Dr. Ogdie-Beatty’s clinic is participating in a variety of research studies, including an analysis of vascular inflammation in psoriasis patients. The study is examining markers of early joint inflammation among psoriasis patients who don’t have symptoms of joint pain. Another initiative focuses on how to implement psoriasis and PsA disease activity measures into the medical record, Dr. Ogdie-Beatty said.

At a combined dermatology-rheumatology clinic within the University Health Network, Toronto, doctors are studying the incidence of arthritis and comorbidities in patients with psoriasis, said Dr. Vinod Chandran, a rheumatologist at the University of Toronto. Another ongoing study focuses on identifying risk factors for PsA in patients with psoriasis. The Toronto clinic is participating in the studies as part of the International Psoriasis and Arthritis Research Team.

“There are a number of research opportunities in the combined clinic since a detailed clinical evaluation is extremely important in biomarker and translational studies,” said Dr. Chandran, who codirects the psoriatic arthritis program at the Centre for Prognosis Studies in the Rheumatic Diseases, Toronto. “The clinic also provides an opportunity to participate in phase II and III clinical trials.”

Managing the combined derm-rheum clinics does come with challenges, doctors said. The obstacles are primarily logistical, and include identifying the space, time, and scheduling for the clinic, Dr. Garg said. Other challenges revolve around reimbursement, such as figuring out the best payment structure and ensuring that insurers will cover the simultaneous care, Dr. Merola said. Generally, it also takes longer to see the patient, and physicians may not be able to see as many patients together per day as they could alone, he added. However, physicians stress that the benefits of the combined clinics far outweigh the negatives.

“We’ve always felt the value has been there because we feel the patients really appreciate the service,” he said. “And we think the quality of care around what we do is better.”

agallegos@frontlinemedcom.com

On Twitter@legal_med

The severity of psoriasis appears to correlate with the degree of aortic vascular inflammation in patients who have psoriasis, according to a prospective observational study comparing patients with psoriasis with age- and sex-matched controls.

To better characterize the known relationship between psoriatic skin disease and atherosclerosis, they assessed vascular inflammation using 18F-fluorodeoxyglucose–positron emission tomography/computed tomography (FDG-PET/CT) of the aorta in 60 adults with moderate to severe psoriasis and 22 healthy control subjects (mean age, 44 years) during a 2-year period. FDG uptake in the blood vessel wall denotes activated endothelial cells and cellular infiltration in noncalcified atherosclerotic plaques and is a direct, reliable marker of vascular inflammation, said Dr. Haley B. Naik of the cardiovascular and pulmonary branch, National Heart, Lung, and Blood Institute in Bethesda Md., and her associates. The study was published online on Oct. 8 (Arterioscler Thromb Vasc Biol. 2015 Oct 8. doi: 10.1161/ATVBAHA.115.306460).

As the severity of psoriasis increased, as measured by scores on the Psoriasis Area Severity Index (PASI), the degree of vascular inflammation also increased. This association was stronger than would be expected, given the psoriasis patients’ already increased cardiovascular risk based on traditional risk factors (their higher incidence of obesity, dyslipidemia, hypertension, diabetes, and smoking) and their elevated Framingham risk scores and higher levels of C-reactive protein. This suggests that “psoriasis plaques are biologically active in promoting inflammation at remote sites,” the investigators concluded.

In addition, they found that the absolute neutrophil count in the circulation was significantly elevated in psoriasis patients, compared with control subjects (mean, 3.7 vs. 2.9). Immunophenotyping by flow cytometry identified a significant increase in neutrophil frequencies in whole blood (mean, 65.2 vs. 56.3). Protein markers of neutrophil activation also were significantly elevated. Levels of these markers correlated with both psoriasis severity and vascular inflammation, suggesting that the two disorders may share the same immune-mediated mechanism.

“Our observation that the psoriatic atherosclerotic milieu is upregulated in concert with markers of neutrophil activation underscores the concept that atherosclerosis may involve complex neutrophil biology, which future studies should focus on elucidating, especially after intervention,” Dr. Naik and her associates added.

The severity of psoriasis appears to correlate with the degree of aortic vascular inflammation in patients who have psoriasis, according to a prospective observational study comparing patients with psoriasis with age- and sex-matched controls.

To better characterize the known relationship between psoriatic skin disease and atherosclerosis, they assessed vascular inflammation using 18F-fluorodeoxyglucose–positron emission tomography/computed tomography (FDG-PET/CT) of the aorta in 60 adults with moderate to severe psoriasis and 22 healthy control subjects (mean age, 44 years) during a 2-year period. FDG uptake in the blood vessel wall denotes activated endothelial cells and cellular infiltration in noncalcified atherosclerotic plaques and is a direct, reliable marker of vascular inflammation, said Dr. Haley B. Naik of the cardiovascular and pulmonary branch, National Heart, Lung, and Blood Institute in Bethesda Md., and her associates. The study was published online on Oct. 8 (Arterioscler Thromb Vasc Biol. 2015 Oct 8. doi: 10.1161/ATVBAHA.115.306460).

As the severity of psoriasis increased, as measured by scores on the Psoriasis Area Severity Index (PASI), the degree of vascular inflammation also increased. This association was stronger than would be expected, given the psoriasis patients’ already increased cardiovascular risk based on traditional risk factors (their higher incidence of obesity, dyslipidemia, hypertension, diabetes, and smoking) and their elevated Framingham risk scores and higher levels of C-reactive protein. This suggests that “psoriasis plaques are biologically active in promoting inflammation at remote sites,” the investigators concluded.

In addition, they found that the absolute neutrophil count in the circulation was significantly elevated in psoriasis patients, compared with control subjects (mean, 3.7 vs. 2.9). Immunophenotyping by flow cytometry identified a significant increase in neutrophil frequencies in whole blood (mean, 65.2 vs. 56.3). Protein markers of neutrophil activation also were significantly elevated. Levels of these markers correlated with both psoriasis severity and vascular inflammation, suggesting that the two disorders may share the same immune-mediated mechanism.

“Our observation that the psoriatic atherosclerotic milieu is upregulated in concert with markers of neutrophil activation underscores the concept that atherosclerosis may involve complex neutrophil biology, which future studies should focus on elucidating, especially after intervention,” Dr. Naik and her associates added.

The severity of psoriasis appears to correlate with the degree of aortic vascular inflammation in patients who have psoriasis, according to a prospective observational study comparing patients with psoriasis with age- and sex-matched controls.

To better characterize the known relationship between psoriatic skin disease and atherosclerosis, they assessed vascular inflammation using 18F-fluorodeoxyglucose–positron emission tomography/computed tomography (FDG-PET/CT) of the aorta in 60 adults with moderate to severe psoriasis and 22 healthy control subjects (mean age, 44 years) during a 2-year period. FDG uptake in the blood vessel wall denotes activated endothelial cells and cellular infiltration in noncalcified atherosclerotic plaques and is a direct, reliable marker of vascular inflammation, said Dr. Haley B. Naik of the cardiovascular and pulmonary branch, National Heart, Lung, and Blood Institute in Bethesda Md., and her associates. The study was published online on Oct. 8 (Arterioscler Thromb Vasc Biol. 2015 Oct 8. doi: 10.1161/ATVBAHA.115.306460).

As the severity of psoriasis increased, as measured by scores on the Psoriasis Area Severity Index (PASI), the degree of vascular inflammation also increased. This association was stronger than would be expected, given the psoriasis patients’ already increased cardiovascular risk based on traditional risk factors (their higher incidence of obesity, dyslipidemia, hypertension, diabetes, and smoking) and their elevated Framingham risk scores and higher levels of C-reactive protein. This suggests that “psoriasis plaques are biologically active in promoting inflammation at remote sites,” the investigators concluded.

In addition, they found that the absolute neutrophil count in the circulation was significantly elevated in psoriasis patients, compared with control subjects (mean, 3.7 vs. 2.9). Immunophenotyping by flow cytometry identified a significant increase in neutrophil frequencies in whole blood (mean, 65.2 vs. 56.3). Protein markers of neutrophil activation also were significantly elevated. Levels of these markers correlated with both psoriasis severity and vascular inflammation, suggesting that the two disorders may share the same immune-mediated mechanism.

“Our observation that the psoriatic atherosclerotic milieu is upregulated in concert with markers of neutrophil activation underscores the concept that atherosclerosis may involve complex neutrophil biology, which future studies should focus on elucidating, especially after intervention,” Dr. Naik and her associates added.

Cardiovascular disease and major adverse cardiovascular events are significantly more common in patients with psoriatic arthritis (PsA) than in those without, according to two case-control studies involving individuals in the longitudinal, population-based United Kingdom Clinical Practice Research Datalink.

Dr. Lin Li and associates determined that the incidence of cardiovascular disease (CVD) in patients with PsA was 12.8 per 1,000 person-years, compared with 9.6 per 1,000 person-years in the non-PsA group, giving an incidence rate ratio (IRR) of 1.33. The investigators defined CVD as arrhythmias, ischemic heart disease, angina, myocardial infarction, stroke, pericardial disease, pulmonary hypertension, and sudden death, and only counted cases that had one of these diagnoses during the 1988-2012 study period.

©Dutko/Thinkstock

In a separate cohort from the U.K. database, the researchers selected individuals who had a major adverse cardiovascular event (MACE) – myocardial infarctions, strokes, and sudden deaths – since entering the cohort. The MACE incidence in the PsA group was 4.6 per 1,000 person-years and 3.5 per 1,000 person-years in the non-PsA group, yielding an IRR of 1.30.

Rates of CVD and MACE within the PsA group were higher in those who had received a prescription for systemic therapy. Patients who had taken corticosteroids had the highest rates of CVD and MACE, compared with those who had taken disease-modifying antirheumatic drugs, biologics, or immunosuppressants.

“The higher risk in treated patients with PsA compared to non-treated patients may be explained by the severity of the PsA disease: Patients who receive treatments are likely to have more severe disease than those who do not,” the investigators noted.

Find the full study in the Journal of Clinical Rheumatology (2015. doi: 10.1097/RHU.0000000000000306).

lfranki@frontlinemedcom.com

Cardiovascular disease and major adverse cardiovascular events are significantly more common in patients with psoriatic arthritis (PsA) than in those without, according to two case-control studies involving individuals in the longitudinal, population-based United Kingdom Clinical Practice Research Datalink.

Dr. Lin Li and associates determined that the incidence of cardiovascular disease (CVD) in patients with PsA was 12.8 per 1,000 person-years, compared with 9.6 per 1,000 person-years in the non-PsA group, giving an incidence rate ratio (IRR) of 1.33. The investigators defined CVD as arrhythmias, ischemic heart disease, angina, myocardial infarction, stroke, pericardial disease, pulmonary hypertension, and sudden death, and only counted cases that had one of these diagnoses during the 1988-2012 study period.

©Dutko/Thinkstock

In a separate cohort from the U.K. database, the researchers selected individuals who had a major adverse cardiovascular event (MACE) – myocardial infarctions, strokes, and sudden deaths – since entering the cohort. The MACE incidence in the PsA group was 4.6 per 1,000 person-years and 3.5 per 1,000 person-years in the non-PsA group, yielding an IRR of 1.30.

Rates of CVD and MACE within the PsA group were higher in those who had received a prescription for systemic therapy. Patients who had taken corticosteroids had the highest rates of CVD and MACE, compared with those who had taken disease-modifying antirheumatic drugs, biologics, or immunosuppressants.

“The higher risk in treated patients with PsA compared to non-treated patients may be explained by the severity of the PsA disease: Patients who receive treatments are likely to have more severe disease than those who do not,” the investigators noted.

Find the full study in the Journal of Clinical Rheumatology (2015. doi: 10.1097/RHU.0000000000000306).

lfranki@frontlinemedcom.com

Cardiovascular disease and major adverse cardiovascular events are significantly more common in patients with psoriatic arthritis (PsA) than in those without, according to two case-control studies involving individuals in the longitudinal, population-based United Kingdom Clinical Practice Research Datalink.

Dr. Lin Li and associates determined that the incidence of cardiovascular disease (CVD) in patients with PsA was 12.8 per 1,000 person-years, compared with 9.6 per 1,000 person-years in the non-PsA group, giving an incidence rate ratio (IRR) of 1.33. The investigators defined CVD as arrhythmias, ischemic heart disease, angina, myocardial infarction, stroke, pericardial disease, pulmonary hypertension, and sudden death, and only counted cases that had one of these diagnoses during the 1988-2012 study period.

©Dutko/Thinkstock

In a separate cohort from the U.K. database, the researchers selected individuals who had a major adverse cardiovascular event (MACE) – myocardial infarctions, strokes, and sudden deaths – since entering the cohort. The MACE incidence in the PsA group was 4.6 per 1,000 person-years and 3.5 per 1,000 person-years in the non-PsA group, yielding an IRR of 1.30.

Rates of CVD and MACE within the PsA group were higher in those who had received a prescription for systemic therapy. Patients who had taken corticosteroids had the highest rates of CVD and MACE, compared with those who had taken disease-modifying antirheumatic drugs, biologics, or immunosuppressants.

“The higher risk in treated patients with PsA compared to non-treated patients may be explained by the severity of the PsA disease: Patients who receive treatments are likely to have more severe disease than those who do not,” the investigators noted.

Find the full study in the Journal of Clinical Rheumatology (2015. doi: 10.1097/RHU.0000000000000306).

lfranki@frontlinemedcom.com

Brodalumab met all primary endpoints against its first-in-class rival, ustekinumab, and against placebo in two phase III trials of more than 3,700 patients with moderate to severe plaque psoriasis, investigators reported in the New England Journal of Medicine.

The results of the two studies, AMAGINE-2 and AMAGINE-3, were published on Sept. 30 (N Eng J Med. 2015;373:1318-28).

“The data for brodalumab are the best data we’ve seen. It literally is twice as effective at achieving PASI [Psoriasis Area Severity Index] 100 as ustekinumab, which is a spectacular drug,” lead investigator Dr. Mark Lebwohl said in an interview. “More than two-thirds of patients achieved PASI 90. We’ve never seen data like this before,” said Dr. Lebwohl, professor and chairman of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Dermatologists and patients have closely followed brodalumab, an investigational interleukin-17 receptor A inhibitor, which, in March 2015, was reported to have doubled the PASI 100 response rate of ustekinumab in the AMAGINE-2 trial. But 2 months later, Amgen pulled funding and ended its partnership with AstraZeneca on the biologic in the wake of suicides of two patients who had recently completed brodalumab treatment. At the time, Amgen stated that it was concerned that brodalumab would receive restrictive labeling related to suicidal ideation and behavior. An Amgen spokeswoman on Sept. 29 declined to elaborate.

On Sept. 1, however, Valeant Pharmaceuticals announced that it was partnering with AstraZeneca to continue with plans to develop and commercialize brodalumab and that regulatory submissions in the United States and the European Union were planned for the 4th quarter of 2015.

In the interview, Dr. Lebwohl said he did not know of a mechanism by which blocking the IL-17 receptor might increase the risk of depression or suicide. “But psoriasis is certainly associated with depression,” he added. “Two out of more than 3,700 patients committed suicide over more than a year, and that could certainly be attributable to the depression associated with the underlying skin disease.”

AMAGINE-2 and AMAGINE-3 were replicate phase III, double-blind, randomized, controlled trials of 3,712 patients with moderate to severe plaque psoriasis. In the two studies, week 12 PASI 75 rates were about 85% with 210 mg of brodalumab, about 68% for 140 mg of brodalumab, and 6%-8% for placebo (P less than .001). Moreover, week 12 PASI 100 response rates with 210 mg of brodalumab were 37% and 44%, compared with 19% and 22% for ustekinumab (P less than .001), the investigators reported.

Median time to PASI 75 on 210 mg of brodalumab was 4 weeks – about twice as fast as for ustekinumab. Rates of static Physician’s Global Assessment (sPGA) scores of 0 or 1 (clear or almost clear skin) also were significantly higher for brodalumab, compared with placebo (P less than .001).

Mild to moderate candidiasis was more common during induction of brodalumab, compared with ustekinumab or placebo, underscoring the role of interleukin-17A in microbial surveillance, Dr. Lebwohl and his associates pointed out. They estimated that 1-1.3 serious infections occurred for every 100 patient-years of exposure to brodalumab, through 52 weeks.

The investigators reported but did not comment on the suicides, stating only that the study populations were large enough to assess common adverse events but “may have been inadequate for the detection of rare adverse events, which would require longer follow-up of large numbers of patients to provide a full understanding of the safety profile of brodalumab.”

Ustekinumab is marketed as Stelara.

Amgen funded the AMAGINE-2 and AMAGINE-3 studies. Dr. Lebwohl reported having received grant support from Amgen, AbbVie, Janssen Biotech, UCB Pharma, Pfizer, Celgene, Eli Lilly, and Novartis outside the submitted work. Twenty-four coauthors reported grant support or personal fees from Amgen, Abbvie, Merck, Janssen, and several other pharmaceutical companies. The other investigators declared no competing interests.

Brodalumab met all primary endpoints against its first-in-class rival, ustekinumab, and against placebo in two phase III trials of more than 3,700 patients with moderate to severe plaque psoriasis, investigators reported in the New England Journal of Medicine.

The results of the two studies, AMAGINE-2 and AMAGINE-3, were published on Sept. 30 (N Eng J Med. 2015;373:1318-28).

“The data for brodalumab are the best data we’ve seen. It literally is twice as effective at achieving PASI [Psoriasis Area Severity Index] 100 as ustekinumab, which is a spectacular drug,” lead investigator Dr. Mark Lebwohl said in an interview. “More than two-thirds of patients achieved PASI 90. We’ve never seen data like this before,” said Dr. Lebwohl, professor and chairman of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Dermatologists and patients have closely followed brodalumab, an investigational interleukin-17 receptor A inhibitor, which, in March 2015, was reported to have doubled the PASI 100 response rate of ustekinumab in the AMAGINE-2 trial. But 2 months later, Amgen pulled funding and ended its partnership with AstraZeneca on the biologic in the wake of suicides of two patients who had recently completed brodalumab treatment. At the time, Amgen stated that it was concerned that brodalumab would receive restrictive labeling related to suicidal ideation and behavior. An Amgen spokeswoman on Sept. 29 declined to elaborate.

On Sept. 1, however, Valeant Pharmaceuticals announced that it was partnering with AstraZeneca to continue with plans to develop and commercialize brodalumab and that regulatory submissions in the United States and the European Union were planned for the 4th quarter of 2015.

In the interview, Dr. Lebwohl said he did not know of a mechanism by which blocking the IL-17 receptor might increase the risk of depression or suicide. “But psoriasis is certainly associated with depression,” he added. “Two out of more than 3,700 patients committed suicide over more than a year, and that could certainly be attributable to the depression associated with the underlying skin disease.”

AMAGINE-2 and AMAGINE-3 were replicate phase III, double-blind, randomized, controlled trials of 3,712 patients with moderate to severe plaque psoriasis. In the two studies, week 12 PASI 75 rates were about 85% with 210 mg of brodalumab, about 68% for 140 mg of brodalumab, and 6%-8% for placebo (P less than .001). Moreover, week 12 PASI 100 response rates with 210 mg of brodalumab were 37% and 44%, compared with 19% and 22% for ustekinumab (P less than .001), the investigators reported.

Median time to PASI 75 on 210 mg of brodalumab was 4 weeks – about twice as fast as for ustekinumab. Rates of static Physician’s Global Assessment (sPGA) scores of 0 or 1 (clear or almost clear skin) also were significantly higher for brodalumab, compared with placebo (P less than .001).

Mild to moderate candidiasis was more common during induction of brodalumab, compared with ustekinumab or placebo, underscoring the role of interleukin-17A in microbial surveillance, Dr. Lebwohl and his associates pointed out. They estimated that 1-1.3 serious infections occurred for every 100 patient-years of exposure to brodalumab, through 52 weeks.

The investigators reported but did not comment on the suicides, stating only that the study populations were large enough to assess common adverse events but “may have been inadequate for the detection of rare adverse events, which would require longer follow-up of large numbers of patients to provide a full understanding of the safety profile of brodalumab.”

Ustekinumab is marketed as Stelara.

Amgen funded the AMAGINE-2 and AMAGINE-3 studies. Dr. Lebwohl reported having received grant support from Amgen, AbbVie, Janssen Biotech, UCB Pharma, Pfizer, Celgene, Eli Lilly, and Novartis outside the submitted work. Twenty-four coauthors reported grant support or personal fees from Amgen, Abbvie, Merck, Janssen, and several other pharmaceutical companies. The other investigators declared no competing interests.

Brodalumab met all primary endpoints against its first-in-class rival, ustekinumab, and against placebo in two phase III trials of more than 3,700 patients with moderate to severe plaque psoriasis, investigators reported in the New England Journal of Medicine.

The results of the two studies, AMAGINE-2 and AMAGINE-3, were published on Sept. 30 (N Eng J Med. 2015;373:1318-28).

“The data for brodalumab are the best data we’ve seen. It literally is twice as effective at achieving PASI [Psoriasis Area Severity Index] 100 as ustekinumab, which is a spectacular drug,” lead investigator Dr. Mark Lebwohl said in an interview. “More than two-thirds of patients achieved PASI 90. We’ve never seen data like this before,” said Dr. Lebwohl, professor and chairman of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Dermatologists and patients have closely followed brodalumab, an investigational interleukin-17 receptor A inhibitor, which, in March 2015, was reported to have doubled the PASI 100 response rate of ustekinumab in the AMAGINE-2 trial. But 2 months later, Amgen pulled funding and ended its partnership with AstraZeneca on the biologic in the wake of suicides of two patients who had recently completed brodalumab treatment. At the time, Amgen stated that it was concerned that brodalumab would receive restrictive labeling related to suicidal ideation and behavior. An Amgen spokeswoman on Sept. 29 declined to elaborate.

On Sept. 1, however, Valeant Pharmaceuticals announced that it was partnering with AstraZeneca to continue with plans to develop and commercialize brodalumab and that regulatory submissions in the United States and the European Union were planned for the 4th quarter of 2015.

In the interview, Dr. Lebwohl said he did not know of a mechanism by which blocking the IL-17 receptor might increase the risk of depression or suicide. “But psoriasis is certainly associated with depression,” he added. “Two out of more than 3,700 patients committed suicide over more than a year, and that could certainly be attributable to the depression associated with the underlying skin disease.”

AMAGINE-2 and AMAGINE-3 were replicate phase III, double-blind, randomized, controlled trials of 3,712 patients with moderate to severe plaque psoriasis. In the two studies, week 12 PASI 75 rates were about 85% with 210 mg of brodalumab, about 68% for 140 mg of brodalumab, and 6%-8% for placebo (P less than .001). Moreover, week 12 PASI 100 response rates with 210 mg of brodalumab were 37% and 44%, compared with 19% and 22% for ustekinumab (P less than .001), the investigators reported.

Median time to PASI 75 on 210 mg of brodalumab was 4 weeks – about twice as fast as for ustekinumab. Rates of static Physician’s Global Assessment (sPGA) scores of 0 or 1 (clear or almost clear skin) also were significantly higher for brodalumab, compared with placebo (P less than .001).

Mild to moderate candidiasis was more common during induction of brodalumab, compared with ustekinumab or placebo, underscoring the role of interleukin-17A in microbial surveillance, Dr. Lebwohl and his associates pointed out. They estimated that 1-1.3 serious infections occurred for every 100 patient-years of exposure to brodalumab, through 52 weeks.

The investigators reported but did not comment on the suicides, stating only that the study populations were large enough to assess common adverse events but “may have been inadequate for the detection of rare adverse events, which would require longer follow-up of large numbers of patients to provide a full understanding of the safety profile of brodalumab.”

Ustekinumab is marketed as Stelara.

Amgen funded the AMAGINE-2 and AMAGINE-3 studies. Dr. Lebwohl reported having received grant support from Amgen, AbbVie, Janssen Biotech, UCB Pharma, Pfizer, Celgene, Eli Lilly, and Novartis outside the submitted work. Twenty-four coauthors reported grant support or personal fees from Amgen, Abbvie, Merck, Janssen, and several other pharmaceutical companies. The other investigators declared no competing interests.

Inhibition of interleukin-17A with secukinumab gave half of psoriatic arthritis patients treated with either a low or high dose of the monoclonal antibody at least 20% improvement in the American College of Rheumatology response criteria, according to investigators in the FUTURE 1 trial published Sept. 30 in the New England Journal of Medicine.

A team of researchers led by Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, assessed the efficacy of secukinumab by measuring the proportion of patients from baseline to week 24 who attained an ACR20 level of response, defined as 20% improvement in the number of tender joints (from an analysis of 78 joints), in the number of swollen joints (from an analysis of 76 joints), and in at least three of five other important domains.

Dr. Mease and his associates examined 606 patients in this double-blind, phase III study and randomly assigned them in a 1:1:1 ratio to receive IV secukinumab 10 mg/kg at weeks 0, 2, and 4, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks, or placebo.

They found that ACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%). There also was significantly less radiographic progression, as measured by the change from baseline on the van der Heijde–modified total Sharp score at week 24, in the secukinumab groups, compared with patients in the placebo group. The researchers, however, also noted that infections were more common in the secukinumab groups and that four patients in the secukinumab groups had a stroke.

Read the full article here (N Engl J Med. 2015 Sept. 30;373:1329-39. doi: 10.1056/NEJMoa1412679).

mbock@frontlinemedcom.com

Inhibition of interleukin-17A with secukinumab gave half of psoriatic arthritis patients treated with either a low or high dose of the monoclonal antibody at least 20% improvement in the American College of Rheumatology response criteria, according to investigators in the FUTURE 1 trial published Sept. 30 in the New England Journal of Medicine.

A team of researchers led by Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, assessed the efficacy of secukinumab by measuring the proportion of patients from baseline to week 24 who attained an ACR20 level of response, defined as 20% improvement in the number of tender joints (from an analysis of 78 joints), in the number of swollen joints (from an analysis of 76 joints), and in at least three of five other important domains.

Dr. Mease and his associates examined 606 patients in this double-blind, phase III study and randomly assigned them in a 1:1:1 ratio to receive IV secukinumab 10 mg/kg at weeks 0, 2, and 4, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks, or placebo.

They found that ACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%). There also was significantly less radiographic progression, as measured by the change from baseline on the van der Heijde–modified total Sharp score at week 24, in the secukinumab groups, compared with patients in the placebo group. The researchers, however, also noted that infections were more common in the secukinumab groups and that four patients in the secukinumab groups had a stroke.

Read the full article here (N Engl J Med. 2015 Sept. 30;373:1329-39. doi: 10.1056/NEJMoa1412679).

mbock@frontlinemedcom.com

Inhibition of interleukin-17A with secukinumab gave half of psoriatic arthritis patients treated with either a low or high dose of the monoclonal antibody at least 20% improvement in the American College of Rheumatology response criteria, according to investigators in the FUTURE 1 trial published Sept. 30 in the New England Journal of Medicine.

A team of researchers led by Dr. Philip J. Mease of the Swedish Medical Center and the University of Washington, both in Seattle, assessed the efficacy of secukinumab by measuring the proportion of patients from baseline to week 24 who attained an ACR20 level of response, defined as 20% improvement in the number of tender joints (from an analysis of 78 joints), in the number of swollen joints (from an analysis of 76 joints), and in at least three of five other important domains.

Dr. Mease and his associates examined 606 patients in this double-blind, phase III study and randomly assigned them in a 1:1:1 ratio to receive IV secukinumab 10 mg/kg at weeks 0, 2, and 4, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every 4 weeks, or placebo.

They found that ACR20 response rates at week 24 were significantly higher in the group receiving secukinumab at doses of 150 mg (50.0%) and 75 mg (50.5%) than in those receiving placebo (17.3%). There also was significantly less radiographic progression, as measured by the change from baseline on the van der Heijde–modified total Sharp score at week 24, in the secukinumab groups, compared with patients in the placebo group. The researchers, however, also noted that infections were more common in the secukinumab groups and that four patients in the secukinumab groups had a stroke.

Read the full article here (N Engl J Med. 2015 Sept. 30;373:1329-39. doi: 10.1056/NEJMoa1412679).

mbock@frontlinemedcom.com

The CADMUS trial showed improvements in moderate to severe psoriasis in adolescent patients 12 years or older treated with ustekinumab, a study showed.

Treatment of psoriasis in pediatric patients is complicated by the limited number of approved treatments, despite approximately one-third of patients developing psoriasis before the age of 20 years. A human monoclonal antibody that targets the p40 subunit of interleukin-12/23, known as ustekinumab, was found to be effective and safe in moderate to severe psoriasis in adults.

Dr. Ian Landells of Memorial University of Newfoundland in St. John’s and his colleagues presented the results of the CADMUS trial, a randomized phase III trial of ustekinumab for active psoriasis in patients aged 12-17 years (J Am Acad Dermatol. 2015;73:594-603).

Lori Farmer/Frontline Medical News

Patients aged 12-17 years with moderate to severe plaque psoriasis as defined by a Physician’s Global Assessment (PGA) score of greater than or equal to 3, a Psoriasis Area and Severity Index (PASI) of greater than or equal to 12, or 10% or more of body surface area involved for at least 6 months were included in the study.

The investigators conducted a multicenter, double-blind placebo-controlled trial with patients randomly assigned to weight-based standard dosing (SD) or weight-based half-standard dosing (HSD) at weeks 0, 4, and 16, then every 12 weeks until week 40. Conversely, participants could receive placebo at weeks 0 and 4 with crossover at week 12 and 16, then every 12 weeks until week 40 with either SD or HSD. Early escape to topical steroids at week 8 to week 12 for patients with a PASI increase to more than 50% above baseline was considered.

The primary endpoint of the study was the proportion of patients who achieved a PGA 0/1 by week 12. Secondary endpoints included the proportion of patients with 75% improvement by PASI (PASI 75) and 90% improvement by PASI (PASI 90) at 12 weeks, and change in the Children’s Dermatology Life Quality Index (CDLQI) at 12 weeks.

Between March 2010 and January 2014, 110 patients were included in the study: 36 randomly assigned to weight-based SD ustekinumab, 37 to weight-based HSD, and 37 to placebo, with 18 participants crossing over to SD and 19 participants crossing over to HSD. One participant each from the HSD and SD achieved early escape at 8 weeks. A total of nine participants (8%) discontinued the study because of adverse events (n = 3), death in an automobile accident (n = 1), or an unsatisfactory response (n = 5).

After 12 weeks, there were significantly more participants receiving either SD (69%) or HSD (68%) achieving a PGA of 0/1 vs. placebo (5%, P less than .001 for both doses). About one-third of the treatment participants achieved a PGA of 0/1 by week 4. Likewise, in the treatment group, significantly more participants achieved a PGA of 0 by week 12 (SD, 47%; HSD, 32%; placebo, 3%; P less than .001 for both doses).

When treatment response by PASI was assessed, a PASI 75 and PASI 90 were achieved significantly more often in the treatment groups (P less than .001 for both) than among controls. A PASI score of 0 (cleared) was achieved in 39% of the SD group and 22% of the HSD group vs. 3% with placebo (P less than .001 and P = .014, respectively).

Participants treated with ustekinumab demonstrated improvements in quality of life that were maintained at 52 weeks.

At week 12, 44% of the SD group, 51% of the HSD group, and 57% of the placebo group reported one or more adverse events. At the conclusion of the study at week 60, 82% of the participants had reported adverse events. Most of the adverse events were under the category of infections and infestations, which the authors noted were consistent with those observed in adults treated with ustekinumab.

Dr. Landells and his colleagues wrote, “Patients in both the HSD and SD ustekinumab groups experienced robust and clinically meaningful improvements in disease activity.”

The study was funded by Janssen Research and Development. The authors reported multiple financial disclosures.

The CADMUS trial showed improvements in moderate to severe psoriasis in adolescent patients 12 years or older treated with ustekinumab, a study showed.

Treatment of psoriasis in pediatric patients is complicated by the limited number of approved treatments, despite approximately one-third of patients developing psoriasis before the age of 20 years. A human monoclonal antibody that targets the p40 subunit of interleukin-12/23, known as ustekinumab, was found to be effective and safe in moderate to severe psoriasis in adults.

Dr. Ian Landells of Memorial University of Newfoundland in St. John’s and his colleagues presented the results of the CADMUS trial, a randomized phase III trial of ustekinumab for active psoriasis in patients aged 12-17 years (J Am Acad Dermatol. 2015;73:594-603).

Lori Farmer/Frontline Medical News

Patients aged 12-17 years with moderate to severe plaque psoriasis as defined by a Physician’s Global Assessment (PGA) score of greater than or equal to 3, a Psoriasis Area and Severity Index (PASI) of greater than or equal to 12, or 10% or more of body surface area involved for at least 6 months were included in the study.

The investigators conducted a multicenter, double-blind placebo-controlled trial with patients randomly assigned to weight-based standard dosing (SD) or weight-based half-standard dosing (HSD) at weeks 0, 4, and 16, then every 12 weeks until week 40. Conversely, participants could receive placebo at weeks 0 and 4 with crossover at week 12 and 16, then every 12 weeks until week 40 with either SD or HSD. Early escape to topical steroids at week 8 to week 12 for patients with a PASI increase to more than 50% above baseline was considered.

The primary endpoint of the study was the proportion of patients who achieved a PGA 0/1 by week 12. Secondary endpoints included the proportion of patients with 75% improvement by PASI (PASI 75) and 90% improvement by PASI (PASI 90) at 12 weeks, and change in the Children’s Dermatology Life Quality Index (CDLQI) at 12 weeks.

Between March 2010 and January 2014, 110 patients were included in the study: 36 randomly assigned to weight-based SD ustekinumab, 37 to weight-based HSD, and 37 to placebo, with 18 participants crossing over to SD and 19 participants crossing over to HSD. One participant each from the HSD and SD achieved early escape at 8 weeks. A total of nine participants (8%) discontinued the study because of adverse events (n = 3), death in an automobile accident (n = 1), or an unsatisfactory response (n = 5).

After 12 weeks, there were significantly more participants receiving either SD (69%) or HSD (68%) achieving a PGA of 0/1 vs. placebo (5%, P less than .001 for both doses). About one-third of the treatment participants achieved a PGA of 0/1 by week 4. Likewise, in the treatment group, significantly more participants achieved a PGA of 0 by week 12 (SD, 47%; HSD, 32%; placebo, 3%; P less than .001 for both doses).

When treatment response by PASI was assessed, a PASI 75 and PASI 90 were achieved significantly more often in the treatment groups (P less than .001 for both) than among controls. A PASI score of 0 (cleared) was achieved in 39% of the SD group and 22% of the HSD group vs. 3% with placebo (P less than .001 and P = .014, respectively).

Participants treated with ustekinumab demonstrated improvements in quality of life that were maintained at 52 weeks.

At week 12, 44% of the SD group, 51% of the HSD group, and 57% of the placebo group reported one or more adverse events. At the conclusion of the study at week 60, 82% of the participants had reported adverse events. Most of the adverse events were under the category of infections and infestations, which the authors noted were consistent with those observed in adults treated with ustekinumab.

Dr. Landells and his colleagues wrote, “Patients in both the HSD and SD ustekinumab groups experienced robust and clinically meaningful improvements in disease activity.”

The study was funded by Janssen Research and Development. The authors reported multiple financial disclosures.

The CADMUS trial showed improvements in moderate to severe psoriasis in adolescent patients 12 years or older treated with ustekinumab, a study showed.

Treatment of psoriasis in pediatric patients is complicated by the limited number of approved treatments, despite approximately one-third of patients developing psoriasis before the age of 20 years. A human monoclonal antibody that targets the p40 subunit of interleukin-12/23, known as ustekinumab, was found to be effective and safe in moderate to severe psoriasis in adults.

Dr. Ian Landells of Memorial University of Newfoundland in St. John’s and his colleagues presented the results of the CADMUS trial, a randomized phase III trial of ustekinumab for active psoriasis in patients aged 12-17 years (J Am Acad Dermatol. 2015;73:594-603).

Lori Farmer/Frontline Medical News

Patients aged 12-17 years with moderate to severe plaque psoriasis as defined by a Physician’s Global Assessment (PGA) score of greater than or equal to 3, a Psoriasis Area and Severity Index (PASI) of greater than or equal to 12, or 10% or more of body surface area involved for at least 6 months were included in the study.

The investigators conducted a multicenter, double-blind placebo-controlled trial with patients randomly assigned to weight-based standard dosing (SD) or weight-based half-standard dosing (HSD) at weeks 0, 4, and 16, then every 12 weeks until week 40. Conversely, participants could receive placebo at weeks 0 and 4 with crossover at week 12 and 16, then every 12 weeks until week 40 with either SD or HSD. Early escape to topical steroids at week 8 to week 12 for patients with a PASI increase to more than 50% above baseline was considered.

The primary endpoint of the study was the proportion of patients who achieved a PGA 0/1 by week 12. Secondary endpoints included the proportion of patients with 75% improvement by PASI (PASI 75) and 90% improvement by PASI (PASI 90) at 12 weeks, and change in the Children’s Dermatology Life Quality Index (CDLQI) at 12 weeks.

Between March 2010 and January 2014, 110 patients were included in the study: 36 randomly assigned to weight-based SD ustekinumab, 37 to weight-based HSD, and 37 to placebo, with 18 participants crossing over to SD and 19 participants crossing over to HSD. One participant each from the HSD and SD achieved early escape at 8 weeks. A total of nine participants (8%) discontinued the study because of adverse events (n = 3), death in an automobile accident (n = 1), or an unsatisfactory response (n = 5).

After 12 weeks, there were significantly more participants receiving either SD (69%) or HSD (68%) achieving a PGA of 0/1 vs. placebo (5%, P less than .001 for both doses). About one-third of the treatment participants achieved a PGA of 0/1 by week 4. Likewise, in the treatment group, significantly more participants achieved a PGA of 0 by week 12 (SD, 47%; HSD, 32%; placebo, 3%; P less than .001 for both doses).

When treatment response by PASI was assessed, a PASI 75 and PASI 90 were achieved significantly more often in the treatment groups (P less than .001 for both) than among controls. A PASI score of 0 (cleared) was achieved in 39% of the SD group and 22% of the HSD group vs. 3% with placebo (P less than .001 and P = .014, respectively).

Participants treated with ustekinumab demonstrated improvements in quality of life that were maintained at 52 weeks.

At week 12, 44% of the SD group, 51% of the HSD group, and 57% of the placebo group reported one or more adverse events. At the conclusion of the study at week 60, 82% of the participants had reported adverse events. Most of the adverse events were under the category of infections and infestations, which the authors noted were consistent with those observed in adults treated with ustekinumab.

Dr. Landells and his colleagues wrote, “Patients in both the HSD and SD ustekinumab groups experienced robust and clinically meaningful improvements in disease activity.”

The study was funded by Janssen Research and Development. The authors reported multiple financial disclosures.