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Guselkumab Found Safe, Effective for Treatment of Psoriatic Arthritis
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WASHINGTON — During a 24-week period, guselkumab was found to be safe and effective in the treatment of patients with active psoriatic arthritis, according to results of a phase 2a trial presented at the American College of Rheumatology Annual Meeting.
“Treatment with guselkumab (Janssen) showed significant improvements in joint symptoms, physical function, psoriasis, enthesitis, dactylitis and quality of life,” Atul A. Deodhar, MD, from Oregon Health and Science University, said in his presentation, here.
Deodhar and colleagues performed a double-blind, placebo-controlled multicenter study in patients with psoriatic arthritis and with at least 3% body surface area of plaque psoriasis who previously failed treatment. Patients were randomized to receive 100 mg of subcutaneous guselkumab (n = 100) or placebo (n = 49) at baseline, 4 weeks and then every 8 weeks through 44 weeks.
Overall, 8.2% of the placebo group and 9% of the guselkumab group were previously exposed to TNF-alpha medication. After 16 weeks, patients from both groups with less than 5% improvement from baseline in joint counts could switch to usekinumab (Stelara, Janssen). After 24 weeks, the remaining patients who received placebo switched to the guselkumab. Researchers assessed ACR20 response at 16 weeks and 24 weeks. Response at 24 weeks was the primary outcome of the study.
At 24 weeks, the researchers assessed reduction in 75% of Psoriasis Area and Severity Index (PASI 75), ACR50, change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), Leeds enthesitis index, dactylitis score, response to a 36-item Short Form health survey and proportion of patients achieving Minimal Disease Activity. Non-responders were patients who failed treatment, switched treatment or had missing data.
The researchers found more patients who were treated with guselkumab achieved ACR20, ACR50, ACR70, PASI 75, PASI 90 and PASI 100 responses at 24 weeks. After 4 weeks, ACR20 response was achieved in 21% of the guselkumab group and 0% of the placebo group. After 16 weeks, ACR20 occurred in 60% of the guselkumab group and 16.3% of the placebo group. After 24 weeks, researchers reported adverse events in 36% of the guselkumab group and 32.7% of the placebo group, with infections in 17% of the guselkumab group and 24% of the placebo group.
“Guselkumab was well-tolerated with no unexpected safety findings,” Deodhar said. – by Will Offit
Reference:
Deodhar AA, et al. Abstract #4L. Presented at: American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.
Disclosure: Deodhar reports he receives funding from AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer and UCB Pharma.