The study’s secondary endpoints were a 75% reduction in the Psoriasis Area and Severity Index (PASI75) and ACR50 responses, as well as change from baseline in Health Assessment Questionnaire—Disability Index (HAQ-DI), improvement in enthesitis (Leeds enthesitis index) and dactylitis score (a 0–3 scoring system) at Week 24, as well as ACR20 response at Week 16. At Week 24, GUS treatment led to significantly greater improvements in dactylitis, enthesitis and health-related quality of life as measured by the Short Form Health Survey (SF-36 physical and mental component summary scores) compared with placebo-treated patients. In addition, at Week 24, minimal disease activity was attained by a higher percentage of GUS-treated patients compared with placebo-treated patients (23% vs. 2%; P=0.001). “It is difficult to compare guselkumab with other existing therapies for PsA, since no head-to-head studies have been done,” says Dr. Deodhar. “However, the improvements seen with guselkumab in the various manifestations of psoriatic arthritis and patient-reported outcomes are very promising.”
GUS was well-tolerated with no unexpected safety findings. Both the treatment and control groups had comparable numbers of adverse events through Week 24 (placebo: 33%; GUS: 36.0%). The most common adverse event was infection, which occurred in 20% of placebo-treated patients and 17% of GUS-treated patients.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
Lara C. Pullen, PhD, is a medical writer based in the Chicago area.
Reference
- Deodhar AA, Gottlieb AB, Boehncke WH, et al. Efficacy and safety results of guselkumab, an anti-IL23 monoclonal antibody, in patients with active psoriatic arthritis over 24 weeks: A phase 2a, randomized, double-blind, placebo-controlled study [abstract]. Arthritis Rheumatol. 2016;68(suppl 10).
