SAN DIEGO, CA—Patients with psoriatic arthritis experienced significant improvement in joint pain and physical functioning when treated with brodalumab (AMG 827), a study presented at the 2013 ACR/ARHP Annual Meeting has found.
Mark C. Genovese, MD, of Stanford University, Palo Alto, CA, and colleagues evaluated the efficacy of brodalumab, a human anti-IL-17 receptor A monoclonal antibody, on health-related quality of life (HRQoL) in patients with psoriatic arthritis, with an emphasis on pain and physical functioning.
They analyzed data from a Phase 2 study of patients meeting Classification Criteria for Psoriatic Arthritis (≥3 tender and ≥3 swollen joints) for ≥6 months. A total of 113 patients were randomized to brodalumab (140mg or 280mg every 2 weeks) and 55 to placebo for 12 weeks followed by an open-label extension in which all patients received brodalumab 280mg.
Patient-reported outcome measures of pain and HRQoL included subject global assessment (SGA)-joint pain, SGA-disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form Health Survey (SF-36 v2), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Analyses included available data up to Week 24 of the ongoing open-label extension and were based on observed data.
Median (IQR) percent change in SGA-joint pain from baseline to Week 12 was -23% (-54, 10) in the 140mg group (P=0.06) and -28% (-49, 10; P=0.04) in the 280mg group vs. -5% (-32, 29) for placebo.
Median (IQR) percent change in HAQ-DI from baseline to Week 12 was ‑7% (-45, 6) in the 140mg group (P=0.30) and -14% (-36, 0) in the 280mg group (P=0.12), compared with -8% (-23, 13) in the placebo group. Subject global assessment-disease activity was significantly lower in the 140mg group (least squares mean difference -17.2 [95% CI -32.7–-1.6]; P=0.031) and the 280mg group (-24.6 [95% CI -40.3–-8.9]; P=0.002) vs. placebo.
Compared with placebo, a significantly greater change in BASDAI score from baseline to Week 12 in the 140mg group (-0.7 [95% CI -1.3–-0.1]; P=0.03) and 280mg group (-0.8 [95% CI -1.4–-0.2]; P=0.01) was observed.
Nonsignificant trends of improvement were observed for SF-36 physical component, mental component, and some other domain scores. During the open-label extension, all response measures continued to improve in both brodalumab groups. Responses in the prior placebo group at Week 24 were similar to those of the brodalumab group at Week 12, they concluded.