Background/Purpose: Psoriatic arthritis (PsA) has a significant impact on health related quality of life (HRQoL). This analysis evaluated the efficacy of brodalumab, a human anti-IL-17 receptor A monoclonal antibody, on HRQoL with an emphasis on pain and physical functioning in patients with PsA.

Methods: Analysis of data from a phase 2 study of subjects with PsA (Classification Criteria for PsA and ≥3 tender and ≥3 swollen joints) for ≥6 months randomized to brodalumab (140 or 280 mg Q2W) or placebo for 12 weeks followed by an open-label extension (OLE) in which all subjects received 280 mg brodalumab. Patient reported outcome (PRO) 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 OLE and were based on observed data.

Results: The majority of subjects enrolled (113 brodalumab and 55 placebo) were female (64%), white (94%), and rheumatoid factor negative (92%). Mean (SD) age, weight, and duration of PsA were 52 (12) years, 91 (21) kg, and 9 (8) years, respectively. 156 subjects enrolled in the OLE. Median (IQR) percent change in SGA-joint pain from baseline to week 12 was -23% (-54, 10) in the 140-mg group (P=.06) and -28% (-49, 10; P=.04) in the 280-mg group, compared with -5% (‑32, 29) in placebo. Median (IQR) percent change in HAQ-DI from baseline to week 12 was ‑7% (-45, 6) in the 140-mg group (P = .30) and -14% (-36, 0) in the 280-mg group (P = .12), compared with -8% (-23, 13) in placebo.  Compared with placebo, SGA-disease activity was significantly lower in the 140-mg group (least squares mean difference [95% CI] -17.2 [-32.7, -1.6]; P=.031) and the 280-mg group (least squares mean difference [95% CI] -24.6 [-40.3, -8.9]; P=.002). There was a significantly greater change in BASDAI score from baseline to week 12 in the 140-mg group (least squares mean difference [95% CI] -0.7 [-1.3, -0.1]; P=.03) and 280-mg group (least squares mean difference [95% CI] -0.8 [-1.4, -0.2]; P=.01) compared with placebo. Nonsignificant trends of improvement were observed for SF-36 physical component, mental component, and some other domain scores. During the OLE, all response measures continued to improve in both brodalumab groups and responses in the prior placebo group at week 24 were similar to those of the brodalumab group at week 12.

Conclusion: Brodalumab treatment was associated with significant improvements in joint pain and physical functioning in subjects with PsA.

ACR Meeting Abstracts - https://acrabstracts.org/abstract/effect-of-brodalumab-amg-827-on-pain-and-physical-functioning-in-patients-with-psoriatic-arthritis/