Risankumab (RZB) is a safe and effective treatment option for patients with active psoriatic arthritis (PsA), according to a recent study.
Findings were presented at the ACR/AHRP Annual Meeting, which is taking place from November 3 to 8, 2017, in San Diego, California.
Multiple effector cytokines are regulated by interleukin-23 (IL-23), which is associated with psoriatic lesions, synovitis, enthesitis, and bone erosion. The potent humanized immunoglobulin G1 monoclonal antibody (IgG1 mAb) RZB inhibits IL-23.
For their study, the researchers assessed 185 patients with active PsA. Median patient age was 51 years. A total of 80 (43.2%) patients were women, and 89 (49.4%) patients had psoriasis covering at least 3% of their body surface area.
Patients were randomly assigned to receive 150 mg RZB at baseline and at weeks 4, 8, 12, and 16 (arm 1); 150 mg RZB at baseline and at weeks 4 and 16 (arm 2); 150 mg RZB at baseline and at week 12 (arm 3); 75 mg single-dose RZB at baseline (arm 4); or matching placebo (arm 5). Baseline demographics and disease characteristics were similar in each treatment arm.
Patients were classified by prior tumor necrosis factor inhibitor use and concurrent methotrexate use. The primary outcome was self-reported disease score on multiple questionnaires, dactylitis count, enthesitis index, and pain on visual analog scale (VAS).
A total of 172 of 185 patients (93.0%) had completed the 16-week treatment. At baseline, 56 patients had dactilytis, 119 had enthesitis, 45 had prior exposure to tumor necrosis factor inhibitors, and 106 had been taking concomitant methotrexate.
Compared with placebo at week 16, RZB use was associated with significant improvements in disease scores, enthesitis from baseline, minimal disease activity responses, and pain on VAS.
“In this Phase 2 study, RZB significantly improved joint and skin symptoms in [patients] with active PsA,” the researchers concluded. “RZB was well-tolerated with no new or unexpected safety findings.”
Mease PJ, Kellner H, Morita A, et al. Efficacy and safety results from a phase 2 trial of risankumab, a selective IL-23p19 inhibitor, in patients with active psoriatic arthritis. Paper presented at: ACR/ARHP Annual Meeting; November 3-8, 2017; San Diego, CA. http://acrabstracts.org/abstract/efficacy-and-safety-results-from-a-phase-2-trial-of-risankizumab-a-selective-il-23p19-inhibitor-in-patients-with-active-psoriatic-arthritis/.