Vunakizumab in patients with active psoriatic arthritis: a multicentre, randomized, double-blind, placebo-controlled, phase 2 study

Abstract Objectives Current psoriatic arthritis (PsA) therapies, from conventional agents (e.g. methotrexate) to targeted biologics (e.g. TNF and IL-17 inhibitors), demonstrate distinct therapeutic profiles. Vunakizumab (SHR-1314) is a novel humanized monoclonal antibody targeting IL-17A. The phase 2 trial evaluated the efficacy and safety of vunakizumab in patients with active PsA. Methods Patients aged 18–75 years with a confirmed diagnosis of active PsA were randomized (1:1:1) to receive either subcutaneous vunakizumab 120 mg (n = 38), vunakizumab 240 mg (n = 37), or placebo (n = 37) at weeks 0, 2, 4, and 8. At week 12, patients on placebo were switched to vunakizumab (1:1 re-randomized to 120 mg or 240 mg through week 20), while vunakizumab groups continued treatment. The primary end point was American College of Rheumatology 20% improvement (ACR20) response rate at week 12. Results At week 12, ACR20 response rates were higher in the vunakizumab 120 mg (47.4%) or 240 mg (59.5%) groups vs placebo group (21.6%; p = 0.02 and p = 0.001, respectively). Also, improvements were sustained through 24 weeks and were noted in patients who switched from placebo after week 12. Treatment-emergent adverse events (TEAEs) incidence exhibited analogous frequencies between vunakizumab (73.7% [120 mg], 64.9% [240 mg]) and placebo (70.3%) during the 12-week core treatment period, and no severe TEAEs occurred. Conclusions Vunakizumab demonstrated superior efficacy to placebo and was well tolerated with an acceptable safety profile in patients with active PsA. The findings support proceeding to a phase 3 study. Trial registration number www. clinicaltrials.gov; NCT05055934