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

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OBJECTIVES: Current PsA therapies, from conventional agents (e.g. MTX) to targeted biologics (e.g. TNF and IL-17 inhibitors), demonstrate distinct therapeutic profiles. Vunakizumab (SHR-1314) is a novel humanized mAb 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 s.c. 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 endpoint was ACR 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). In addition, 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: ClinicalTrials.gov, www. clinicaltrials.gov, NCT05055934.

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