Vunakizumab effective and Well Tolerated in psoriatic arthritis: Study
Vunakizumab was found to be more effective than the placebo in the efficacy trial for the treatment of active psoriatic arthritis (PsA), with favorable safety in the subjects. It is considered appropriate to progress the compound into phase 3 clinical trials. In the phase 2 efficacy trial of the compound, it has been found that the frequency of ACR20 response was substantially greater in the 120 mg dose group as well as the 240 mg dose group compared with the placebo group. The study was published in the Rheumatology journal by Yu Xue and colleagues.
Psoriatic arthritis is a chronic inflammatory disease that causes joint damage, functional inability, and reduced quality of life. Current therapeutic approaches, which cover conventional synthetic disease-modifying antirheumatic drugs and biologics, including tumor necrosis factor and interleukin-17 inhibitors, have varying levels of response and unmet need. Vunakizumab ( SHR-1314), which is a new humanized monoclonal antibody to interleukin-17A, was investigated in the current Phase 2 to evaluate its efficacy and safety in treating psoriatic arthritis in adults.
This randomized placebo-controlled phase 2 trial involved patients between 18 and 75 years old with active confirmed PsA. The patients were randomly allocated in a ratio of 1:1:1 to:
Vunakizumab 120 mg (n = 38)
Vunakizumab 240 mg (n = 37)
Placebo (n = 37)
In the 12-week core treatment phase, the week 0, 2, 4, and 8 doses of the study medication were given.
At week 12, the patients receiving the placebo were given the option of switching over from the placebo to vunakizumab 120 mg or 240 mg in a 1:1 ratio until week 20. Patients who were initially given the vunakizumab were given the option of continuing with the drug. The primary endpoint used in the study was the proportion of patients who demonstrated American College of Rheumatology 20% improvement (ACR20) at 12 weeks.
Key findings
In this phase 2 randomized trial of patients with active PsA:
- 38 patients received vunakizumab 120 mg
- 37 patients received vunakizumab 240 mg
37 patients received a placebo
At week 12:
- ACR20 response was 47.4% with 120 mg
- ACR20 response was 59.5% with 240 mg
- ACR20 response was 21.6% with placebo
Statistical significance: p = 0.02 (120 mg), p = 0.001 (240 mg)
Treatment-emergent adverse events during 12 weeks:
- 73.7% (120 mg)
- 64.9% (240 mg)
- 70.3% (placebo)
No severe TEAEs reported
Improvements were sustained through 24 weeks and were observed in patients switched from placebo after week 12.
Vunakizumab therapy was shown to have clear superiority in efficacy over placebo and was found to be well-tolerated and have an acceptable safety profile among patients with active psoriatic arthritis. The high ACR20 response rates in the 120 mg and 240 mg dosing regimens of vunakizumab, consistency of efficacy up to week 24, and lack of severe adverse drug experiences warrant the advancement of this therapy to phase 3 clinical testing and position it as a promising treatment for the evolving landscape of psoriatic arthritis therapies focused on the IL-17A pathway.
Reference:
Yu Xue, Lingyun Sun, Ning Zhang, Haiying Chen, Xiaofei Shi, Shengyun Liu, Lin Chen, Xinmei Ma, Hua Wei, Zhenyu Jiang, Xiaomei Li, Hongtao Fan, Hongbin Li, Jingyang Li, Rui Wu, Guixiu Shi, Jing Zhu, Xiaodan Kong, Yuewu Lu, Pan Liu, Qianning Zheng, Xiaoyan Bai, Su Zhang, Weiguo Wan, Hejian Zou, Vunakizumab in patients with active psoriatic arthritis: a multicentre, randomized, double-blind, placebo-controlled, phase 2 study, Rheumatology, 2026;, keag060, https://doi.org/10.1093/rheumatology/keag060
