TOPLINE:

Treatment with vunakizumab, a monoclonal antibody targeting interleukin-17A, at 120- and 240-mg doses showed higher rates of 20% improvement in American College of Rheumatology (ACR20) response criteria in patients with active psoriatic arthritis (PsA) than treatment with placebo. The improvements noted at week 12 were sustained through week 24, with mild or moderate treatment-emergent adverse events.

METHODOLOGY:

• Researchers conducted a placebo-controlled phase 2 trial in 19 hospitals across China (December 2021 to October 2023) to assess the efficacy and safety of vunakizumab in 112 patients with active PsA and to determine optimal dosing.
• Patients aged 18-75 years with BMI of 18-32 who met the PsA classification criteria, had symptoms for at least 6 months, had active disease at baseline (three or more tender and swollen joints), and had at least one active plaque psoriatic lesion were included.
• Patients were randomly assigned to receive 120 mg vunakizumab (n = 38), 240 mg vunakizumab (n = 37), or a placebo (n = 37) subcutaneously at specified intervals (weeks 0, 2, 4, and 8), with patients receiving placebo switching to either 120- or 240-mg doses of vunakizumab at week 12 up to week 20. Those who were initially assigned to vunakizumab continued to receive the treatment every 4 weeks up to week 20.
• The primary endpoint was the ACR20 response rate at week 12, defined as an improvement of at least 20% from baseline in tender and swollen joint counts and in three of five domains: patient and physician global assessments, pain assessment, disability (measured using Health Assessment Questionnaire-Disability Index [HAQ-DI] scores), and acute phase reactants.
• Secondary endpoints were ACR50/70 response rates, as well as changes in Disease Activity Score in 28 joints, C-reactive protein, HAQ-DI scores, and Psoriasis Area and Severity Index scores from baseline to week 12.

TAKEAWAY:

• At week 12, the ACR20 response rate was 47.4% in the vunakizumab 120-mg group and 59.5% in the 240-mg group, compared with 21.6% in the placebo group (two-sided P = .02 and P = .001, respectively).
• The ACR50 response rates were higher with vunakizumab for both 120- and 240-mg doses (28.9% and 43.2%, respectively) than with placebo (0% for both; P = .0004 and P < .0001, respectively). Similar findings were noted for the ACR70 response.
• The efficacy of vunakizumab was sustained through week 24, with improvements noted in patients who switched from placebo to vunakizumab after week 12.
• Vunakizumab was well tolerated, with mild or moderate treatment-emergent adverse events reported. During the initial 12-week treatment, 73.7% of patients on vunakizumab 120 mg, 64.9% of those on vunakizumab 240 mg, and 70.3% of those on placebo reported at least one treatment-emergent adverse event, with the most common in the vunakizumab group being upper respiratory tract infection, hypertriglyceridemia, and hyperuricemia.

IN PRACTICE:

“[The study] results demonstrate that vunakizumab exhibits similar efficacy to other IL-17 [interleukin-17] inhibitors in treating PsA,” the authors wrote.

SOURCE:

This study was led by Yu Xue, Huashan Hospital, Fudan University, Shanghai, China. It was published online on February 3, 2026, in Rheumatology.

LIMITATIONS:

This study lacked an active comparator, which restricted direct efficacy and safety comparisons with other biologics. The use of a simple swelling digit count instead of the Leeds Dactylitis Index may have affected dactylitis assessment. Only Chinese patients were included, thereby limiting the generalizability to other ethnic groups.

DISCLOSURES:

This study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Four authors reported being employed by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.