Selected adverse events during the 12-week induction period of a phase III trial of vunakizumab: an exploratory post-hoc analysis
In brief
Vunakizumab increased injection reactions by 4.3 percentage points, not overall adverse events
Among 690 people with moderate-to-severe plaque psoriasis, about 70% had an adverse event during 12 weeks, with no significant difference between vunakizumab and placebo. Injection-site reactions were more common with vunakizumab, while fewer skin events appeared largely tied to better psoriasis control. This exploratory post-hoc analysis leaves longer-term safety uncertain.
- Journal
- Frontiers in immunology (Q1)
- Published
- 14 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Zhendong Wei, Lu Xu, Aoxue Wang
- PMID
- 42952621
- DOI
- 10.3389/fimmu.2026.1894231
Why clinicians should know about it
- Picked for Dermatology (paper of the day, 30 October 2026): Phase III psoriasis trial safety analysis of targeted therapy
Abstract
OBJECTIVE: This study aimed to investigate the impact of vunakizumab on adverse events (AEs) in patients with moderate-to-severe plaque psoriasis. METHODS: This exploratory post-hoc analysis used data from a phase III trial (NCT04839016). A total of 690 patients were included. The primary outcome was any AE occurrence during the 12-week induction treatment period. RESULTS: The incidence of any AE during the induction period was 69.9%. No significant difference in the incidence of any AE was observed between the two groups [risk difference (RD): -2.6%; 95% confidence interval (CI): -9.8% to 4.6%]. Sensitivity analyses showed that vunakizumab was not an independent influencing factor for the occurrence of any AE [odds ratio (OR): 0.828; 95% CI: 0.574 to 1.193; P = 0.311]. At the system organ class (SOC) level, investigations, metabolic and nutritional disorders, infectious and parasitic diseases, and skin and subcutaneous tissue diseases had incidences of 31.9%, 26.7%, 18.0%, and 14.6%, respectively. At the preferred term (PT) level, incidences were 11.3% for hyperuricemia, 7.1% for elevated liver enzymes, and 5.1% for injection site reaction. At the SOC level, the incidence of skin and subcutaneous tissue diseases was lower in the vunakizumab group than in the placebo group (RD: -6.2%; 95% CI: -12.1% to -0.3%). At the PT level, the incidence of injection site reaction was higher in the vunakizumab group than in the placebo group (RD: 4.3%; 95% CI: 1.4% to 7.3%). Notably, after excluding psoriasis exacerbation, the association between vunakizumab and skin and subcutaneous tissue diseases was no longer significant. CONCLUSION: Vunakizumab is not significantly associated with the occurrence of any AE or most selected AE categories in patients with moderate-to-severe plaque psoriasis, whereas vunakizumab is associated with a higher likelihood of injection site reaction and a lower likelihood of skin and subcutaneous tissue diseases. The observed lower incidence of skin and subcutaneous tissue diseases may largely reflect improved control of psoriasis rather than a specific safety benefit of vunakizumab. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT04839016.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.