Selected adverse events during the 12-week induction period of a phase III trial of vunakizumab: an exploratory post-hoc analysis
- 1Department of Dermatology, The Second Hospital of Dalian Medical University
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.
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BibTeX
@article{wei2026selected,
title = {{Selected adverse events during the 12-week induction period of a phase III trial of vunakizumab: an exploratory post-hoc analysis}},
author = {Zhendong Wei and Lu Xu and Aoxue Wang},
journal = {Frontiers in Immunology},
year = {2026},
month = oct,
doi = {10.3389/fimmu.2026.1894231},
url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1894231/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Selected adverse events during the 12-week induction period of a phase III trial of vunakizumab: an exploratory post-hoc analysis
AU - Zhendong Wei
AU - Lu Xu
AU - Aoxue Wang
PY - 2026
DA - 2026/10/14
JO - Frontiers in Immunology
DO - 10.3389/fimmu.2026.1894231
UR - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1894231/full
AB - 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.
SN - 1664-3224
ER -