Acontecimentos adversos selecionados durante o período de indução de 12 semanas de um ensaio de fase III de vunakizumab: uma análise exploratória pós-hoc

Resumo original em inglês

O que aconteceu

This study aimed to investigate the impact of vunakizumab on adverse events (AEs) in patients with moderate-to-severe plaque psoriasis.

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.

https://clinicaltrials.gov/, identifier NCT04839016.

O que encontraram

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.

Por que isso importa

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.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.