Efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis with a high drug interruption rate during the COVID-19 pandemic: a post hoc analysis from a single center of a phase III trial.
During the phase III trial (NCT04839016), the outbreak of coronavirus disease 2019 (COVID-19) inevitably caused vunakizumab interruption in patients with psoriasis. This study extracted the data from Huashan Hospital, where almost all patients experienced drug interruption, and aimed to explore the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis and the impact of treatment interruption. A total of 90 patients with moderate-to-severe plaque psoriasis receiving vunakizumab (n = 65) or placebo (n = 25) were enrolled. Patients in the placebo group were switched to vunakizumab treatment at week (W)12. The 75% or more improvement in the Psoriasis Area Severity Index (PASI 75), PASI 90, and PASI 100 response rates at W12 were higher in the vunakizumab group than in the placebo group. This trend was observed at most time points over 52 weeks. Dermatology life quality index (DLQI) score, DLQI 0/1 response rate, and itch numerical rating scale score at W4, W8, and W12 were improved in the vunakizumab group compared to the placebo group. The incidence of adverse events during the induction period was numerically lower in the vunakizumab group than the placebo group. Sixty-four (98.5%) patients in the vunakizumab group experienced drug interruption, with 59 (92.2%) patients due to COVID-19 pandemic. All patients in the placebo group experienced any-cause drug interruption. In the vunakizumab group, elevated frequency of drug interruption was related to reduced PASI 75 and PASI 90 response rates at W52. Despite the high drug interruption rate in Huashan Hospital during COVID-19 pandemic, vunakizumab shows acceptable efficacy and safety for treating patients with moderate-to-severe plaque psoriasis. However, the long-term efficacy of vunakizumab appears attenuated in this single-center cohort compared with the overall phase III trial population.
