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Efficacy and safety of guselkumab in Japanese patients with palmoplantar pustulosis: A phase 3 randomized clinical trial

JAMA Oct 16, 2019

Terui T, Kobayashi S, Okubo Y, et al. - In this 60-week, randomized clinical trial carried out from December 15, 2015, to December 12, 2017, of 159 individuals with palmoplantar pustulosis (PPP, a chronic, relapsing, inflammatory skin disease identified by the presence of multiple sterile pustules following the formation of vesicles along with erythematous scaling and is limited to the palms and soles), experts ascertained the efficiency and safety of guselkumab, an anti–IL-23 monoclonal antibody, in Japanese individuals with PPP. Treatment groups included guselkumab, 100 mg (n = 54), guselkumab, 200 mg (n = 52), or placebo (n = 53). Both guselkumab groups exhibited notable betterment in least-squares mean changes in PPP Area and Severity Index (PPPASI) score in comparison with placebo. Least-squares mean changes in the PPSI score revealed notable advancement in both guselkumab groups. A considerably greater proportion of individuals in the guselkumab 100-mg group accomplished a PPPASI-50 response at week 16 vs placebo, nevertheless, for the guselkumab 200-mg group, the result was non-significant. Each efficiency endpoint advanced constantly through week 52. As designated by a decrease in the Dermatology Life Quality Index score, health-related quality of life got better notably. Serious treatment-emergent adverse events were seen in eight individuals and no serious infections were seen. Thus, for a stubborn disease like PPP, targeting interleukin 23 with guselkumab could be an efficient and safe treatment choice.
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