Safety and effectiveness of secukinumab in Japanese patients with generalized pustular psoriasis: A post-marketing surveillance.

Secukinumab is one of the human monoclonal antibodies recommended in the Japanese guidelines for patients with psoriasis, but few case reports and clinical studies on secukinumab for pustular psoriasis are available because of the rarity of the disease. This was an open-label, multicenter, uncontrolled, single-arm, prospective observational surveillance conducted in a clinical practice setting to evaluate the safety and effectiveness of secukinumab in Japanese patients with generalized pustular psoriasis (GPP). Patients were monitored for 1 year after starting secukinumab and followed up for an additional 2 years. Of 99 patients from 71 sites, 95 were included in safety and 82 in effectiveness analysis. The mean (standard deviation) observation period was 346.2 (64.87) days, and 91.58% of patients were observed over 52 weeks. Adverse events, serious adverse events, and adverse reactions were reported in 51.58%, 12.63%, and 35.79% of patients, respectively. Safety evaluations showed no significant difference in the incidence of events based on the history of biologics The proportion of patients with either "complete response" or "partial response" was ~90% from week 2 and remained stable until week 52. The proportion of patients with "remission (no symptom)" in the Japanese Dermatological Association total score increased from week 4 (22.22%) to week 52 (47.83%). The mean Psoriasis Area and Severity Index score decreased from week 1 (17.26) to week 16 (1.18), with the mean percentage change decreasing from -28.07% to -90.18%. The mean Dermatology Life Quality Index (DLQI) total score decreased from 8.7 at the start of secukinumab treatment to 1.9 at week 52. At week 52, the proportion of patients with DLQI total score of 0/1 was 57.14%. No new safety signals for secukinumab in long-term treatment were observed from this surveillance, and no additional measures needed to be taken. Moreover, secukinumab showed sustained effectiveness in patients with GPP in Japan.