Safety and effectiveness of secukinumab subcutaneous injection in Japanese patients with psoriasis vulgaris and psoriatic arthritis: A post-marketing surveillance.

Abstract

Secukinumab is the first human monoclonal antibody that targets human interleukin-17A. This open-label, multicenter, uncontrolled, single-arm, prospective observational surveillance evaluated the long-term safety and effectiveness of secukinumab in patients with psoriasis vulgaris and psoriatic arthritis (PsA) in Japan. Of 997 patients whose surveillance forms were collected, 976 were included in the safety analysis and 729 in the effectiveness analysis. Prior to the start of secukinumab treatment, biologics were used in 42.52% of patients for the treatment of conditions including psoriasis. The mean ± standard deviation (SD) duration of secukinumab administration was 288.1 ± 106.51 days and the median (range) was 344.0 (1-365) days. The most commonly used dose per administration was 300 mg in 96.21% (939 patients) and the mean ± SD total number of administrations was 13.6 ± 3.87. Adverse events (AEs), AEs suspected to be related to secukinumab, AEs that led to secukinumab treatment discontinuation, serious AEs, and deaths were reported in 36.17%, 18.85%, 8.09%, 5.84%, and 1.13%, respectively. The proportion of patients with an Investigator's Global Assessment score improvement to 0/1 increased over time from the start of secukinumab treatment to week 24 and remained stable thereafter. The Psoriasis Area and Severity Index 75 response rates and the proportions of patients with a Dermatology Life Quality Index score of 0/1 increased from baseline and were maintained up to week 52. This surveillance did not show any new safety concerns of secukinumab treatment. The effectiveness of secukinumab treatment was observed in patients with psoriasis vulgaris and PsA.