Abstract
Guselkumab is a monoclonal antibody that binds to the p19 subunit of interleukin-23 and inhibits its downstream signaling. The safety profile of guselkumab and its superior efficacy over placebo and adalimumab for the treatment of patients with moderate-to-severe psoriasis were reported in phase 3 studies conducted within and outside Japan. To assess the real-world safety and effectiveness of guselkumab in Japanese patients with psoriasis, we conducted a multicenter, single-arm, prospective, post-marketing surveillance study. Guselkumab was administered by subcutaneous injection at a dose of 100 mg at weeks 0 and 4, then every following 8 weeks. The patient observation period was 52 weeks after the initial guselkumab dose or until treatment withdrawal. The safety analysis set consisted of 416 patients, including 310 patients with vulgaris (PsV); and the effectiveness analysis set consisted of 251 patients, including 236 patients with PsV or psoriatic arthritis (PsA). There were more men (71.3%, 221/310) than women among the PsV group. The median age among those with PsV was 58 years, the median disease duration was 11.50 years, 50.0% (155/310) had comorbidity, and 41.3% (128/310) had previously been treated with biologic agents. During the observation period, 8.4% (35/416) of patients experienced 49 adverse drug reactions, 2.9% (12/416) experienced 13 serious adverse drug reactions, and 3.4% (14/416) experienced 16 adverse events leading to treatment discontinuation. In the effectiveness analysis set of 236 patients with PsV or PsA, the Psoriasis Area and Severity Index (PASI) 75, 90, and 100 response rates at week 52 were 69.9%, 54.5%, and 32.5%, respectively. Bio-naïve patients consistently had higher PASI 75 and 90 response rates than bio-experienced patients. This post-marketing surveillance study demonstrated that guselkumab was well-tolerated and effective in a real-world setting in Japanese patients with psoriasis.