Abstract
We report findings from a post-marketing study conducted from November 2016 to September 2022, which evaluated the safety and effectiveness of ixekizumab in Japanese patients with psoriasis under routine clinical practice for up to 52 weeks, and the incidence of serious infections and malignancies for up to 3 years. Of 804 patients in this analysis (67.9% male; median age, 54 years; mean disease duration, 11.8 years), 72.9%, 37.7%, 7.8%, and 3.7% had psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and erythrodermic psoriasis, respectively (subtypes not mutually exclusive). At 52 weeks, adverse events were reported in 203 patients (25.3%). Serious adverse events were reported in 36 patients (4.5%), including serious infections and infestations (n = 13, 1.6%). The incidence of serious infections and benign, malignant, and unspecified neoplasms was 0.8% (n = 5) and 0.6% (n = 4) respectively, at 3 years. Overall, 137 patients (17.0%) received Q2/Q2 treatment (160 mg starting dose, followed by 80 mg every 2 weeks from week 12); 550 patients (68.4%) received Q2/Q4 treatment (160 mg starting dose, followed by 80 mg every 2 weeks from weeks 2 to 12 and 80 mg every 4 weeks thereafter); and 117 patients (14.6%) discontinued before week 12 or received only one dose after week 12. A higher proportion of patients in the Q2/Q2 group had psoriatic arthritis (56.9% [n = 78]) compared with the Q2/Q4 group (32.9% [n = 181]). Among patients in the Q2/Q2 versus the Q2/Q4 dose groups, 21 (15.3%) and 141 (25.6%) respectively had adverse events and 2 (1.5%) and 32 (5.8%) respectively had serious adverse events. The mean Psoriasis Area and Severity Index score and body surface area percentage significantly decreased from baseline to week 52 for all psoriasis subtypes and by Q2/Q2 and Q2/Q4 ixekizumab doses (p < 0.01 or p < 0.001). Overall, the safety and effectiveness of ixekizumab in real-world settings in Japan were similar to those reported in clinical trials.