Background Real-world data on the long-term effectiveness of tildrakizumab in Japanese patients with psoriasis remain limited, particularly in cohorts with relatively low baseline disease severity. Objectives To evaluate the 52-week effectiveness and safety of tildrakizumab in a real-world Japanese clinical setting, including exploratory subgroup analyses. Methods This retrospective, single-center observational study included 30 consecutive patients with psoriasis treated with tildrakizumab 100 mg in accordance with the approved Japanese dosing regimen. Disease severity was assessed using the Psoriasis Area and Severity Index (PASI) at weeks 0, 4, 16, 28, 40, and 52 (visit window ±1 week). Mean PASI scores were analyzed using observed values. For responder analyses, non-responder imputation (NRI) was applied; patients who discontinued treatment or had missing PASI data were classified as non-responders. Responder endpoints included PASI75 and absolute PASI ≤3. Exploratory subgroup analyses were conducted according to baseline characteristics. Statistical analyses were performed using GraphPad Prism. Results The mean PASI score improved from 11.45 at baseline (median 9.2) to 2.90 at week 52. Using NRI, PASI75 and PASI ≤3 achievement rates reached 56.7% and 60.0% at week 52, respectively. Four patients discontinued treatment because of insufficient efficacy, with final PASI scores of 7.5 (week 4), 1.6 (week 16), 3.7 (week 28), and 3.2 (week 40). Twenty-six patients (86.7%) continued treatment through week 52. Seven adverse events were documented during the study period, and no treatment discontinuations related to adverse events occurred. Conclusion Tildrakizumab demonstrated sustained real-world effectiveness in Japanese patients with psoriasis, with no treatment discontinuations related to adverse events. Interpretation of the safety and subgroup findings should take into account the retrospective single-center design and exploratory nature of the analyses.
Watabe et al. (Wed,) studied this question.