A Phase III, Open-Label, Single-Arm, Multicentric Study of Tildrakizumab in Indian Patients with Moderate-to-Severe Plaque Psoriasis

Abstract

Moderate-to-severe plaque psoriasis is a chronic inflammatory disease linked to significant morbidity and reduced quality of life (QoL). Prospective data on interleukin-23 (IL-23) inhibitors in Indian patients remain limited. This phase III, open-label, multicentre, single-arm bridging study assessed the efficacy, safety and immunogenicity of tildrakizumab 100 mg in Indian patients. Adults with plaque psoriasis for ≥ 6 months, body surface area (BSA) involvement of 10–50%, Psoriasis Area and Severity Index (PASI) score ≥ 12 and Physician’s Global Assessment (PGA) rating ≥ 3 received tildrakizumab 100 mg subcutaneously at weeks 0, 4 and 16, followed through week 28. The primary endpoint was PASI 75 (≥ 75% reduction in a patient's PASI score compared to their baseline score before treatment) at week 12. Secondary endpoints included PASI 90 (≥ 90% reduction in PASI score), PGA rating, Dermatology Life Quality Index (DLQI), safety and immunogenicity. Among the 115 patients participating in the study, mean (± standard deviation) psoriasis duration was 7.4 ± 6.9 years, baseline PASI was 21.1 ± 7.8 and BSA involvement was 23.9 ± 9.6%. PASI 75 response rose from 62.3% at week 12 to 93.9% at week 28. PASI 90 was achieved by 78.1% of participants at week 28, and PGA 0/1 with ≥ 2-grade improvement was achieved by 91.2%. DLQI improved markedly (mean change − 13.2 ± 7.43; p < 0.0001). Treatment-emergent adverse events (TEAEs) occurred in 30 patients (26.3%), of which most were mild. One serious TEAE (acute myocardial infarction, unrelated to study drug) was reported. Anti-drug antibodies were detected in 7.1% of patients at week 28. In this short-term, single-arm bridging study, tildrakizumab 100 mg demonstrated sustained skin clearance and meaningful QoL improvement through week 28 after three doses, with a favourable safety profile in Indian patients. Longer-term comparative data are needed to confirm durability and relative effectiveness. CTRI/2023/06/053784.