Real-World Effectiveness and Safety of Ixekizumab in Moderate-to-Severe Plaque Psoriasis in the Indian Population: A Pilot Study.

backgroundIndia has a significant burden of psoriasis, with an incidence reported between 0.44% and 2.2% among total dermatology patients and a reported prevalence of 4.78% over 5 years. Psoriasis is now recognized as a multisystem disease, and targeted therapies are needed to reduce morbidity. The need for newer biologics exists not only for better disease control but also to treat patients who manifest primary or secondary failure to a previous biologic. Ixekizumab is a newer IL-17 inhibitor that has recently been approved by the Drug Controller General of India for use in patients with psoriasis vulgaris in India. AIMS AND

objectivesTo evaluate the effectiveness and safety of ixekizumab in the treatment of patients with plaque psoriasis of Indian origin. PATIENTS AND

methodsThe study was a prospective, single-center, single-arm interventional study approved prospectively by Clinical Trial Registry-India with reg. no. CTRI/2025/02/081205. The induction phase of ixekizumab was used to treat 40 patients with moderate-to-severe plaque psoriasis. The psoriasis area severity index (PASI), body surface area (BSA), and dermatology life quality index (DLQI) were measured at 2, 4, and 12 weeks of therapy. Median values of absolute PASI and BSA were assessed statistically using the Friedman test and Wilcoxon-signed rank test. PASI 75/90/100 responses were measured at 2, 4, and 12 weeks and analyzed using Cochran's Q test and McNemar test. Safety and adverse events, if any, were documented.

resultsThe median absolute PASI, BSA, and DLQI showed progressive improvement during the study period and these values when compared between baseline and 12 weeks were statistically significant. PASI 75/90/100 at the end of 12 weeks was 100%, 75%, and 20%, respectively. All eleven patients who had primary or secondary failure to a previous biologic showed a comparable response to that achieved by biologic naïve patients. No major adverse events were noted. LIMITATIONS: Considering that it is a pilot study which concluded in the induction phase of the treatment, long-term treatment outcomes and adverse events cannot be commented upon.

conclusionIxekizumab achieved high PASI targets during the induction phase. The treatment improved the DLQI significantly. It has an excellent safety profile in the Indian population. Its effectiveness in patients with previous biologic failure is comparable to that in biologic naïve patients.