Topical Tofacitinib for Atopic Dermatitis – Outcomes from Randomized Phase 3 Clinical Trial: First Approval
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Background: The Janus kinase (JAK) enzyme plays a crucial role in the pathophysiology of atopic dermatitis (AD). The United States Food and Drug Administration (USFDA) has recently granted approval for three JAK inhibitors intended for AD treatment. These comprise topical Ruxolitinib, oral Abrocitinib, and Upadacitinib. In alignment with these advancements, we developed a topical formulation of Tofacitinib, a JAK inhibitor, and evaluated its potential in mild-to-moderate AD, which has been recently approved on the basis of a phase 3 clinical trial. Aims and Objectives: The present trial was conducted to evaluate the efficacy and safety of tofacitinib ointment 2% w/w (Tof-O) versus pimecrolimus cream 1% w/w (Pim-C) in adult patients with mild-to-moderate AD. Materials and Methods: In this prospective, open-label, multicenter phase 3 trial, 184 patients with mild-to-moderate AD were randomized (1:1) to receive either Tof-O or Pim-C for 4 weeks. The efficacy evaluations included percent change in Eczema Area and Severity Index (EASI) score, percentage of patients achieving EASI 50, 75, and 90% improvement, change in validated Investigator Global Assessment (vIGA-AD) score, change in affected percentage body surface area (BSA), and change in pruritus using numeric scale. Safety and tolerability were assessed by laboratory parameters, physical examination, and adverse events (AEs). Results: < 0.05) improvements in vIGA-AD scores, affected BSA, and pruritus from baseline after 4 weeks of treatment. There were no significant changes observed in laboratory values and other safety parameters in both groups. Conclusion: Tof-O demonstrated favourable safety and efficacy in mild-to-moderate AD patients following 4 weeks of treatment. Trial Registration: Clinical Trial Registry-India (CTRI). CTRI/2022/07/044136 [Registered on: 19/07/2022] Trial Registered Prospectively. URL: https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=71771&EncHid=&userName=tofacitinib%20ointment. Type of Trial: Interventional.
Source: Indian Journal of Dermatology
Authors: Alok R. Chaturvedi, Hemant G. Zaveri, Dhaval V. Patel, Tof-O in AD Trial Investigators
Institution: Intas Pharmaceuticals (India)
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4414964448