Evaluation of The Safety and Efficacy of Ruxolitinib Cream in The Treatment of Vitiligo- A Comparative Observational Study
Author(s): Md. Nazmul Haque Sarker, Samia Subreen Shila, Kismat Ara Islam, Humayoun Kabir
Background: Vitiligo is a chronic autoimmune disease characterised by depigmented patches of skin that result from the loss of melanocytes. The global prevalence of vitiligo is approximately 0.5–2%, which varies geographically. Patients with vitiligo have a reduced quality of life and often have psychosocial and autoimmune comorbidities. We investigated the therapeutic potential of ruxolitinib cream in patients with vitiligo and report the efficacy and safety results up to 52 weeks of double-blind treatment.
Methods: A comparative observational study was conducted in the department of Dermatology and Venereology, Shaheed Monsur Ali Medical College Hospital, Dhaka, Bangladesh from July to December 2023. All the patients of vitiligo came for treatment at the Department of Dermatology and Venereology in SMAMCH and during this period the patients were studied. Total 100 patients included in our Study. The patients who did not develop enough signs and symptoms of vitiligo were excluded from the study. Patients, investigators, and the study sponsor (except members of the interim analysis and primary endpoint analysis data monitoring teams) remained masked to treatment assignment throughout the study. The primary endpoint was the proportion of patients achieving a 50% or higher improvement from baseline in F-VASI (F-VASI50) at week 24, assessed in the intention-to-treat population.
Results: Total 100 patients were randomly assigned to receive ruxolitinib cream. The mean age was 48·3 years (SD 12·9) and the median age was 49·0 years (range 18–73), 46 (46%) of 100 patients were men and 54 (54%) were women. Most patients (93%) had non-segmental vitiligo and skin types II–III (64%). Median disease duration was 14·0 years (range 0·3–67·9). The mean percentage of T-BSA involvement at baseline was 22·05 (SD 18·38%) and for F-BSA 1·48 (0·86%). The baseline mean T-VASI score was 17·96 (SD 15·45) and the mean F-VASI score was 1·26 (0·82). The reliability and validity of F-VASI and T-VASI instruments as measures of treatment efficacy were confirmed in a post-hoc analysis. Clinically meaningful change was detected for F-VASI with a percentage change of 56% and T-VASI with a percentage change of 42% from baseline, using an approach anchored on the 7-point PaGIC-V scale (appendix pp 30–40). A larger proportion of patients with baseline T-BSA 20% or less who received ruxolitinib cream 1·5% twice daily noted very much or much improvement (scores of 1 or 2) of vitiligo per the PaGIC-V at week 24. Patients who received any dose of ruxolitinib cream showed visible improvement in repigmentation of facial and non-facial vitiligo lesions; repigmentation was most notable with 0.15% once daily and 1·5% twice daily, and patients showed continued improvement up until week 52. All treatment-related adverse events were mild or moderate in severity and similar across treatment groups.
Conclusion: In conclusion, study data up until week 52 suggest that ruxolitinib cream monotherapy is an effective treatment option for patients with vitiligo. These data suggest that ruxolitinib cream might be an effective treatment option for patients with vitiligo.