Abstract
IMPORTANCE: Vitiligo is a chronic skin disorder causing depigmentation. There is a lack of evidence-based medical evidence regarding ruxolitinib efficacy and safety for vitiligo. OBJECTIVE: To assess the efficacy and safety of ruxolitinib cream in the treatment of vitiligo. METHODS: The databases of PubMed, Embase, and Cochrane Library were searched. The literature screening was independently conducted by two reviewers. DATA EXTRACTION AND SYNTHESIS: For continuous variables, weighted mean difference (WMD) along with a 95% confidence interval (CI) was performed. For dichotomous outcomes, we calculated the odds ratios (ORs) or risk ratios (RRs), and their corresponding 95% CIs. The certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). MAIN OUTCOMES AND MEASURES: Symptoms, quality of life, and safety were evaluated using various measures, including the Facial Vitiligo Area Scoring Index (F-VASI), Total Vitiligo Area Scoring Index (T-VASI), Facial Body Surface Area (F-BAS), Total Body Surface Area (T-BAS) and Treatment-emergent Adverse Events (TEAEs). RESULTS: Three trials, involving a total of 830 participants from nine countries were included (female 388, 46.7%, male 442, 53.3%). The meta-analysis demonstrated a significant increase in the likelihood of participants achieving F-VASI75 (OR, 4.34 [95% CI 2.67-7.06]; high), F-VASI50 (OR 4.71 [95% CI 3.24-6.84]; high), T-VASI75 (OR 2.78 [95% CI 1.10-7.00]; moderate), and T-VASI50 (OR 4.47 [95% CI 2.52-7.92]; high) when compared ruxolitinib to vehicle. Ruxolitinib was associated with more lowered percentage change of F-VASI scores (MD - 32.79 [95% CI - 36.37 to - 29.21]; moderate), and T-VASI scores (MD - 20.22 [95% CI - 23.11 to - 17.33]; moderate) from baseline compared to vehicle. There may not be a significant difference in the occurrence of TEAEs between ruxolitinib and vehicle (RR 1.46 [95% CI 0.85-2.49]; high). CONCLUSIONS: The findings suggest that ruxolitinib cream holds promise as a treatment option for vitiligo. Further long-term studies are needed to assess its sustained efficacy and safety profile. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023431112.