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Vitiligo is a chronic skin disorder causing depigmentation. There is a lack of evidence-based medical evidence regarding ruxolitinib efficacy and safety for vitiligo. To assess the efficacy and safety of ruxolitinib cream in the treatment of vitiligo. The databases of PubMed, Embase, and Cochrane Library were searched. The literature screening was independently conducted by two reviewers. 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). 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). 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). 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. PROSPERO CRD42023431112. Does ruxolitinib cream effectively and safely treat vitiligo? Three trials, involving a total of 830 participants from nine countries were included (female 388, 46.7%, male 442, 53.3%) in this systematic review. High evidence showed that a significant increase in the likelihood of participants achieving F-VASI75 (OR = 4.34, 95%CI 2.67–7.06), F-VASI50 (OR = 4.71, 95%CI 3.24–6.84), T-VASI75 (OR = 2.78, 95%CI 1.10–7.00), and T-VASI50 (OR = 4.47, 95%CI 2.52–7.92) when compared ruxolitinib to vehicle. This study found that ruxolitinib cream holds promise as a treatment option for vitiligo.

Traditional pharmacovigilance (PV) relies heavily on spontaneous reporting systems (SRS), which remain vulnerable to under-reporting and limited mechanisti