Value of tacrolimus 0.1% in the treatment of vitiligo in the era of targeted therapy

Abstract

Background

Vitiligo, a prevalent depigmenting condition, affects both adults and children, significantly impacting their quality of life. The standard treatment approach involves the application of topical corticosteroids in conjunction with narrow-band ultraviolet B (UVB) phototherapy. A novel topical treatment, ruxolitinib (a Janus kinase inhibitor), has recently received approval. Notwithstanding the absence of marketing authorization for this particular indication in France, numerous practitioners have adopted the use of tacrolimus ointment 0.1% for the treatment of vitiligo, frequently in conjunction with phototherapy. The objective of this study is to present the benefit/risk ratio of tacrolimus in the treatment of vitiligo.

Methods

A comprehensive literature search was conducted by the Centre of Evidence (CDP) of the French Society of Dermatology (SFD) to ascertain the efficacy and safety of topical calcineurin inhibitors (TCIs) in vitiligo. The search strategy encompassed meta-analyses (MAs) and prospective multicentric cohort studies.

Results

Literature data – in particular three meta-analyses and one randomised controlled trial – confirm the superiority of tacrolimus versus placebo and its non-inferiority versus super-potent topical corticosteroids. In a subgroup analysis, tacrolimus suggests superior efficacy in children and in facial vitiligo. The combined use of tacrolimus and phototherapy exhibited synergistic efficacy.

Conclusion

Notwithstanding the market access of topical ruxolitinib, tacrolimus remains a viable treatment option for vitiligo, as substantiated by extant efficacy and safety in the literature. A recent decision of the French National Agency for the Safety of Medicines and Health Products (ANSM) authorized the compassionate prescription of tacrolimus and its reimbursement for patients.