Ruxolitinib cream for the treatment of vitiligo

We read with interest the study by David Rosmarin and colleagues,1Rosmarin D Pandya AG Lebwohl M et al.Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial.Lancet. 2020; 396: 110-120Summary Full Text Full Text PDF PubMed Scopus (35) Google Scholar which investigated the safety and efficacy of ruxolitinib cream in vitiligo. The study concluded that ruxolitinib cream is safe and effective as monotherapy in treating patients with vitiligo.1Rosmarin D Pandya AG Lebwohl M et al.Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial.Lancet. 2020; 396: 110-120Summary Full Text Full Text PDF PubMed Scopus (35) Google Scholar We believe that this generalised statement cannot be concluded based on major study limitations. The study did not make protocol adjustments to address young adults (20–30 years of age), an age group predominantly affected by vitiligo.2Halder RM Chappell JL Vitiligo update.Semin Cutan Med Surg. 2009; 28: 86-92Crossref PubMed Scopus (93) Google Scholar Although inclusion parameters included patients aged 18–75 years, the mean age of patients was 48·3 years and median age 49·0 years.1Rosmarin D Pandya AG Lebwohl M et al.Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial.Lancet. 2020; 396: 110-120Summary Full Text Full Text PDF PubMed Scopus (35) Google Scholar Most patients (64%) also had fairer skin types (ie, Fitzpatrick skin types I–III), whereas 9% of patients had dark skin types (ie, Fitzpatrick skin types V–VI). Since vitiligo has equal representation in patients with fair and dark skin, the limited diversity of skin types minimises the generalisability of the study's results.3Bergqvist C Ezzedine K Vitiligo: a review.Dermatology. 2020; 236: 1-22Crossref Scopus (27) Google Scholar Patients with darker skin with vitiligo, especially Black patients, are also more likely to have concurrent autoimmune conditions, such as rheumatoid arthritis, which are associated with an increased risk of thrombosis with Janus kinase inhibitor use.4Rothstein B Joshipura D Saraiya A et al.Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib.J Am Acad Dermatol. 2017; 76: 1054-1060Summary Full Text Full Text PDF PubMed Scopus (75) Google Scholar, 5Dahir AM Thomsen SF Comorbidities in vitiligo: comprehensive review.Int J Dermatol. 2018; 57: 1157-1164Crossref PubMed Scopus (32) Google Scholar Systemic exposure with topical ruxolitinib, by application to more than 10% of body surface area or a total of 3·75 gm, could impose an increased risk of thrombosis in Black patients with vitiligo.4Rothstein B Joshipura D Saraiya A et al.Treatment of vitiligo with the topical Janus kinase inhibitor ruxolitinib.J Am Acad Dermatol. 2017; 76: 1054-1060Summary Full Text Full Text PDF PubMed Scopus (75) Google Scholar, 5Dahir AM Thomsen SF Comorbidities in vitiligo: comprehensive review.Int J Dermatol. 2018; 57: 1157-1164Crossref PubMed Scopus (32) Google Scholar To conclude, it is difficult to extend the study's findings and conclusions to clinical practice given the lack of sufficient age and racial representation in research cohorts. Further investigation of ruxolitinib cream is suggested with these specific patient populations in mind. JJW is or has been an investigator, consultant, or speaker for AbbVie, Almirall, Amgen, Arcutis, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr Reddy's Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, Regeneron, Sanofi Genzyme, Sun Pharmaceutical, UCB, and Valeant Pharmaceuticals North America. All other authors declare no competing interests. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trialTreatment with ruxolitinib cream was associated with substantial repigmentation of vitiligo lesions up to 52 weeks of treatment, and all doses were well tolerated. These data suggest that ruxolitinib cream might be an effective treatment option for patients with vitiligo. Full-Text PDF Ruxolitinib cream for the treatment of vitiligo – Authors' replyWe thank Shelley Uppal and colleagues for their comments on the randomised phase 2 trial of ruxolitinib cream for the treatment of vitiligo,1 in which concerns over the generalisability of the study population were raised. As a phase 2 study, the goal was to evaluate the efficacy and safety of different concentrations and dosing regimens of ruxolitinib cream in patients with non-segmental vitiligo before progressing to phase 3 studies, in which generalisability would be assessed. As such, our study1 does not state that ruxolitinib cream is a safe and effective treatment for vitiligo or conclude that the study's findings should extend to clinical practice. Full-Text PDF