Portal de Periódicos da CAPES

Ruxolitinib cream for the treatment of vitiligo – Authors' reply

2020; Elsevier BV; Volume: 396; Issue: 10264 Linguagem: Inglês

10.1016/s0140-6736(20)32470-3

1474-547X

David Rosmarin, Kathleen Butler, Fiona I. Kuo, John E. Harris,

Mast cells and histamine

We thank Shelley Uppal and colleagues for their comments on the randomised phase 2 trial of ruxolitinib cream for the treatment of 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 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 study1Rosmarin 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 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. Instead, we rather suggest that ruxolitinib cream might potentially become an effective treatment option based on results of the phase 2 dose-finding study. We agree with Uppal and colleagues that young patients (≤30 years old) with vitiligo are reported to have a higher psychosocial burden than older patients (>30 years old), and that there is generally equal representation among individuals with fair skin and dark skin.2Ezzedine K Eleftheriadou V Whitton M van Geel N Vitiligo.Lancet. 2015; 386: 74-84Summary Full Text Full Text PDF PubMed Scopus (339) Google Scholar Patient age (majority >30 years) and the high proportion of patients with fairer skin types are noted as study limitations.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 Although most patients were white (84%) and had Fitzpatrick skin types I–III (64%), all skin types were represented (32% with Fitzpatrick skin types IV–VI). We are working on a secondary analysis evaluating treatment response by patient demographic and clinical characteristic subgroups. With respect to comments regarding comorbid autoimmune conditions, the study included patients with other autoimmune disorders (most commonly thyroid disease), as described in the baseline characteristics table.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 The underlying conditions in our study population are representative of the background disorders in patients with vitiligo, and the rates of autoimmune comorbidities were in alignment with those reported in vitiligo chart review studies.3Gill L Zarbo A Isedeh P Jacobsen G Lim HW Hamzavi I Comorbid autoimmune diseases in patients with vitiligo: a cross-sectional study.J Am Acad Dermatol. 2016; 74: 295-302Summary Full Text Full Text PDF PubMed Scopus (70) Google Scholar, 4Sheth VM Guo Y Qureshi AA Comorbidities associated with vitiligo: a ten-year retrospective study.Dermatology. 2013; 227: 311-315Crossref PubMed Scopus (54) Google Scholar No significant safety concerns were noted in our study. Confirmatory global phase 3 trials of ruxolitinib cream for vitiligo enrolling adolescents and a higher proportion of patients with darker skin types are ongoing (NCT04052425, NCT04057573). These studies will further address safety as well as the generalisability of our findings to a larger patient population. DR has received honoraria as a consultant for AbbVie, Celgene, Dermavant Sciences, Dermira, Eli Lilly and Company, Janssen, Kyowa Kirin, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sun Pharmaceuticals, UCB, and VielaBio; research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Eli Lilly and Company, Incyte Corporation, Janssen, Merck, Novartis, Pfizer, and Regeneron Pharmaceuticals; and has served as a paid speaker for AbbVie, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, Regeneron Pharmaceuticals, and Sanofi. KB and FK are employees and shareholders of Incyte Corporation. JEH has served as a consultant for AbbVie, Aclaris Therapeutics, BiologicsMD, EMD Serono, Genzyme/Sanofi, Janssen, Pfizer, Rheos Medicines, Sun Pharmaceuticals, TeVido BioDevices, The Expert Institute, 3rd Rock Ventures, and Villaris Therapeutics; has served as an investigator for Aclaris Therapeutics, Celgene, Dermira, EMD Serono, Genzyme/Sanofi, Incyte Corporation, LEO Pharma, Pfizer, Rheos Medicines, Stiefel/GSK, Sun Pharmaceuticals, TeVido BioDevices, and Villaris Therapeutics; holds equity in Rheos Medicines, TeVido BioDevices, and Villaris Therapeutics; is a scientific founder of Villaris Therapeutics; and has patents pending for interleukin-15 blockade for treatment of vitiligo, Janus kinase inhibition with light therapy for vitiligo, and CXCR3 antibody depletion for treatment of vitiligo. Ruxolitinib cream for the treatment of vitiligoWe read with interest the study by David Rosmarin and colleagues,1 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.1 We believe that this generalised statement cannot be concluded based on major study limitations. Full-Text PDF 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