Long-term ruxolitinib improves vitiligo lesions
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Long-term treatment with ruxolitinib cream significantly increased repigmentation of vitiligo lesions and was well tolerated, according to a study presented at AAD VMX 2021.
“Vitiligo is a chronic autoimmune disease resulting in skin depigmentation,” John E. Harris, MD, PhD, of the University of Massachusetts Medical School, and colleagues wrote. “Disease pathogenesis is driven by interferon-gamma, which activates signaling pathways regulated by Janus kinase (JAK) 1 and JAK2.”
The phase 2 randomized, dose-ranging trial evaluated ruxolitinib, a JAK1/JAK2 inhibitor, in adult patients with vitiligo that included depigmentation of 0.5% or more of body surface area (BSA) on the face and 3% or more of BSA on nonfacial areas.
Subjects received ruxolitinib cream 1.5% twice daily, ruxolitinib cream 1.5% once daily, ruxolitinib cream 0.5% once daily, ruxolitinib cream 0.15% once daily or vehicle cream twice daily for 24 weeks. Patients in the vehicle and 0.15% cohorts who did not achieve 25% or greater improvement after 24 weeks were rerandomized to one of the other three study groups or continued on their current regimen until week 52.
Open-label treatment with ruxolitinib 1.5% twice daily was then available from week 52 through week 104.
Fifty-five patients completed the week 104 study visit. Among this group, Facial Vitiligo Area Scoring Index (F-VASI) 50 was achieved by 83.6% of patients, while F-VASI75 was achieved by 65.5% and F-VASI90 by 52.7%.
Total Vitiligo Area Scoring Index (T-VASI) 50 was achieved by 58.2% and T-VASI75 by 27.3%.
For patients in the original 1.5% group twice daily, improvement continued to increase from week 24 through week 104. F-VASI50, F-VASI75 and F-VASI90 was achieved in 45.5%, 30.3% and 12.1% of these patients at week 24 and 89.5%, 73.7% and 57.9% at week 104, respectively.
During the 52-week open-label treatment period, no significant safety signals were recorded, with no treatment-related serious adverse events observed.
“Treatment with ruxolitinib cream produced substantial facial and total body repigmentation of vitiligo lesions through 104 weeks of treatment,” the authors wrote. “Longer duration of therapy was associated with greater repigmentation per assessment of F-VASI and T-VASI responses at weeks 24, 52 and 104.”