Adolescents with non-segmental vitiligo who applied topical ruxolitinib, 1.5% cream were more likely than adults to achieve complete repigmentation, a post hoc analysis of pivotal clinical trial data showed.
“We consider repigmenting vitiligo a two-step process, where the overactive immune system needs to be calmed down and then the melanocytes need to repopulate to the white areas,” one of the study investigators, David Rosmarin, MD, chair of the Department of Dermatology at Indiana University School of Medicine, Indianapolis, told this news organization in advance of the annual meeting of the Society for Pediatric Dermatology, where the study results were presented during a poster session. “In younger patients, it may be that the melanocytes are more rapidly repigmenting the patches, which is why we see this effect.”
Ruxolitinib, 1.5% cream (Opzelura) is a Janus kinase inhibitor approved for the treatment of non-segmental vitiligo in patients 12 years of age and older. Rosmarin and colleagues sought to evaluate differences in rates of complete or near-complete repigmentation and repigmentation by body region between adolescents 12-17 years of age and adults 18 years of age and older who applied ruxolitinib cream twice daily. The researchers evaluated patients who were initially randomized to ruxolitinib cream, 1.5% in the pivotal TRuE-V1 and TRuE-V2 studies and applied it for up to 104 weeks. Complete facial improvement was defined as 100% improvement on the Facial Vitiligo Area Scoring Index (F-VASI100) from baseline, and near-total improvement was categorized as a ≥ 75% or ≥ 90% improvement from baseline on the Total body VASI (T-VASI). Responses for each of six body regions, excluding the face, were assessed by the proportion of patients who achieved at least a 50% improvement from baseline on the T-VASI.
Compared with adults, a greater proportion of adolescents achieved F-VASI100 at week 24 (5.7% [3/53] vs 2.9% [10/341], respectively), but there were no differences between the two groups at week 52 (8.0% [4/50] vs 8.0% [24/300]). Response rates were greater among adolescents vs adults for T-VASI75 at weeks 24 (13.2% [7/53] vs 5.6% [19/341]) and 52 (22.0% [11/50] vs 20.3% [61/300]), as well as T-VASI90 at weeks 24 (3.8% [2/53] vs 0.3% [1/341]) and 52 (12.0% [6/50] vs 4.0% [12/300]).
The researchers observed that VASI50 responses by body region were generally similar between adolescents and adults, but a greater proportion of adolescents achieved a VASI50 in lower extremities (67.3% [33/49] vs 51.8% [118/228]) and feet (37.5% [12/32] vs 27.9% [51/183]) at week 52.
“Adolescents repigmented more rapidly than adults, so that at 24 weeks, more teens had complete facial repigmentation and T-VASI75 and T-VASI90 results,” Rosmarin said. “With continued use of ruxolitinib cream, both more adults and adolescents achieved greater repigmentation.” He acknowledged certain limitations of the study, including the fact that it was only vehicle controlled up through 24 weeks and that after week 52, there were fewer patients who completed the long-term extension.
“The take-home message is that ruxolitinib cream can effectively and safely help many patients repigment, including adolescents,” he said.
The study was funded by topical ruxolitinib manufacturer Incyte. Rosmarin disclosed that he has consulted, spoken for, or conducted trials for AbbVie, Abcuro, Almirall, AltruBio, Amgen, Arena, Astria, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant Sciences, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Nektar, Novartis, Pfizer, RAPT, Regeneron, Recludix Pharma, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, Viela Bio, and Zura.
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