Amid a packed roster of of late-breaking research at the American Academy of Dermatology 2023 Annual Meeting, investigators presented findings from long-term extensions of the Topical Ruxolitinib Evaluation in Vitiligo phase 3 studies.
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In an auditorium full of attendees awaiting a packed schedule of late-breaking research at the American Academy of Dermatology (AAD) 2023 Annual Meeting, investigators presented findings from long-term extensions of the Topical Ruxolitinib Evaluation in Vitiligo (TRuE-V) phase 3 studies.
Ruxolitinib cream 1.5%, a Janus kinase (JAK) inhibitor, was approved by the FDA as a topical treatment for vitiligo in the summer of 2022, marking the first approval for this melanocyte-destroying condition that can have severe impacts on patients’ self-esteem. The approval was based on safety and efficacy findings from TRuE-V1 and TRuE-V2.
First, John Harris, MD, PhD, of UMass Chan Medical School, delivered results on relapse and maintenance of clinical response among patients who either continued or ceased treatment with ruxolitinib after achieving a response of at least 90% improvement from baseline facial Vitiligo Area Scoring Index (F-VASI), or F-VASI90, during the 52 weeks of the TRuE-V studies.1 Relapse was defined as response dropping from at least F-VASI90 to less than F-VASI75.
The investigators found that patients randomly assigned to the withdrawal arm experienced relapse faster than those who continued applying ruxolitinib cream. Of those who had achieved F-VASI90 or better at 52 weeks, maintenance rates after another 52 weeks were 21% for the vehicle arm and 62% in the ruxolitinib cream arm. Median duration of maintained response was 195 days for the vehicle arm and not estimable for the ruxolitinib cream arm.
Those who withdrew, relapsed, and then restarted ruxolitinib cream saw a regained response in a median time of 12 weeks, and 75% of those who relapsed were able to achieve F-VASI75 when restarting ruxolitinib cream.
Harris noted that there were no additional safety signals observed over the second year of therapy compared with the first 52 weeks. In response to an audience question, he confirmed that some biomarkers appeared to differ between those who demonstrated a consistent response to ruxolitinib cream and those who did not.
Overall, he concluded, “for patients who lose their pigment after withdrawing topical ruxolitinib, if you put them back on it, they’ll regain it.”
Next, David Rosmarin, MD, of Indiana University School of Medicine, presented findings on the cohort of patients who did not achieve F-VASI90 response in the first year of the TRuE-V trials, who were all given ruxolitinib cream in the following 52-week extension.2
The investigators discovered that the rate of attaining F-VASI75 increased from 31% at week 52 to 55% at week 80 and 66% at week 104. Notably, those who switched from vehicle to ruxolitinib cream at the 1-year mark did not catch up as quickly in terms of response as those who had received ruxolitinib cream the entire time.
“The messaging here for our patients is that with continued use of the medicine, they can get continued benefit, and they still haven’t necessarily plateaued even after 1.5 to 2 years of using the medication,” Rosmarin said.
In terms of maintenance, 47% of participants saw their F-VASI improve from week 52 to week 80, whereas 36% remained stable; and from week 80 to week 104, 20% saw improvement and 64% remained stable. Improvement in response over time was also seen in total VASI over the entire body.
Further, 31% of this cohort were able to achieve F-VASI90, indicating almost completely repigmented skin on the face, at the end of the 102 weeks.
Similar to Harris’ findings, there were no new safety signals observed in this extension, and in fact, rates of application-site pruritis and acne were lower than those seen in the first year.
Answering a question on predictors of response, Rosmarin noted that repigmentation of the body takes longer than it does for the face, but it is still possible, which he has witnessed in patients in his own practice in addition to the participants of this extension study.
1. Harris JE, et al. Relapse and maintenance of clinical response in the randomized withdrawal arm of the TRuE-V long-term extension phase 3 study of ruxolitinib cream in vitiligo. Presented at: AAD 2023; March 17-21, 2023; New Orleans, LA. Abstract 46159.
2. Rosmarin D, et al. Facial and total vitiligo area scoring index response shift during 104 weeks of ruxolitinib cream treatment for vitiligo: results from the open-label arm of the TRuE-V long-term extension phase 3 study. Presented at: AAD 2023; March 17-21, 2023; New Orleans, LA. Abstract 46163.