TRuE-V Studies Overview and Unmet Needs in Vitiligo

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EP: 1.TRuE-V Studies Overview and Unmet Needs in Vitiligo

EP: 2.Safety and Efficacy Data Results at 24-Week Mark of TRuE-V Studies

EP: 3.TRuE-V Long-Term Extension Study Design

EP: 4.Key Results from the TRuE-V Long-term Extension Study

EP: 5.Notable Adverse Events from TRuE-V Studies

EP: 6.Evaluating TRuE-V Study Limitations

EP: 7.Payer Considerations Surrounding TRuE-V Studies

In this video discussion, Gary Owens, M.D., the president of Gary Owens Associates, and David Rosmarin, M.D., chair of dermatology at Indiana University School of Medicine, delve into the intricacies of treating vitiligo. The conversation begins with a focus on the unmet needs that sparked the investigation of the drug ruxolitinib for vitiligo patients.

Dr. Rosmarin emphasizes the lack of approved medications for repigmenting vitiligo patients before the FDA approval of ruxolitinib in July 2022. He highlights the limited options, including the use of topical corticosteroids, topical calcineurin inhibitors, and phototherapy, which were not always covered by payers and did not consistently yield the desired repigmentation results. This lack of effective treatments underlines the pressing need for new therapeutics.

The discussion progresses to elucidate the objectives and patient demographics of the TRuE-V studies. The main goal of these phase 3 trials was to demonstrate the superiority of ruxolitinib cream over the vehicle in repigmenting both facial and whole-body vitiligo. Participants included adolescents and adults aged 12 years and older, presenting with nonsegmental vitiligo covering 10% or less of their whole body, with at least half a hand’s worth of vitiligo on the face.

Dr. Rosmarin details the design of the TRuE-V studies, which followed a randomized control trial format, with patients randomly assigned in a 2:1 ratio to receive ruxolitinib or the vehicle. The primary end point was set at achieving 75% or more repigmentation on the facial VASI [Vitiligo Area Scoring Index] score at week 24. Key secondary end points included assessing total body VASI improvement of at least 50% at the 24-week mark. Furthermore, the extension study of 28 weeks analyzed similar end points, providing crucial data beyond the typical trial period, revealing the durability of the treatment’s effects over a longer period.

The experts also discuss the importance of data from the two-year study, which indicates that prolonged use of ruxolitinib cream leads to increased patient benefit. Dr. Rosmarin highlights the unique challenge in treating vitiligo compared to other inflammatory conditions, where optimal results are typically achieved within six months. In contrast, vitiligo patients often require a year or more to achieve their desired degree of repigmentation, emphasizing the prolonged time frame required for successful treatment.

The discussion underscores the significance of the TRuE-V studies in filling the therapeutic gap for vitiligo patients, addressing the challenges posed by existing treatment options and shedding light on the potential of ruxolitinib as a promising therapeutic option. The data analysis from the trials serves as a crucial reference point for healthcare professionals and policymakers, providing insights into the long-term efficacy and durability of the treatment, ultimately leading to improved care and management strategies for individuals living with vitiligo.

Video synopsis is AI-generated and reviewed by Managed Health Care Executive editorial staff.