Key Results from the TRuE-V Long-term Extension Study

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

Now Viewing

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 segment of the video discussion on vitiligo, Gary Owens, M.D., and David Rosmarin, M.D., focused on analyzing the F-VASI [facial Vitiligo Area Scoring Index] and T [total]-VASI responses between weeks 52 and 104 in patients in the TRuE-V study who did not achieve almost complete facial repigmentation by week 52. They began by highlighting the results for cohort B, where patients didn’t reach the F-VASI 90 end point, indicative of almost complete facial repigmentation. Despite this, continued use of the medicine showed a gradual increase in repigmentation over time. The F-VASI 75 end point was achieved by 30% of patients at the one-year mark and increased to 66% by the two-year mark. However, the F-VASI 90 end point remained elusive for patients in cohort B at the one-year mark, with only one-third achieving it by the two-year mark. This suggested that continued use of the medication proved beneficial even for patients who did not experience exceptional results initially.

The experts delved into the aspect of patients’ prior use of the vehicle during the study and their subsequent shift to ruxolitinib cream for up to a year and a half, emphasizing the importance of this difference in the results. They discussed the significance of the delayed treatment of six months, which led to patients being worse off compared to those who started the cream earlier in the trial. Acknowledging the importance of these findings, they emphasized the need for continued active treatment in the long-term extension, highlighting the need for patients to catch up with the desired results over time.

Shifting the focus to T-VASI responses during the one- to two-year period, the experts noted similar trends in repigmentation, emphasizing that prolonged use of the cream yielded positive outcomes not only for facial repigmentation but also for repigmentation of the entire body. They highlighted the notable progress in T-VASI 50 percentages, which increased from around 40% to over 60% by the two-year mark. Additionally, patients who switched from the vehicle to ruxolitinib cream showed significant improvements by the two-year mark, though they still lagged behind those who had been on the treatment for the entire two years, emphasizing the impact of the initial six-month delay in treatment.

Discussing the implications of the study, the experts emphasized the significance of the findings, especially in comparison to standard clinical practices that often involve a combination of treatments, such as phototherapy, topical corticosteroids, and topical calcineurin inhibitors. They highlighted the impressive results achieved with ruxolitinib cream as a monotherapy, underscoring its efficacy and potential as a viable treatment option for vitiligo patients. They also acknowledged the prevalence of combination therapy in clinical practice, recognizing the importance of considering different treatment options tailored to each patient’s specific needs.

In conclusion, the discussion emphasized the gradual yet promising effects of prolonged ruxolitinib cream usage, particularly in achieving significant repigmentation results for patients with vitiligo, underscoring the importance of continued active treatment for optimal outcomes.

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