TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573) were randomized, double-blind, vehicle-controlled phase 3 studies that investigated ruxolinitib cream for the treatment of vitiligo over 52 weeks. We were delighted to speak to Dr. Amit G. Pandya (Palo Alto Foundation Medical Group, Sunnyvale, CA, USA) around the efficacy and safety findings from the TRuE-V phase 3 studies and whether these were consistent with the oral version of ruxolitinib.
The abstract ‘Treatment-Emergent Adverse Events of Interest for Janus Kinase Inhibitors: Pooled Analysis of the 52-Week TRuE-V Phase 3 Studies of Ruxolitinib Cream Treatment for Vitiligo.’ (Poster ID: 43978) was presented at AAD 2023, 17-21 March, 2023.
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Questions
- What do we already know about the clinical efficacy of ruxolitinib cream from the TRuE-V phase 3 studies? (0:21)
- Are the safety findings with ruxolitinib cream consistent with the oral version? (1:30)
Disclosures: Amit G. Pandya discloses consulting for: Abbvie, Arcutis, Avita, Chromaderm, Incyte, Pfizer, Viela Bio, Villaris, Immune Tolerance Network, Thalocan, Trifecta, TWi, and Vyne; receiving grant/ research support from: Incyte and stock options with Tara Medical and Zerigo Health.
Support:Â Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones.
Filmed in coverage of the 2023 AAD Annual Meeting.
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Transcript
What do we already know about the clinical efficacy of ruxolitinib cream from the TRuE-V phase 3 studies? (0:21)
In the phase 3 studies of ruxolitinib, we found that the results were similar to the phase 2 studies, the F-VASI 75, which means 75% of the colour returns to the face in vitiligo lesions was 50 or 50% after one year. So in other words, a patient has a 50/50 chance of getting 75% of their colour coming back on their face after one year of application. When it comes to the body, the F-VASI 50 was also 50% In other words, the patient has a 50/50 chance of getting 50% of the colour back over the whole body, and that would be the average over the whole body. Certainly all the patients will do better on the face and the upper arms, the upper legs, the trunk, and will do worse on the hands and feet, ankles and wrists. But those are the results that we found in the TRUE-V studies.
Are the safety findings with ruxolitinib cream consistent with the oral version? (1:30)
Well, the good thing about the TRUE-V studies is that the safety was excellent. About 6% of patients had acne where they applied it. But when it comes to other side effects, especially side effects that would be associated with the oral form of ruxolitinib, these were just not seen there was no bone marrow toxicity or any increased infections in those patients who applied the ruxolitinib cream to their skin. And so it seems to be very safe.
Subtitles and transcript are autogenerated.
