DeterMine (NCT03813160) was a phase 3 randomized, double-blind, placebo-controlled study investigating the efficacy and safety of lenabasum for the treatment of dermatomyositis. It was a pleasure to talk with Prof. Victoria P. Werth (University of Pennsylvania, Philadelphia, PA, USA) to discuss the aims, design, eligibility criteria and findings of the phase 3 study.
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The abstract ‘Cutaneous Manifestations, Clinical Trials, Safety Efficacy and Safety of Lenabasum in the Phase 3 DeterMine Trial in Dermatomyositis.‘ (Abstract number: 0173) was presented at the ACR Convergence, November 10–14, 2022.
Questions
- Could you tell us a little about dermatomyositis and the unmet needs in its treatment? (0:16)
- What is lenabasum and what is the rationale for its use in this indication? (2:38)
- What were the aims, design and eligibility criteria of your phase 3 study? (3:29)
- What were the primary and secondary outcome measures and how well were they achieved? (5:49)
- Why do you think these endpoints were not met, and what were the positive outcomes of this study? (7:26)
Disclosures: Victoria P. Werth discloses receiving grants from: Celgene, Amgen, Janssen, Biogen, Gilead, Viela, Horizon therapeutics, and Ventus; consulting for: Astra-Zeneca, Pfizer, Biogen, Celgene, Resolve, Janssen, Gilead, Lilly, BMS, Nektar, Abbvie, Viela, GSK, EMD Serona, Sanofi, Anaptysbio, Amgen, Merck Kyowa Kirin, Rome Therapeutics, and Xencor; serving on advisory boards for: Lupus Foundation of America; and receiving honorarium from: Astra-Zeneca, Pfizer, Biogen, Celgene, Resolve, Janssen, Gilead, Lilly, BMS, Nektar, Abbvie, Viela, GSK, EMD Serona, Sanofi, Anaptysbio, Amgen, Merck Kyowa Kirin, Rome Therapeutics, and Xencor.
Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones.
Filmed in coverage of the ACR Convergence 2022.
