DMT38
Analysis of Post-Treatment Relapse Activity in the Phase 3 Optimum Study of Ponesimod Compared with Teriflunomide

Thursday, June 2, 2022
Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)
Ludwig Kappos, MD , Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel, and University of Basel, Basel, Switzerland
Robert J Fox, MD , Mellen Center for Treatment and Research in Multiple Sclerosis, Cleveland Clinic, Cleveland, OH
Michel Burcklen, PhD , Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland
Mark S Freedman, MSc, MD , Department of Medicine and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada
Brian Hennessy, PhD , Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland
Antoine Stos, MSc , Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland
Philippe Linscheid, PhD , Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies of Johnson & Johnson, Allschwil, Switzerland
Andrea Vaclavkova, MD , Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland
Hilke Kracker, PhD , Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland
Tatiana Sidorenko, MD, PhD , Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies of Johnson & Johnson, Allschwil, Switzerland
Carlo Pozzilli, MD, PhD , Department of Human Neuroscience, La Sapienza University, Rome, Italy
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Background: Cases of exacerbation of multiple sclerosis (MS) disease activity have been reported after discontinuation of S1P-receptor modulators.

Objectives: Here we report on post-treatment relapse activity in the OPTIMUM study of ponesimod.

Methods: In this phase 3 study, patients with relapsing MS were randomized (1:1) to 20-mg ponesimod or 14-mg teriflunomide once-daily for up to 108 weeks. Patients who stopped treatment prematurely or after completing the treatment period were asked to participate in a safety follow up (approximately 30 days after the last dose) and a post-treatment observation period (from last dose up to 108 weeks after randomization) and were included in this analysis.

Results: Of the 1124 (1133 randomized) patients with post-treatment observation in the OPTIMUM study (ponesimod: 559; teriflunomide: 565), 8 ponesimod and 14 teriflunomide patients experienced 23 post- treatment relapses within 182 days of last dosage of study drug. Available post-treatment follow-up during this period was similar for both treatment arms: mean (median [range]), days: ponesimod: 31.6 (17 [1-182]) and teriflunomide: 30.8 (17 [1-182]). Post-treatment relapses for ponesimod (3 confirmed, 4 unconfirmed, 2 unknown) occurred between 6 and 168 days without any pattern of latency or severity. The post-treatment annualized relapse rate (ARR) did not exceed the on-treatment ARR for ponesimod (0.186 and 0.246, respectively; includes non-confirmed relapses).

Conclusions: These prospectively obtained post-treatment observation data in patients who stopped ponesimod treatment in the OPTIMUM study, do not support increased early post-treatment relapse activity as compared to activity on treatment.

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