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Abstract Details

Long-Term Efficacy, Safety and Tolerability of Ponesimod in Patients with Relapsing-Remitting Multiple Sclerosis
MS and Related Diseases
P01 - (-)
156
BACKGROUND: In the 24-week core study, once-daily ponesimod at 10, 20 and 40 mg significantly and dose-dependently reduced inflammatory MRI activity compared with placebo; reduction in annualized relapse rate (ARR) was also observed.
DESIGN/METHODS: All patients entering the extension study received ponesimod; former placebo patients were re-randomized at Week 24 to ponesimod 10, 20 or 40 mg in a 1:1:1 ratio (placebo/active group). Exploratory efficacy endpoints included ARR and MRI variables.
RESULTS: Overall, 353 patients (90% of those completing the core study) entered the extension study and 326 completed at least 48 weeks of study treatment. At the time of data collection, mean combined (core plus extension) treatment duration was 92 weeks. The ARR in patients continuously treated with ponesimod 10, 20, or 40 mg was 0.22 (95% CI 0.15-0.34), 0.23 (0.15-0.34), and 0.15 (0.09-0.24), respectively. In the placebo/active group, ARR was reduced from 0.52 (95% CI 0.33-0.83) at Week 24 to 0.25 (0.13-0.48) at Week 48. At baseline, mean total number of T1-weighted gadolinium-enhancing lesions was 2.8 (SD 7.0), 2.7 (7.3), 2.1 (4.0) and 1.6 (3.3) in ponesimod 10, 20, 40 mg and placebo/active groups, respectively; at Week 48 the respective figures were 1.0 (3.4), 0.2 (0.5), 0.2 (0.7), and 0.4 (1.0), and at Week 72 the respective figures were 0.8 (2.4), 0.2 (0.8), 0.2 (0.7), and 0.2 (0.8). Study treatment was prematurely discontinued in 10.2% of patients. Adverse events reported in ?15% of patients in any group were nasopharyngitis, headache, dyspnea and upper respiratory tract infection.
CONCLUSIONS: Long-term treatment with ponesimod maintained efficacy on clinical and MRI outcomes; efficacy on both measures was re-affirmed in ex-placebo patients. No new safety findings were identified.
Authors/Disclosures
Mark S. Freedman, MD, FAAN (University of Ottawa)
PRESENTER 		Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion(Janssen/J&J). Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BiogenIdec. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS/Celgene. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Inc. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion (Janssen/J&J). Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Atara Biotherapeutics. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer Healthcare. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BiogenIdec. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Clene Nanomedicine. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GRI Bio. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Magenta Therapeutics. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Freedman has received research support from Sanofi Genzyme.
Aaron L. Boster, MD (Ohiohealth) Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for sanofi. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for roche. Dr. Boster has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for novartis. Dr. Boster has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Serono. The institution of Dr. Boster has received research support from Sanofi. The institution of Dr. Boster has received research support from Roche.
Oscar Fernandez, MD (Hospital Carlos Haya) No disclosure on file
Maria J. Melanson, MD No disclosure on file
Carlo Pozzilli Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion.
No disclosure on file
Tatiana Sidorenko, MD, PhD (Actelion Pharmaceuticals Ltd.) Dr. Sidorenko has received personal compensation for serving as an employee of Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical company of Johnson&Johnson. Dr. Sidorenko has stock in Johnson&Johnson.
Ronald C. Petersen, MD, PhD, FAAN (Mayo Clinic) Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly and Co.. Dr. Petersen has received personal compensation in the range of $0-$499 for serving as a Consultant for Eisai, Inc.. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novo Nordisk. Dr. Petersen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Petersen has received publishing royalties from a publication relating to health care. Dr. Petersen has received publishing royalties from a publication relating to health care. Dr. Petersen has received publishing royalties from a publication relating to health care. Dr. Petersen has a non-compensated relationship as a Board of Directors with American Brain Foundation that is relevant to AAN interests or activities.
Tomas Olsson, MD, PhD (Karolinska Institutet) Prof. Olsson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Prof. Olsson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Olsson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Olsson has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. The institution of Prof. Olsson has received research support from Biogen. The institution of Prof. Olsson has received research support from Novartis. The institution of Prof. Olsson has received research support from Sanofi. The institution of Prof. Olsson has received research support from Merck.