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Abstract Details

Longitudinal Clinical and MRI Outcomes in Relapsing Multiple Sclerosis (RMS) Patients After Short-term Ponesimod Treatment Interruption and Re-initiation
Multiple Sclerosis
P6 - Poster Session 6 (5:30 PM-6:30 PM)
3-007
Current multiple sclerosis (MS) disease-modifying treatments alter patients’ immune system due to different pharmacokinetic/pharmacodynamic profiles. Clinical situations such as pregnancies, infections or live vaccinations may require rapid drug elimination and a fully functioning immune system. Lymphocyte counts return to normal range in >90% of patients within 1 week of stopping ponesimod treatment. It is important to evaluate MS disease activity over time following ponesimod treatment interruption and re-initiation. 
To assess clinical and magnetic resonance imaging (MRI) outcomes in RMS patients at 48 weeks of follow-up after short-term interruption and re-initiation of ponesimod treatment.
Patients who completed 108 weeks of ponesimod or teriflunomide treatment in the Phase-3 OPTIMUM study and underwent an accelerated elimination procedure were eligible for the open-label extension (OLE) study and received ponesimod 20mg. Of 567 patients randomized to ponesimod in OPTIMUM, 439 (77.4%) entered the OLE and 239 (42.2%) had ≥48 weeks of follow up. The annualized relapse rate (ARR) and cumulative number of combined-unique-active-lesions (CUALs) following short-term treatment interruption (between OPTIMUM and OLE) and re-initiation (at start of the OLE) were evaluated in 239 patients.

 The mean duration of ponesimod treatment interruption (between the end of OPTIMUM and initiation of OLE) was 17.6 days (range 13-45). The ARR at OLE week 48, and considering treatment interruption and re-initiation, was 0.191 (95% CI:0.140, 0.261). This was numerically lower than the 2-year ARR of 0.234 (95% CI: 0.186, 0.296) with a relative rate reduction (RRR) of 18.4% (RRR: 0.816, 95% CI: 0.595, 1.120). At OLE week 48, patients had 1.73 CUALs/year (95% CI:1.30, 2.31), which was not statistically significantly different from 1.48 CUALs/year (95% CI: 1.19, 1.82) in OPTIMUM.

Based on clinical and imaging outcomes at 48 weeks following short-term interruption and re-initiation of ponesimod, disease activity remained consistent with that observed prior to interruption.
Authors/Disclosures
Janice Chun Yee Wong, MD
PRESENTER
Dr. Wong has received personal compensation for serving as an employee of Janssen Research & Development. Dr. Wong has received personal compensation for serving as an employee of Biogen. Dr. Wong has stock in Biogen. Dr. Wong has stock in Janssen Research & Development.
Alexander Keenan Alexander Keenan has received personal compensation for serving as an employee of Janssen Pharmaceuticals. Alexander Keenan has received stock or an ownership interest from Johnson and Johnson.
Ludwig Kappos, MD, FAAN ( RC2NB, University Hospital Basel) The institution of Dr. Kappos has received research support from Bayer. The institution of Dr. Kappos has received research support from Biogen. The institution of Dr. Kappos has received research support from Genentech. The institution of Dr. Kappos has received research support from Genzyme. The institution of Dr. Kappos has received research support from Janssen. The institution of Dr. Kappos has received research support from Merck Serono. The institution of Dr. Kappos has received research support from Minoryx. The institution of Dr. Kappos has received research support from Novartis. The institution of Dr. Kappos has received research support from Roche. The institution of Dr. Kappos has received research support from Sanofi. The institution of Dr. Kappos has received research support from Santhera. The institution of Dr. Kappos has received research support from Swiss MS Society, Swiss National Research Foundation, European Union, Roche Research Foundation, Innosuisse. The institution of Dr. Kappos has received research support from Shionogi. The institution of Dr. Kappos has received research support from Japan Tobacco. The institution of Dr. Kappos has received research support from Auriga Vision AG. The institution of Dr. Kappos has received research support from EMD Serono. The institution of Dr. Kappos has received research support from Glaxo Smith Kline. The institution of Dr. Kappos has received research support from Wellmera AG. The institution of Dr. Kappos has received research support from Eli Lilly (Suisse) SA. The institution of Dr. Kappos has received research support from Bristol Myers Squibb. The institution of Dr. Kappos has received research support from Celltrion Inc. Dr. Kappos has received intellectual property interests from a discovery or technology relating to health care.
Maria Ait Tihyaty, PhD (Johnson and Johnson Innovative Medicine) Dr. Ait Tihyaty has received personal compensation for serving as an employee of Janssen.
Kavita Gandhi, Other (Janssen Pharmaceuticals) Ms. Gandhi has received personal compensation for serving as an employee of Janssen Pharmaceuticals. Ms. Gandhi has received personal compensation for serving as an employee of Pfizer. An immediate family member of Ms. Gandhi has received personal compensation for serving as an employee of AstraZeneca LLC. Ms. Gandhi has stock in Janssen Pharmaceuticals. An immediate family member of Ms. Gandhi has stock in AstraZeneca LLC.
Ibrahim Turkoz, PhD (Janssen R&D) Dr. Turkoz has received personal compensation for serving as an employee of Janssen R&D. Dr. Turkoz has received stock or an ownership interest from J&J.
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.
Fred D. Lublin, MD, FAAN (Icahn School of Medicine At Mount Sinai) Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche/Genentech. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurogene. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medimmune/Viela Bio/Horizon. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Receptos/Celgene/BMS. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Labcorp. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuralight. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Entelexo. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Lublin has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Multiple entities. Dr. Lublin has stock in Avotres. Dr. Lublin has stock in Neuralight. The institution of Dr. Lublin has received research support from Brainstorm. The institution of Dr. Lublin has received research support from biogen. The institution of Dr. Lublin has received research support from NIH.