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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
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.
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. 
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 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) Dr. Kappos has nothing to disclose.
Maria Ait Tihyaty (Johnson and Johnson Innovative Medicine) Dr. Ait Tihyaty has received personal compensation for serving as an employee of Dianthus Therapeutics.
No disclosure on file
Ibrahim Turkoz (Janssen R&D) Ibrahim Turkoz has received personal compensation for serving as an employee of Johnson and Johnson. Ibrahim Turkoz has stock in Johnson and Johnson.
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.