Abstract Details

Title Effect of Ponesimod Compared With Teriflunomide on Treatment With Concomitant Corticosteroids for Relapse in Patients with Relapsing Forms of Multiple Sclerosis

Topic Multiple Sclerosis

Presentation(s) P5 - Poster Session 5 (11:45 AM-12:45 PM)

Poster/Presentation
Number 12-008

Objective The objective of this analysis was to compare the use of systemic corticosteroids (SCS) for the treatment of relapses between ponesimod (PON) and teriflunomide (TER) groups in the OPTIMUM trial.

Background In the OPTIMUM trial, patients with relapsing forms of multiple sclerosis (RMS) treated with PON had a significantly greater reduction in annualized relapse rate compared with patients treated with TER. Therapy with SCS is commonly used for acute treatment of relapses in patients with RMS.

Design/Methods OPTIMUM (NCT02425644) was a phase 3, double-blind, randomized clinical trial that evaluated the efficacy, safety, and tolerability of PON (20 mg) versus TER (14 mg) in patients with RMS. Patients were excluded from the primary analysis if they received treatment with SCS, unless it was for a multiple sclerosis (MS) relapse or short-term treatment of pulmonary conditions. In this analysis, we compared the proportions of patients in each treatment group who received concomitant treatment with ≥1 SCS to treat MS relapse between the start of study treatment and end of study (EOS). In addition, we assessed the mean accumulated steroid dose (prednisone equivalent doses in mg) administered to treat relapse between start of study treatment and EOS.

Results Among a total 1133 patients, 567 received PON (20 mg) and 566 received TER (14 mg). A significantly smaller proportion of patients in the PON group compared with the TER group received ≥1 SCS therapy for treatment of relapse (29.1% versus 40.1%, respectively; P<0.001). The mean accumulated steroid dose for treatment of relapse from start of study treatment to EOS was 2338.0 mg and 3389.9 mg in the PON and TER groups, respectively (P<0.01).

Conclusions In the OPTIMUM trial, patients with RMS treated with PON achieved a lower rate of concomitant SCS usage for the management of relapses compared with patients treated with TER.

Authors/Disclosures
Camilo Obando, MD PRESENTER	Dr. Obando has received personal compensation for serving as an employee of Johnson & Johnson. An immediate family member of Dr. Obando has received personal compensation for serving as an employee of Johnson & Johnson. Dr. Obando has stock in Johnson & Johnson. An immediate family member of Dr. Obando has stock in Johnson & Johnson.
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.
James Simples, Jr., PhD (Johnson & Johnson)	Dr. Simples has stock in Janssen.
	No disclosure on file
Maria Ait Tihyaty (Johnson and Johnson Innovative Medicine)	Dr. Ait Tihyaty has received personal compensation for serving as an employee of Dianthus Therapeutics.

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