Abstract Details

Title Fatigue evolution for patients without relapses on the FSIQ-RMS Symptoms Domain

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 032

Objective To understand the change in the Fatigue Symptoms and Impact Questionnaire–RMS (FSIQ-RMS) for patients receiving ponesimod 20mg compared with teriflunomide 14mg, who did not experience a confirmed relapse during the Phase 3 OPTIMUM study.

Background Multiple sclerosis (MS) is a chronic, demyelinating disease of the central nervous system that results in progressive and irreversible disability, with MS-related fatigue reported as one of the most common symptoms. Ponesimod 20 mg demonstrated superiority relative to teriflunomide 14 mg on the FSIQ-RMS, a secondary study endpoint, although less is known about changes in fatigue in the absence of clinical relapses.

Design/Methods Clincal relapses were confirmed by the treating neurologist if symptoms also demonstrated an increase in EDSS/FS score, compared with a previous stable assessment. The FSIQ-RMS symptoms sub-scale consists of 7 items with a daily recall period and administered over 7 days. Patients without a confirmed relapse at any time during the study and with ≥4 entries on the FSIQ-RMS symptoms scale over the 7 day period were assessed in a mixed effects model repeated measure on the change from baseline on the FSIQ-RMS for both ponesimod 20mg and teriflunomide 14mg.

Results The change from baseline to Week 108 was statistically significantly lower in the ponesimod 20mg group compared with teriflunomide 14mg (least square mean: −1.38 for ponesimod 20mg [n=313] and 2.29 for teriflunomide 14mg [n=273; mean difference: −3.67 [95% CLs: −6.32, −1.02]; p=0.0068 (an increase indicates worsening fatigue symptoms).

Conclusions These results are consistent with the full analysis which yielded a mean difference of -3.57 [95% CLs: −5.83, −1.32]; p=0.0019; favoring ponesimod 20mg relative to teriflunomide 14mg. The robustness and consistency of results in the change from baseline for patients without a confirmed relapse during the study relative to the full analysis suggests a potential treatment effect for ponesimod on MS-related fatigue independent of relapse activity.

Authors/Disclosures
Alexander Keenan PRESENTER	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.
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.
	No disclosure on file
	No disclosure on file

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