DX24
The Association Between Confirmed Disability Progression and Patient-Reported Fatigue in Patients with PPMS in the ORATORIO Study

Thursday, May 25, 2017
B2 (New Orleans Convention Center)
Deborah M Miller, PhD, LISW , Mellen Center, Cleveland Clinic, Cleveland, OH
Stephen L Hauser, MD , University of California, San Francisco, San Francisco, CA
Ludwig Kappos, MD , University Hospital Basel, University of Basel, Basel, Switzerland
Fred Lublin, MD , Icahn School of Medicine at Mount Sinai, New York, NY
Xavier Montalban, MD, PhD , Vall d'Hebron University Hospital, Barcelona, Spain
Fiona Mc Dougall, PhD, ClinPsyD , Roche Products Limited, Welwyn Garden City, United Kingdom
Gurpreet Deol-Bhullar, BSc, OT , F. Hoffmann-La Roche Ltd, Basel, Switzerland
Jian Han, PhD , Genentech Inc., South San Francisco, CA
Laura Julian, PhD , Genentech, Inc., South San Francisco, CA
Bruno Musch, MD, PhD , Genentech Inc., South San Francisco, CA
Jerry S Wolinsky, MD , McGovern Medical School, UTHealth, Houston, TX
Deborah M MIller, PhD, LISW , Mellon Center, Cleveland Clinic, Cleveland, OH



Background:

Fatigue is commonly reported in patients with multiple sclerosis (MS); however, its relationship with confirmed disability progression (CDP) is not well understood in patients with primary progressive MS (PPMS).

Objectives:

To describe changes in fatigue in patients with and without 12-week CDP and the impact of ocrelizumab (OCR) on this measure.

Methods:

In ORATORIO, the Modified Fatigue Impact Scale (MFIS) was administered at baseline (BL), Week 48 and Week 120. 12-week CDP, which was defined as an increase of ≥1 (or ≥0.5) point from BL in Expanded Disability Status Scale (EDSS) score if the BL EDSS was ≤5.5 (or >5.5) with the sustained increase in EDSS confirmed for at least 12 weeks in a subsequent visit, was assessed throughout the trial. The relationship between change in fatigue at Week 120 and 12-week CDP was assessed through the analysis of covariance, adjusting for BL MFIS score, region and age group, and including the effects of treatment, CDP status, treatment-by-CDP interaction and BL MFIS-by-CDP interaction.

Results:

Patients with CDP had a significantly greater increase in fatigue from BL to Week 120 than patients without CDP (adjusted mean [AM] [95% CI] 3.763 [1.479–6.047] vs –0.978 [–2.941 to 0.986]; p=0.0003). In patients without CDP, a significantly greater decrease in fatigue from BL was reported by OCR- vs placebo (PBO)-treated patients (AM [95% CI] –2.849 [–4.848 to –0.850] vs 0.893 [–2.166 to 3.952]; p=0.0337). In patients with CDP, the increase in fatigue from BL was numerically lower in OCR- vs PBO-treated patients.

Conclusions:

In ORATORIO, 12-week CDP was strongly associated with increased fatigue, underlining the importance of preventing disability progression in patients with PPMS. The significant reduction in fatigue in patients without 12-week CDP who were treated with OCR vs PBO suggests a beneficial effect of OCR, even in those patients with PPMS who did not have documented disability progression.

See more of: Disease Modifying Therapy
See more of: Poster
<< Previous Abstract | Next Abstract >>