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Abstract Details

Characterizing disability improvement among patients with early relapsing-remitting multiple sclerosis (RRMS) using functional systems (FS): results from the multicenter, observational STRIVE study
Multiple Sclerosis
P7 - Poster Session 7 (5:30 PM-6:30 PM)
9-001
To use FS to characterize disability improvement over 4 years of natalizumab treatment in patients with early RRMS.
Natalizumab treatment early in the RRMS disease course may improve clinical outcomes. The 4-year, multicenter, observational, open-label, single-arm STRIVE study evaluated natalizumab in patients with early RRMS (<3 years after diagnosis).

Confirmed disability improvement (CDI) was defined as Expanded Disability Status Scale (EDSS) score decrease ≥1.0 from a baseline ≥2.0. Confirmed disability worsening (CDW) was defined as EDSS score increase ≥0.5 from a baseline ≥6.0, ≥1.0 from a baseline of 1.0-5.5, or ≥1.5 from a baseline of 0.0. Improvement/worsening was confirmed at 24 weeks. Kaplan-Meier curves estimated the cumulative probability of CDI/CDW. Changes in individual FS scores (FSS) were analyzed; logistic regression predicted CDI versus CDW.
In the STRIVE intent-to-treat population (N=222), 43/133 patients (32.3%) with baseline EDSS scores ≥2.0 exhibited CDI; 33/222 (14.9%) exhibited CDW. Probabilities of CDI and CDW at 4 years were 43.9% and 19.3%, respectively. Patients with CDI exhibited improvements across all FS, with largest mean (standard deviation) changes from baseline in pyramidal (−0.65 [0.84]), sensory (−0.58 [0.91]), and cerebellar (−0.53 [0.80]) functions. Among those with worsening, FS worsening from baseline occurred primarily in ambulation score (−1.19 [2.10]) and visual function (0.42 [0.79]). Patients with ≥1-point worsening in ambulation, sensory, or visual FSS were significantly less likely to improve than worsen (CDI vs CDW odds ratio [95% CI]: 0.18 [0.06-0.54; P=0.0021], 0.24 [0.08-0.73; P=0.0125], and 0.09 [0.01-0.65; P=0.0165], respectively).
 

In this analysis of STRIVE, more natalizumab-treated patients experienced CDI than CDW. Improvements occurred across all FS, with pyramidal, sensory, and cerebellar function improvements most predominant in CDI patients. These findings are consistent with those from real-world studies like the TYSABRI Observational Program and support the effectiveness of natalizumab among patients with early RRMS.

 
Authors/Disclosures

PRESENTER 		No disclosure on file
Robert J. Fox, MD, FÂ鶹´«Ã½Ó³»­ (Cleveland Clinic) Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AB Science. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Immunic. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Siemens. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria Biologica. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for InnoCare Pharma. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AB Science. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. The institution of Dr. Fox has received research support from National Institutes of Health. The institution of Dr. Fox has received research support from National MS Society. Dr. Fox has received publishing royalties from a publication relating to health care.
Roumen D. Balabanov, MD (Northwestern University) Dr. Balabanov has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Balabanov has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Balabanov has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Balabanov has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Balabanov has received research support from NextCure. The institution of Dr. Balabanov has received research support from Biogen. The institution of Dr. Balabanov has received research support from NINDS.
Laura J. Balcer, MD, MSCE, FÂ鶹´«Ã½Ó³»­ (NYU Grossman School of Medicine) An immediate family member of Dr. Balcer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Children's Hospital of Philadelphia.
Steven Galetta, MD, FÂ鶹´«Ã½Ó³»­ (NYU Langone Medical Center) Dr. Galetta has nothing to disclose.
No disclosure on file
No disclosure on file
Menglan Pang Menglan Pang has received personal compensation for serving as an employee of Biogen. Menglan Pang has received stock or an ownership interest from Biogen.
Denise I. Campagnolo, MD, MS Dr. Campagnolo has received personal compensation for serving as an employee of Biogen. Dr. Campagnolo has received stock or an ownership interest from Biogen.
Christophe Hotermans, MD, PhD (Alexion) No disclosure on file
Lily Lee, PhD Dr. Lee has nothing to disclose.