Abstract Details

Title Preservation of Ambulation and Hand Function at Healthy-control Levels With First-line Treatment With Ocrelizumab: Six-year Findings From the ENSEMBLE Trial

Topic Multiple Sclerosis

Presentation(s) S8 - Multiple Sclerosis: Imaging, Biomarkers, and Environmental Exposures (3:54 PM-4:06 PM)

Poster/Presentation
Number 003

Objective To evaluate the long-term impact of first-line ocrelizumab on ambulation and hand function in patients with early relapsing-remitting multiple sclerosis (RRMS).

Background Loss of ambulation and hand function are key drivers of disability in MS. Preserving these functions from the earliest disease stages is a primary treatment goal that may be best achieved with early initiation of high-efficacy therapies.

Design/Methods ENSEMBLE (NCT03085810)-LIBERTO (NCT03599245) was a 6-year, open-label, single-arm, Phase IIIb study evaluating the effectiveness and safety of ocrelizumab in treatment-naive patients with early RRMS. Worsening of ambulation and hand function were defined as increases of ≥20% in Timed 25-Foot Walk Test (T25FW) and 9-Hole Peg Test (9HPT) sustained for at least 48 weeks. Proportions of patients whose values remained within or improved to those of normative healthy controls (HC; T25FW <6.7 seconds; 9HPT <23 seconds) were determined. Additional thresholds will be explored.

Results A total of 616 patients were enrolled, with a median age of 32 years; 62.2% were female, median disease duration was 0.91 years and patients had a median Expanded Disability Status Scale score of 2.0, T25FW of 5.0 seconds and 9HPT of 21.0 seconds. After 6 years, 82.2% and 93.5% of patients had not experienced worsening of ambulation or hand function, respectively. Among patients with normal ambulation at baseline (n=476), 89.1% remained within normative HC values. Notably, 45.7% of those with baseline walking impairment improved to HC levels. For hand function, 93.0% of those with normal baseline performance (n=442) maintained it, while 55.2% of those with baseline dysfunction (n=172) improved to within the HC range.

Conclusions Early first-line treatment with ocrelizumab led to clinically meaningful preservation of normal ambulation and hand function over 6 years. About half of patients with preexisting impairment improved to levels seen in healthy controls, highlighting the benefit of ocrelizumab in early MS.

Authors/Disclosures
Robert A. Bermel, MD, FAAN (Cleveland Clinic) PRESENTER	Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Bermel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Bermel has received research support from Biogen. The institution of Dr. Bermel has received research support from Roche. The institution of Dr. Bermel has received research support from Novartis. Dr. Bermel has received intellectual property interests from a discovery or technology relating to health care.
Ralph H. Benedict, PhD (University At Buffalo)	Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic Therapeutics. Dr. Benedict has received intellectual property interests from a discovery or technology relating to health care.
Thomas A. Berger, MD (Dept. of Neurology, Medical University of Vienna)	Prof. Berger has received personal compensation in the range of $10,000-$49,999 for serving as a speaker at scientific meetings and participant of local and international advisory boards with various companies producing and markerting treatments for multiple sclerosis (Almirall, Biogen, Biologix, Bionorica, Celgene-BMS, Merck, Novartis, Roche, Sanofi-Genzyme, TG Therapeutics, UCB).
Ludo J. Vanopdenbosch, MD, FAAN (Dr Ludo Vanopdenbosch BVBA)	Dr. Vanopdenbosch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for celgene. Dr. Vanopdenbosch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen . Dr. Vanopdenbosch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for F Hoffmann La Roche. Dr. Vanopdenbosch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Vanopdenbosch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Vanopdenbosch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme.
Trygve Holmoy, MD (Aventis Pharma AS)	Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Norwegian MS Society. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Holmoy has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.
Suzanne Moore	Suzanne Moore has received personal compensation for serving as an employee of Hoffmann-la-Roche. Suzanne Moore has stock in Hoffmann-la-Roche.
Licinio M. Craveiro, MD, PhD (Roche)	Dr. Craveiro has received personal compensation for serving as an employee of Hoffmann La-Roche. Dr. Craveiro has received stock or an ownership interest from Hoffmann La-Roche.
Joep Killestein (Amsterdam UMC)	Joep Killestein has nothing to disclose.

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