Preservation of Ambulation and Hand Function at Healthy-control Levels With First-line Treatment With Ocrelizumab: Six-year Findings From the ENSEMBLE Trial
Robert A Bermel1, Ralph HB Benedict2, Thomas Berger3, Ludo Vanopdenbosch4, Trygve Holmoy5, Suzanne Moore6, Licinio Craveiro6, Joep Killestein7
1Department of Neurology, Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, OH, USA, 2Department of Neurology; Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, NY, USA, 3Department of Neurology, Medical University of Vienna and Comprehensive Center for Clinical Neurosciences and Mental Health, Medical University of Vienna, Vienna, Austria, 4Department of Neurology, AZ Sint-Jan Brugge, Brugge, Belgium, 5Department of Neurology, Department of Neurology, Akershus University Hospital, Lørenskog, Norway and Institute of Clinical Medicine, University of Oslo, Oslo, Norway, 6F. Hoffmann-La Roche Ltd, Basel, Switzerland, 7Department of Neurology, MS Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands
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.
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