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Impact of ozanimod on early and advanced relapsing multiple sclerosis: annualised relapse rate and MRI endpoints from two randomised, multicentre, double-blind, Phase 3 studies (SUNBEAM and RADIANCE)
Author(s): ,
G. Comi
Affiliations:
Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy
,
L. Kappos
Affiliations:
Neurologic Clinic and Policlinic, University Hospital and University of Basel, Basel, Switzerland
,
B.A.C. Cree
Affiliations:
Department of Neurology, Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States
,
D.L. Arnold
Affiliations:
NeuroRx Research, Montréal Neurological Institute, McGill University, Montréal, QC, Canada
,
K.W. Selmaj
Affiliations:
Department of Neurology, Center of Neurology, Lodz, Poland
,
A. Bar-Or
Affiliations:
Department of Neurology, Center for Neuroinflammation and Experimental Therapeutics, and Multiple Sclerosis Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
,
L. Steinman
Affiliations:
Departments of Neurology and Neurological Sciences, Beckman Center for Molecular Medicine, Stanford University School of Medicine, Stanford, CA, United States
,
H.-P. Hartung
Affiliations:
Department of Neurology, Medical Faculty, Heinrich-Heine-University Hospital, Düsseldorf, Germany
,
X. Montalbán
Affiliations:
Division of Neurology, University of Toronto; MS Centre, St Michael’s Hospital, Toronto, ON, Canada; Multiple Sclerosis Center of Catalonia (Cemcat), Hospital Universitari Vall d’Hebron, Barcelona, Spain
,
E.K. Havrdová
Affiliations:
Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic
,
B. Ferguson
Affiliations:
Celgene Corporation, San Diego, CA
,
J.K. Sheffield
Affiliations:
Celgene Corporation, San Diego, CA
,
J.A. Cohen
Affiliations:
Mellen Center for MS Treatment and Research, Cleveland Clinic, Cleveland, OH, United States
The SUNBEAM and RADIANCE Study Groups
The SUNBEAM and RADIANCE Study Groups
Affiliations:
ECTRIMS Online Library. Comi G. Oct 12, 2018; 229031
Prof. Giancarlo Comi
Prof. Giancarlo Comi
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Abstract: P1191

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

Introduction: Early treatment for multiple sclerosis (MS) may prevent the accumulation of irreversible nervous tissue damage, reducing the risk of disability accumulation. Ozanimod, an oral, once-daily immunomodulator selectively targeting sphingosine 1-phosphate receptors 1 and 5, was evaluated in patients (Pts) with early and advanced relapsing MS (RMS).
Methods: 2659 RMS Pts received daily oral ozanimod HCl 1 or 0.5 mg (equivalent to ozanimod 0.92 or 0.46 mg, respectively) vs weekly intramuscular interferon β-1a (IFN) 30 µg for ≥12 (SUNBEAM) or 24 months (RADIANCE). We report post-hoc analysis of pooled data for Pts with early RMS based on a composite baseline profile, including ≤3 years since MS diagnosis, Expanded Disability Status Scale (EDSS) ≤3.5, and ≤1 disease-modifying treatment (n=1392), and Pts classified as later in their disease course (advanced RMS; n=1267). MRI endpoints were based on the last common timepoint for the 2 studies.
Results: Early RMS Pts were evenly distributed between ozanimod HCl 1 mg (n=448, 51%), 0.5 mg (n=472, 53%), and IFN (n=472, 53%). At baseline, Pts with early vs advanced RMS had 0.5 vs 5.7 median years since diagnosis, 2.0 vs 3.5 median EDSS, and 1.4 vs 1.2 mean relapses within the last year, respectively. Baseline mean gadolinium-enhancing (GdE) lesion count was 1.77 and 1.67, and T2 lesion counts were 45.12 and 57.92, respectively. ARR was lower with ozanimod in Pts with early RMS (ozanimod HCl 1 mg [0.149] and 0.5 mg [0.200] vs IFN [0.285]), as well as in advanced RMS (ozanimod HCl 1 mg [0.217] and 0.5 mg [0.277] vs IFN [0.363]). Adjusted mean number of GdE lesions at 12 months was lower with ozanimod in Pts with early RMS (ozanimod HCl 1 mg [0.263] and 0.5 mg [0.458] vs IFN [0.656]) and advanced RMS (ozanimod HCl 1 mg [0.278] and 0.5 mg [0.323] vs IFN [0.915]). Adjusted mean new/enlarging T2 lesions over 12 months were also lower with ozanimod (early RMS: ozanimod HCl 1 mg [2.952] and 0.5 mg [3.744] vs IFN [4.633]; advanced RMS: ozanimod HCl 1 mg [2.514] and 0.5 mg [2.903] vs IFN [4.710]).
Conclusions: Ozanimod treatment resulted in lower ARR and MRI activity vs IFN in Pts with early RMS. Similar effects were seen in Pts with more advanced disease. These data support the potential of ozanimod as an effective treatment in Pts with both early and advanced RMS.
Disclosure: Dr. Giancaro Comi reports compensation for consulting and/or speaking activities from Almirall, Biogen, Celgene Corporation, EXCEMED, Forward Pharm, Genzyme, Merck, Novartis, Roche, Sanofi, and Teva. Dr. Ludwig Kappos's institution (University Hospital Basel) has received the following in the last 3 years, which was used exclusively for research support: steering committee, advisory board, and consultancy fees from Actelion, Alkermes, Almirall, Bayer, Biogen, Celgene Corporation, df-mp, EXCEMED, GeNeuro SA, Genzyme, Japan Tobacco, Merck, Minoryx, Mitsubishi Pharma, Novartis, Roche, Sanofi-Aventis, Santhera, Teva, and Vianex and royalties for Neurostatus-UHB products. The research of the MS Center in Basel has been supported by grants from Bayer, Biogen, Novartis, the Swiss MS Society, the Swiss National Research Foundation, the European Union, and the Roche Research Foundation. Dr. Bruce A.C. Cree reports personal compensation for consulting for Abbvie, Biogen, EMD Serono, GeNeuro, Novartis, and Sanofi Genzyme. Dr. Douglas L. Arnold has received personal fees for consulting from Acorda, Biogen, Celgene Corporation, MedImmune, Mitsubishi Pharma, Novartis, Roche, and Sanofi; grant support from Biogen and Novartis; and holds an equity interest in NeuroRx research. Dr. Krzysztof W. Selmaj has served as a consultant for Biogen, Celgene Corporation, Genzyme, Merck, Novartis, Ono Pharma, Roche, Synthon, and Teva. Dr. Amit Bar-Or has received personal compensation for consulting from Biogen, Celgene Corporation, EMD Serono, Genzyme, MedImmune, Novartis, and Roche. Dr. Lawrence Steinman has served as a consultant for Abbvie, Atreca, Celgene Corporation, Novartis, Teva, Tolerion, and EMD Serono, and has received research support from Atara, Biogen, and Celgene Corporation. Dr. Hans-Peter Hartung has received personal fees for consulting, serving on steering committees and speaking from Bayer, Biogen, GeNeuro, Genzyme, Merck, MedImmune, Novartis, Octapharma, Opexa, Roche, Sanofi, and Teva. Dr. Xavier Montalbán has received speaking honoraria and travel expenses for scientific meetings or has participated in steering committees or in advisory boards for clinical trials with Almirall, Bayer Schering Pharma, Biogen, Genentech, Genzyme, GSK, Merck Serono, MS International Federation, National Multiple Sclerosis Society, Novartis, Roche, Sanofi-Aventis, and Teva, and is the editor for Clinical Cases for Multiple Sclerosis Journal. Dr. Eva K. Havrdová has received personal compensation for consulting and speaking for Actelion, Biogen, Celgene Corporation, Merck, Novartis, Roche, Sanofi, and Teva, and is supported by the Czech Ministry of Education, project PROGRES Q27/LF1. Ms. Beatrice Ferguson is a salaried employee of Celgene Corporation. Dr. James K. Sheffield is a salaried employee of Celgene Corporation. Dr. Jeffrey A. Cohen has received personal compensation for consulting for Adamas, Celgene Corporation, Novartis, and PendoPharma, and as a Co-Editor of Multiple Sclerosis Journal - Experimental, Translational and Clinical.

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