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.
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.