Contributions
Abstract: P639
Type: Poster Sessions
Abstract Category: Therapy - Others
Introduction: African-descended patients with multiple sclerosis (MS) have more severe disease than and may not respond as well to disease-modifying therapies as European-descended patients. Ocrelizumab (OCR) demonstrated superior efficacy vs interferon β-1a (IFN β-1a) in patients with relapsing MS (RMS) in two Phase III studies (OPERA I [NCT01412333], OPERA II [NCT01247324]).
Objective: To evaluate the efficacy of OCR vs IFN β-1a in African-descended patients enrolled in OPERA I and II.
Methods: Patients in the OPERA studies received double-blind treatment with OCR 600 mg or IFN β-1a 44 µg for 96 weeks. This post hoc analysis in African-descended patients evaluated protocol-defined annualised relapse rate (ARR), time to onset of 12- and 24-week confirmed disability progression (CDP) on the Expanded Disability Status Scale (EDSS), rate of T1 gadolinium-enhancing (Gd+) and new/enlarging T2 lesions, proportion of patients with no evidence of disease activity (NEDA; no protocol-defined relapses, no 12-week CDP, no T1 Gd+ or new/enlarging T2 lesions) and no evidence of progression or active disease (NEPAD; NEDA and no 12-week confirmed progression of ≥20% on timed 25-foot walk or 9-hole peg tests).
Results: African-descended patients in the OPERA studies who received OCR (40/827, 4.8%) or IFN β-1a (32/829, 3.9%) were mostly female (72.5% and 68.8%) with a mean (SD) age of 35.8 (9.9) and 34.2 (9.1) years, baseline disease duration of 2.98 (4.48) and 2.66 (3.03) years and baseline EDSS of 2.89 (1.42) and 2.66 (1.27), respectively. Over 96 weeks, findings with OCR vs IFN β-1a were as follows: ARR (0.131 vs 0.262; rate ratio [RR], 0.497; 95% CI 0.180-1.371; p=0.2), 12-week CDP (15.0% vs 15.6%; hazard ratio [HR], 0.81; 95% CI 0.25-2.67; p=0.7) and 24-week CDP (12.5% vs 15.6%; HR, 0.67; 95% CI 0.19-2.32; p=0.7). OCR significantly reduced the rate vs IFN β-1a of T1 Gd+ lesions (0.026 vs 0.717; RR, 0.037; 95% CI 0.006-0.223; p=0.001) and new/enlarging T2 lesions (0.372 vs 2.650; RR, 0.140; 95% CI 0.062-0.315; p< 0.001). A greater proportion of OCR- vs IFN β-1a-treated patients achieved NEDA (45.5% vs 10.0%; RR, 4.365; 95% CI 1.443-13.204; p=0.002) and NEPAD (36.4% vs 6.9%; relative risk, 5.56; 95% CI 1.34-23.00; p=0.005).
Conclusions: Among a small sample of African-descended RMS patients in the OPERA studies, ocrelizumab demonstrated a treatment benefit on MRI and composite efficacy outcomes, consistent with that seen in the overall pooled OPERA I/II population.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd. B.A.C. Cree has received personal compensation for consulting from AbbVie, Biogen, EMD Serono, GeNeuro, Novartis and Sanofi Genzyme; J. Han is an employee of Genentech, Inc.; A. Pradhan is an employee of Genentech, Inc.; D. Masterman is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd; M.J. Williams has received personal compensation for consulting from Biogen, EMD Serono, Genentech, Inc. and Sanofi Genzyme.
Abstract: P639
Type: Poster Sessions
Abstract Category: Therapy - Others
Introduction: African-descended patients with multiple sclerosis (MS) have more severe disease than and may not respond as well to disease-modifying therapies as European-descended patients. Ocrelizumab (OCR) demonstrated superior efficacy vs interferon β-1a (IFN β-1a) in patients with relapsing MS (RMS) in two Phase III studies (OPERA I [NCT01412333], OPERA II [NCT01247324]).
Objective: To evaluate the efficacy of OCR vs IFN β-1a in African-descended patients enrolled in OPERA I and II.
Methods: Patients in the OPERA studies received double-blind treatment with OCR 600 mg or IFN β-1a 44 µg for 96 weeks. This post hoc analysis in African-descended patients evaluated protocol-defined annualised relapse rate (ARR), time to onset of 12- and 24-week confirmed disability progression (CDP) on the Expanded Disability Status Scale (EDSS), rate of T1 gadolinium-enhancing (Gd+) and new/enlarging T2 lesions, proportion of patients with no evidence of disease activity (NEDA; no protocol-defined relapses, no 12-week CDP, no T1 Gd+ or new/enlarging T2 lesions) and no evidence of progression or active disease (NEPAD; NEDA and no 12-week confirmed progression of ≥20% on timed 25-foot walk or 9-hole peg tests).
Results: African-descended patients in the OPERA studies who received OCR (40/827, 4.8%) or IFN β-1a (32/829, 3.9%) were mostly female (72.5% and 68.8%) with a mean (SD) age of 35.8 (9.9) and 34.2 (9.1) years, baseline disease duration of 2.98 (4.48) and 2.66 (3.03) years and baseline EDSS of 2.89 (1.42) and 2.66 (1.27), respectively. Over 96 weeks, findings with OCR vs IFN β-1a were as follows: ARR (0.131 vs 0.262; rate ratio [RR], 0.497; 95% CI 0.180-1.371; p=0.2), 12-week CDP (15.0% vs 15.6%; hazard ratio [HR], 0.81; 95% CI 0.25-2.67; p=0.7) and 24-week CDP (12.5% vs 15.6%; HR, 0.67; 95% CI 0.19-2.32; p=0.7). OCR significantly reduced the rate vs IFN β-1a of T1 Gd+ lesions (0.026 vs 0.717; RR, 0.037; 95% CI 0.006-0.223; p=0.001) and new/enlarging T2 lesions (0.372 vs 2.650; RR, 0.140; 95% CI 0.062-0.315; p< 0.001). A greater proportion of OCR- vs IFN β-1a-treated patients achieved NEDA (45.5% vs 10.0%; RR, 4.365; 95% CI 1.443-13.204; p=0.002) and NEPAD (36.4% vs 6.9%; relative risk, 5.56; 95% CI 1.34-23.00; p=0.005).
Conclusions: Among a small sample of African-descended RMS patients in the OPERA studies, ocrelizumab demonstrated a treatment benefit on MRI and composite efficacy outcomes, consistent with that seen in the overall pooled OPERA I/II population.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd. B.A.C. Cree has received personal compensation for consulting from AbbVie, Biogen, EMD Serono, GeNeuro, Novartis and Sanofi Genzyme; J. Han is an employee of Genentech, Inc.; A. Pradhan is an employee of Genentech, Inc.; D. Masterman is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd; M.J. Williams has received personal compensation for consulting from Biogen, EMD Serono, Genentech, Inc. and Sanofi Genzyme.