Abstract: Ofatumumab Improves Neda-3 Likelihood in Patients with Relapsing MS Identifying As Black or African American: Subgroup Analysis of the Asclepios Studies (2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DMT47
Ofatumumab Improves Neda-3 Likelihood in Patients with Relapsing MS Identifying As Black or African American: Subgroup Analysis of the Asclepios Studies

Thursday, June 2, 2022

Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)

Mitzi J Williams, MD , Joi Life Wellness, MS Neurology Center, Smyrna, GA

Lilyana Amezcua, MD , Keck School of Medicine, University of Southern California, Los Angeles, CA

Stanley L Cohan, MD, PhD , Providence Multiple Sclerosis Center, Providence Brain Institute, Portland, OR

Jeffrey A Cohen, MD , Cleveland Clinic Mellen Center, Cleveland, OH

Silvia R Delgado, MD , Department of Neurology, University of Miami Miller School of Medicine, Miami, FL

Le H Hua, MD , Lou Ruvo Center for Brain Health, Las Vegas, NV

Elisabeth B Lucassen, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ

Xiangyi Meng, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ

James Stankiewicz, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ

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Background: Ofatumumab (OMB), a fully human anti-CD20 monoclonal antibody, is approved by the FDA for the treatment of adults with relapsing multiple sclerosis (RMS). Black/African American people with MS may experience a different disease course and it is well established that drug effect can vary by race/ethnicity.

Objectives: Report findings of a post hoc analysis assessing achievement of NEDA-3 with subcutaneous OMB vs oral teriflunomide (TER) in a subgroup of patients with RMS from ASCLEPIOS who identified as Black/African American.

Methods: This analysis included pooled data from the Phase 3 ASCLEPIOS I/II studies. Patients achieving NEDA-3 (defined as no 6-month confirmed disability worsening, no confirmed MS relapse, no new/enlarging T2 lesions, and no Gd+ T1 lesions) were assessed via Fisher’s Exact test according to patient-reported race/ethnicity. No adjustment was made for multiple comparisons. Rates of adverse events (AEs) are also reported.

Results: Of 1882 patients in the overall ASCLEPIOS population, 1658 (88.1%) identified as White and 66 (3.5%) Black/African American. Mean (SD) age was 38.4 (9.1) years White and 37.8 (9.2) years Black/African American; 67% and 79% were female, respectively. Mean (SD) time since MS diagnosis was 5.7 (6.3) and 5.4 (5.7) years; median EDSS scores were 2.5 and 2.8, respectively. In the Black/African American subgroup, OMB increased odds of achieving NEDA-3 vs TER during Months 0-12 [OR (95% CI): 5.7 (1.5, 21.8); p=0.013], Months 12-24 [9.5 (2.5, 36.4); p=0.0006], and Months 0-24 [8.7 (1.7, 45.8); p=0.007]. Corresponding numbers in the White subgroup were: Months 0-12 [OR (95% CI): 2.8 (2.2, 3.5)], Months 12-24 [7.6 (5.8, 9.9)], and Months 0-24 [3.1 (2.5, 3.9)] (all p<0.0001). AE rates were balanced between OMB and TER in both subgroups, with at least 1 AE reported in 92.4% of the Black/African American subgroup, vs 84.5% White; there were no significant differences in reported types of AEs between subgroups. In the Black/African American subgroup, serious AE rates were 10.7% OMB (7.9% TER), and rates of AEs resulting in discontinuations were 0% OMB (5.3% TER); corresponding numbers in the White subgroup were 9.4% OMB (8.1% TER) and 6.3% OMB (5.3% TER), respectively.

Conclusions: NEDA-3 achievement and the safety profile of OMB in the Black/African American subgroup are consistent with the White subgroup in the ASCLEPIOS studies.

DMT47 Ofatumumab Improves Neda-3 Likelihood in Patients with Relapsing MS Identifying As Black or African American: Subgroup Analysis of the Asclepios Studies

DMT47
Ofatumumab Improves Neda-3 Likelihood in Patients with Relapsing MS Identifying As Black or African American: Subgroup Analysis of the Asclepios Studies