Abstract: Ofatumumab Improves Neda-3 Likelihood in Hispanic/Latino Patients with Relapsing Multiple Sclerosis: Subgroup Analysis of the Asclepios Studies (2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DMT56
Ofatumumab Improves Neda-3 Likelihood in Hispanic/Latino Patients with Relapsing Multiple Sclerosis: Subgroup Analysis of the Asclepios Studies

Thursday, June 2, 2022

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

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

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 , Mellen MS Center, Cleveland Clinic, Cleveland, OH

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

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

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

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Background: Ofatumumab (OMB) is a fully human anti-CD20 monoclonal antibody approved by the FDA for treatment of adults with relapsing multiple sclerosis (RMS). Hispanic people with MS may experience a different disease course and it is well established that race/ethnicity plays a role in drug response variability.

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 the Phase 3 ASCLEPIOS I/II studies who identified as Hispanic/Latino.

Methods: ASCLEPIOS trials included patients aged 18–55 years with RMS, EDSS 0–5.5, randomized to receive OMB or TER for up to 30 months. 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 147 (7.8%) Hispanic/Latino. Mean (SD) age was 38.4 (9.1) years White and 37.7 (9.4) years Hispanic/Latino; 67% were female in both subgroups. Mean (SD) time since MS diagnosis was 5.7 (6.3) and 5.5 (5.5) years; median EDSS scores were 2.5 and 3.0, respectively. In the Hispanic/Latino subgroup, OMB significantly increased odds of achieving NEDA-3 vs TER during Months 0-12 [OR (95% CI): 2.5 (1.2, 5.1); p=0.02], Months 12-24 [11.5 (3.7, 35.7); p<0.0001], and Months 0-24 [2.7 (1.3, 5.8); p=0.01]. 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). At least 1 AE was reported in 83.0% Hispanic/Latino, vs 84.5% White; there were no significant differences in reported types of AEs between subgroups. In the Hispanic/Latino subgroup, serious AE rates were 6.6% OMB (8.5% TER), and rates of AEs resulting in discontinuations were 7.9% OMB (8.5% 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 efficacy data and the safety profile of OMB in the Hispanic/Latino subgroup are suggested to be consistent with the White subgroup in the ASCLEPIOS studies.

DMT56 Ofatumumab Improves Neda-3 Likelihood in Hispanic/Latino Patients with Relapsing Multiple Sclerosis: Subgroup Analysis of the Asclepios Studies

DMT56
Ofatumumab Improves Neda-3 Likelihood in Hispanic/Latino Patients with Relapsing Multiple Sclerosis: Subgroup Analysis of the Asclepios Studies