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Clinical Trial
. 2024 Aug 13;103(3):e209610.
doi: 10.1212/WNL.0000000000209610. Epub 2024 Jul 17.

Efficacy of Ofatumumab and Teriflunomide in Patients With Relapsing MS From Racial/Ethnic Minority Groups: ASCLEPIOS I/II Subgroup Analyses

Mitzi J Williams  1 , Lilyana Amezcua  1 , Stanley L Cohan  1 , Jeffrey A Cohen  1 , Silvia R Delgado  1 , Le H Hua  1 , Elisabeth B Lucassen  1 , Rebecca S Piccolo  1 , Chloe R Koulouris  1 , James Stankiewicz  1
Affiliations
Clinical Trial

Efficacy of Ofatumumab and Teriflunomide in Patients With Relapsing MS From Racial/Ethnic Minority Groups: ASCLEPIOS I/II Subgroup Analyses

Mitzi J Williams et al. Neurology. .

Abstract

Background and objectives: Race and ethnicity may influence the efficacy of disease-modifying therapies in patients with multiple sclerosis (MS). Incidence of MS in ethnically diverse groups may be higher; however, these populations are under-represented in MS trials. This post hoc analysis compared the proportion of patients achieving 3-parameter no evidence of disease activity (NEDA-3) with ofatumumab vs teriflunomide in participants with relapsing MS (RMS) enrolled in the ASCLEPIOS I/II trials by race/ethnicity subgroup.

Methods: ASCLEPIOS I/II were identical, double-blind, double-dummy, active-controlled, multicenter, phase 3 trials. Participants were randomized (1:1) to receive ofatumumab 20 mg every 4 weeks or teriflunomide 14 mg once daily for up to 30 months. Pooled data were used to determine the efficacy/safety of ofatumumab vs teriflunomide in participants who self-identified as non-Hispanic Black, non-Hispanic Asian, Hispanic/Latino, or non-Hispanic White. Participants who did not self-identify into one of these groups were classified as other/unknown.

Results: Of the 1,882 participants, 64 (3.4%) self-identified as non-Hispanic Black, 71 (3.8%) as non-Hispanic Asian, 145 (7.7%) as Hispanic/Latino, and 1,538 (81.7%) as non-Hispanic White. Baseline participant demographics/characteristics were largely balanced across subgroups, aside from minor variations in sex, disease duration, and MRI lesions. From months 0 to 24, the proportion of ofatumumab vs teriflunomide-treated patients achieving NEDA-3 (odds ratio [95% CI]) was as follows: non-Hispanic Black, 33.3% vs 3.4% (15.9 [1.67-151.71; p = 0.0162]); non-Hispanic Asian, 42.9% vs 21.9% (3.18 [0.95-10.59; p = 0.06]); Hispanic/Latino, 36.6% vs 18.6% (3.21 [1.32-7.79; p = 0.01]); and non-Hispanic White, 37.4% vs 16.6% (3.57 [2.73-4.67; p < 0.0001]). Rates of AEs were generally similar between treatment groups and across race/ethnicity subgroups; no new or unexpected safety signals were identified.

Discussion: Ofatumumab was associated with greater proportions of NEDA-3 achievement than teriflunomide across race/ethnicity subgroups in the ASCLEPIOS trials. Within each treatment group, the proportion of patients achieving NEDA-3 from months 0 to 24 was similar across the subgroups and overall pooled population. Both ofatumumab and teriflunomide were well tolerated. Future MS trials should include ethnically diverse groups to better inform treatment decisions and improve real-world patient outcomes.

Trial registration information: ClinicalTrials.gov: NCT02792218 (clinicaltrials.gov/ct2/show/NCT02792218), NCT02792231 (clinicaltrials.gov/ct2/show/NCT02792231). Submission date: June 2, 2016. First enrollment: August 26, 2016.

Classification of evidence: This study provides Class II evidence that among patients aged 18-55 years with RMS, the improvement in NEDA-3 with ofatumumab was comparably better than with teriflunomide among patients self-identified as non-Hispanic Black, non-Hispanic Asian, non-Hispanic White, Hispanic/Latino, and other/unknown.

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Conflict of interest statement

M.J. Williams has received consulting/speaking fees from Alexion, Biogen, Bristol Myers Squibb, EMD Serono, Genentech, Janssen, Novartis, Sanofi Genzyme, and TG Therapeutics and has received research support from Biogen, Genentech, and Novartis. L. Amezcua has received personal compensation for serving as a consultant for Biogen, EMD Serono, and Novartis, has received personal compensation for serving on a scientific advisory or data safety monitoring board for Genentech, and has received research support from Biogen, Bristol Myers Squibb Foundation, Genentech, NIH/National Institute of Neurological Disorders and Stroke, National Multiple Sclerosis Society, and Race to Erase MS. S.L. Cohan has served on advisory boards or steering committees for AbbVie, Biogen, Bristol Myers Squibb, EMD Serono, Novartis, Roche/Genentech, and Sanofi Genzyme, has received research support from AbbVie, ADAMAS, Biogen, EMD Serono, MedDay, Novartis, Opexa, Roche/Genentech, and Sanofi Genzyme, and has received speaker honoraria from Biogen, Bristol Myers Squibb, EMD Serono, Roche/Genentech, and Sanofi Genzyme. J.A. Cohen has received personal compensation for consulting from Biogen, Convelo, EMD Serono, Gossamer Bio, Mylan, and PSI and has received personal compensation for serving as an Editor of Multiple Sclerosis Journal. S.R. Delgado has received research support from EMD Serono and Novartis. L.H. Hua has received personal fees for speaking, consulting, and advisory board activities from Alexion, Bristol Myers Squibb, EMD Serono, Genentech, Genzyme, Greenwich Biosciences, Horizon, and Novartis, and has received research support from Biogen (paid to institution). E. Lucassen is an employee of and stockholder in Novartis. R. Piccolo is an employee of and stockholder in Novartis. J. Stankiewicz is an employee of and stockholder in Novartis. The other authors report no relevant disclosures. Go to Neurology.org/N for full disclosures.

Figures

Figure 1
Figure 1. Achievement of NEDA-3 in Race/Ethnicity Subgroups From the ASCLEPIOS I and II Trials
Months 0–24 (A), 0–12 (B), and 12–24 (C). N′ represents the number of participants with evaluable NEDA-3 data. NEDA-3 = 3-parameter no evidence of disease activity; OR = odds ratio.
Figure 2
Figure 2. Mean Serum IgG (A) and IgM (B) Levels From Baseline Over Time in Ofatumumab-Treated Participants From the ASCLEPIOS I and II Trials
Ig = immunoglobulin.
See this image and copyright information in PMC

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