Ofatumumab vs Teriflunomide Is More Efficacious in Minority Patients With MS

Compared with teriflunomide, ofatumumab was associated with greater proportions of  3-parameter no evidence of disease activity achievement across different racial and ethnic subgroups of adults with relapsing multiple sclerosis (MS), according to study findings published in Neurology.

Study authors conducted 2 identical, randomized, double-blind, double-dummy, active-controlled, multicenter phase 3 trials (ASCLEPIOS I/II; ClinicalTrials.gov Identifiers: NCT02792218 and NCT02792231) to evaluate whether the overall efficacy and safety outcomes observed in the ASCLEPIOS I and II trials can be extrapolated to its racial and ethnic subgroups, as well as determine whether ofatumumab and teriflunomide are comparably efficacious and safe across different racial and ethnic subgroups. Adults aged between 18 and 55 who had relapsing MS were randomly assigned 1:1 to receive either 20 mg ofatumumab every 4 weeks or 14 mg teriflunomide once daily for up to 30 months. Patients self-reported their race (ie, Black or African American, Asian, and White) and ethnicity (ie, Hispanic/Latino and non-Hispanic/non-Latino). Primary outcomes included treatment efficacy, measured as no evidence of disease activity, and annualized relapse rate, as well as adverse events (AEs), serious AEs, and AEs leading to drug discontinuation. Logistic regression models were used in statistical analyses.

A total of 1882 patients were included in the pooled population, of whom 946 (non-Hispanic Black, 2.7%; non-Hispanic Asian, 3.8%; Hispanic/Latino, 8.0%; non-Hispanic White, 81.0%; other/unknown, 4.4%) received ofatumumab and 936 (non-Hispanic Black, 4.1%; non-Hispanic Asian, 3.7%; Hispanic/Latino, 7.4%; non-Hispanic White, 82.5%; other/unknown, 2.4%) received teriflunomide.

Between months 0 and 24, ofatumumab vs teriflunomide was associated with statistically significantly increased likelihood of no evidence of disease activity achievement among patients who identified as non-Hispanic Black (33.3% vs 3.4%; odds ratio [OR], 15.9; 95% CI, 1.67-151.71; P =.0162), Hispanic/Latino (36.6% vs 18.6%; OR, 3.21; 95% CI, 1.32-7.79; P =.01), and non-Hispanic White (37.4% vs 16.6%; OR, 3.57; 95% CI, 2.73-4.67; P <.0001). The same subgroups also demonstrated statistically significantly increased odds of achieving no evidence of disease activity between months 0 and 12, as well as between months 12 and 24.

Aside from the non-Hispanic White and overall pooled populations, the proportion of patients free of confirmed MS relapses was greater, but not statistically significantly different for patients receiving ofatumumab vs teriflunomide over the 2-year treatment period.

Between months 0 and 24, 97.6% and 68.4% of patients in the ofatumumab and teriflunomide treatment arms, respectively, had no gadolinium-enhancing lesions. Further, 51.8% and 28.8% of patients in the ofatumumab and teriflunomide treatment arms, respectively, had no new or enlarging T2 lesions. No lesion activity was experienced by 51.5% and 28.7% of patients in the same 2 respective treatment arms.

Rates of AEs, serious AEs, and AEs resulting in drug discontinuation were comparable between the ofatumumab and teriflunomide treatment arms across racial and ethnic subgroups; however, the highest rates of AEs and serious AEs were observed among patients who identified as non-Hispanic Black. The most frequently reported AEs included injection-related reaction, nasopharyngitis, headache, upper respiratory tract infection, alopecia, urinary tract infection, and diarrhea.

Study limitations include the post hoc nature of the analysis, small sample sizes, and self-reported race and ethnicity.

“[F]uture studies should strive to enroll racially and ethnically diverse groups, including Black and African American, Asian, and Hispanic/Latino individuals, to better inform treatment decisions and outcomes for these populations,” the study authors concluded.

Disclosure: This research was supported by Novartis Pharmaceuticals Corporation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.