Ofatumumab Bests Teriflunomide for RRMS Across Racial Groups

TOPLINE:

The monoclonal antibody ofatumumab appears to be more effective in achieving a disease-free state in relapsing-remitting multiple sclerosis (RRMS) than the immunomodulatory drug teriflunomide, across racial groups, show results of a randomized, double-blind clinical, phase 3 trial.

METHODOLOGY:

• Researchers conducted a post hoc analysis of the phase 3 ASCLEPIOS I and II trials to compare the efficacy and safety of ofatumumab and teriflunomide in diverse racial and ethnic subgroups of participants with RRMS.
• ASCLEPIOS I and II were identical, randomized, double-blind, double-dummy, active-controlled, multicenter, phase 3 trials conducted concurrently.
• Participants were randomized (1:1) to receive ofatumumab 20 mg subcutaneously every 4 weeks (after 20-mg loading doses at days 1, 7, and 14) or teriflunomide 14 mg orally once daily for up to 30 months.
• A total of 1882 participants aged 18-55 years with RRMS were included in the study, with 946 receiving ofatumumab and 936 receiving teriflunomide.
• Outcome measures included the proportion of participants achieving no evidence of disease activity (NEDA-3), annualized relapse rate, adverse events, and serious adverse events.

TAKEAWAY:

• Of the 1882 participants, 946 received ofatumumab and 936 received teriflunomide, with consistent efficacy observed across all racial and ethnic subgroups.
• From months 0 to 24, ofatumumab was associated with a higher likelihood of achieving NEDA-3 vs teriflunomide, with significant differences observed in non-Hispanic Black, Hispanic/Latino, and non-Hispanic White subgroups (P < .0001).
• Participants treated with ofatumumab in the non-Hispanic Black subgroup demonstrated the greatest odds of achieving NEDA-3, with odds ratios ranging from 8.88 to 15 (P = .0067).
• The proportion of participants free of gadolinium-enhancing T1 lesions was higher in the ofatumumab group across all subgroups than in the teriflunomide group, with significant differences in the overall population and specific subgroup (P < .0001).

IN PRACTICE: 

“Determining whether there are differences in how people respond to MS therapies is of great importance so that ultimately, each person is given the most effective treatment for them,” Mitzi Joi Williams, MD, Joi Life Wellness MS Center, Atlanta, said in a press release. “Underrepresentation of diverse populations continues to be an issue in research. Future studies should strive to enroll racially and ethnically diverse groups to better inform treatment decisions.”

SOURCE: 

Mitzi Joi Williams, MD, Joi Life Wellness MS Center, Atlanta, led the study, which was published online on July 17, in Neurology.

LIMITATIONS: 

The small sample sizes of the race and ethnicity subpopulations did not appropriately power this post hoc analysis to identify small differences in treatment effect. Additionally, the original studies were not designed to examine the efficacy and safety of the drugs based on race and ethnicity, which may have limited the generalizability of the findings.

DISCLOSURES: 

This study was funded by Novartis. Williams received consulting and speaking fees from multiple pharmaceutical companies, including Alexion, Biogen, Bristol Myers Squibb, EMD Serono, Genentech, Janssen, Novartis, Sanofi Genzyme, and TG Therapeutics. She also received research support from Biogen, Genentech, and Novartis. Additional disclosures are noted in the original article.