Diroximel Fumarate vs Anti-CD20s: Which Has Lower Severe Infection Risk in MS?

Patients with multiple sclerosis (MS) who receive treatment with diroximel fumarate vs anti-CD20 monoclonal antibodies (anti-CD20s) have a lower risk for severe infections, according to study results presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024, held from February 29 to March 2, in West Palm Beach, Florida.

Although disease-modifying therapies (DMTs) reduce disease burden in MS, they have been associated with risk for severe infections.

Using real-world data, researchers aimed to evaluate the risk for severe infections among different DMTs, including diroximel fumarate and anti-CD20s.

The researchers identified participants between 2016 and 2023 using the Komodo Healthcare database, with study eligibility criteria including age 18 to 64, US residence, and at least 12 months of MS. Exclusion criteria were prior treatment with DMTs and switching/adding other therapies during follow-up.

Index date was defined as initiation of diroximel fumarate or anti-CD20s, including ocrelizumab and ofatumumab. Infection severity was classified based on hospitalization or the use of antibiotics.

Patients receiving diroximel fumarate were matched 1:1 with those receiving anti-CD20s, based on age, sex, race and ethnicity, infection rates, and disease severity and relapse rates.

Of 2232 patients with MS, 1116 each received diroximel fumarate and anti-CD20s. Both groups of patients had similar patient characteristics and other variables. Mean duration of treatment with diroximel fumarate vs anti-CD20s was 11.2 vs 11.3 months, respectively.

The researchers found that patients who received diroximel fumarate vs anti-CD20s had a 32% lower risk for severe infections (hazard ratio [HR], 0.68; 95% CI, 0.48-0.96; P =.029), with outcomes of 4 (0.3%) vs 9 (0.8%) participants, respectively, resulting in death.

The annual rate of severe infections with diroximel fumarate vs anti-CD20s was 7.2 vs 18.3 per 100 patient-years, respectively (P <.001).

The researchers wrote, “In this first of its kind study, patients on DRF [diroximel fumarate] were found to be at significantly lower risk of SIs [severe infections] versus anti-CD20s.”

Disclosure: This research was supported by Biogen.