Most Real-World Studies Report Positive Outcomes of Rituximab Use in Multiple Sclerosis

Rituximab is an anti-CD20 monoclonal antibody FDA-approved to treat several types of cancer and autoimmune conditions, including non-Hodgkin lymphoma, leukemia, and rheumatoid arthritis. It is used off-label as a treatment for multiple sclerosis (MS).

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Rituximab is available under the brand name Rituxan (Genentech and Biogen) and three biosimilars: Truxima (rituximab-abbs), Ruxience (rituximab-pvvr), and Riabni (rituximab-arrx).

Although several clinical trials have confirmed the safety and efficacy of rituximab in oncology and autoimmune disease, and even as off-label use in MS, real-world evidence is still necessary to help guide clinicians and managed care professionals in their treatment and coverage decision-making.

To assess the state of real-world research evaluating the use of rituximab in oncology, rheumatoid arthritis, and MS, a group of researchers led by Kevin H. Li, B.S., B.A., conducted a review of observational real-world studies published between January 1, 2010, and June 14, 2022.

The results were published this month in the Journal of Managed Care and Specialty Pharmacy.

Eligible studies included adults treated with infliximab for non-Hodkin lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, or MS. A total of 260 studies were included in the review, 37 of which were for MS.

For all disease states, most studies were retrospective, and the majority were conducted in Europe, North America, and Asia. About 68% of studies used data from hospital or electronic health records, 23% used registry databases, and 6% used insurance claims databases. However, none of the MS studies used insurance claims as a data source.

In all the MS studies, rituximab was used as monotherapy for relapsing-remitting MS, primary progressive MS, or secondary progressive MS. Of the 37 MS studies evaluated, 18 compared rituximab with other MS treatments, such as alemtuzumab, natalizumab, ocrelizumab, glatiramer acetate, interferon-β, fingolimod, and dimethyl fumarate.

Endpoints for determining rituximab efficacy in MS included the expanded disability status scale score, annualized relapse rate, and gadolinium-enhancing lesion activity, a marker of disease activity reflecting acute inflammation.

Of all disease states evaluated, MS had the most studies (81%) reporting positive outcomes for rituximab.

The researchers conclude that this real-world evidence can be used to help managed healthcare professionals make decisions regarding rituximab coverage and treatment, given the availability of several biosimilars that can help reduce economic burden.