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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

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Comparative Effectiveness of Rituximab Dosed Every 6 and 12 Months in Relapsing Multiple Sclerosis.

Annette Langer-Gould^1,2, Bonnie H Li³, Jessica B Smith³

¹Department of Neurology, Los Angeles Medical Center, Southern California Permanente Medical Group.

|December 22, 2025

Summary

Extending rituximab (RTX) dosing to every 12 months for relapsing multiple sclerosis (RMS) is effective and safe. This approach did not increase disease activity despite higher B-cell counts compared to 6-month intervals.

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Area of Science:

Neurology
Immunology
Pharmacology

Background:

Rituximab (RTX) is effective for relapsing multiple sclerosis (RMS), but higher doses increase infection risk.
The safety of extending RTX dosing intervals to 12 months (q12mo) in RMS patients with stable disease is uncertain.
Potential risks include disease activity return, especially with B-cell repopulation.

Purpose of the Study:

To compare the risk of disease activity return in RMS patients treated with RTX at 12-month intervals (q12mo) versus 6-month intervals (q6mo).
To assess if extending RTX dosing impacts disease stability despite B-cell repopulation.

Main Methods:

Emulated a target trial comparing RTX 500 mg q12mo vs. q6mo in RMS patients achieving no evidence of disease activity (NEDA) in the first year.
Utilized a retrospective cohort (2008-2023) from Kaiser Permanente Southern California.
Analyzed NEDA-3 (no relapses, MRI activity, or disability progression) using intention-to-treat (ITT) and per-protocol (PP) with inverse probability of treatment weighting.

Main Results:

140 patients received q12mo and 468 received q6mo dosing.
Disease activity (relapses/MRI) and failing NEDA-3 were uncommon up to 4 years.
Q12mo dosing led to significant B-cell repopulation compared to q6mo.
No increased risk of failing NEDA-3 was observed with q12mo dosing in adjusted analyses (ITT HR 1.60, PP HR 1.44).

Conclusions:

Extending RTX dosing intervals to q12mo in stable RMS patients is highly effective.
This strategy does not increase disease activity risk, even with B-cell count recovery.
Q12mo dosing offers a safe and effective alternative to q6mo intervals for RMS treatment.