Effectiveness of rituximab in the treatment of multiple sclerosis: A multicenter, retrospective, observational study...

The demonstration of the strong efficacy of selective B-cell-depleting therapies, such as anti-CD20 monoclonal antibodies in multiple sclerosis (MS), point out the key role of B cells in triggering MS disease activity.

To investigate the effectiveness and safety of rituximab (RTX) in MS.

We report a retrospective observational study to describe the effectiveness of off-label Rituximab (RTX) in the treatment of a population of 93 Moroccan MS patients including 66 (71 %) relapsing-remitting multiple sclerosis (RRMS) and 27 (29 %) progressive forms of multiple sclerosis (PMS).

Our study showed that the RTX treatment was associated with the mean ARR decreasing by 71.5 % (p < 0.001) with respect to the previous year and the majority of relapses (62.5 %) occurred within 6 months of starting treatment. The mean EDSS score of the overall patient cohort fell from 4.9 to 4.1 (p = 0.039) after 1 year of treatment with RTX and remained stable in the second year of therapy. EDSS scores improved (CID) after 1 year of treatment with RTX by a score of 0.5-1.0 in 43 (46.2 %) patients and remained stable in the following two years of therapy. Moreover, there was no evidence of disease activity measured by NEDA-3 in 74.2 % of the total sample up to their last follow-up, i.e., 53 (80.3 % ) of RRMS patients and 17 (62.9) % of PMS patients, and there was also a reduction in the number of GEL from 2.3 to 0.2 (p < 0.001). Finally, RTX was discontinued in 7 (7.5 %) patients (4 SPMS, 3 PPMS) and the confirmed worsening of disability (CWD) was the reason for withdrawal.

Off-label RTX treatment should be considered as a therapeutic option for RRMS and some PMS patients, given its efficacy and safety profile with faster onset of action, long duration of action and favorable cost-effectiveness profile.