Original Article from The New England Journal of Medicine — B-Cell Depletion with Rituximab in Relapsing–Remitting Multiple Sclerosis (@lodaox @MustStopMS #Rituximab reduced relapses in half in Phase II trial in #MS.

 

RESULTS

As compared with patients who received placebo, patients who received rituximab had reduced counts of total gadolinium-enhancing lesions at weeks 12, 16, 20, and 24 (P<0.001) and of total new gadolinium-enhancing lesions over the same period (P<0.001); these results were sustained for 48 weeks (P<0.001). As compared with patients in the placebo group, the proportion of patients in the rituximab group with relapses was significantly reduced at week 24 (14.5% vs. 34.3%, P=0.02) and week 48 (20.3% vs. 40.0%, P=0.04). More patients in the rituximab group than in the placebo group had adverse events within 24 hours after the first infusion, most of which were mild-to-moderate events; after the second infusion, the numbers of events were similar in the two groups.

Full Text of Results...

 CONCLUSIONS

A single course of rituximab reduced inflammatory brain lesions and clinical relapses for 48 weeks. This trial was not designed to assess long-term safety or to detect uncommon adverse events. The data provide evidence of B-cell involvement in the pathophysiology of relapsing–remitting multiple sclerosis. (ClinicalTrials.gov number,NCT00097188.)


Via Krishan Maggon