Rituxan for multiple sclerosis – pro
Phase II studies suggest a therapeutic effect of drugs targeting CD20+ B-cells such as rituximab in MS. The safety and efficacy of these medications beyond one year has not been described in MS. A 2011 Cochrane guideline does not recommend Rituxan for multiple sclerosis.
A 48-week, randomized, placebo-controlled Phase 2 study included 104 people with relapsing-remitting MS (RRMS) who were randomly assigned to receive intravenous rituximab 1000 mg (given as 2 infusions separated by 2 weeks) (n=69) or placebo (n=35). Rituximab resulted in a 91% reduction in gadolinium (Gd)-enhancing lesions compared with placebo. Additionally, a significantly lower percentage of people who received rituximab (20%) had relapses compared with those who received placebo (40%).
A 96-week, Phase 2/3 randomized, placebo-controlled study of rituximab in people with primary-progressive MS (PPMS) was also conducted as the OLYMPUS trial. This study included 439 participants who were randomly assigned to receive intravenous rituximab 1000 mg (2 infusions given 2 weeks apart every 24 weeks through week 74) (n=292) or placebo (n=147). The primary efficacy endpoint (the key measure used to determine the effectiveness of the medication) for the study was time to confirmed disease progression defined by sustained increase in disability as measured by the Expanded Disability Status Scale (EDSS). While rituximab did not result in a significant improvement in time to progression compared with placebo in the overall study population, it did result in significant improvement in this measure among people under the age of 51 years and among people with Gd-enhancing lesions at the start of the study. Additionally, rituximab resulted in a significantly lower volume of T2 brain lesions on magnetic resonance imaging (MRI) compared with placebo in the study population as a whole.
Seltezer in 2016 published a large restrospected review, showing a benefit to rituximab. I did not find any literature on maintenance Rituxan after an autologous stem ell transplant.
“Rituximab for relapsing-remitting multiple sclerosis” (first published in The Cochrane Library 2011, Issue 12.
Hauser SL, Waubant E, Arnold DL, et al. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med 2008;358:676-88.
Hawker K, O’Connor P, Freedman MS, et al. Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol 2009;66:460-71.
Jonatan Salzer et al, Rituximab in multiple sclerosis: A retrospective observational study on safety and efficacy. Neurology November 15, 2016 vol. 87 no. 20 2074-2081