Neuromyelitis Optica, also called Devic’s Syndrome, is similar to multiple sclerosis but more rapidly progressive and affects optic nerves to a greater degree. There is phase II data to support rituxan for multiple sclerosis, primarily from the double-blind, multicenter Helping to Evaluate Rituxan in Relapsing-Remitting Multiple Sclerosis (HERMES) trial. It randomized 104 patients 2:1 to rituximab or placebo. The drug was given at 1,000 mg IV on days one and 15. The study’s primary endpoint was the effect on gadolinium-enhancing lesion counts as seen on MRI brain scans at weeks 12, 16, 20, and 24. and this endpoint was met in favor of the rituximab arm. More than 80% of the rituximab group had no lesions at these evaluations, compared 51.4% of the placebo group (P<0.001).
If these encouraging results are confirmed in a phase III trial, they will establish B cells as a novel cellular target for MS therapy. For neuromyelititis, there is a case series of 8 patients and another one that is a retrospective review of 25 patients. A 2011 Cochrane guideline does not recommend Rituxan for multiple sclerosis. The authors did not find convincing evidence to support rituximab as an effective treatment for RRMS also because the small number of participants and the short term follow-up in the one comparative study of Rituxan vs. placebo. As far as safety is concerned, patients reported infusion-associated adverse events within 24 hours after the first infusion, including headache, back pain, depression, limb pain, general pain, heat sensations, pruritus, and rash.
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Cochrane Guideline, Rituximab for relapsing-remitting multiple sclerosis, Article first published online: 11 MAY 2011 |
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