Rituxan for MS and optic neuromyelitis – pro

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.

 

 

Jacob A, Weinshenker BG, Violich I, McLinskey N, Krupp L, Fox RJ, Wingerchuk DM, Boggild M, Constantinescu CS, Miller A, De Angelis T, Matiello M, Cree BA. Treatment of neuromyelitis optica with rituximab: retrospective analysis of 25 patients.Arch Neurol. 2008 Nov;65(11):1443-8.

B-Cell Depletion for MS. JWatch Neurology 2008: 1-1

Stephen L. Hauser, M.D., Emmanuelle Waubant, M.D., Ph.D., Douglas L. Arnold, M.D., Timothy Vollmer, M.D., Jack Antel, M.D., Robert J. Fox, M.D., Amit Bar-Or, M.D., Michael Panzara, M.D., Neena Sarkar, Ph.D., Sunil Agarwal, M.D., Annette Langer-Gould, M.D., Ph.D., Craig H. Smith, M.D., for the HERMES Trial Group B-Cell Depletion with Rituximab in Relapsing–Remitting Multiple Sclerosis NEJM Volume 358:676-688 February 14, 2008 Number 7

B. A. Choudry and J. W. Chan
An Update on Monoclonal Antibody Therapies in Multiple Sclerosis
Journal of Pharmacy Practice, April 1, 2007; 20(2): 167 – 180.

B. A.C. Cree, MD, PhD, MCR, S. Lamb, RN, K. Morgan, A. Chen, MD, E. Waubant, MD and C. Genain, MD An open label study of the effects of rituximab in neuromyelitis optica NEUROLOGY 2005;64:1270-1272

Sellner J, Boggild M, Clanet M, Hintzen RQ, Illes Z, Montalban X, Du Pasquier RA, Polman CH, Sorensen PS, Hemmer B.EFNS guidelines on diagnosis and management of neuromyelitis optica. Eur J Neurol. 2010 Jun 7.

Dian He, Hongyu Zhou, Wenjie Han and Shihong Zhang
Cochrane Guideline, Rituximab for relapsing-remitting multiple sclerosis, Article first published online: 11 MAY 2011 |

Mixalis L. KosmidisPractical considerations on the use of rituximab in autoimmune neurological disorders, Ther Adv Neurol Disord. 2010 Mar; 3(2): 93–105.

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