DX10
Safety and Efficacy of Rituximab: Experience of a Single MS Center
Multiple sclerosis (MS) is an immune mediated disease of the central nervous system (CNS). Genetic and environmental factors play an important role in the development of MS, but the precise precipitant remains unknown. Though historical theories focused on T cells, numerous immune cells and cytokines play important roles in the pathogenesis of MS. The B cell has been implicated in the pathology of MS since Kabat et als report of immunoglobulin production in the CNS in the 1940s. Several additional lines of evidence implicate important roles of the B cell in the pathophysiology of MS. Accordingly, numerous B cell depleting anti-CD20 drugs demonstrate efficacy in treating MS and are currently under development. The first of these, rituximab (RT), remains a viable off-label treatment option. In the absence of larger clinical trials or long term follow up the preliminary studies, long term and real world data are lacking.
Objectives:
This study reports the results of RT use in MS and neuromyelitis optica (NMO) patients at a single MS center. Patient characteristics, safety, and efficacy measures are reported to review the therapeutic benefit and safety of RT in these conditions.
Methods:
This is a retrospective chart review of patients who received RT at The Ohio State University’s infusion clinic from January 2005 through October 2016.
Results:
Of the 64 patient charts reviewed, 23 had a relapsing remitting MS (RRMS), 17 had primary progressive MS (PPMS), and 24 had NMO. When comparing post and pre treatment EDSS scores, a mean improvement of 0.22 was observed in the RRMS cohort with an annual relapse rate (ARR) of 0.005. Mean age and time on RT in the RRMS cohort was 41 and 2.5 years respectively. At the end of the chart review period, 87% of RRMS patients were documented to have a stable neurologic exam by his/her primary neurologist. In the PPMS cohort, there was a mean EDSS improvement of 0.12 and 47% were reported as clinically stable at the end of the chart review period. The mean age and time on RT in the PPMS group was 47 and 3.3 years respectively. In the NMO cohort, there was a mean EDSS improvement of 0.08, an ARR of 0.0074, and a mean time on RT of 3.1 years. At the end of the chart review period 79% of the NMO cohort were reported as clinically stable. A total of 29 infusion reactions were reported in 21 patients. Of these reactions none were serious, and only 1 patient elected to stop RT due to an adverse event.
Conclusions:
Rituximab demonstrated good tolerability and efficacy in cases of both relapsing and progressive forms of MS as well as NMO in this chart review.