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Original Investigation |

A 5-Year Follow-up of Rituximab Treatment in Patients With Neuromyelitis Optica Spectrum Disorder

Su-Hyun Kim, MD1; So-Young Huh, MD1; Sun Ju Lee, MS1; AeRan Joung, RN1; Ho Jin Kim, MD, PhD1
[+] Author Affiliations
1Department of Neurology, Research Institute and Hospital of National Cancer Center, Gyeonggi, Korea
JAMA Neurol. 2013;70(9):1110-1117. doi:10.1001/jamaneurol.2013.3071.
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Importance  A previous 2-year analysis of repeated rituximab treatment in patients with neuromyelitis optica (NMO) revealed significant improvements in relapse rates and disability. We report the findings from the longest follow-up of rituximab treatment in NMO, which provide reassurance regarding the long-term efficacy and safety of rituximab in NMO.

Objective  To report the results of rituximab treatment in patients with relapsing NMO or NMO spectrum disorder (NMOSD) for a median of 60 months.

Design, Setting, and Participants  Retrospective case series in an institutional referral center for multiple sclerosis, including 30 patients with relapsing NMO or NMOSD.

Interventions  After induction therapy, a single infusion of rituximab (375 mg/m2) as maintenance therapy was administered whenever the frequency of reemerging CD27+ memory B cells in peripheral blood mononuclear cells, as measured with flow cytometry, exceeded 0.05% in the first 2 years and 0.1% thereafter.

Main Outcomes and Measures  Annualized relapse rate (ARR), disability (Expanded Disability Status Scale score), change in anti–aquaporin 4 antibody, and safety of rituximab treatment.

Results  Of 30 patients, 26 (87%) exhibited a marked reduction in ARR over 5 years (mean [SD] pretreatment vs posttreatment ARR, 2.4 [1.5] vs 0.3 [1.0]). Eighteen patients (60%) became relapse free after rituximab treatment. In 28 patients (93%), the disability was either improved or stabilized after rituximab treatment. No serious adverse events leading to discontinuation were observed during follow-up.

Conclusions and Relevance  Repeated treatment with rituximab in patients with NMOSD over a 5-period, using an individualized dosing schedule according to the frequency of reemerging CD27+ memory B cells, leads to a sustained clinical response with no new adverse events.

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Figures

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Figure 1.
Treatment Protocol

Flowchart shows treatment protocol in the current study. IV indicates intravenous; NMO, neuromyelitis optica; NMOSD, NMO spectrum disorder.

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Figure 2.
Neuromyelitis Optica Relapses Before and After Start of Rituximab Treatment

Charts depict occurrence of relapses in patients with neuromyelitis optica before and after the start of rituximab treatment. On the x-axis, 0 indicates the start of treatment. Each row of symbols on the y-axis represents a patient.

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Figure 3.
Clinical Response, CD27+ Memory B Cells, and Anti–Aquaporin 4 Antibody Levels During Rituximab Treatment

Graphs display relationships among clinical response, frequency of CD27+ memory B cells, and anti–aquaporin 4 (AQP4) antibody levels during rituximab treatment. SU indicates standard unit.

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Figure 4.
Reconstitution of B Cells at Re-treatment

Reconstitution of CD19+ B cells is not necessarily proportional to repopulation of CD27+ memory B cells at the time of re-treatment. PBMCs indicates peripheral blood mononuclear cells.

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