Rituximab in multiple sclerosis

Abstract

Objective:To investigate the safety and efficacy of rituximab in multiple sclerosis (MS).Methods:In this retrospective uncontrolled observational multicenter study, off-label rituximab-treated patients with MS were identified through the Swedish MS register. Outcome data were collected from the MS register and medical charts. Adverse events (AEs) grades 2–5 according to the Common Terminology Criteria for Adverse Events were recorded.Results:A total of 822 rituximab-treated patients with MS were identified: 557 relapsing-remitting MS (RRMS), 198 secondary progressive MS (SPMS), and 67 primary progressive MS (PPMS). At baseline, 26.2% had contrast-enhancing lesions (CELs). Patients were treated with 500 or 1,000 mg rituximab IV every 6–12 months, during a mean 21.8 (SD 14.3) months. During treatment, the annualized relapse rates were 0.044 (RRMS), 0.038 (SPMS), and 0.015 (PPMS), and 4.6% of patients displayed CELs. Median Expanded Disability Status Scale remained unchanged in RRMS (p = 0.42) and increased by 0.5 and 1.0 in SPMS and PPMS, respectively (p = 0.10 and 0.25). Infusion-related AEs occurred during 7.8% of infusions and most were mild. A total of 89 AEs grades ≥2 (of which 76 infections) were recorded in 72 patients. No case of progressive multifocal leukoencephalopathy was detected.Conclusions:This is the largest cohort of patients with MS treated with rituximab reported so far. The safety, clinical, and MRI findings in this heterogeneous real-world cohort treated with different doses of rituximab were similar to those reported in previous randomized controlled trials on B-cell depletion therapy in MS.Classification of evidence:This study provides Class IV evidence that for patients with MS, rituximab is safe and effective.

Anti-CD20 Agents for Multiple Sclerosis: Spotlight on Ocrelizumab and Ofatumumab

“…While level 1 evidence is lacking, there are a small number of observational and cohort studies which support the use of rituximab in MS. These studies have shown that the medication appears to improve MRI and clinical findings in RRMS, PPMS, and SPMS, with reduced ARR, T2, and gadolinium-enhancing lesions [ 35 , 36 , 37 , 38 , 39 ]. The clinical studies on rituximab are summarized in Table 1 .…”

Human Tregs Made Antigen Specific by Gene Modification: The Power to Treat Autoimmunity and Antidrug Antibodies with Precision

“…Current treatment options include immunosuppressive drugs, β-interferon, or Copaxone, a random amino acid copolymer ( 76 – 78 ). Recently, treatment with B-cell depleting antibodies such as ocrelizumab and rituximab ( 79 – 83 ), has been used to relieve symptoms, but their side effects can be severe and also can lead to global immunosuppression ( 84 , 85 ). Better treatment options thus are clearly warranted.…”

B-cell–targeted therapies in relapsing forms of MS

“…The mean duration of follow-up was 21.8 months (SD 14.3 months). 33 The majority of these patients had RRMS (557) followed by secondary progressive MS (SPMS) (198) and PPMS (67). The annualized relapse rates were 0.044, 0.038, and 0.015 in RRMS, SPMS, and PPMS, respectively.…”