(Abst.) Rituximab in MS: Retrospective observational study on safety and efficacy

Neurology. 2016 Oct 19.

Rituximab in multiple sclerosis: A retrospective observational study on safety and efficacy.

Salzer J1, Svenningsson R2, Alping P2, Novakova L2, Björck A2, Fink K2, Islam-Jakobsson P2, Malmeström C2, Axelsson M2, Vågberg M2, Sundström P2, Lycke J2, Piehl F2, Svenningsson A2.

Author information

1From the Department of Pharmacology and Clinical Neuroscience (J.S., R.S., P.I.-J., M.V., P.S., A.S.), Umeå University; Departments of Clinical Neuroscience (R.S., P.A., A.B., K.F., F.P.) and Clinical Sciences, Danderyd Hospital (A.S.), Karolinska Institutet, Stockholm; and Department of Clinical Neuroscience (L.N., C.M., M.A., J.L.), Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden. jonatan.salzer@umu.se.

2From the Department of Pharmacology and Clinical Neuroscience (J.S., R.S., P.I.-J., M.V., P.S., A.S.), Umeå University; Departments of Clinical Neuroscience (R.S., P.A., A.B., K.F., F.P.) and Clinical Sciences, Danderyd Hospital (A.S.), Karolinska Institutet, Stockholm; and Department of Clinical Neuroscience (L.N., C.M., M.A., J.L.), Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Sweden.

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.