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Safety and Clinical Outcomes of Rituximab Treatment in Patients with Multiple Sclerosis and Neuromyelitis Optica: Experience from a National Online Registry (GRAID)

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Abstract

Introduction

Multiple sclerosis (MS) is an immune-mediated disease. Over the last decades therapeutic options have broadened tremendously. Nevertheless, various therapeutic agents, e.g., rituximab, are currently used in the treatment of MS off label. Disease or health registries are useful methods to collect information about off-label treatments. The German registry for autoimmune disease (GRAID) is a multicenter, retrospective, non-interventional database of patients with various autoimmune diseases.

Aim/Methods

The aim of this observational analysis is to present safety data of rituximab in the treatment of MS and neuromyelitis optica (NMO) in a real life clinical setting based on the available registry data.

Results

Data were collected nationwide in patients who received rituximab. 56 patients were treated with rituximab for MS or NMO. Average observation period was 9.6 months (SD 7.6, ranging from 6 to 29.7 months). Interval between treatments cycles differed tremendously (ranging from 0 to 21 months, median 10 months). Number of infusions ranged from 1 up to more than 8. The analysis provides experience on almost 50 patient years. Infusion related reactions were most common and reported in four patients; infections were seen in three patients (two of them were hospitalized for urinary tract infection and urosepsis). All patients recovered from infection. Full treatment response was attested in a quarter of the patients; two thirds benefited partially from treatment.

Discussion

Safety data of almost 50 patient years of treatment with rituximab show that rituximab is tolerated well in MS/NMO patients. Infections and infusion reactions are the most common adverse events. Our data may help the individual physician to balance efficacy of rituximab against the risk.

• Data on rituximab in MS and NMO are provided for almost 50 patientyears

• Rituximab was tolerated well

• No unexpected side effects were seen

• Almost 80 % of the patients benefited at least partially from treatment

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Acknowledgments

We want to thank Jens Westphal, MD and Waltraud Jakob for their support in the collection of patients’ data.

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Authors and Affiliations

  1. Department of Neurology, Neuroimmunological Section, University of Rostock, Rostock, Germany

    P. S. Rommer & U. K. Zettl

  2. Department of Neurology, Medical University of Vienna, Vienna, Austria

    P. S. Rommer

  3. Department of Medicine/Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany

    T. Dörner

  4. Analytica GmbH, Lörrach, Germany

    K. Freivogel & E. Schmidt

  5. Department of Neurology, Jewish Hospital Berlin, Berlin, Germany

    J. Haas

  6. Department of Neurology, Medical Faculty, Heinrich Heine-University, Düsseldorf, Germany

    B. C. Kieseier

  7. Institute of Clinical Neuroimmunology, Ludwig-Maximilians-University, Munich, Germany

    T. Kümpfel

  8. NeuroCure Clinical Research Center, Charité – Universitätsmedizin Berlin, Berlin, Germany

    F. Paul

  9. Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany

    F. Proft & H. Schulze-Koops

  10. Department of Neurology, University of Muenster, Muenster, Germany

    H. Wiendl

  11. Department of Neurology & Stroke, Hertie Institute for Clinical Brain Research, Eberhard-Karls-University, Tübingen, Germany

    U. Ziemann

  12. Department of Neurology, Goethe University Frankfurt, Frankfurt/Main, Germany

    U. Ziemann

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GRAID investigators

Corresponding author

Correspondence to P. S. Rommer.

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Potential Conflicts of Interests

TD received study support from Roche; consulting fees or honoraria from Roche, Chugai, UCB, J&J, Eli Elly; payment for lectures including service on speakers bureau from Roche, Chugai, UCB, Sanofi, J&J, Eli Elly. FrP received grants from the Guthy Jackson Charitable foundation; grant application is underway to Alexion pharmaceuticals; FrP received consulting fees or honoraria from Alexion, Chugai and MedImmune. HW received compensation for serving on Scientific Advisory Boards/Steering Committees for Bayer Healthcare, Biogen Idec, Genzyme, Merck Serono, Novartis and Sanofi Aventis. He has received speaker honoraria and travel support from Bayer Vital GmbH, Bayer Schering AG, Biogen Idec, CSL Behring, Fresenius Medical Care, Genzyme, Glaxo Smith Kline, GW Pharmaceuticals, Lundbeck, Merck Serono, Omniamed, Novartis and Sanofi Aventis. He has received compensation as a consultant from Biogen Idec, Merck Serono, Novartis and Sanofi Aventis, received research support from Bayer Vital, Biogen Idec, Genzyme Merck Serono, Novartis, Sanofi Aventis Germany, Sanofi US. All the other authors report no potential conflicts of interest.

The study was supported in part by an unrestricted educational grant by Roche Pharma AG Germany.

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Rommer, P.S., Dörner, T., Freivogel, K. et al. Safety and Clinical Outcomes of Rituximab Treatment in Patients with Multiple Sclerosis and Neuromyelitis Optica: Experience from a National Online Registry (GRAID). J Neuroimmune Pharmacol 11, 1–8 (2016). https://doi.org/10.1007/s11481-015-9646-5

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  • DOI: https://doi.org/10.1007/s11481-015-9646-5

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