Safety and clinical outcomes of rituximab therapy in patients with different autoimmune diseases: experience from a national registry (GRAID)

Introduction Evidence from a number of open-label, uncontrolled studies has suggested that rituximab may benefit patients with autoimmune diseases who are refractory to standard of care. The objective of this study was t
Introduction Evidence from a number of open-label, uncontrolled studies has suggested that rituximab may benefit patients with autoimmune diseases who are refractory to standard of care. The objective of this study was to evaluate the safety and clinical outcomes of rituximab in several standard of care-refractory autoimmune diseases (within rheumatology, nephrology, dermatology and neurology) other than rheumatoid arthritis or non-Hodgkin's lymphoma in a real-life clinical setting. Methods Patients who received rituximab having shown an inadequate response to standard of care had their safety and clinical outcomes data retrospectively analysed as part of the German Registry of Autoimmune Diseases. The main outcome measures were safety and clinical response, as judged at the discretion of the investigators. Results A total of 370 patients (299 patient-years) with various autoimmune diseases (23.0% with systemic lupus erythematosus, 15.7% antineutrophil cytoplasmic antibody-associated vasculitides, 15.1% multiple sclerosis and 10.0% pemphigus) from 42 centres received a mean dose of 2440 mg of rituximab over a median (range) of 194 (180 to 1407) days. The overall rate of serious infections was 5.3 per 100 patient-years during rituximab therapy. Opportunistic infections were infrequent across the whole study population, and mostly occurred in patients with systemic lupus erythematosus. There were 11 deaths (3.0% of patients) after rituximab treatment (mean 11.6 months after first infusion, range 0.8 to 31.3 months), with most of the deaths caused by infections. Overall (n = 293), 13.3% of patients showed no response, 45.1% showed a partial response and 41.6% showed a complete response. Responses were also reflected by reduced use of glucocorticoids and various immunosuppressives during rituximab therapy and follow-up compared with before rituximab. Rituximab generally had a positive effect on patient well-being (physician's visual analogue scale; mean improvement from baseline of 12.1 mm). Conclusions Data from this registry indicate that rituximab is a commonly employed, well-tolerated therapy with potential beneficial effects in standard of care-refractory autoimmune diseases, and support the results from other open-label, uncontrolled studies. Additional file 1: Supplemental tables. Table A1. Duration of follow-up from first rituximab infusion to last control visit by diagnosis. Table A2. Number of rituximab infusions by diagnosis.
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Author:Hans-Peter Tony, Gerd-Rüdiger Burmester, Hendrik Schulze-Koops, Mathias Grunke, Joerg Christoph Henes, Ina Kötter, Judith Haas, Leonore Unger, Svjetlana Lovric, Marion Haubitz, Rebecca Fischer-Betz, Gamal Chehab, Andrea Rubbert-Roth, Christof Specker, Jutta Weinerth, Julia Ulrike Holle, Ulf Müller-Ladner, Ramona König, Christoph Fiehn, Philip Burgwinkel, Klemens Budde, Helmut Sörensen, Michael Meurer, Martin Aringer, Bernd Kieseier, Cornelia Erfurt-Berge, Michael Sticherling, Roland Veelken, Ulf Ziemann, Frank Strutz, Praxis von Wussow, Florian M. P. Meier, Nico Hunzelmann, Nico Schmidt, Raoul Bergner, Andreas Schwarting, Rüdiger Eming, Michael Hertl, Rudolf Stadler, Michael Schwarz-Eywill, Siegfried Wassenberg, Martin Fleck, Claudia Metzler, Uwe Zettl, Jens Westphal, Stefan Heitmann, Anna Laura Herzog, Heinz Wiendl, Waltraud Jakob, Enno Schmidt, Enno Schmidt, Klaus Freivogel, Thomas Dörner, GRAID investigators
URN:urn:nbn:de:hebis:30-108033
Document Type:Article
Language:English
Date of Publication (online):2011/07/22
Year of first Publication:2011
Publishing Institution:Univ.-Bibliothek Frankfurt am Main
Release Date:2011/07/22
Note:
© 2011 Tony et al. ; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Source:Arthritis Research & Therapy 2011, 13:R75 ; doi:10.1186/ar3337 ; http://arthritis-research.com/content/13/3/R75/
HeBIS PPN:272558524
Institutes:Medizin
Dewey Decimal Classification:610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 2.0

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