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

Hans-Peter Tony1, Gerd Burmester2, Hendrik Schulze-Koops3, Mathias Grunke3, Joerg Henes4, Ina Kötter4, Judith Haas5, Leonore Unger6, Svjetlana Lovric7, Marion Haubitz7, Rebecca Fischer-Betz8, Gamal Chehab8, Andrea Rubbert-Roth9, Christof Specker10, Jutta Weinerth11, Julia Holle12, Ulf Müller-Ladner13, Ramona König13, Christoph Fiehn14, Philip Burgwinkel2, Klemens Budde2, Helmut Sörensen15, Michael Meurer16, Martin Aringer16, Bernd Kieseier8, Cornelia Erfurt-Berge17, Michael Sticherling17, Roland Veelken17, Ulf Ziemann18, Frank Strutz19, Praxis von Wussow20, Florian MP Meier21, Nico Hunzelmann22, Enno Schmidt23, Raoul Bergner24, Andreas Schwarting25, Rüdiger Eming26, Michael Hertl26, Rudolf Stadler27, Michael Schwarz-Eywill28, Siegfried Wassenberg29, Martin Fleck30, Claudia Metzler31, Uwe Zettl32, Jens Westphal33, Stefan Heitmann34, Anna L Herzog35, Heinz Wiendl35, Waltraud Jakob36, Elvira Schmidt36, Klaus Freivogel36, Thomas Dörner2* and GRAID investigators

Author affiliations

1 Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Klinikstr 6-8, 97070 Würzburg, Germany

2 Department Medicine/Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Schumannstr 20/21, 10098 Berlin, Germany

3 Medizinische Poliklinik, Klinikum der Universität München, Pettenkoferstr. 8a, 80336 München, Germany

4 Department of Internal Medicine II, Universitätsklinikum Tübingen, Otfried-Müller-Str. 10, 72 076 Tübingen, Germany

5 Department of Neurology, Jüdisches Krankenhaus Berlin, Heinz-Galinski-Strasse 1, 13347 Berlin, Germany

6 Internal Medicine Rheumatology, Krankenhaus Dresden-Friedrichstadt, Friedrich Strasse 41, 01067 Dresden, Germany

7 Internal Medicine ICU, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

8 Endokrinologie, Diabetologie und Rheumatologie, Heinrich Heine-Universität Düsseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany

9 Klinik für Innere Medizin I, Uniklinik Köln, Josef-Stelzmann-Str 9, 50931 Köln, Germany

10 Department of Rheumatology and Clinical Immunology, Kliniken Essen-Süd, Propsteistr. 2, 45239 Essen, Germany

11 Klinikum Augsburg, Stenglinstr., 86156 Augsburg, Germany

12 University Hospital Schleswig-Holstein Campus Lübeck, Universität Lübeck/Klinikum Bad Bramstedt, Oskar-Alexander-Straße 26, 24576 Bad Bramstedt, Germany

13 Department of Internal Medicine and Rheumatology, Universität Giessen/Kerckhoff-Klinik, 61231 Bad Nauheim, Germany

14 ACURA Rheumazentrum Baden-Baden, Red River Valley Road 5, 76530 Baden-Baden, Germany

15 Ambulantes Rheumazentrum, Argentinische Allee 42, 14163 Berlin, Germany

16 Department of Dermatology, Technische Universität Dresden, Haus 105 auf der Blasewitzer Str. 86, 01304 Dresden, Germany

17 Department of Dermatology, Universitätsklinikum Erlangen, Hartmannstrasse 14, 91054 Erlangen, Germany

18 Klinik für Neurologie, Klinikum der Johann Wolfgang Goethe-Universität, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany

19 Zentrum Innere Medizin Abt. Nephrologie/Rheumatologie, Universitätsmedizin Göttingen, Robert-Koch-Str. 40, 37075 Göttingen, Germany

20 Praxis für Hämatologie und Internistische Onkologie, Rösebeckstr. 15, 30449 Hannover, Germany

21 Rheumapraxis Hofheim, Reifenberger Strasse 6, 65719 Hofheim, Germany

22 Klinik und Poliklinik für Dermatologie und Venerologie, Universität zu Köln, Kerpener Straße 62, 50937 Köln, Germany

23 Klinik für Dermatologie, Allergologie und Venerologie, Universität, Ratzeburger Allee 160, 23538 Lübeck, Germany

24 Medizinische Klinik A, Klinikum der Stadt Ludwigshafen, Bremserstr. 79, 67063 Ludwigshafen, Germany

25 Medizinische Klinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, 55131 Mainz, Germany

26 Abteilung von Dermatologien und Allergology, Philipps Universität Marburg, Deutschhausstrasse 9, 35033 Marburg, Germany

27 Department of Dermatology, Johannes Wesling Klinikum Minden, Hans-Nolte-Straße 1, 32429 Minden, Germany

28 Facharzt f. Innere Medizin-Rheumatologie, Evangelisches Krankenhaus, Marienstr. 11, 26121 Oldenburg, Germany

29 Rheumatologe, Ev. Fachkrankenhaus Ratingen, Rosenstr. 2, 40882 Ratingen, Germany

30 Rheumatologie, Universitätsklinikum Regensburg, Franz-Josef-Strauß-Allee 11, 93053 Regensburg, Germany

31 Medizinische Klinik II, Krankenhaus der Barmherzigen Brüder, Prüfeninger Str. 86, 93049 Regensburg, Germany

32 Klinik für Neurologie und Poliklinik, Universitätsklinikum Rostock, Gehlsheimer Straße 20, 18147 Rostock, Germany

33 Praxis für Allgemeinmedizin, Goethestr. 35, 78669 Schramberg-Sulgen, Germany

34 Schwerpunkt Rheumatologie und klinische Immunologie, Marienhospital Stuttgart, Böheimstr. 37, 70199 Stuttgart, Germany

35 Abteilung der Neurologie, Universität Würzburg, Josef-Schneider-Str. 11, 97080 Würzburg, Germany

36 Analytica International GmbH, Untere Herrenstr. 25, 79539 Lörrach, Germany

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Citation and License

Arthritis Research & Therapy 2011, 13:R75  doi:10.1186/ar3337

Published: 13 May 2011



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.


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.


A total of 370 patients (299 patient-years) with various autoimmune diseases (23.0% with systemic lupus erythematosus, 15.7% antineutrophil cytoplasmic antibody-associated granulomatous vasculitides, 15.1% multiple sclerosis and 10.0% pemphigus) from 42 centres received a mean dose of 2,440 mg of rituximab over a median (range) of 194 (180 to 1,407) 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).


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.