Research article
Safety and clinical outcomes of rituximab therapy in patients with different autoimmune diseases: experience from a national registry (GRAID)
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
Citation and License
Arthritis Research & Therapy 2011, 13:R75 doi:10.1186/ar3337
Published: 13 May 2011Abstract
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 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).
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.
