Witt, M., Grunke, M., Proft, F., Baeuerle, M., Aringer, M., Burmester, G., Chehab, G., Fiehn, C., Fischer-Betz, R., Fleck, M., Freivogel, K., Haubitz, M., Koetter, I., Lovric, S., Metzler, C., Rubberth-Roth, A., Schwarting, A., Specker, C., Tony, H-P, Unger, L., Wassenberg, S., Doerner, T. and Schulze-Koops, H. (2013). Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) - results from a nationwide cohort in Germany (GRAID). Lupus, 22 (11). S. 1142 - 1150. LONDON: SAGE PUBLICATIONS LTD. ISSN 1477-0962

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Abstract

ObjectiveThe objective of this article is to evaluate the safety and clinical outcome of rituximab treatment in systemic lupus erythematosus (SLE) patients refractory to standard of care therapy in a real-life setting in Germany. MethodsThe GRAID registry included patients with different autoimmune diseases who were given off-label treatment with rituximab. Data on safety and clinical response were collected retrospectively. In SLE patients, clinical parameters included tender and swollen joint counts, fatigue, myalgia, general wellbeing, Raynaud's and the SLEDAI index. Laboratory tests included dsDNA antibody titres, complement factors, hematologic parameters and proteinuria. Finally, the investigators rated their patients as non-, partial or complete responders based on clinical grounds. ResultsData from 85 SLE patients were collected, 69 female and 16 male, with a mean disease duration of 9.8 years. The mean follow-up period was 9.67.4 months, resulting in 66.8 patient years of observation. A complete response was reported in 37 patients (46.8%), partial response in 27 (34.2%), no response in 15 (19.0%). On average, major clinical as well as laboratory efficacy parameters improved substantially, with the SLEDAI decreasing significantly from 12.2 to 3.3 points. Concerning safety, one infusion reaction leading to discontinuation of treatment occurred. Infections were reported with a rate of 19.5 (including six severe infections) per 100 patient years. ConclusionWith the restrictions of a retrospective data collection, the results of this study confirm data of other registries, which suggest a favourable benefit-risk ratio of rituximab in patients with treatment-refractory SLE.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Witt, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grunke, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Proft, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baeuerle, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aringer, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burmester, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chehab, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fiehn, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer-Betz, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fleck, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Freivogel, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haubitz, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koetter, I.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lovric, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Metzler, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rubberth-Roth, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schwarting, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Specker, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tony, H-PUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Unger, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wassenberg, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doerner, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schulze-Koops, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-474951
DOI: 10.1177/0961203313503912
Journal or Publication Title: Lupus
Volume: 22
Number: 11
Page Range: S. 1142 - 1150
Date: 2013
Publisher: SAGE PUBLICATIONS LTD
Place of Publication: LONDON
ISSN: 1477-0962
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CELL DEPLETION THERAPY; B-LYMPHOCYTE STIMULATOR; RHEUMATOID-ARTHRITIS; DISEASE-ACTIVITY; AUTOIMMUNE-DISEASES; EFFICACY; CYCLOPHOSPHAMIDE; NEPHRITIS; INFECTIONS; BELIMUMABMultiple languages
RheumatologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/47495

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