Current state of evidence on 'off-label' therapeutic options for systemic lupus erythematosus, including biological immunosuppressive agents, in Germany, Austria and Switzerland - a consensus report

Aringer, M. and Burkhardt, H. and Burmester, G. R. and Fischer-Betz, R. and Fleck, M. and Graninger, W. and Hiepe, F. and Jacobi, A. M. and Koetter, I. and Lakomek, H. J. and Lorenz, H. M. and Manger, B. and Schett, G. and Schmidt, R. E. and Schneider, M. and Schulze-Koops, H. and Smolen, J. S. and Specker, C. and Stoll, T. and Strangfeld, A. and Tony, H. P. and Villiger, P. M. and Voll, R. and Witte, T. and Doerner, T. (2012) Current state of evidence on 'off-label' therapeutic options for systemic lupus erythematosus, including biological immunosuppressive agents, in Germany, Austria and Switzerland - a consensus report. LUPUS, 21 (4). pp. 386-401. ISSN 0961-2033, 1477-0962

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Abstract

Systemic lupus erythematosus (SLE) can be a severe and potentially life-threatening disease that often represents a therapeutic challenge because of its heterogeneous organ manifestations. Only glucocorticoids, chloroquine and hydroxychloroquine, azathioprine, cyclophosphamide and very recently belimumab have been approved for SLE therapy in Germany, Austria and Switzerland. Dependence on glucocorticoids and resistance to the approved therapeutic agents, as well as substantial toxicity, are frequent. Therefore, treatment considerations will include 'off-label' use of medication approved for other indications. In this consensus approach, an effort has been undertaken to delineate the limits of the current evidence on therapeutic options for SLE organ disease, and to agree on common practice. This has been based on the best available evidence obtained by a rigorous literature review and the authors' own experience with available drugs derived under very similar health care conditions. Preparation of this consensus document included an initial meeting to agree upon the core agenda, a systematic literature review with subsequent formulation of a consensus and determination of the evidence level followed by collecting the level of agreement from the panel members. In addition to overarching principles, the panel have focused on the treatment of major SLE organ manifestations (lupus nephritis, arthritis, lung disease, neuropsychiatric and haematological manifestations, antiphospholipid syndrome and serositis). This consensus report is intended to support clinicians involved in the care of patients with difficult courses of SLE not responding to standard therapies by providing up-to-date information on the best available evidence. Lupus (2012) 21, 386-401.

Item Type: Article
Uncontrolled Keywords: B-CELL-DEPLETION; THROMBOTIC THROMBOCYTOPENIC PURPURA; RANDOMIZED CONTROLLED-TRIAL; CENTRAL-NERVOUS-SYSTEM; INTRAVENOUS IMMUNOGLOBULIN THERAPY; AUTOIMMUNE HEMOLYTIC-ANEMIA; CONNECTIVE-TISSUE-DISEASE; INTERSTITIAL LUNG-DISEASE; CONTROLLED CLINICAL-TRIAL; PLACEBO-CONTROLLED TRIAL; adverse events; biological response modifiers; consensus; evidence; off-label treatment; systemic lupus erythematosus
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin I
Depositing User: Dr. Gernot Deinzer
Date Deposited: 18 May 2020 08:25
Last Modified: 18 May 2020 08:25
URI: https://pred.uni-regensburg.de/id/eprint/19016

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