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

• Published in: Lupus Vol. 21; no. 4; pp. 386 - 401
• Main Authors: Aringer, M, Burkhardt, H, Burmester, GR, Fischer-Betz, R, Fleck, M, Graninger, W, Hiepe, F, Jacobi, AM, Kötter, I, Lakomek, HJ, Lorenz, HM, Manger, B, Schett, G, Schmidt, RE, Schneider, M, Schulze-Koops, H, Smolen, JS, Specker, C, Stoll, T, Strangfeld, A, Tony, HP, Villiger, PM, Voll, R, Witte, T, Dörner, T
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-04-2012; Sage Publications Ltd
• Subjects: antiphospholipid syndrome; Arthritis; Austria; azathioprine; Biological products; Biological Products - adverse effects; Biological Products - therapeutic use; Chloroquine; Consensus; Cyclophosphamide; Disease; Drugs; Evidence-Based Medicine - standards; Germany; Glucocorticoids; Humans; Hydroxychloroquine; Immunology; Immunosuppressive agents; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; Literature reviews; Lung diseases; Lupus; Lupus Erythematosus, Systemic - complications; Lupus Erythematosus, Systemic - drug therapy; Lupus nephritis; Medicine; Mental disorders; Off-Label Use - standards; Patient Selection; Rheumatology; Risk Assessment; Risk Factors; Switzerland; Systemic lupus erythematosus; Toxicity; Treatment Outcome; Tumor necrosis factor-TNF; Switzerland; Austria; Germany; Berlin Germany; consensus; off-label treatment; biological response modifiers; systemic lupus erythematosus; adverse events; evidence
• ISSN: 0961-2033; 1477-0962
• DOI: 10.1177/0961203311426569

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.