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

被引：63

作者：

Aringer, M. ^{[1
]}

Burkhardt, H. ^{[2
]}

Burmester, G. R. ^{[3
]}

Fischer-Betz, R. ^{[4
]}

Fleck, M. ^{[5
]}

Graninger, W. ^{[6
]}

Hiepe, F. ^{[3
]}

Jacobi, A. M. ^{[7
]}

Koetter, I. ^{[8
]}

Lakomek, H. J. ^{[9
]}

Lorenz, H. M. ^{[10
]}

Manger, B. ^{[11
]}

Schett, G. ^{[11
]}

Schmidt, R. E. ^{[12
]}

Schneider, M. ^{[4
]}

Schulze-Koops, H. ^{[13
]}

Smolen, J. S. ^{[14
]}

Specker, C. ^{[15
]}

Stoll, T. ^{[16
]}

Strangfeld, A. ^{[17
]}

Tony, H. P. ^{[18
]}

Villiger, P. M. ^{[19
]}

Voll, R. ^{[20
]}

Witte, T. ^{[12
]}

Doerner, T. ^{[3
]}

机构：

[1] Tech Univ Dresden, Univ Med Ctr, D-01309 Dresden, Germany

[2] Goethe Univ Frankfurt, Dept Med, Frankfurt, Germany

[3] Charite Univ Med Berlin, Dept Med Rheumatol & Clin Immunol, Berlin, Germany

[4] Univ Dusseldorf, Dept Med, Dusseldorf, Germany

[5] Univ Regensburg, Dept Med, D-8400 Regensburg, Germany

[6] Graz Univ, Dept Med, A-8010 Graz, Austria

[7] Univ Munster, Dept Med D, D-4400 Munster, Germany

[8] Univ Tubingen, Dept Med, D-72074 Tubingen, Germany

[9] Klinikum Minden, Dept Med, Minden, Germany

[10] Heidelberg Univ, Dept Med, D-6900 Heidelberg, Germany

[11] Univ Erlangen Nurnberg, Dept Med 3, Erlangen, Germany

[12] Hannover Med Sch, Dept Immunol & Rheumatol, Hannover, Germany

[13] Univ Munich, Dept Med, Div Rheumatol, Munich, Germany

[14] Med Univ Vienna, Dept Rheumatol, Vienna, Austria

[15] Klinikum Essen Sud, Dept Med, Essen, Germany

[16] Kantonsspital Schaffhausen, Ctr Rheumatol, Schaffhausen, Switzerland

[17] Deutsch Rheumaforsch Inst, Div Epidemiol, Berlin, Germany

[18] Univ Wurzburg, Dept Med, D-97070 Wurzburg, Germany

[19] Univ Bern, Dept Rheumatol Clin Immunol & Allergol, CH-3012 Bern, Switzerland

[20] Univ Med Ctr Freiburg, Dept Med, Freiburg, Germany

来源：

LUPUS | 2012年 / 21卷 / 04期

关键词：

adverse events; biological response modifiers; consensus; evidence; off-label treatment; systemic lupus erythematosus; 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;

D O I：

10.1177/0961203311426569

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：386 / 401

页数：16

共 157 条

[1] Azathioprine therapy for patients with systemic lupus erythematosus [J].