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Autoimmun Rev. 2017 Jun;16(6):650-657. doi: 10.1016/j.autrev.2017.04.011. Epub 2017 Apr 18.

International and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus.

Author information

1
Rheumatology Department, Strasbourg University Hospital, Strasbourg, France.
2
Epidemiology and Clinical Research, AP-HP, Pitié-Salpétrière Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France.
3
Internal Medicine Department, AP-HP, Cochin Hospital, Paris, France; Université René-Descartes Paris V, Paris, France.
4
Internal Medicine Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France.
5
Rheumatology Department, Bordeaux University Hospital, University of Bordeaux, Bordeaux, France.
6
Internal Medicine and Clinical Immunology Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.
7
Internal Medicine Department, AP-HP, Bichat Hospital, INSERM U1149, Paris, France; Université René-Descartes Paris V, Paris, France.
8
Rheumatology Department, AP-HP, Saint Antoine Hospital, INSERM UMRS_938, DHU i2B, Paris, France; Université Pierre et Marie Curie, Paris 6, France.
9
Rheumatology Department, AP-HP, Bicêtre Hospital, Le Kremlin Bicêtre, France; Université Paris Sud, Le Kremlin Bicêtre, France.
10
Internal Medicine Department, Strasbourg University Hospital, Strasbourg, France; Université de Strasbourg, Strasbourg, France.
11
Internal Medicine and Clinical Immunology Department, Dijon University Hospital, University of Bourgogne Franche-Comté, INSERM UMR 1098, FHU INCREASE, Dijon, France.
12
Paediatric Immunology and Rheumatology Department, AP-HP, Necker Hospital, Institut Imagine, Paris, France.
13
Internal Medicine Department, Colmar Hospital, Colmar, France.
14
Internal Medicine and Clinical Immunology Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France.
15
Nephrology Department, Strasbourg University Hospital, Strasbourg, France.
16
Internal Medicine Department, Hôpital Européen, Marseille, France.
17
Dermatology Department, AP-HP, Henri Mondor Hospital, Paris, France.
18
Internal Medicine Department, AP-HP, Cochin Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France.
19
Rheumatology Department, Montpellier University Hospital, Montpellier, France.
20
Nephrology Department, AP-HP, Bichat Hospital, Paris, France.
21
Medicine Department-DIMED, University of Padova, Padova, Italy.
22
Internal Medicine Department, AP-HP, Saint Antoine Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France.
23
Nephrology Department, Nantes University Hospital, Nantes, France.
24
Internal Medicine Department, AP-HP, Saint Louis Hospital, University of Paris Diderot, Paris, France.
25
Rheumatology Department, Geneva University Hospital, Geneva, Switzerland.
26
Epidemiology and Clinical Research, AP-HP, Pitié-Salpétrière Hospital, Paris, France.
27
Internal Medicine Department, Lille University Hospital, University of Lille, Lille, France.
28
Rheumatology Department, El Ayachi University Hospital, URAC 30, Faculty of Medicine, Salé, Morocco; University Mohammed V, Rabat, Morocco.
29
Internal Medicine Department, Nantes University Hospital, Nantes, France.
30
Pôle de maladies rhumatismales, Université Catholique de Louvain, Louvain-la-Neuve, Belgium.
31
Nephrology Department, AP-HM, Marseille University Hospital, University Aix-Marseille, Marseille, France.
32
Paediatric Rheumatology Department, AP-HP, Bicêtre Hospital, Le Kremlin Bicêtre, France; Université Paris Sud, Le Kremlin Bicêtre, France.
33
Medicine Department, University of Algiers 1, Algiers, Algeria.
34
Internal Medicine and Clinical Immunology Department, AP-HP, Bicêtre Hospital, Le Kremlin Bicêtre, France; INSERM UMR 1184, Immunologie des Maladies Virales et Autoimmunes (IMVA), Le Kremlin Bicêtre, France; CEA, DSV/iMETI, Division of Immuno-Virology, IDMIT, France; Université Paris Sud, Le Kremlin Bicêtre, France.
35
Dermatology Department, Strasbourg University Hospital, Strasbourg, France; Université de Strasbourg, Strasbourg, France.
36
Internal Medicine Department, Caen University Hospital, Caen, France.
37
Internal Medicine and Clinical Immunology Department, Strasbourg University Hospital, Strasbourg, France; IBMC, CNRS, UPR3572, Strasbourg, France; Université de Strasbourg, Strasbourg, France.
38
Internal Medicine Department, Metz Hospital, Metz, France.
39
Internal Medicine and Infectious Diseases Department, Versailles Hospital, Versailles, France.
40
Internal Medicine Department, AP-HP, Saint Antoine Hospital, Paris, France.
41
Rheumatology Department, AP-HP, Bichat Hospital, Paris, France.
42
Internal Medicine Department, Nancy University Hospital, Nancy, France; Université de Lorraine, Nancy, France.
43
Nephrology Department, Strasbourg University Hospital, Strasbourg, France; Université de Strasbourg, Strasbourg, France.
44
Rheumatology Department, Tours University Hospital, University François Rabelais, CNRS 7292, Tours, France.
45
Internal Medicine Department, AP-HP, Bichat Hospital, INSERM U1149, Paris, France.
46
Internal Medicine and Clinical Immunology Department, Strasbourg University Hospital, Strasbourg, France.
47
Internal Medicine Department, AP-HP, Cochin Hospital, Paris, France.
48
Internal Medicine Department, Toulouse University Hospital, Toulouse, France.
49
Internal Medicine Department, Amiens University Hospital, Amiens, France.
50
Dermatology Department, Clinique Mutualiste Catalane, Perpignan, France.
51
Internal Medicine Department, Ibn Sina Hospital, Rabat, Morocco; University Mohammed V, Rabat, Morocco.
52
Rheumatology Department, Tunis University Hospital, Tunis, Tunisia.
53
Vascular Medicine Department, Nancy University Hospital, INSERM U1116, Nancy, France; Université de Lorraine, Nancy, France.
54
Rheumatology Department, Strasbourg University Hospital, Strasbourg, France; INSERM UMR_S1109, Fédération de Médecine Translationnelle de Strasbourg (FMTS), FHU OMICARE, Strasbourg, France; Université de Strasbourg, Strasbourg, France.
55
Rheumatology Department, Strasbourg University Hospital, Strasbourg, France; IBMC, CNRS, UPR3572, Strasbourg, France; Université de Strasbourg, Strasbourg, France. Electronic address: jacques-eric.gottenberg@chru-strasbourg.fr.

Abstract

BACKGROUND/PURPOSE:

Despite conventional immunosuppressants, active and steroid-dependent systemic lupus erythematosus (SLE) represents a therapeutic challenge. Only one biologic, belimumab, has been approved, but other biologics are sometimes used off-label. Given the lack of evidence-based data in some clinical situations encountered in real life, we developed expert recommendations for the use of biologics for SLE.

METHODS:

The recommendations were developed by a formal consensus method. This method aims to formalize the degree of agreement among experts by identifying, through iterative ratings with feedback, the points on which experts agree, disagree or are undecided. Hence, the recommendations are based on the agreed-upon points. We gathered the opinion of 59 French-speaking SLE experts from 3 clinical networks dedicated to systemic autoimmune diseases (FLEUR, IMIDIATE, FAI2R) from Algeria, Belgium, France, Italy, Morocco, Switzerland and Tunisia. Represented medical specialities were internal medicine (49%), rheumatology (34%), nephrology (7%), dermatology (5%), pediatrics (3%) and cardiology (2%). Two methodologists and 3 strictly independent SLE expert groups contributed to developing these recommendations: a steering group (SG) (n=9), an evaluation group (EG) (n=28) and a reading group (RG) (n=22). Preliminary recommendations were drafted by the SG, then proposed to the EG. Each EG member rated the degree of agreement from 1 to 9 (1: lowest; 9: strongest) for each recommendation. After 2 rating rounds, the SG submitted a new version of the recommendations to the RG. With comments from the RG, the SG finalised the recommendations.

RESULTS:

A total of 17 final recommendations were formulated by the SG, considering all agreement scores and comments by the EG and RG members and the two methodologists. These recommendations define the subset of patients who require a biologic; the type of biologics to use (belimumab, rituximab, etc.) depending on the organ involvement and associated co-treatments; what information should be given to patients; and how to evaluate treatment efficacy and when to consider discontinuation.

CONCLUSION:

Overall, 17 recommendations for the good use of biologics in SLE were formulated by a large panel of SLE experts to provide guidance for clinicians in daily practice. These recommendations will be regularly updated according to the results of new randomized trials and increasing real life experience.

KEYWORDS:

Biological; Lupus; Recommendation

PMID:
28434948
DOI:
10.1016/j.autrev.2017.04.011
[Indexed for MEDLINE]

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