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

Jean-François Kleinmann 1 Florence Tubach 2 Veronique Le Guern 3 Alexis Mathian 4 Christophe Richez 5 David Saadoun 6 Karim Sacré 7 Jérémie Sellam 8 Raphaèle Seror 9 Zahir Amoura 10 Emmanuel Andrès 11, 12 Sylvain Audia 13 Brigitte Bader-Meunier 14 Gilles Blaison 15 Bernard Bonnotte 13 Patrice Cacoub 6 Sophie Caillard 16 Laurent Chiche 17 Olivier Chosidow 18 Nathalie Costedoat-Chalumeau 19 Claire Daien 20 Eric Daugas 7 Nairouz Derdèche 12 Andrea Doria 21 Olivier Fain 22 Fadi Fakhouri 23 Dominique Farge 24 Cem Gabay 25 Sylvie Guillo 26 Eric Hachulla 27 Najia Hajjaj-Hassouni 28 Mohamed Hamidou 29 Frédéric Houssiau 30 Noemie Jourde-Chiche 31, 32 Isabelle Kone-Paut 33 Aïcha Ladjouz-Rezig 34 Olivier Lambotte 9 Dan Lipsker 35 Xavier Mariette 9 Nicolas Martin-Silva 36 Thierry Martin 37 François Maurier 38 Roderich Meckenstock 39 Arsene Mekinian 40 Olivier Meyer 41 Shirine Mohamed 42, 43 Jacques Morel 44 Bruno Moulin 45 Denis Mulleman 46 Thomas Papo 47 Vincent Poindron 48 Xavier Puéchal 49 Leonardo Punzi 21 Pierre Quartier 50 Laurent Sailler 51 Amar Smail 52 Martin Soubrier 53 Agnès Sparsa 54 Zoubida Tazi-Mezalek 55 Leith Zakraoui 56 Stéphane Zuily 43 Jean Sibilia 57 Jacques-Eric Gottenberg 58
1 CHU Strasbourg
2 CIC epidémiologie clinique/ essais cliniques, Hôpital Bichat - Claude Bernard
3 Service de médecine interne et centre de référence des maladies rares [CHU Cochin]
4 Service de médecine interne [CHU Pitié-Salpétrière]
5 Hôpital Pellegrin
6 I3 - Immunologie - Immunopathologie - Immunothérapie
7 CRI (UMR_S_1149 / ERL_8252 / U1149) - Centre de recherche sur l'Inflammation
8 CHU Saint-Antoine [AP-HP]
9 Régulation de la réponse immune, infection VIH-1 et autoimmunité
10 Service d'immunologie [CHU Pitié-Salpétrière]
11 CHRU Strasbourg
12 UNISTRA - Université de Strasbourg
13 RIGHT - Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098)
14 Service Immunologie et Hématologie
15 CH Colmar - Hôpital Louis Pasteur [Colmar]
16 Service de néphrologie
17 Hôpital Européen [Fondation Ambroise Paré - Marseille]
18 Service de dermatologie [Mondor]
19 I3 - Immunologie - Immunopathologie - Immunothérapeutique
20 IGMM - Institut de Génétique Moléculaire de Montpellier
21 Universita degli Studi di Padova
22 service de médecine interne
23 Service de néphrologie adultes [CHU Necker]
24 UPD7 - Université Paris Diderot - Paris 7
25 Division of Rheumatology
26 CIC Paris Est
27 Service de médecine interne [Lille]
28 Rheumatology and Physical Rehabilitaion Department
29 CHU Nantes - Centre hospitalier universitaire de Nantes
30 UCL - Université Catholique de Louvain
31 AMU - Aix Marseille Université
32 VRCM - Vascular research center of Marseille
33 Service Pédiatrie
34 The University of Algiers
35 Biologie des Cellules Dendritiques Humaines
36 CHU Caen
37 Les Hôpitaux Universitaires de Strasbourg (HUS)
38 Service de médecine interne
39 CHV - Centre Hospitalier de Versailles André Mignot
40 DHU i2B - Service de rhumatologie, inflammation-immunopathologie- biothérapie [CHU Saint-Antoine]
41 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
42 Service de Médecine Interne et Médecine Générale [CHRU Nancy]
43 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
44 Département de Rhumatologie[Montpellier]
45 Service de Néphrologie et Transplantation
46 GICC UMR 7292 CNRS - Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017]
47 Hôpital Bichat - Claude Bernard
48 ICT - Immunologie et chimie thérapeutiques
49 IC UM3 (UMR 8104 / U1016) - Institut Cochin
50 Service d'immuno-hématologie pédiatrique [CHU Necker]
51 CHU Toulouse [Toulouse]
52 Service de Néphrologie - Médecine Interne
53 CHU Clermont-Ferrand
54 Clinique Mutualiste Catalane
55 University of Mohammed V
56 Faculty of Medicine of Tunis, University of Tunis El Manar, 1007 La Rabta, Tunis, Tunisia.
57 Service Physiologie
58 Immuno-Rhumatologie Moléculaire
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 : Recommendation Lupus Biological
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Jean-François Kleinmann, Florence Tubach, Veronique Le Guern, Alexis Mathian, Christophe Richez, et al.. International and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus. Autoimmunity Reviews, Elsevier, 2017, 16 (6), pp.650-657. ⟨10.1016/j.autrev.2017.04.011⟩. ⟨hal-01787368⟩

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