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
(4)
,
Emmanuel Andrès
(10, 11)
,
Sylvain Audia
(12)
,
Brigitte Bader-Meunier
(13)
,
Gilles Blaison
(14)
,
Bernard Bonnotte
(12)
,
Patrice Cacoub
(6)
,
Sophie Caillard
(15)
,
Laurent Chiche
(16)
,
Olivier Chosidow
(17)
,
Nathalie Costedoat-Chalumeau
(18)
,
Claire Daien
(19)
,
Eric Daugas
(7)
,
Nairouz Derdèche
(11)
,
Andrea Doria
(20)
,
Olivier Fain
(21)
,
Fadi Fakhouri
(22)
,
Dominique Farge
(23)
,
Cem Gabay
(24)
,
Sylvie Guillo
(25)
,
Eric Hachulla
(26)
,
Najia Hajjaj-Hassouni
(27)
,
Mohamed Hamidou
(28)
,
Frédéric Houssiau
(29)
,
Noemie Jourde-Chiche
(30, 31)
,
Isabelle Kone-Paut
(32)
,
Aïcha Ladjouz-Rezig
(33)
,
Olivier Lambotte
(9)
,
Dan Lipsker
(34)
,
Xavier Mariette
(9)
,
Nicolas Martin-Silva
(35)
,
Thierry Martin
(36)
,
François Maurier
(37)
,
Roderich Meckenstock
(38)
,
Arsene Mekinian
(8)
,
Olivier Meyer
(39)
,
Shirine Mohamed
(40, 41)
,
Jacques Morel
(42)
,
Bruno Moulin
(43)
,
Denis Mulleman
(44)
,
Thomas Papo
(45)
,
Vincent Poindron
(46)
,
Xavier Puéchal
(47)
,
Leonardo Punzi
(20)
,
Pierre Quartier
(48)
,
Laurent Sailler
(49)
,
Amar Smail
(50)
,
Martin Soubrier
(51)
,
Agnès Sparsa
(52)
,
Zoubida Tazi-Mezalek
(53)
,
Leith Zakraoui
(54)
,
Stéphane Zuily
(41)
,
Jean Sibilia
(55)
,
Jacques-Eric Gottenberg
(56)
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 CHU Pitié-Salpêtrière [AP-HP]
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 CHRU Strasbourg
11 UNISTRA - Université de Strasbourg
12 RIGHT - Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098)
13 Service Immunologie et Hématologie
14 CH Colmar - Hôpital Louis Pasteur [Colmar]
15 Service de néphrologie [Rennes]
16 Hôpital Européen [Fondation Ambroise Paré - Marseille]
17 Service de dermatologie [Mondor]
18 I3 - Immunologie - Immunopathologie - Immunothérapeutique
19 IGMM - Institut de Génétique Moléculaire de Montpellier
20 Unipd - Università degli Studi di Padova = University of Padua
21 service de médecine interne
22 Service de néphrologie adultes [CHU Necker]
23 UPD7 - Université Paris Diderot - Paris 7
24 Division of Rheumatology
25 CIC Paris-Est - Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière]
26 Service de médecine interne [Lille]
27 Rheumatology and Physical Rehabilitaion Department
28 CHU Nantes - Centre hospitalier universitaire de Nantes
29 UCL - Université Catholique de Louvain = Catholic University of Louvain
30 AMU - Aix Marseille Université
31 VRCM - Vascular research center of Marseille
32 Service Pédiatrie
33 The University of Algiers
34 Biologie des Cellules Dendritiques Humaines
35 CHU Caen
36 Les Hôpitaux Universitaires de Strasbourg (HUS)
37 Service de médecine interne
38 CHV - Centre Hospitalier de Versailles André Mignot
39 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
40 Service de Médecine Interne et Médecine Générale [CHRU Nancy]
41 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
42 Département de Rhumatologie[Montpellier]
43 Service de Néphrologie et Transplantation
44 GICC UMR 7292 CNRS - Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017]
45 Hôpital Bichat - Claude Bernard
46 ICT - Immunologie et chimie thérapeutiques
47 IC UM3 (UMR 8104 / U1016) - Institut Cochin
48 Service d'immuno-hématologie pédiatrique [CHU Necker]
49 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
50 Service de Néphrologie - Médecine Interne
51 CHU Clermont-Ferrand
52 Clinique Mutualiste Catalane
53 UM5 - Université Mohammed V de Rabat [Agdal]
54 University of Tunis El Manar
55 Service Physiologie
56 Immuno-Rhumatologie Moléculaire
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 CHU Pitié-Salpêtrière [AP-HP]
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 CHRU Strasbourg
11 UNISTRA - Université de Strasbourg
12 RIGHT - Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098)
13 Service Immunologie et Hématologie
14 CH Colmar - Hôpital Louis Pasteur [Colmar]
15 Service de néphrologie [Rennes]
16 Hôpital Européen [Fondation Ambroise Paré - Marseille]
17 Service de dermatologie [Mondor]
18 I3 - Immunologie - Immunopathologie - Immunothérapeutique
19 IGMM - Institut de Génétique Moléculaire de Montpellier
20 Unipd - Università degli Studi di Padova = University of Padua
21 service de médecine interne
22 Service de néphrologie adultes [CHU Necker]
23 UPD7 - Université Paris Diderot - Paris 7
24 Division of Rheumatology
25 CIC Paris-Est - Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière]
26 Service de médecine interne [Lille]
27 Rheumatology and Physical Rehabilitaion Department
28 CHU Nantes - Centre hospitalier universitaire de Nantes
29 UCL - Université Catholique de Louvain = Catholic University of Louvain
30 AMU - Aix Marseille Université
31 VRCM - Vascular research center of Marseille
32 Service Pédiatrie
33 The University of Algiers
34 Biologie des Cellules Dendritiques Humaines
35 CHU Caen
36 Les Hôpitaux Universitaires de Strasbourg (HUS)
37 Service de médecine interne
38 CHV - Centre Hospitalier de Versailles André Mignot
39 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
40 Service de Médecine Interne et Médecine Générale [CHRU Nancy]
41 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
42 Département de Rhumatologie[Montpellier]
43 Service de Néphrologie et Transplantation
44 GICC UMR 7292 CNRS - Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017]
45 Hôpital Bichat - Claude Bernard
46 ICT - Immunologie et chimie thérapeutiques
47 IC UM3 (UMR 8104 / U1016) - Institut Cochin
48 Service d'immuno-hématologie pédiatrique [CHU Necker]
49 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
50 Service de Néphrologie - Médecine Interne
51 CHU Clermont-Ferrand
52 Clinique Mutualiste Catalane
53 UM5 - Université Mohammed V de Rabat [Agdal]
54 University of Tunis El Manar
55 Service Physiologie
56 Immuno-Rhumatologie Moléculaire
Florence Tubach
- Function : Author
- PersonId : 1101022
- IdHAL : florencetubach
- ORCID : 0000-0002-7802-944X
David Saadoun
- Function : Author
- PersonId : 759697
- ORCID : 0000-0003-3628-9996
- IdRef : 119038765
Raphaèle Seror
- Function : Author
- PersonId : 842130
Sylvain Audia
- Function : Author
- PersonId : 763846
- ORCID : 0000-0003-1772-1392
- IdRef : 128667648
Bernard Bonnotte
- Function : Author
- PersonId : 766701
- ORCID : 0000-0001-7229-3808
Nathalie Costedoat-Chalumeau
- Function : Author
- PersonId : 768024
- ORCID : 0000-0002-1555-9021
Noemie Jourde-Chiche
- Function : Author
- PersonId : 1064169
Xavier Mariette
- Function : Author
- PersonId : 861676
Thierry Martin
- Function : Author
- PersonId : 1647
- IdHAL : thierry-martin
- IdRef : 170408108
Jacques Morel
- Function : Author
- PersonId : 762356
- ORCID : 0000-0001-7545-6385
Denis Mulleman
- Function : Author
- PersonId : 171465
- IdHAL : denis-mulleman
- ORCID : 0000-0003-4089-7513
- IdRef : 12436425X
Xavier Puéchal
- Function : Author
- PersonId : 756835
- ORCID : 0000-0003-3573-9203
- IdRef : 083261885
Pierre Quartier
- Function : Author
- PersonId : 944386
Stéphane Zuily
- Function : Author
- PersonId : 781485
- IdRef : 144593211
Jacques-Eric Gottenberg
- Function : Author
- PersonId : 756827
- ORCID : 0000-0002-9469-946X
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.
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Kleinmann et al, recommandations for the use of biologics in SLE, Autoimmunity Reviews 2017.pdf (502.84 Ko)
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