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


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International and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus
Autoimmun Rev
Kleinmann J. F., Tubach F., Le Guern V., Mathian A., Richez C., Saadoun D., Sacre K., Sellam J., Seror R., Amoura Z., Andres E., Audia S., Bader-Meunier B., Blaison G., Bonnotte B., Cacoub P., Caillard S., Chiche L., Chosidow O., Costedoat-Chalumeau N., Daien C., Daugas E., Derdeche N., Doria A., Fain O., Fakhouri F., Farge D., Gabay C., Guillo S., Hachulla E., Hajjaj-Hassouni N., Hamidou M., Houssiau F. A., Jourde-Chiche N., Kone-Paut I., Ladjouz-Rezig A., Lambotte O., Lipsker D., Mariette X., Martin-Silva N., Martin T., Maurier F., Meckenstock R., Mekinian A., Meyer O., Mohamed S., Morel J., Moulin B., Mulleman D., Papo T., Poindron V., Puechal X., Punzi L., Quartier P., Sailler L., Smail A., Soubrier M., Sparsa A., Tazi-Mezalek Z., Zakraoui L., Zuily S., Sibilia J., Gottenberg J. E.
1873-0183 (Electronic)
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Kleinmann, Jean-Francois
Tubach, Florence
Le Guern, Veronique
Mathian, Alexis
Richez, Christophe
Saadoun, David
Sacre, Karim
Sellam, Jeremie
Seror, Raphaele
Amoura, Zahir
Andres, Emmanuel
Audia, Sylvain
Bader-Meunier, Brigitte
Blaison, Gilles
Bonnotte, Bernard
Cacoub, Patrice
Caillard, Sophie
Chiche, Laurent
Chosidow, Olivier
Costedoat-Chalumeau, Nathalie
Daien, Claire
Daugas, Eric
Derdeche, Nairouz
Doria, Andrea
Fain, Olivier
Fakhouri, Fadi
Farge, Dominique
Gabay, Cem
Guillo, Sylvie
Hachulla, Eric
Hajjaj-Hassouni, Najia
Hamidou, Mohamed
Houssiau, Frederic A
Jourde-Chiche, Noemie
Kone-Paut, Isabelle
Ladjouz-Rezig, Aicha
Lambotte, Olivier
Lipsker, Dan
Mariette, Xavier
Martin-Silva, Nicolas
Martin, Thierry
Maurier, Francois
Meckenstock, Roderich
Mekinian, Arsene
Meyer, Olivier
Mohamed, Shirine
Morel, Jacques
Moulin, Bruno
Mulleman, Denis
Papo, Thomas
Poindron, Vincent
Puechal, Xavier
Punzi, Leonardo
Quartier, Pierre
Sailler, Laurent
Smail, Amar
Soubrier, Martin
Sparsa, Agnes
Tazi-Mezalek, Zoubida
Zakraoui, Leith
Zuily, Stephane
Sibilia, Jean
Gottenberg, Jacques-Eric
Autoimmun Rev. 2017 Jun;16(6):650-657. doi: 10.1016/j.autrev.2017.04.011. Epub 2017 Apr 18.
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.
Biological Products/*therapeutic use, Humans, Interdisciplinary Communication, Lupus Erythematosus, Systemic/*drug therapy/immunology, *Practice Guidelines as Topic, Biological, Lupus, Recommendation
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01/03/2022 11:18
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