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

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.

DOI: 10.1016/j.autrev.2017.04.011

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@article{Kleinmann2017InternationalAM, title={International and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus.}, author={Jean-François Kleinmann and Florence Tubach and V{\'e}ronique le Guern and Alexis Mathian and Christophe Richez and David Saadoun and Karim Sacr{\'e} and J{\'e}r{\'e}mie Sellam and Rapha{\'e}le Seror and Zahir Amoura and Emmanuel Andres and Sylvain Audia and Brigitte Bader-Meunier and Gilles Blaison and Bernard Bonnotte and P Cacoub and Sophie Caillard and Laurent Chiche and Olivier Chosidow and Nathalie Cost{\'e}doat-Chalumeau and Claire I. Daien and {\'E}ric Daugas and Nairouz Derd{\`e}che and Andrea Doria and Olivier Fain and Fadi Fakhouri and Dominique Farge and Cem Gabay and Sylvie Guillo and {\'E}ric Hachulla and Najia Hajjaj-Hassouni and Mohamed Amine Hamidou and Fr{\'e}d{\'e}ric A. Houssiau and No{\'e}mie Jourde-Chiche and Isabelle Kon{\'e}-Paut and A{\"{i}cha Ladjouz-Rezig and Olivier Lambotte and Dan Lipsker and Xavier Mariette and Nicolas Martin-Silva and Thierry Martin and François Maurier and Roderich Meckenstock and A Mekinian and Olivier Meyer and Shirine Mohamed and Jacques C M Morel and Bruno Moulin and Denis Mulleman and Thomas Papo and Vincent Poindron and Xavier Pu{\'e}chal and Leonardo Punzi and Pierre Quartier and Laurent J Sailler and Amar Smail and Martin Soubrier and Agn{\'e}s Sparsa and Zoubida Tazi-Mezalek and Leith Zakraoui and St{\'e}phane Zuily and Jean Sibilia and J E Gottenberg}, journal={Autoimmunity reviews}, year={2017}, volume={16 6}, pages={650-657} }