Background Refractory and corticodependent Systemic Lupus Erythematous (SLE) often represents a therapeutic challenge. Only one biologic, belimumab, has been approved to date, but others are used off-label. However, the strategy of use remains a “grey area” in the available recommendations (1-3), because of the lack of evidence-based data and the wide range of situations encountered in real-life practice. We decided to set-up recommendations, following the French High Authority for Health (HAS) guidelines.
Objectives To establish Recommendations of Good Practice (RGP) for the use of biologics in SLE, in 5 domains: Which patient might benefit from biologics?; Which biologic might be used?; Which information and co-medication(s) should be given to patients?; How should the effectiveness of a biologic be evaluated?; When does the biologic have to be discontinued?
Methods We used the “Experts Formalized Consensus” methodology, as recommended by HAS. In brief, the degree of agreement on each recommendation is formalized, and a recommendation is validated only after a consensus has been reached. In case of controversy, proposed recommendations are modified and submitted again to the panel of experts until a consensus is reached. This process highlights extremes and not only median opinion. Transparency requires publishing all comments that are not retained. If the degree of agreement is not strong enough, proposals may be rejected.
Results Three strictly independent SLE experts groups were established: a steering group SG (n=9), an evaluation group EG (n=28) and a reading group RG (n=40). Cf Fig. 1.
A systematic literature review was conducted by SG in Pubmed-MeSH. The search terms were “SLE” AND [biological] – [mode of action] – [study design]. Until June 2014, 444 references matched.
According to the state of art, 20 initial recommendations were drafted by the SG and then submitted to the EG. Each individual expert of the EG scored his degree of agreement from 1 to 9 (1: lowest agreement; 9: strongest agreement). The 1st evaluation round showed 4 recommendations with strong agreement (median ≥7; values ≥7), 5 with relative agreement (median ≥7; some values <7); and 11 recommendations without sufficient consensus. These latter recommendations are currently being reformulated before a 2nd round scoring.
The SG will then formulate a last version. Then the RG will score and comment each recommendation. At last, the recommendations will be finalized and published by the SG.
Conclusions After the 1st evaluation round, the large number of uncertainties is due to some extreme values in score distribution, which illustrates the wide range of practice among experts. The methodology provides several rounds to try to reach a consensus, by taking into account punctual disagreement.
We report our experience of using the Experts Formalized Consensus methodology in the establishment of international recommendations for the use of biologics in SLE. 2nd round results and/or final recommandations will be prepared and presented at EULAR.
Disclosure of Interest None declared