ReviewInternational and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus
Introduction
Systemic lupus erythematosus (SLE) is a severe systemic autoimmune disease that often represents a therapeutic challenge because of diverse manifestations, clinical course and prognosis. Patients with SLE are followed by different specialists because of several organ involvements, and treatments are tailored depending on the disease activity and/or severity of the organ involvement(s), comorbidities, side effects, drug interactions, drug availability, previous treatment and patient preference. Poorly controlled disease drives a vicious cycle, with organ damage undermining the long-term prognosis [1], [2], [3], triggered itself by persistent disease activity and particularly by corticosteroids abuse [4], [5], [6], [7], [8], [9], [10]. Hence, the main target in clinical practice is to prevent damage and maintain stable disease control with limited doses of corticosteroids [7], [11].
An evidence-based approach to therapy is desirable, but the actual benefit demonstrated by randomized controlled trials and cohort evaluations of biologics in SLE are still limited [10], [12]. Only one biologic, belimumab [13], has been approved to date, but other biologics are sometimes used off-label. The strategy of use of biologics remains a “grey area” in the literature [14], [15], [16], [17], [18], [19], [20], [21], [22] because of the limited evidence-based data and the wide range of situations encountered in real-life practice [10]. Opinions of highly qualified experts in SLE treatment are essential when data are absent or controversial.
Therefore, we established a set of expert recommendations for the use of biologics in SLE.
Section snippets
Literature search of available data
To assess the amount of available data, we searched for articles published up to June 2014. This search is synthetized in a published book in which most of the authors contributed. The book is presented in the Supplementary Information.
Definition of the recommendations scope
In light of the available literature, four clinical questions were defined: 1) Which patients might benefit from biologic therapy? 2) Which biologic and co-treatment might be used? 3) Which information should be given to patients? 4) How should the effectiveness
Results
For an overview of the recommendations development, see Table 1.
Discussion
A large panel of SLE experts formulated 17 recommendations for the good use of biologics in SLE to provide guidance for clinicians in daily practice.
The main advantages of the method to develop the recommendations are 1) the strict independence between the SG, which formulated proposals for voting, and the EG and RG, which judged the appropriateness of the proposals, thus avoiding one group as judge and jury; 2) the ability to identify the degree of agreement or indecision among experts by
Conclusion
We report 17 recommendations for the use of biologics in SLE that were developed with a formalized consensus of an international panel of experts. These recommendations are based on the most recent evidence in lupus management and discussions by a large and broadly international task force. The recommendations synthesize the current approaches to lupus treatment. The task force is convinced of the importance of disseminating these recommendations. It hopes that following these recommendations (
Take-home messages
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17 recommendations for the good use of biologics in SLE were formulated by a large panel of SLE experts.
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These recommendations define:
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the subset of patients who require a biologic
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the type of biologics and co-treatment to use
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what information should be given to patients
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how to evaluate treatment efficacy and when to consider discontinuation.
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Acknowledgments
These recommendations for the use of biologics in SLE were developed by multidisciplinary panels of experts on behalf of the Club Rhumatismes et Inflammation. French national networks focused on rare systemic autoimmune diseases contributed to this work by identifying SLE experts in France, Europe and North Africa and by the contribution of network-affiliated methodologists.
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FAI2R (Filière Nationale des Maladies Autoimmunes et Autoinflammatoires Rares), including 7 referee centres, 73
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Deceased.
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On behalf of the Société Royale Belge de Rhumatologie/Koninklijke Belgische Vereniging voor Reumatologie (Belgian Society of Rheumatology), the Société Française de Rhumatologie (French Society of Rheumatology) and the Société Suisse de Rhumatologie (Swiss Society of Rheumatology), the CRI (Club Rhumatismes et Inflammation), FLEUR (Réseau Français du Lupus), IMIDIATE (Immune-Mediated Inflammatory Disease Alliance for Translational and Clinical Research) and FAI2R (Filière Nationale des Maladies Autoimmunes et Autoinflammatoires Rares) networks.