The benefit–risk balance for biological agents in juvenile idiopathic arthritis: a meta-analysis of randomized clinical trials

Author:

Cabrera Natalia1ORCID,Avila-Pedretti Gabriela2,Belot Alexandre3,Larbre Jean-Paul4,Mainbourg Sabine15,Duquesne Agnès3,Janiaud Perrine1,Kassai Behrouz16,Cucherat Michel1,Lega Jean-Christophe15

Affiliation:

1. Laboratoire de Biométrie et Biologie Évolutive (UMR - CNRS 5558), University of Lyon, Lyon, France

2. Department of Research, Universidad Nacional de Asuncion, San Lorenzo, Paraguay

3. Department of Paediatric Rheumatology, National Referral Centre for Rare Juvenile Rheumatological and Autoimmune Diseases (RAISE), Lyon University Hospital, University of Lyon, Lyon

4. Department of Rheumatology, Hospices Civils de Lyon, Lyon University Hospital, University of Lyon, Pierre-Bénite

5. Department of Internal and Vascular Medicine, National Referral Centre for Rare Juvenile Rheumatological and Autoimmune Diseases (RAISE), Hospices Civils de Lyon, University of Lyon, Pierre-Bénite

6. Department of Pharmaco-toxicology, Clinical Investigation Centre 1407 - INSERM, Hospices Civils de Lyon, Lyon, France

Abstract

Abstract Objective To assess the net benefit of biological agents (BA) used in JIA. Methods We systematically searched databases up to March 2019 for randomized controlled trials (RCT) performed in JIA disease. Separate random-effects meta-analyses were conducted for efficacy (ACR paediatric score 30%, ACRpedi30) and serious adverse events for safety. In order to standardize the baseline risk, we performed a meta-analysis of baseline risk in the control group (for both efficacy and safety meta-analysis). The net benefit was determined as the risk difference of efficacy subtracted by the risk difference of safety. Results We included 19 trials: 11 parallel RCTs (754 patients) and 8 withdrawal RCTs (704 patients). The net benefit ranged from 2.4% (adalimumab) to 17.6% (etanercept), and from 2.4% (etanercept) to 36.7%, (abatacept) in parallel and withdrawal trials assessing non-systemic JIA, respectively. In the systemic JIA category, the net benefit ranged from 22.8% (rilonacept) to 70.3% (canakinumab), and from 32.3% (canakinumab) to 58.2% (tocilizumab) in parallel and withdrawal trials, respectively. Conclusion The results suggest that a greater number of patients experienced therapeutic success without serious adverse events in the systemic onset JIA category compared with the BAs for non-systemic JIA categories. Baseline risk, design of trial and JIA categories impact the measure of net benefit of BAs in JIA patients.

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Rheumatology

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