The benefit-risk balance for biological agents in juvenile idiopathic arthritis : a meta-analysis of randomized clinical trials
© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissionsoup.com..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:59 |
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| Enthalten in: |
Rheumatology (Oxford, England) - 59(2020), 9 vom: 01. Sept., Seite 2226-2236 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Cabrera, Natalia [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 18.01.2021 Date Revised 18.01.2021 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/rheumatology/keaa170 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM310320941 |
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| 245 | 1 | 4 | |a The benefit-risk balance for biological agents in juvenile idiopathic arthritis |b a meta-analysis of randomized clinical trials |
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| 500 | |a Date Revised 18.01.2021 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a OBJECTIVE: To assess the net benefit of biological agents (BA) used in JIA | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Systematic Review | |
| 650 | 4 | |a absolute net benefit | |
| 650 | 4 | |a benefit-risk balance | |
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| 700 | 1 | |a Mainbourg, Sabine |e verfasserin |4 aut | |
| 700 | 1 | |a Duquesne, Agnès |e verfasserin |4 aut | |
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| 700 | 1 | |a Kassai, Behrouz |e verfasserin |4 aut | |
| 700 | 1 | |a Cucherat, Michel |e verfasserin |4 aut | |
| 700 | 1 | |a Lega, Jean-Christophe |e verfasserin |4 aut | |
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