Comparative effectiveness and safety of biological treatment options after tumour necrosis factor α inhibitor failure in rheumatoid arthritis: systematic review and indirect pairwise meta-analysis
Identifieur interne : 003575 ( Main/Exploration ); précédent : 003574; suivant : 003576Comparative effectiveness and safety of biological treatment options after tumour necrosis factor α inhibitor failure in rheumatoid arthritis: systematic review and indirect pairwise meta-analysis
Auteurs : Monika Schoels [Autriche, États-Unis] ; Daniel Aletaha [Autriche] ; Josef S. Smolen [Autriche] ; John B. Wong [États-Unis]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2012-08.
Descripteurs français
- KwdFr :
- Abatacept, Adulte d'âge moyen, Anticorps monoclonaux (usage thérapeutique), Anticorps monoclonaux d'origine murine (usage thérapeutique), Anticorps monoclonaux humanisés (usage thérapeutique), Antirhumatismaux (usage thérapeutique), Essais contrôlés randomisés comme sujet, Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs), Femelle, Humains, Immunoconjugués (usage thérapeutique), Medline, Mâle, Rhumatisme articulaire aigu (traitement médicamenteux), Rituximab, Résultat thérapeutique, Substitution de médicament, Échec thérapeutique.
- MESH :
- antagonistes et inhibiteurs : Facteur de nécrose tumorale alpha.
- traitement médicamenteux : Rhumatisme articulaire aigu.
- usage thérapeutique : Anticorps monoclonaux, Anticorps monoclonaux d'origine murine, Anticorps monoclonaux humanisés, Antirhumatismaux, Immunoconjugués.
- Pascal (Inist)
- MESH :
English descriptors
- KwdEn :
- Abatacept, Anti-Tumor Necrosis Factor-alpha, Antibodies, Monoclonal (therapeutic use), Antibodies, Monoclonal, Humanized (therapeutic use), Antibodies, Monoclonal, Murine-Derived (therapeutic use), Antirheumatic Agents (therapeutic use), Antirheumatic agent, Bibliographic review, Chronic, Comparative study, Drug Substitution, Failure, Female, Humans, Immunoconjugates (therapeutic use), MEDLINE, Male, Middle Aged, Randomized Controlled Trials as Topic, Review, Rheumatic Fever (drug therapy), Rheumatoid arthritis, Rheumatology, Rituximab, Toxicity, Treatment, Treatment Failure, Treatment Outcome, Tumor Necrosis Factor-alpha (antagonists & inhibitors).
- MESH :
- chemical , antagonists & inhibitors : Tumor Necrosis Factor-alpha.
- chemical , therapeutic use : Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antibodies, Monoclonal, Murine-Derived, Antirheumatic Agents, Immunoconjugates.
- drug therapy : Rheumatic Fever.
- Teeft :
- Abatacept, Adverse events, American college, Antirheumatic drugs, Arthritis, Arthritis rheum, Baseline, Baseline characteristics, Biological agents, Biological treatment options, Black line, Cochrane databases, Comparator drug, Control clin trials, Direct comparisons, Disease activity, Disease duration, Drug Substitution, Drug efficacy, Drug safety, Epidemiological research, Epidemiological research figure, Female, Golimumab, Hietzing hospital, Higher risk, Humans, Inadequate responders, Inadequate response, Indirect comparison, Indirect comparisons, Indirect pairwise comparisons, Infusion, Infusion reactions, Inhibitor, Internal medicine, Jadad score, Joint counts, MEDLINE, Male, Middle Aged, Necrosis, Other reasons, Pairwise, Pairwise comparisons, Patient characteristics, Placebo, Previous tnfi, Previous tnfi treatments, Primary analyses, Primary efficacy outcome, Primary outcome, Random effects model, Randomised, Randomized Controlled Trials as Topic, Rcts, Rescue treatment, Response rates, Rheum, Rheumatoid, Rheumatoid arthritis, Risk differences, Risk ratios, Rituximab, Safety outcomes, Sensitivity analyses, Serious infections, Significant improvement, Synthetic dmards, Systematic literature search, Systematic review, Systematic reviews, Time points, Tnfi, Tocilizumab, Treatment Failure, Treatment Outcome, Treatment arms, Trial populations, Tumour, Tumour necrosis factor inhibitors.
Abstract
Background Optimal treatment for rheumatoid arthritis (RA) after inadequate response (IR) to tumour necrosis factor α inhibitors (TNFi) remains uncertain. Objective To compare the efficacy and safety of biological agents after TNFi-IR. Methods A systematic literature search was carried out using Medline and Cochrane databases, as well as http://www.clinicaltrials.gov, and bibliographies of the retrieved literature were searched by hand. Randomised, placebo-controlled trials that enrolled patients with RA with TNFi-IR were included and American College of Rheumatology (ACR) response as primary efficacy outcome and adverse events (AEs), serious adverse events (SAEs) and serious infections (SIs) as safety measures were extracted. An indirect meta-analysis with pairwise comparisons of efficacy and safety data was then carried out using ORs or risk differences (RDs) in a random effects model. Results In four randomised controlled trials with 24 weeks' follow-up, direct comparisons of abatacept, golimumab, rituximab and tocilizumab versus placebo showed statistically significant mean ORs of 3.3–8.9 for ACR20, 5.5–10.2 for ACR50 and 4.1–13.5 for ACR70. Risks of AEs, SAEs and SIs versus placebo were non-significant. Indirect pairwise comparisons of the four biological agents showed no significant differences in ACR50 and ACR70. Golimumab had a significantly lower OR (0.56–0.59) for ACR20 but significantly fewer AEs (RD 0.13–0.18). Efficacy after one versus multiple TNFi failures did not differ significantly between the different biological agents. Conclusion In patients refractory to one or more TNFi, new biological agents provide significant improvement with good safety. Lacking head-to-head trials, indirect meta-analysis enables a comparison of effectiveness and safety of biological agents with each other and shows that all biological agents have similar effects.
Url:
DOI: 10.1136/annrheumdis-2011-200490
Affiliations:
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<term>Anti-Tumor Necrosis Factor-alpha</term>
<term>Antibodies, Monoclonal (therapeutic use)</term>
<term>Antibodies, Monoclonal, Humanized (therapeutic use)</term>
<term>Antibodies, Monoclonal, Murine-Derived (therapeutic use)</term>
<term>Antirheumatic Agents (therapeutic use)</term>
<term>Antirheumatic agent</term>
<term>Bibliographic review</term>
<term>Chronic</term>
<term>Comparative study</term>
<term>Drug Substitution</term>
<term>Failure</term>
<term>Female</term>
<term>Humans</term>
<term>Immunoconjugates (therapeutic use)</term>
<term>MEDLINE</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Randomized Controlled Trials as Topic</term>
<term>Review</term>
<term>Rheumatic Fever (drug therapy)</term>
<term>Rheumatoid arthritis</term>
<term>Rheumatology</term>
<term>Rituximab</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>Treatment Failure</term>
<term>Treatment Outcome</term>
<term>Tumor Necrosis Factor-alpha (antagonists & inhibitors)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Abatacept</term>
<term>Adulte d'âge moyen</term>
<term>Anticorps monoclonaux (usage thérapeutique)</term>
<term>Anticorps monoclonaux d'origine murine (usage thérapeutique)</term>
<term>Anticorps monoclonaux humanisés (usage thérapeutique)</term>
<term>Antirhumatismaux (usage thérapeutique)</term>
<term>Essais contrôlés randomisés comme sujet</term>
<term>Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Immunoconjugués (usage thérapeutique)</term>
<term>Medline</term>
<term>Mâle</term>
<term>Rhumatisme articulaire aigu (traitement médicamenteux)</term>
<term>Rituximab</term>
<term>Résultat thérapeutique</term>
<term>Substitution de médicament</term>
<term>Échec thérapeutique</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Tumor Necrosis Factor-alpha</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Antibodies, Monoclonal, Humanized</term>
<term>Antibodies, Monoclonal, Murine-Derived</term>
<term>Antirheumatic Agents</term>
<term>Immunoconjugates</term>
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<keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Facteur de nécrose tumorale alpha</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Rheumatic Fever</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Rhumatisme articulaire aigu</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux</term>
<term>Anticorps monoclonaux d'origine murine</term>
<term>Anticorps monoclonaux humanisés</term>
<term>Antirhumatismaux</term>
<term>Immunoconjugués</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Anti-TNF-alpha</term>
<term>Antirhumatismal</term>
<term>Article synthèse</term>
<term>Chronique</term>
<term>Echec</term>
<term>Etude comparative</term>
<term>Polyarthrite rhumatoïde</term>
<term>Revue bibliographique</term>
<term>Rhumatologie</term>
<term>Toxicité</term>
<term>Traitement</term>
</keywords>
<keywords scheme="Teeft" xml:lang="en"><term>Abatacept</term>
<term>Adverse events</term>
<term>American college</term>
<term>Antirheumatic drugs</term>
<term>Arthritis</term>
<term>Arthritis rheum</term>
<term>Baseline</term>
<term>Baseline characteristics</term>
<term>Biological agents</term>
<term>Biological treatment options</term>
<term>Black line</term>
<term>Cochrane databases</term>
<term>Comparator drug</term>
<term>Control clin trials</term>
<term>Direct comparisons</term>
<term>Disease activity</term>
<term>Disease duration</term>
<term>Drug Substitution</term>
<term>Drug efficacy</term>
<term>Drug safety</term>
<term>Epidemiological research</term>
<term>Epidemiological research figure</term>
<term>Female</term>
<term>Golimumab</term>
<term>Hietzing hospital</term>
<term>Higher risk</term>
<term>Humans</term>
<term>Inadequate responders</term>
<term>Inadequate response</term>
<term>Indirect comparison</term>
<term>Indirect comparisons</term>
<term>Indirect pairwise comparisons</term>
<term>Infusion</term>
<term>Infusion reactions</term>
<term>Inhibitor</term>
<term>Internal medicine</term>
<term>Jadad score</term>
<term>Joint counts</term>
<term>MEDLINE</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Necrosis</term>
<term>Other reasons</term>
<term>Pairwise</term>
<term>Pairwise comparisons</term>
<term>Patient characteristics</term>
<term>Placebo</term>
<term>Previous tnfi</term>
<term>Previous tnfi treatments</term>
<term>Primary analyses</term>
<term>Primary efficacy outcome</term>
<term>Primary outcome</term>
<term>Random effects model</term>
<term>Randomised</term>
<term>Randomized Controlled Trials as Topic</term>
<term>Rcts</term>
<term>Rescue treatment</term>
<term>Response rates</term>
<term>Rheum</term>
<term>Rheumatoid</term>
<term>Rheumatoid arthritis</term>
<term>Risk differences</term>
<term>Risk ratios</term>
<term>Rituximab</term>
<term>Safety outcomes</term>
<term>Sensitivity analyses</term>
<term>Serious infections</term>
<term>Significant improvement</term>
<term>Synthetic dmards</term>
<term>Systematic literature search</term>
<term>Systematic review</term>
<term>Systematic reviews</term>
<term>Time points</term>
<term>Tnfi</term>
<term>Tocilizumab</term>
<term>Treatment Failure</term>
<term>Treatment Outcome</term>
<term>Treatment arms</term>
<term>Trial populations</term>
<term>Tumour</term>
<term>Tumour necrosis factor inhibitors</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Abatacept</term>
<term>Adulte d'âge moyen</term>
<term>Essais contrôlés randomisés comme sujet</term>
<term>Femelle</term>
<term>Humains</term>
<term>Medline</term>
<term>Mâle</term>
<term>Rituximab</term>
<term>Résultat thérapeutique</term>
<term>Substitution de médicament</term>
<term>Échec thérapeutique</term>
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<front><div type="abstract">Background Optimal treatment for rheumatoid arthritis (RA) after inadequate response (IR) to tumour necrosis factor α inhibitors (TNFi) remains uncertain. Objective To compare the efficacy and safety of biological agents after TNFi-IR. Methods A systematic literature search was carried out using Medline and Cochrane databases, as well as http://www.clinicaltrials.gov, and bibliographies of the retrieved literature were searched by hand. Randomised, placebo-controlled trials that enrolled patients with RA with TNFi-IR were included and American College of Rheumatology (ACR) response as primary efficacy outcome and adverse events (AEs), serious adverse events (SAEs) and serious infections (SIs) as safety measures were extracted. An indirect meta-analysis with pairwise comparisons of efficacy and safety data was then carried out using ORs or risk differences (RDs) in a random effects model. Results In four randomised controlled trials with 24 weeks' follow-up, direct comparisons of abatacept, golimumab, rituximab and tocilizumab versus placebo showed statistically significant mean ORs of 3.3–8.9 for ACR20, 5.5–10.2 for ACR50 and 4.1–13.5 for ACR70. Risks of AEs, SAEs and SIs versus placebo were non-significant. Indirect pairwise comparisons of the four biological agents showed no significant differences in ACR50 and ACR70. Golimumab had a significantly lower OR (0.56–0.59) for ACR20 but significantly fewer AEs (RD 0.13–0.18). Efficacy after one versus multiple TNFi failures did not differ significantly between the different biological agents. Conclusion In patients refractory to one or more TNFi, new biological agents provide significant improvement with good safety. Lacking head-to-head trials, indirect meta-analysis enables a comparison of effectiveness and safety of biological agents with each other and shows that all biological agents have similar effects.</div>
</front>
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