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Risk of serious adverse effects of biological and targeted drugs in patients with rheumatoid arthritis: a systematic review meta-analysis

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  1. Elevated faecal calprotectin is linked to worse disease status in axial spondyloarthritis: results from the SPARTAKUS cohort

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  2. Adjustment of the multi-biomarker disease activity score to account for age, sex and adiposity in patients with rheumatoid arthritis

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  3. Secular trends in the incidence and prevalence of gout in Denmark from 1995 to 2015: a nationwide register-based study

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  4. Dose tapering and discontinuation of biological therapy in rheumatoid arthritis patients in routine care - 2-year outcomes and predictors

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  1. Adaptive Trial Designs in Rheumatology: Report from the OMERACT Special Interest Group

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  2. OMERACT Development of a Core Domain Set of Outcomes for Shared Decision-making Interventions

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  3. Core Outcome Sets Specifically for Longterm Observational Studies: OMERACT Special Interest Group Update in Rheumatoid Arthritis

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Objectives.: To determine possible differences in serious adverse effects among the 10 currently approved biological and targeted synthetic DMARDs (b/ts-DMARDs) for RA.

Methods.: Systematic review in bibliographic databases, trial registries and websites of regulatory agencies identified randomized trials of approved b/ts-DMARDs for RA. Network meta-analyses using mixed-effects Poisson regression models were conducted to calculate rate ratios for serious adverse events (SAEs) and deaths between each of the 10 drugs and control (i.e. no b/ts-DMARD treatment), based on subjects experiencing an event in relation to person-years. Confidence in the estimates was assessed by applying the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE).

Results.: A total of 117 trials (47 615 patients) were included. SAEs were more common with certolizumab compared with abatacept (rate ratio = 1.58, 95% CI: 1.18, 2.14), adalimumab (1.36, 95% CI: 1.02, 1.81), etanercept (1.60, 95% CI: 1.18, 2.17), golimumab (1.45, 95% CI: 1.00, 2.08), rituximab (1.63, 95% CI: 1.16, 2.30), tofacitinib (1.44, 95% CI: 1.03, 2.02) and control (1.45, 95% CI: 1.13, 1.87); and tocilizumab compared with abatacept (1.30, 95% CI: 1.03, 1.65), etanercept (1.31, 95% CI: 1.04, 1.67) and rituximab (1.34, 95% CI: 1.01, 1.78). No other comparisons were statistically significant. Accounting for study duration confirmed our findings for up to 6 months' treatment but not for longer-term treatment (6-24 months). No differences in mortality between b/ts-DMARDs and control were found. Based on the GRADE approach, confidence in the estimates was low due to lack of head-to-head comparison trials and imprecision in indirect estimates.

Conclusion.: Despite low confidence in the estimates, our analysis found potential differences in rates of SAEs. Our data suggest caution should be taken when deciding among available drugs.

Systematic review registration number.: PROSPERO CRD42014014842.

Original languageEnglish
JournalRheumatology (Oxford, England)
Volume56
Issue number3
Pages (from-to)417-425
Number of pages9
ISSN1462-0324
DOIs
Publication statusPublished - 1 Mar 2017

    Research areas

  • Abatacept, Adalimumab, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antirheumatic Agents, Arthritis, Rheumatoid, Biological Products, Certolizumab Pegol, Etanercept, Humans, Network Meta-Analysis, Piperidines, Poisson Distribution, Pyrimidines, Pyrroles, Regression Analysis, Risk, Rituximab, Journal Article, Meta-Analysis, Review

ID: 50634553