Biological and targeted drugs can present increased risk of serious adverse effects in rheumatoid arthritis patients

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Biological and targeted drugs can present increased risk of serious adverse effects in rheumatoid arthritis patients

Rheumatoid arthritis (RA) is an autoimmune disorder causing pain, inflammation and sstiffness around the joints. Th Tarp S et al. conducted a systematic review to establish possible differences in serious adverse effects (SAEs) among the ten currently approved biological and targeted synthetic DMARDs (b/ts-DMARDs) for RA.

The systematic review in bibliographic databases, trial registries and websites of regulatory agencies recognized randomized trials of approved b/ts-DMARDs for RA. To calculate rate ratios for SAEs and deaths between each of the ten drugs and control (i.e. no b/ts-DMARD treatment) the network meta-analyses using mixed-effects Poisson regression models. This model was based on subjects undergoing an event in relation to person-years. By applying the Grading of Recommendations Assessment Development and Evaluation approach (GRADE), the confidence in the estimates was analyzed. 

Overall, 117 trails comprising 47615 patients were included in the review. It was found that SAEs were more frequent with certolizumab when 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). There were no other statistically significant  comparisons reported. Accounting for study duration establish our results for up to 6 months' treatment but not for longer-term treatment (6-24 months). There were no differences in mortality between b/ts-DMARDs and control. The confidence  in the estimates was low due to paucity of head-to-head comparison trials and imprecision in indirect estimates based on the GRADE approach.

The investigations reported potential differences in rates of SAEs despite low confidence in the estimates. This data puts forward that caution should be taken when considering available drugs.


Rheumatology (Oxford)

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Original title of article:

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


 Tarp S et al.

Rheumatology (Oxford)
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