Drug-specific risk and characteristics of lupus and vasculitis-like events in rheumatoid arthritis patients treated with TNFi: results from BSRBR-RA

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Abstract

Objective
To compare the risk of lupus-like events (LLE) and vasculitis-like events (VLE) in TNFi-treated rheumatoid arthritis (RA) patients to those receiving non-biologic disease-modifying anti-rheumatic drugs (nbDMARDs).
Methods
Patients were recruited to the British Society for Rheumatology Biologics Register-RA, a national prospective cohort study. Two cohorts recruited between 2001-2015:(i) Patients starting first TNFi (adalimumab, etanercept, infliximab, certolizumab) (n=12,937); (ii) biologic-naïve comparison cohort receiving nbDMARDs (n=3,673). Risk of an event was compared between the two cohorts using Cox proportional-hazard models, adjusted using propensity scores. Rates of LLE/VLE were compared between TNFi and nbDMARD patients.
Results
The crude incidence rates for LLE were: TNFi 10/10,000 patient-years (pyrs) (95% CI 8, 13), nbDMARD 2/10,000 pyrs (95% CI 1, 6); for VLE: TNFi 15/10,000 pyrs (95% CI 12, 19), nbDMARD 7/10,000 pyrs (95% CI 4, 12). Risk of both events was highest in the first year of TNFi treatment. After adjusting for differences in baseline characteristics there was no difference in risk of LLEs (adjHR 1.86; 95% CI 0.52, 6.58) or VLEs (adjHR 1.27; 95% CI 0.40, 4.04) for TNFi compared to nbDMARD-treated patients. Infliximab conferred the highest overall risk, followed by etanercept although 95% CIs overlapped following adjustment.
Conclusion
In one of the largest biologic registers, the absolute risk of both events is low. The addition of TNFi to nbDMARD does not alter the risk of either event in RA patients selected for TNFi. This is the first study to assess the risk of these outcomes in a prospective, observational cohort.
Original languageEnglish
Pages (from-to)e000314
JournalRMD Open
Volume3
Issue number1
DOIs
Publication statusPublished - 21 Jan 2017

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