@article {Janie000314, author = {Meghna Jani and William G Dixon and Lianne Kersley-Fleet and Ian N Bruce and Hector Chinoy and Anne Barton and Mark Lunt and Kath Watson and BSRBR-RA* and BSRBR-RA Control Centre Consortium* and Deborah P Symmons and Kimme L Hyrich}, editor = {, and , and Maiden, Nicola and Price, Tom and Hopkinson, Neil and O{\textquoteright}Reilly, Sheila and Hordon, Lesley and Griffiths, Ian and Porter, Duncan and Capell, Hilary and Hassell, Andy and Benitha, Romela and Choy, Ernest and Walsh, David and Emery, Paul and Knight, Susan and Taggart, Allister and Scott, David and Thompson, Paul and McCrae, Fiona and Goodfellow, Rhian and Kitas, George and Jubb, Ronald and Abernethy, Rikki and Clarke, Shane and Green, Sandra and Sanders, Paul and Coulson, Amanda and Harrison, Bev and Bukhari, Marwan and Klimiuk, Peter}, title = {Drug-specific risk and characteristics of lupus and vasculitis-like events in patients with rheumatoid arthritis treated with TNFi: results from BSRBR-RA}, volume = {3}, number = {1}, elocation-id = {e000314}, year = {2017}, doi = {10.1136/rmdopen-2016-000314}, publisher = {BMJ Specialist Journals}, abstract = {Objective To compare the risk of lupus-like events (LLEs) and vasculitis-like events (VLEs) in tumour necrosis factor-α inhibitor (TNFi)-treated patients with rheumatoid arthritis (RA) to those receiving non-biological disease-modifying antirheumatic drugs (nbDMARDs).Methods Patients were recruited to the British Society for Rheumatology Biologics Register{\textemdash}RA, a national prospective cohort study. Two cohorts recruited between 2001 and 2015: (1) patients starting first TNFi (adalimumab, etanercept, infliximab and certolizumab) (n=12 937) and (2) biological-na{\"\i}ve comparison cohort receiving nbDMARDs (n=3673). The 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 LLEs were: TNFi 10/10 000 patient-years (pyrs) (95\% CI 8 to 13) and nbDMARD 2/10 000 pyrs (95\% CI 1 to 6); for VLEs: TNFi 15/10 000 pyrs (95\% CI 12 to 19) and nbDMARD 7/10 000 pyrs (95\% CI 4 to 12). The 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 to 6.58) or VLEs (adjHR 1.27; 95\% CI 0.40 to 4.04) for TNFi compared to nbDMARD-treated patients. Infliximab conferred the highest overall risk, followed by etanercept, although 95\% CIs overlapped following adjustment.Conclusions In one of the largest biological registers, the absolute risk of both events is low. The addition of TNFi to nbDMARD does not alter the risk of either event in patients with RA selected for TNFi. This is the first study to assess the risk of these outcomes in a prospective, observational cohort.}, URL = {https://rmdopen.bmj.com/content/3/1/e000314}, eprint = {https://rmdopen.bmj.com/content/3/1/e000314.full.pdf}, journal = {RMD Open} }