Systematic review and meta-analysis of serious infections with tofacitinib and biologic disease-modifying antirheumatic drug treatment in rheumatoid arthritis clinical trials
Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. By modulating the signalling of cytokines that are integral to lymphocyte activation, proliferation, and function, tofacitinib may suppress multiple elements of immune response. A systematic literature search including all biologics and tofacitinib procured 66 RCTs and 22 LTEs that were included in a meta-analysis to provide estimated incidence rates, risk ratios, and risk differences of serious infection for each therapy.
Estimated incidence rates, risk ratios, and risk differences were comparable between therapies. Incidence rates were 3.04 (2.49, 3.72), 3.72 (2.99, 4.62), 5.45 (4.26, 6.96), 4.90 (4.41, 5.44), 3.02 (2.25, 4.05) and 3.00 (2.24, 4.02) for abatacept, rituximab, tocilizumab, TNFi, tofacitinib 5 and 10 mg BID, respectively. Concomitant glucocorticoid intake increases risk of serious infection with bDMARD use.
In interventional studies, tofacitinib presented a comparable risk of serious infections to published results from bDMARDs in patients with moderate to severe RA.