Safety profiles of tocilizumab and tofacitinib in rheumatoid arthritis: a propensity score-weighted comparative...

Biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs) have been the primary advanced treatment options for rheumatoid arthritis (RA) in Taiwan since 2010. Tocilizumab is an interleukin-6 receptor inhibitor (IL-6Ri), whereas tofacitinib is a Janus kinase inhibitor (JAKi). The two medications have similar mechanisms and efficacy. We compared the safety outcomes of tocilizumab and tofacitinib in patients with RA in real-world clinical settings.

Patients with RA at any period between 2010 and 2018 were identified from the Taiwan National Health Insurance Research Database and followed until 2020. Propensity score stabilized weighting was used to balance the baseline characteristics of the tocilizumab and tofacitinib groups. The incidences of safety outcomes, specifically all-cause mortality, cancer, coronary heart disease (CHD), stroke, overall venous thromboembolism (OVT), tuberculosis (TB), joint replacement events, and herpes zoster infection, were compared between the study groups.

A total of 1074 patients with RA who were administered tocilizumab (n = 463) or tofacitinib (n = 611) were included in this study. The mean follow-up duration was 1.96 years in the tocilizumab group and 1.98 years in the tofacitinib group. A substantially lower incidence rate of herpes zoster infection (per 100 patient-years) was observed in the tocilizumab group (3.125) than in the tofacitinib group (6.875), with a hazard ratio of 0.455 (95% CI = 0.289-0.716; P = 0.0007). All-cause mortality, CHD, stroke, total hip replacement, and TB infection were similar between the two medication groups.

Although tocilizumab (an IL-6 receptor inhibitor) and tofacitinib (a JAK inhibitor) effectively modulate the immune response through distinct mechanisms, a lower herpes zoster incidence rate was observed in the tocilizumab group. No statistically significant differences were detected for the other evaluated safety outcomes and mortality rates between the two groups, although the relatively small number of events resulted in wide confidence intervals. Key Points • For moderate to severe RA patients concerned about herpes zoster risk, the tocilizumab group had a lower incidence rate than the tofacitinib group. • In real-world settings, RA patients with tocilizumab or tofacitinib had comparable incidence rates of other safety concerns and mortality.