No elevated risk for influenza AE in tofacitinib-treated RA patients

A posthoc analysis covering 14-15 influenza seasons revealed that influenza adverse events were similar between rheumatoid arthritis patients treated with tofacitinib, adalimumab, methotrexate, and placebo.

A previous study has shown that rheumatoid arthritis (RA) is associated with an increased incidence of seasonal influenza and its complications [1]. The COVID-19 pandemic highlights the need to understand how RA itself and its therapy can influence acute respiratory RNA viral infections. To evaluate how this risk is influenced by therapy with tofacitinib, a posthoc analysis from 21 phase 1–3b/4 studies and 2 open-label, long-term extension studies from 2005-2019 with RA patients was performed, which covered a total of 14–15 influenza seasons [2]. Data was analysed from 2 cohorts: in the phase 2–3b/4 cohort, patients received tofacitinib as monotherapy or with background DMARDs (adalimumab or methotrexate). In the overall cohort, patients received ≥1 dose of tofacitinib, as monotherapy or with background DMARDs, in phase 1–3b/4 and long-term extension studies.

Included were 7,964 patients, of which 496 reported influenza. Incidence rates for influenza adverse events (AEs) generally appeared similar across treatment arms in the phase 2-3b/4 cohort. In the overall cohort, different tocilizumab doses (total daily dose of <15 or ≥15 mg) were compared. Again, overall incidence rates were comparable across doses and age groups. Nine (1.8%) patients had serious influenza AEs, 8 were hospitalised and 2 died, both had risk factors for influenza mortality. In the majority of patients with influenza AEs, the dose of tofacitinib was not changed.

The mean number of days to the resolution of influenza AEs was numerically similar irrespective of the medication. The authors concluded that the majority of RA patients taking tofacitinib with or without DMARD experience only mild-to-moderate influenza AEs. These findings are very reassuring to the rheumatology community whose interest in viral respiratory disease has been sharply focused in 2020.

1. Blumentals W, et al. BMC Musculoskelet Disord 2012;13:158.
2. Winthrop, K, et al. Influenza adverse events in patients with rheumatoid arthritis in the tofacitinib clinical program. L04, ACR Convergence 2020, 5-9 Nov.

Posted on 18 January 202118 January 2021