Tofacitinib, Adalimumab, Methotrexate Show Similar Influenza Adverse Events in RA

(©SubbotinaAnna,AdobeStock)

In a study that examined the influenza adverse events (AEs) of tofacitinib (Xeljanz, Pfizer) in patients with rheumatoid arthritis, similar AEs were seen with tofacitinib, adalimumab, methotrexate, and placebo, and between different tofacitinib doses and patient age groups, according to researchers reporting at the annual meeting of the American College of Rheumatology on Monday.

This post hoc analysis was led by Kevin L Winthrop, M.D., M.P.H., of Oregon Health & Science University in Portland. It included 7,964 patients with from 21 clinical trials (tofacitinib 5 or 10 mg twice daily as monotherapy or with background conventional synthetic disease-modifying antirheumatic drugs, adalimumab, methotrexate, or placebo) and two open-label, long-term extension studies (2005 to 2019).

Of the patients, 6.2 percent reported influenza AEs. In patients from the clinical trials (n=6,690), the incidence rates for influenza AEs generally appeared similar across treatment arms. In the overall cohort, the incidence rates for influenza were also similar across average tofacitinib doses (5 or 10 mg twice daily) and patient age groups (<65 years and ≥ 65 years). Mild, moderate, and severe influenza AEs were reported in 62.7 percent, 34.3 percent, and 3 percent of patients, respectively.

Serious influenza AEs occurred in nine (1.8%) patients, of which six were taking tofacitinib 5 mg twice daily and three were taking tofacitinib 10 mg twice daily. Eight patients were hospitalized and two patients died; one patient each was receiving tofacitinib 5 mg and 10 mg twice daily, both had H1N1 and risk factors for mortality due to influenza.

No change to tofacitinib treatment was made in 69.6 percent of patients with influenza AEs. Tofacitinib was stopped temporarily in 28.8 percent of patients with influenza AEs, for a mean duration of 11.1 days. The mean number of days taken to resolve the influenza AEs was similar irrespective of these actions.

“The COVID-19 pandemic highlights the need to understand acute respiratory RNA viral infections in patients receiving tofacitinib,” the authors wrote. “This post hoc analysis of influenza AEs across the rheumatoid arthritis clinical program, over 14 to 15 seasons, showed generally similar rates between tofacitinib, adalimumab, methotrexate and placebo, and between tofacitinib doses and patient age groups.”

_________________

REFERENCE

ABSTRACT: L04.“Influenza Adverse Events in Patients with Rheumatoid Arthritis in the Tofacitinib Clinical Program.”The annual meeting of the American College of Rheumatology. 11:00 AM, Monday, Nov. 9, 2020.