Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis.

ABSTRACT: OBJECTIVES:To evaluate the risk of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with tofacitinib. METHODS:Phase II, III and long-term extension clinical trial data (April 2013 data-cut) from the tofacitinib RA programme were reviewed. OIs defined a priori included mycobacterial and fungal infections, multidermatomal herpes zoster and other viral infections associated with immunosuppression. For OIs, we calculated crude incidence rates (IRs; per 100 patient-years (95% CI)); for tuberculosis (TB) specifically, we calculated rates stratified by patient enrolment region according to background TB IR (per 100 patient-years): low (≤0.01), medium (>0.01 to ≤0.05) and high (>0.05). RESULTS:We identified 60 OIs among 5671 subjects; all occurred among tofacitinib

SUBMITTER: Winthrop KL 

PROVIDER: S-EPMC4893093 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature