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RA patients on tofacitinib who were from high-risk TB countries had greater chance of TB
Patients with rheumatoid arthritis treated with tofacitinib may develop tuberculosis if they come from a country with a high background incidence rate of tuberculosis, according to results from phase 2 and phase 3 trials.
“In summary, we observed an increased risk of [opportunistic infections] OIs among patients with [rheumatoid arthritis] RA using tofacitinib, although they occur rarely and are less frequent in those treated with 5 mg twice daily. [Tuberculosis] TB was the most common OI reported in this setting, but remained rare in regions of low TB prevalence,” Kevin L. Winthrop, MD, MPH, and colleagues wrote in their study.
Kevin L. Winthrop
Winthrop and colleagues evaluated 5,671 patients in phase 2 and phase 3 trials for a tofacitinib rheumatoid arthritis (RA) program in which OIs, such as multidermatomal herpes zoster, mycobacterial and fungal infections and other immunosuppression-based viral infections, were identified in the patient population, according to the abstract. The researchers also evaluated the incidence rate (IR per 100 patient-years) of tuberculosis based on patient enrollment region.
The investigators found 60 OIs within the tofacitinib RA group, with TB as the most common infection (26 TB OI cases; crude IR = 0.21), according to the abstract. Of the TB cases, there were 21 cases (81%) in a location with a high background TB incidence rate. There was a varied rate of TB for these patients in areas with a low (0.02), medium (0.08) and high (0.75) background incidence rate of TB. In the tofacitinib RA group, the median time to diagnosis after initial treatment was 64 weeks (range = 15 weeks to 161 weeks).
Within the phase 3 trial, Winthrop and colleagues treated 263 patients who had a latent TB infection (LTBI) with concurrent isoniazid and tofacitinib; however, no patients developed TB, according to the abstract. Regarding OIs other than TB, there were 34 events reported (crude IR = 0.25).
“As with biological therapy, screening and treating for LTBI should be employed prior to starting tofacitinib, and long-term population-based studies are necessary to understand the comparative risk of tofacitinib with other [disease-modifying antirheumatic drugs] DMARD therapies,” Winthrop and colleagues wrote in their study. – by Jeff Craven
Disclosures: Winthrop reports he is a consultant for Genentech, Pfizer Inc., UCB and AbbVie, and receives research grants from Pfizer Inc. Please see the full study for a list of all other authors’ relevant financial disclosures.