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TB rare but most common infection for patients with RA treated with Xeljanz
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Tuberculosis was the most common opportunistic infection for patients with rheumatoid arthritis who were treated with Xeljanz, however, the incidence was rare, according to recently published research.
Researchers studied the data from 5,671 patients with rheumatoid arthritis (RA) enrolled in six phase 2, six phase 3 and two open label, long-term extension studies which covered 12,664 patient-years of exposure to Xeljanz (tofacitinib, Pfizer) in 48 countries.
Sixty opportunistic infections were identified among the patients. None of the events occurred during phase 2 studies and all occurred in patients treated with tofacitinib. Twenty-six patients developed tuberculosis (TB) with a crude IR of 0.21 for TB and 0.25 for non-TB infections, which included esophageal candidiasis, Pneumocystis jirovecii, cytomegalovirus, nontuberculous mycobacterium, pulmonary infection, cryptococcal infection, meningitis, herpes zoster, BK encephalopathy and toxoplasmosis.
Researchers found a greater proportion of patients who received 10-mg tofacitinib twice daily developed opportunistic infections in phase 3 studies compared to patients who received 5-mg tofacitinib twice daily. Rates of infection among patients in extension studies were similar, regardless of dose. Nine of the 26 cases of TB developed during a phase-3 trial and 17 cases of TB developed during an open-label, extension study. The median time to diagnosis of TB was 64 weeks and non-TB infections occurred at a median of 40 weeks.
Extrapulmonary infection sites were identified in 58% of TB cases and 20 of 26 cases occurred in patients who received 10-mg tofacitinib twice daily. Two patients had positive screens for TB at baseline with a history of adequate treatment. Rates of TB varied by region, with 81% of cases in countries with higher prevalence of TB. – by Shirley Pulawski
Disclosure: Winthrop reports he is a consultant for Genentech, Pfizer, UCB and AbbVie. Please see the full study for a list of all other authors’ relevant financial disclosures.
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