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Tuberculosis rate low among patients with RA treated with Xeljanz
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Tuberculosis was the most common opportunistic infection in patients with rheumatoid arthritis who were treated with Xeljanz, but the rate was low in regions with low and medium incidence of tuberculosis, according to a recently published study.
Researchers studied the results from 5,671 patients with rheumatoid arthritis (RA) treated with Xeljanz (tofacitinib, Pfizer) in six phase 2, six phase 3 and two open label, long-term extension trials covering 12,644 patient-years in 48 countries.
Descriptive clinical information including age, sex, race, location of enrollment, corticosteroid use, use of other disease-modifying anti-rheumatic drugs (DMARDs), comorbidities, smoking status, BMI, disease severity and duration and baseline neutrophil and lymphocyte counts were obtained for each patient. Prior to enrollment, patients were screened for tuberculosis (TB).
The trial data were examined for incidence of TB, nontuberculous mycobacterium infections, all fungal infections (with the exception of oral or vaginal candidiasis and chromomycosis), listeria and viral infections typically associated with immunosuppression, including multidermatomal or disseminated herpes zoster, disseminated herpes virus, cytomegalovirus (CMV), BK virus and progressive multifocal leukoencephalopathy (PML). Legionella was excluded from the analysis.
Sixty opportunistic infections were identified in 58 patients yielding an IR of 0.46 per 100 patient-years. The crude IR was 0.21 for TB (26 patients) and 0.25 for nontuberculosis mycobacterium infections. Esophageal candidiasis occurred in 9 patients, disseminated or multidermatomal herpes zoster occurred in 8 patients, CMV infection occurred in 6 patients, Pneumocystis jirovecii pneumonia occurred in 4 patients, and nontuberculosis mycobacterium infections pulmonary infection, cryptococcal infection, BK encephalopathy toxoplasmosis occurred in one or two patients each. No cases of disseminated herpes virus or PML were observed. One patient death was attributed to pneumocystis and 40 patients who experienced opportunistic infections discontinued the study. – by Shirley Pulawski
Disclosure: Winthrop reports consulting fees from Genentech, Pfizer Inc, UCB and
AbbVie, and research grant support from Pfizer Inc. Please see the full study for a list of all other authors’ relevant financial disclosures.
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