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

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

To evaluate the risk of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with tofacitinib.

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Key take away

This research article puts light to understand that the patients suffering from rheumatoid arthritis have an increased risk of opportunistic infections (OIs) and this was revealed using tofacitinib. However, it occurs rarely and less frequently in those treated with 5 mg twice daily.

Background

To evaluate the risk of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with tofacitinib.

Method

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).

Result

We identified 60 OIs among 5671 subjects; all occurred among tofacitinib-treated patients. TB (crude IR 0.21, 95% CI of (0.14 to 0.30)) was the most common OI (n=26); median time between drug start and diagnosis was 64 weeks (range 15–161 weeks). Twenty-one cases (81%) occurred in countries with high background TB IR, and the rate varied with regional background TB IR: low 0.02 (0.003 to 0.15), medium 0.08 (0.03 to 0.21) and high 0.75 (0.49 to 1.15). In Phase III studies, 263 patients diagnosed with latent TB infection were treated with isoniazid and tofacitinib concurrently; none developed TB. For OIs other than TB, 34 events were reported (crude IR 0.25 (95% CI 0.18 to 0.36)).

Conclusion

Within the global tofacitinib RA development programme, TB was the most common OI reported but was rare in regions of low and medium TB incidence. Patients who screen positive for latent TB can be treated with isoniazid during tofacitinib therapy.

Source:

Annals of the rheumatic diseases

Article:

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

Authors:

K L Winthrop et al.

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