Categories
Change Password!
Reset Password!
To evaluate the risk of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with tofacitinib.
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.
To evaluate the
risk of opportunistic infections (OIs) in patients with rheumatoid arthritis
(RA) treated with tofacitinib.
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).
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)).
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.
Annals of the rheumatic diseases
Tuberculosis and other opportunistic infections in tofacitinib-treated patients with rheumatoid arthritis
K L Winthrop et al.
Comments (0)