Viral reactivation and cases of herpes virus reactivation (e.g. herpes zoster) were observed in clinical studies with XELJANZ. In patients treated with XELJANZ, the incidence of herpes zoster appears to be increased in1
- Japanese or Korean patients.
- Patients with an ALC less than 1,000 cells/mm3.
- Patients with long standing RA who have previously received two or more biological disease modifying antirheumatic drugs (DMARDs).
- Patients treated with 10 mg twice daily.
In the RA clinical trials, 703 of 6,194 patients developed herpes zoster (92% involved one dermatome):
- 53 cases were serious; IR/100 patient years for XELJANZ 5 mg BID was 0.3 (CI 0.2-0.5)2
XELJANZ treatment in patients with UC is associated with a dose dependent risk of herpes zoster:
- During maintenance treatment the incidence rate of herpes zoster was 2.1 for 5 mg BID and 6.6 for 10 mg BID4
In the OCTAVE clinical trial programme, most herpes zoster events were limited to one or two adjacent dermatomes.3,4
Most cases of herpes zoster in the OCTAVE programme (70%) did not require permanent or temporary discontinuation of XELJANZ or dose reduction.3,4