Herpes Zoster and Tofacitinib Therapy in Patients with Rheumatoid Arthritis
Patients who were treated with tofacitinib in the RA clinical development programme were more likely to develop herpes zoster than were those who received placebo.
Cases of herpes zoster reported by investigators in the Phase 2, Phase 3 and long-term extension studies of tofacitinib were evaluated. Herpes zoster was noted in 5% of tofacitinib-treated patients; only 7% of these cases were serious, no patients with herpes zoster died and only 10% permanently discontinued tofacitinib treatment.
The overall crude incidence rate in tofacitinib-treated patients was 4.4 (95% CI 3.8–4.9) per 100 patient-years, with a higher risk among older patients (odds ratio 1.9, 95% CI 1.5–2.6) and those enroled in Asia (2.4, 1.9–3.2). In the Phase 3 clinical trials, rates of herpes zoster were similar among patients receiving tofacitinib 5 mg BID and 10 mg BID. There was a trend to a lower incidence in patients who received adalimumab or placebo.
Further studies are needed to identify possible explanations for the increased risk of herpes zoster among patients with RA receiving treatment with tofacitinib, as well as to evaluate the safety and efficacy of live zoster vaccine in these patients.