Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy
The results of this analysis of patients with herpes zoster (HZ) within the global tofacitinib (TOF) RA programme suggest that there is likely to be a greater HZ risk in patients receiving TOF and glucocorticoids compared with patients receiving TOF monotherapy.
The global TOF RA development programme comprised 2 Phase 1, 9 Phase 2, 6 Phase 3 and 2 long-term extension studies. These studies included 6192 patients; data were reviewed to identify cases of HZ. Crude incidence rates of number of patients with HZ events per 100 patient-years were calculated, and Phase 3 data were used to examine incidence rates stratified with regard to concomitant DMARD treatment and TOF dose. Multivariate analysis using a Cox proportional hazards regression model was performed to evaluate risk factors for HZ.
For both TOF 5 mg and 10 mg groups, the HZ incidence rates were numerically lower in the absence of either background csDMARD or glucocorticoid treatment. Age, glucocorticoid use, tofacitinib dose and enrolment within Asia were independent risk factors for HZ.
Similar efficacy with TOF mono- and combination therapy has been seen in Phase 3 clinical studies, therefore TOF monotherapy could be a HZ risk reduction strategy in patients treated with RA.