2014
Herpes Zoster and Tofacitinib Therapy in Patients With Rheumatoid Arthritis
Abstract: ObjectivePatients with rheumatoid arthritis (RA) are at increased risk for herpes zoster (HZ) (i.e., shingles). The aim of this study was to determine whether treatment with tofacitinib increases the risk of HZ in patients with RA.MethodsHZ cases were identified as those reported by trial investigators from the databases of the phase II, phase III, and long-term extension (LTE) clinical trials in the Tofacitinib RA Development Program. Crude incidence rates (IRs) of HZ per 100 patient-years (with 95% confidenc…
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Cited by 333 publications
(253 citation statements)
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“…The incidence rate of all herpes zoster events (serious and non-serious) was higher in the present study (7.1 events per 100 patient-years with 5 mg BID and 8.6 events per 100 patient-years with 10 mg BID) than in the global pooled analysis (4.3 events per 100 patient-years) and also higher than reported in the pooled analyses of tocilizumab therapy (2.3 events per 100 patient-years) [ 24 ] and etanercept therapy (2.9 events per 100 patient-years) [ 25 ]. The high rate of herpes zoster observed in the current study is consistent with previous risk factor analysis that highlighted high herpes zoster rates in Japanese populations [ 30 ]. The incidence rate of malignancies (excluding non-melanoma skin cancer) for tofacitinib-treated patients (1.2 events per 100 patient-years) in this LTE study was comparable with the rate in the global tofacitinib LTE study (1.0 event per 100 patient-years) [ 14 ] and with global rates previously reported for biologic DMARDs (0.3–1.77 events per 100 patient-years) [ 31 – 34 ].…”
Section: Discussionsupporting
confidence: 92%
“…The incidence rate of all herpes zoster events (serious and non-serious) was higher in the present study (7.1 events per 100 patient-years with 5 mg BID and 8.6 events per 100 patient-years with 10 mg BID) than in the global pooled analysis (4.3 events per 100 patient-years) and also higher than reported in the pooled analyses of tocilizumab therapy (2.3 events per 100 patient-years) [ 24 ] and etanercept therapy (2.9 events per 100 patient-years) [ 25 ]. The high rate of herpes zoster observed in the current study is consistent with previous risk factor analysis that highlighted high herpes zoster rates in Japanese populations [ 30 ]. The incidence rate of malignancies (excluding non-melanoma skin cancer) for tofacitinib-treated patients (1.2 events per 100 patient-years) in this LTE study was comparable with the rate in the global tofacitinib LTE study (1.0 event per 100 patient-years) [ 14 ] and with global rates previously reported for biologic DMARDs (0.3–1.77 events per 100 patient-years) [ 31 – 34 ].…”
Section: Discussionsupporting
confidence: 92%
“…With respect to safety endpoints, the incidence of AEs, SAE, serious infections and discontinuations due to AEs were similar in patients receiving tofacitinib 5 mg two times a day, tofacitinib 10 mg two times a day or placebo and across serotype subgroups. The incidence of herpes zoster was higher following tofacitinib treatment compared with placebo, which is consistent with previously reported studies of tofacitinib 40. Some numerical differences in herpes zoster incidence rates were observed between serotype subgroups; however, the 95% CIs were wide and overlapping.…”
Section: Discussionsupporting
confidence: 91%
“…The higher frequency of herpes zoster in patients in the Japanese population compared with the global clinical trial population is in agreement with previous studies that have shown higher incidence rates of herpes zoster in patients enrolled from Japan and Korea who were treated with baricitinib and tofacitinib compared with other geographic regions [11][12][13][14][15]. The reasons why herpes zoster occurs to a greater extent in populations in Asia than in other regional populations is currently unknown, although it has been suggested that genetic predisposition, regional differences in reporting, and other cultural or medical factors could be involved [13,15]. In this analysis, upadacitinib 15 mg appeared to be associated with a numerically higher incidence of herpes zoster in the Japanese population compared with that of other JAK inhibitors reported in the literature [13][14][15]22].…”
Section: Discussionsupporting
confidence: 90%
