ENBREL Tuberculosis (TB) Reactivation Risk Rates
Cases of TB in Worldwide Clinical Trials*
Tuberculosis reactivation risk is suggested to be lower with ENBREL than with TNF-inhibiting monoclonal antibodies, based on data from clinical and preclinical studies.1
Postmarketing cases of TB reactivation have been reported for TNF blockers, including ENBREL.1 Patients should be evaluated for TB risk factors and be tested for latent TB infection prior to initiating ENBREL and during treatment.1
- In 66 global trials of 17,505 patients with 21,015 patient-years of therapy, 4 cases of TB were reported (approximately 0.02% of patients). Patient totals include 9,895 from 38 clinical trials in the US and Canada and 7,610 from clinical trials outside the US and Canada, but do not include 7,801 in 4 cohort studies in the US and Canada. Adding 17,505 and 7,801, 25,306 patients were studied globally1,2
Cases of reactivation of TB or new TB infections have been observed in patients receiving ENBREL1
October 2007† worldwide across indications1
*The data cut was as of August 2007, except for one registry in which the data was cut from December 2007.1
†Refers to patients from Amgen- and Pfizer-sponsored global interventional clinical trials and Amgen observational registries conducted in North America (United States and Canada).1
Understanding the Data
Expand/Collapse-
- In 38 clinical trials of 9,895 patients and 4 cohort studies of 7,801 patients in the US and Canada, among 17,696 total patients with 27,169 patient-years of treatment, 1 case of TB was reported (approximately 0.006% of patients).1,2
- Global study patients refers to patients from Amgen- and Pfizer-sponsored global interventional clinical trials and Amgen observational registries conducted in North America (United States and Canada).1