ZEPOSIA Offers Patients a Demonstrated Safety Profile1-4a
Studied in 4 clinical trials with more than 1370 ZEPOSIA-treated patients across multiple indications.1 Over 20,000 patient-years of total exposure in clinical trials (Ph 1-3 MS, Ph 2-3 UC) and post-marketing setting.2-4
ZEPOSIA has been studied across multiple indications in 4 clinical trials, including TRUE NORTH (ph 3); TOUCHSTONE (Ph 2); and SUNBEAM (Ph 3) and RADIANCE (Ph 3). 496 patients receiving the 0.92-mg dose of ZEPOSIA during induction in TRUE NORTH or TOUCHSTONE and 882 patients receiving the 0.92-mg dose of ZEPOSIA in SUNBEAM or RADIANCE were assessed in the safety analysis.1
MS: Includes Phase 1, Phase 2, SUNBEAM, RADIANCE, and DAYBREAK (data cutoff: February 2, 2021). UC: Includes TOUCHSTONE, TRUE NORTH, TRUE NORTH OLE (data cutoff: September 30, 2020). Post-marketing setting: data cutoff November 19, 2021. Exposure for patients with MS in clinical trials is 2631 patients and 11,938 patient-years. Exposure for patients with UC in clinical trials is 1158 patients and 2108 patient-years. Exposure for patients in the post-marketing setting across indications is 9738 patients and 6455 patient-years.2-4
Adverse Reactions in Ulcerative Colitis (UC) Clinical Trials1