Prescribing Information can be found at the bottom of this page.
THE BENEFITS OF ILUMETRI® FOR PATIENTS WITH METABOLIC SYNDROME
Median absolute PASI scores by week and metabolic syndrome status in patients treated continuously with ILUMETRI® 100 mg*
Adapted from Gottlieb A, et al. 2019.
Seven patients with MetS and 21 without MetS did not complete the study through Week 148.1
Median absolute PASI scores by week and metabolic syndrome status in patients treated continuously with ILUMETRI® 200 mg*
Adapted from Gottlieb A, et al. 2019.
Five patients with MetS and 16 without MetS did not complete the study through Week 148.1
*Post hoc analysis of observed data from a Phase III, double-blind, randomised, controlled study (reSURFACE 2 trial). Median absolute PASI scores by week and metabolic syndrome status were collected from patients who were treated continuously with ILUMETRI® 100 mg or 200 mg, administered at baseline and every 12 weeks thereafter, through 52 weeks, and then entered the extension phase.
5-year safety data for ILUMETRI® in patients with metabolic syndrome
Adapted from Leonardi C, et al. 2019.
†Metabolic syndrome is a combination of risk factors related to cardiovascular disease and diabetes, including hypertension, dyslipidaemia, elevated fasting glucose and central obesity.
‡Post hoc analysis including data from the Phase III, double-blind, randomised, controlled studies reSURFACE 1 and reSURFACE 2 in patients with and without metabolic syndrome who continuously received ILUMETRI® 100 mg or 200 mg through 64 weeks (reSURFACE 1) or 52 weeks (reSURFACE 2), and then entered the long-term extension studies for up to 5 years.
§Numbers in parentheses represent the number of patients with the event per 100 PY of exposure.
Through 5 years of treatment, rare new cases of diabetes mellitus occurred
at similar numbers in patients with and without metabolic syndrome2
AE, adverse event. MACE, major adverse cardiovascular events. MetS, metabolic syndrome. PASI, Psoriasis Area Severity Index. TEAE, treatment-emergent adverse event.
References
1. Gottlieb A, et al. Tildrakizumab efficacy by metabolic syndrome status in psoriasis: post hoc analysis of 3-year data from the phase 3 reSURFACE 2 study.
28th EADV Congress. 9–13 October 2019. Madrid, Spain. Poster: P1650.
2. Leonardi C, et al. Safety of tildrakizumab in patients with preexisting metabolic syndrome: long-term data from the post hoc analysis of 2 phase 3 clinical studies (reSURFACE 1 and reSURFACE 2). EADV Congress. 9–13 October 2019. Madrid, Spain. Poster: P1737.
UK-ILU-2100075
July 2021