ICOTYDE – Occurrence of Deaths in Patients with Plaque Psoriasis

SUMMARY

• The safety of ICOTYDE in patients with moderate to severe plaque psoriasis (PsO) was evaluated in the ICONIC-TOTAL, ICONIC-LEAD, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 phase 3 clinical trials.¹ 
  • Through week 24, there were 2 deaths reported in the ICOTYDE group of ICONIC-ADVANCE 2. Neither death was attributed to ICOTYDE by the study sponsor.²

CLINICAL DATA

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)¹ evaluated the safety of oral ICOTYDE 200 mg daily in adults with moderate to severe plaque PsO in 2 ongoing, phase 3, multicenter, randomized, double-blind studies comparing ICOTYDE with placebo and deucravacitinib (NCT06143878 and NCT06220604).

• Case 1: A 49-year-old male with parkinsonism, hypertension, electrocardiogram (ECG)
  Q wave abnormalities, and a body mass index (BMI) of 37.1 kg/m² was treated with ICOTYDE for 12 days. On study day 17, after being off treatment for 5 days, he experienced 3 episodes of hematemesis, a seizure, and 2 cardiorespiratory arrests, resulting in death on the same day.^2,3
• Case 2: A 63-year-old male with hyperlipidemia, hypertension, right bundle branch block, and a BMI of 31.5 kg/m². On study day 35, the patient experienced myocardial infarction resulting in death.²

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 13 February 2026.