J&J Medical Connect
ICOTYDE™

(icotrokinra)

J&J Medical Connect

Connect with us

  • Products

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

ICOTYDE™ (icotrokinra)

Medical Information

ICOTYDE – Use in Patients with Plaque Psoriasis and Comorbid Hepatic Impairment

Last Updated: 03/18/2026

Summary

  • The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
  • Please refer to the local labeling for relevant information regarding use of ICOTYDE in patients with hepatic impairment.

COMPANY CORE DATA SHEET

Hepatic Impairment

  • Specific studies of ICOTYDE have not been conducted in patients with hepatic impairment.1 
  • No dose adjustment of ICOTYDE is recommended in patients with mild, moderate, or severe hepatic impairment.1 
  • Changes in hepatic function are unlikely to have any effect on the elimination of icotrokinra as icotrokinra is not metabolized through hepatic pathways.1 

EXCLUSION CRITERIA IN PHASE 3 CLINICAL TRIALS

  • The ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 phase 3 clinical trials evaluated the efficacy and safety of oral ICOTYDE 200 mg once daily in patients with moderate to severe plaque psoriasis.2-4 
    • Patients with a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled liver disturbances were excluded from these studies.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 16 March 2026.

 

References

Show
1 Data on File. Icotrokinra. Company Core Data Sheet v001. Janssen Research & Development, LLC. EDMS-RIM-1387700; 2025.  
2 Bissonnette R, Soung J, Hebert AA, et al. Protocol to: Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795.  
3 Gooderham M, Lain E, Bissonnette R, et al. Protocol to: Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).  
4 Stein Gold L, Armstrong AW, Bissonnette R, et al. Supplement to: Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025;406(10510):1363-1374.