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.
Summary
- The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
- Please refer to the local labeling for relevant information regarding vaccinations with ICOTYDE.
COMPANY CORE DATA SHEET
Immunizations
- Prior to initiating therapy with ICOTYDE, consider completion of all age-appropriate immunizations according to current immunization guidelines.1
- No data are available on the response to live or inactive vaccines.1
- Avoid use of live vaccines in patients during treatment with ICOTYDE. Live vaccines may be administered 3 days after discontinuation of ICOTYDE.1
CLINICAL PROTOCOLS
Bissonnette et al (2025)2, Gooderham et al (2025)3, and Stein Gold et al (2025)4 reported the exclusion criteria for the ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 phase 3 clinical trials evaluating ICOTYDE in patients with moderate to severe plaque psoriasis.
- Exclusion criteria were assessed during the screening period (weeks -5 to 0) and at week 0 (before first dose of study intervention).2-4
- Prohibited medications or class of medications included live virus or bacterial vaccination. The restricted duration (through end of study) was 4 weeks, or longer if required per vaccine package insert, prior to the first administration of study intervention.2-4
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 22 June 2026.
| 1 | Data on File. Icotrokinra. Company Core Data Sheet v002. Janssen Research & Development, LLC. EDMS-RIM-1387700; 2026. |
| 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. |