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 - Occurrence of Gastrointestinal Adverse Events in Patients with Plaque Psoriasis

Last Updated: 10/15/2026

SUMMARY

  • Please refer to the local labeling for relevant information regarding ICOTYDE (icotrokinra) and the occurrence of gastrointestinal (GI) adverse events (AEs).
  • The safety of icotrokinra in patients with moderate to severe plaque psoriasis (PsO) was evaluated in the ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 phase 3 clinical trials.1-3
  • The following pooled analysis summarizes the exposure-adjusted incidence rates (EAIRs) of GI AEs per 100 patient-years (PY) of follow-up across these trials.4
    • Through week 16 across LEAD, TOTAL, ADVANCE 1, and ADVANCE 2, the EAIRs of GI AEs were 22.7/100 PY vs 21.4/100 PY in the icotrokinra vs placebo (PBO) groups.
    • Through week 24 across ADVANCE 1 and ADVANCE 2, the EAIRs of GI AEs were 20.3/100 PY vs 31.0/100 PY in the icotrokinra vs deucravacitinib groups.
    • Through week 52 across LEAD, TOTAL, ADVANCE 1, and ADVANCE 2, the EAIR of GI AEs was 13.0/100 PY in the icotrokinra group.

PRESCRIBING INFORMATION

Adverse Reactions

  • Adverse reactions that occurred in <1% of patients in the icotrokinra group and at a higher rate than in the PBO group through Week 16 in phase 3 trials were gastritis, abdominal discomfort, and 1 fatal case involving upper gastrointestinal bleeding in a patient with underlying risk factors. A relationship of this event to icotrokinra is not established.5

CLINICAL DATA

Pooled Analysis of Phase 3 Clinical Trials

Lebwohl et al (2026)4 evaluated the safety profile of icotrokinra through 1 year using pooled data from the ongoing LEAD, TOTAL, ADVANCE 1, and ADVANCE 2 studies.

Study Design/Methods


Overview of Phase 3 Clinical Trials through Week 524
LEAD
TOTAL
ADVANCE 1 and ADVANCE 2
Overview
  • Multicenter, randomized, controlled, double-blind, phase 3 clinical trials
Key inclusion criteria
  • Age ≥12 years
  • IGA ≥3
  • PASI ≥12
  • BSA ≥10%
  • Candidate for phototherapy or systemic treatment
  • Age ≥12 years
  • IGA ≥2
  • BSA ≥1%
  • ≥1 high-impact site with at least moderate PsO (ss-IGA ≥3, sPGA-G ≥3, or hf-PGA ≥3)
  • Failed ≥1 topical therapy
  • Candidate for phototherapy or systemic treatment
  • Age ≥18 years
  • IGA ≥3
  • PASI ≥12
  • BSA ≥10%
  • Candidate for phototherapy or systemic treatment
Treatment groups
  • ICO (n=456)
    • ICO 200 mg QD W0-24
    • W24–52: randomized withdrawal and retreatmenta
  • PBO (n=228)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • ICO (n=208)
    • ICO 200 mg QD W0-52
  • PBO (n=103)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • ICO (ADVANCE 1, n=311; ADVANCE 2, n=322)
    • ICO 200 mg QD W0-52
  • PBO (ADVANCE 1, n=156; ADVANCE 2, n=82)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • Deucra (ADVANCE 1, n=307; ADVANCE 2, n=327)
    • Deucra 6 mg QD W0-24
    • ICO 200 mg QD W24-52
Abbreviations: BSA, body surface area; Deucra, deucravacitinib; hf-PGA, Physician’s Global Assessment of hands and feet; ICO, icotrokinra; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO. psoriasis; QD, once daily; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment; W, week.aBased on PASI 75 and IGA 0/1 response (adults only; all adolescents continued ICO).

Results

Select Patient Characteristics
  • A total of 2498 patients were included in the pooled analysis. Through week 52, 2400 patients treated with icotrokinra contributed 1840 PY of follow-up.4
  • Baseline medical history: ulcerative colitis was reported in 0.4% (10/2498) of patients and Crohn's disease was reported in 0.2% (4/2498) of patients.4
Safety

Select Safety Results Across Analysis Periods through Week 524,6
PBO-Controlled (W0-16)a
Active-Controlled (W0-24)b
Through W52c
ICO
n=1296
PBO
n=568
ICO
n=632
Deucra
n=634
ICO
n=2400
Total PY of follow-up
395
170
285
283
1840
Average weeks of follow-up
15.9
15.6
23.5
23.3
40.0
EAIRs per 100 PYd
   All GI events
22.7
21.4
20.3
31.0
13.0
   Most frequently reported GI AEs
      Diarrhea
6.92
6.54
6.43
5.74
2.87
      Nausea
3.83
1.77
1.76
2.50
1.26
Abbreviations: AE, adverse event; CI, confidence interval; Deucra, deucravacitinib; EAIR, exposure-adjusted incidence rate; GI, gastrointestinal; ICO, icotrokinra; PBO, placebo; PY, patient-years; W, week.
aIncludes LEAD, TOTAL, ADVANCE 1, and ADVANCE 2. To account for the different PBO:ICO randomization ratio in ADVANCE 2 vs the other studies, rates were adjusted by the total follow-up from the combined PBO and ICO treatment groups in a study.
bIncludes ADVANCE 1 and ADVANCE 2 only.
cIncludes data for patients randomized to ICO, data after W16 for patients randomized to PBO who crossed over to ICO, and data after W24 for patients randomized to Deucra who switched to ICO. For the LEAD study, events that occurred during the withdrawal period (on or after W28 and before retreatment) were excluded for patients who were rerandomized to PBO at W24.
dCalculated as (number of patients with AEs/total PY at risk) x 100. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.6
  • Through week 52, there was 1 (EAIR, 0.05 per 100 PY) AE of ulcerative colitis reported for a patient who switched from deucravacitinib to icotrokinra in ADVANCE 2.4
  • Through week 52, the EAIR for GI disorder serious adverse events (SAEs) was 0.33 per 100 PY.4
  • No AEs of Crohn’s disease were reported in the icotrokinra group.4

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 01 October 2026.

 

References

Show
1 Bissonnette R, Soung J, Hebert AA, et al. Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795.  
2 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12):EVIDoa2500155.  
3 Stein Gold L, Armstrong AW, Bissonnette R, et al. 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.  
4 Lebwohl MG, Gooderham M, Warren RB, et al. Safety of icotrokinra through 1 year for the treatment of moderate-to-severe plaque psoriasis and psoriasis affecting high-impact sites: pooled results across the ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2 phase 3 trials. [published online ahead of print August 28, 2026]. Dermatol Ther (Heidelb). doi:10.1007/s13555-026-01885-w.  
5 ICOTYDE (icotrokinra) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/ICOTYDE-pi.pdf
6 Data on File. Icotrokinra 120-Day Safety update. Janssen Research & Development, LLC. EDMS-RIM-1606208; 2025.  

Would you like to clear and leave your conversation? Message history will be lost.