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

Full Prescribing Information (English)

ICOTYDE – Occurrence of Gastrointestinal Adverse Events in Patients with Plaque Psoriasis

Last Updated: 03/18/2026

SUMMARY

Please refer to the local labeling for relevant information regarding gastrointestinal adverse events (AEs) with (in patients receiving) ICOTYDE.
The safety of ICOTYDE 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. The following summarizes the incidence of gastrointestinal AEs across these trials.¹^-⁵
- The incidence rate of gastrointestinal AEs reported in the ICOTYDE group was 11% through week 52 in ICONIC-LEAD, 10% through week 52 in ICONIC-TOTAL, and 9% through week 24 in the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 combined safety analysis.

PRESCRIBING INFORMATION

Adverse Reactions

Adverse reactions that occurred in <1% of patients in the ICOTYDE group and at a higher rate than in the placebo (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 ICOTYDE is not established.⁶

CLINICAL DATA

ICONIC-LEAD

Bissonnette et al (2025)¹ and Soung et al (2025)² evaluated the efficacy and safety of oral ICOTYDE 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO in an ongoing phase 3, multicenter, randomized, double-blind, PBO-controlled study with randomized withdrawal and retreatment (NCT06095115).

The incidence of gastrointestinal AEs in patients treated with ICOTYDE and PBO in the ICONIC-LEAD study is included in the following Table: Incidence of Gastrointestinal AEs Through Week 52 in ICONIC-LEAD.

Incidence of Gastrointestinal AEs Through Week 52 in ICONIC-LEAD¹^,²

	PBO-Controlled (Adults & Adolescents)		Active Treatment (Adults & Adolescents)		ICO Responders Re-Randomized at W24 (Adults)
	ICO N=456	PBO N=228	ICO N=456	ICO^a N=213	ICO→ICO N=168	ICO→PBO^b N=172
Treatment period	W0-16		W0-52	W16-52	W24-52	W24-52
Mean weeks of follow-up	15.9	15.8	43.4	35.3	27.7	27.8
Gastrointestinal AE^c, n (%)	26 (6)	13 (6)	51 (11)	9 (4)	7 (4)	8 (5)
Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo; W, week. ^aIncludes data after week 16 for PBO-randomized patients who crossed over to receive ICO.^bCombined withdrawal and retreatment group.^cBased on gastrointestinal disorders System Organ Class.

From weeks 0 through 16, the total patient-years (PY) of follow up was 139.2 and 68.9 for the ICOTYDE and PBO groups, respectively.¹
- The incidence of gastrointestinal AEs per 100 PY was 19.4 (95% confidence interval [CI], 12.7-28.5) and 19.6 (95% CI, 10.5-33.6), respectively.
Through week 16, the most common gastrointestinal AE in the ICOTYDE group was nausea (n=8 [2%], versus n=1 [<1%] in the PBO group).⁷

ICONIC-TOTAL

Gooderham et al (2025)³ and Lain et al (2025)⁴ evaluated the efficacy and safety of oral ICOTYDE 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO affecting special sites (scalp, genitals, and/or palms of the hands and soles of the feet) in an ongoing phase 3, multicenter, randomized, double-blind, PBO-controlled study (NCT06095102).

The incidence of gastrointestinal AEs in patients treated with ICOTYDE and PBO in the ICONIC-TOTAL study is included in the following Table: Incidence of Gastrointestinal AEs Through Week 52 in ICONIC-TOTAL.

Incidence of Gastrointestinal AEs Through Week 52 in ICONIC-TOTAL⁴

	PBO-Controlled		Crossover	Active Treatment
	ICO N=208	PBO N=103	PBO→ICO N=92	ICO N=208	ICO Combined^a N=300
Treatment period	W0-16		W16-52	W0-52
Mean weeks/total PY of follow-up	16.0/63.6	15.6/30.8	36.2/63.9	49.3/196.4	45.3/260.2
Gastrointestinal AE, n (%)	15 (7)	8 (8)	7 (8)	21 (10)	28 (9)
Incidence/100 PY (95% CI)^b	25 (12-37)	27 (8-46)	11 (3-20)	12 (7-17)	12 (7-16)
Abbreviations: AE, adverse event; CI, confidence interval; ICO, ICOTYDE; PBO, placebo; PY, patient-years; W, week. ^aIncludes data for ICO-randomized patients through W52 and for PBO-to-ICO patients from W16 through W52.^bCIs were based on a Wald statistic using the normal assumption.

Through week 16, the most common gastrointestinal AE in the ICOTYDE group was diarrhea (n=8 [3.8%], versus n=4 [3.9%] in the PBO group).⁸

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)⁵ evaluated the efficacy and 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 PBO and deucravacitinib (NCT06143878 and NCT06220604).

AE results from both studies were combined into 1 safety analysis set. The incidence of gastrointestinal AEs is included in the following Table: Incidence of Gastrointestinal AEs Through Week 24 in the Combined Safety Analysis Set (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2).

Incidence of Gastrointestinal AEs Through Week 24 in the Combined Safety Analysis Set (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2)⁵

	PBO-Controlled			Active Comparator-Controlled		Crossover
	ICO N=632	PBO N=237	Deucra N=634	ICO N=632	Deucra N=634	PBO→ICO N=215
Treatment period	W0-16			W0-24		W16-24
Mean weeks of follow-up	15.9	15.5	15.8	23.5	23.3	8.1
Gastrointestinal AE, n (%)	45 (7)	15 (6)	63 (10)	55 (9)	80 (13)	5 (2)
Abbreviations: AE, adverse event; Deucra, deucravacitinib; ICO, ICOTYDE; PBO, placebo; W, week. Note: The safety analysis set included all randomized and treated participants.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 4 January 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	Soung J, Cui Y, Bissonnette R, et al. Maintenance of response with icotrokinra, a targeted oral peptide, for the treatment of moderate-to-severe plaque psoriasis: randomized treatment withdrawal in adults (weeks 24-52) and continuous treatment in adolescents (through week 52) from the phase 3, ICONIC-LEAD trial. Oral Presentation presented at: European Academy of Dermatology and Venereology (EADV); September 17-20, 2025; Paris, France.
3	Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).
4	Lain E, Warren RB, Gooderham M, et al. Durability of response to the targeted oral peptide icotrokinra for high-impact site psoriasis: 1-year ICONIC-TOTAL findings. Poster presented at: Fall Clinical Dermatology Conference; October 23-26, 2025; Las Vegas, NV.
5	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.
6	ICOTYDE (icotrokinra) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/ICOTYDE-pi.pdf
7	Bissonnette R, Soung J, Hebert AA, et al. Supplement to: Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795.
8	Gooderham M, Lain E, Bissonnette R, et al. Supplement to: Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).