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ICOTYDE™

(icotrokinra)

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ICOTYDE™ (icotrokinra)
Medical Information

ICOTYDE - Concomitant Use with Glucagon-like Peptide-1 (GLP-1) Agonists

Last Updated: 06/26/2026

SUMMARY

  • The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
  • A post-hoc analysis of phase 3 clinical trials was conducted in patients with moderate to severe plaque psoriasis (PsO) who received concomitant glucagon-like peptide-1 (GLP-1) agonists. The efficacy and safety results are summarized below.1,2

CLINICAL DATA

Pooled Analysis of Phase 3 Studies

A post-hoc analysis of the ICONIC-LEAD (NCT06095115), ICONIC-ADVANCE 1 (NCT06143878), and ICONIC-ADVANCE 2 (NCT06220604) phase 3 clinical trials was conducted in patients with moderate to severe plaque psoriasis (PsO) who received concomitant GLP-1 agonists.1

Study Design/Methods

Study Design of Select ICONIC Phase 3 Studies3

Abbreviations: BSA, body surface area; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; QD, once daily; R, randomization; W, week.

  • The efficacy analysis set included patients who received the first GLP-1 agonist dose prior to study day 84 (week 12) in the ICONIC-LEAD, ADVANCE 1, and ADVANCE 2 trials.1
  • The safety analysis set included patients who received GLP-1 agonists in ICONIC-LEAD, ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, and ICONIC-TOTAL.1,2

Results

Patient Characteristics
  • A total of 31 patients received concomitant GLP-1 agonists in the pooled efficacy analysis set.1
    • Medications included semaglutide, liraglutide, tirzepatide, and dulaglutide.
    • Twenty-four patients started GLP-1 agonists prior to week 0 (10 to 1589 days prior to week 0)
    • Seven patients started GLP-1 agonists between week 0 and week 12 (between days 1 and 75)
  • For information on baseline characteristics in these patients, see Table: PsO Baseline Disease Characteristics Among Patients Who Received GLP-1 Medications.

PsO Baseline Disease Characteristics Among Patients Who Received GLP-1 Medications1
ICO
(N=20)
PBO
(N=11)
PsO duration, years, mean (SD)
20.4 (14.1)
17.4 (10.3)
Age at diagnosis, years, mean (SD)
30.0 (17.3)
39.5 (14.5)
% of BSA with PsO, mean (SD)
21.1 (11.7)
24.7 (18.0)
IGA score, %
    Moderate (3)/severe (4)
85.0/15.0
81.8/18.2
PASI total score (0-72), mean (SD)
17.1 (5.4)
18.7 (7.0)
Abbreviations: BSA, body surface area; GLP-1, glucagon-like peptide-1; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; SD, standard deviation.
Efficacy

Efficacy Results at Week 16 by GLP-1 Agonist Use1
GLP-1 Yes
GLP-1 No
ICO
(N=20)
PBO
(N=11)
ICO
(N=1069)
PBO
(N=455)
IGA 0/1 response, %a
65.0
18.2
67.5
9.0
    Difference, % (95% CI)
46.8 (9.8-71.1)
58.2 (54.0-61.9)
PASI 90 response, %
45.0
9.1
53.5
3.5
    Difference, % (95% CI)
35.9 (1.1-60.2)
49.5 (45.9-52.9)
Abbreviations: CI, confidence interval; GLP-1, glucagon-like peptide-1; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo.
aWith a ≥2-grade improvement from baseline.
Safety
  • A total of 43 patients received concomitant GLP-1 agonists in the safety analysis set.1
  • For adverse events in the safety analysis set and in the broader pooled patient population, see Table: Pooled Safety through Week 16.

Pooled Safety through Week 161,2
GLP-1 Yesa
Pooled Populationb
ICO
(N=30)
PBO
(N=13)
ICO
(N=1296)
PBO
(N=568)
Average follow-up duration, weeks
15.9
15.5
15.9
15.6
Any AE, n (%)
16 (53.3)
9 (69.2)
636 (49.1)
295 (51.9)
Serious AE, n (%)
0
0
21 (1.6)
12 (2.1)
AEs leading to discontinuation, n (%)
0
1 (7.7)
26 (2.0)
17 (3.0)
Infections and infestations, n (%)
9 (30.0)
3 (23.1)
311 (24.0)
148 (26.1)
Gastrointestinal disorders, n (%)c
2 (6.7)
2 (15.4)
86 (6.6)
35 (6.2)
Abbreviations: AE, adverse event; GERD, gastroesophageal reflux disease; GI, gastrointestinal; GLP-1, glucagon-like peptide-1; ICO, ICOTYDE; MedDRA, Medical Dictionary for Regulatory Activities; PBO, placebo.
aIncludes patients who received GLP-1 agonists in ICONIC-LEAD, ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, and ICONIC-TOTAL.bIncludes the pooled cohort of patients across ICONIC-LEAD, ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, and ICONIC-TOTAL.CGLP-1 Yes: GI disorders (any frequency) included diarrhea, dry mouth, and nausea in the ICO group and included diarrhea and GERD in the PBO group. Pooled Population: GI disorders with a frequency of at least 1% in any treatment arm included diarrhea and nausea.Note: Patients are counted only once for any given event, regardless of the number of times they experienced the event. AEs are coded using MedDRA Version 27.0.

LITERATURE SEARCH

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 23 May 2026.

 

References

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1 Data on File. Pooled Analysis (Concomitant GLP-1 Medications). Janssen Research & Development, LLC; 2025.  
2 Data on File. Summary of Clinical Safety. Janssen Research & Development, LLC. EDMS-RIM-1147239; 2025.  
3 Stein Gold L, Armstrong AW, Soung J, et al. Consistency of skin clearance with the targeted oral peptide icotrokinra: results from a large pooled cohort of phase 3 study participants with moderate-to-severe plaque psoriasis. Poster presented at: American Academy of Dermatology (AAD) Annual Meeting; March 27-31, 2026; Denver, CO.  

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