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ICOTYDE™ (icotrokinra)
Medical Information
ICOTYDE - Efficacy Outcomes by Weight or Body Mass Index in Patients with Plaque Psoriasis
Last Updated: 05/13/2026
SUMMARY
- The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
- Response rates in subgroups defined by weight and body mass index (BMI) across 3 phase 3 studies are summarized below.1
- At week 16, the overall Investigator’s Global Assessment score of 0/1 and a ≥2-grade improvement from baseline (IGA 0/1) response rate was 67.5% with ICOTYDE and 9.2% with placebo (PBO; proportion difference, 57.9%).1
CLINICAL DATA
Stein Gold et al (2026)1 conducted a pooled analysis of 3 phase 3 studies (ICONIC-LEAD, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2) to evaluate ICOTYDE vs PBO in achieving skin clearance among patients with moderate to severe plaque psoriasis (PsO) at week 16 across baseline subgroups of high clinical interest.
Study Design/Methods
- The study design is presented in Figure: Study Design for Pooled Analysis of Phase 3 Studies.
Abbreviations: BSA, body surface area; FAS, full analysis set; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; QD, once daily; R, randomization; W, week.
a
Results
- Baseline characteristics are summarized in Table: Baseline Characteristics in the Pooled Cohort.
| ICO (n=1089) | PBO (n=466) | |
|---|---|---|
| Weight, kg, mean (SD) | 87.1 (21.0) | 87.1 (23.2) |
| ≤90 kg, n (%) | 649 (60) | 276 (59) |
| >90 kg, n (%) | 440 (40) | 190 (41) |
| BMIa, kg/m2 | 29.4 (6.6) | 29.4 (7.2) |
| Normal (<25 kg/m2),n (%) | 276 (25) | 112 (24) |
| Overweight (≥25 to <30 kg/m2),n (%) | 377 (35) | 166 (36) |
| Obese (≥30 kg/m2),n (%) | 435 (40) | 187 (40) |
| Abbreviations: BMI, body mass index; ICO, ICOTYDE; PBO, placebo; SD, standard deviation. aICO, n=1088; PBO, n=465. | ||
- At week 16, the overall IGA 0/1 response rates for ICOTYDE and PBO were 67.5% and 9.2%, respectively (proportion difference, 57.9% [95% confidence interval [CI], 53.8-61.6]). For more details, see Table: IGA 0/1 Response Rate by Weight and BMI at Week 16.
| % | ICO (n=1089) | PBO (n=466) | Proportion Difference (95% CI) |
|---|---|---|---|
| Weight | |||
| ≤90 kg | 71.2 | 10.9 | 59.8 (54.2-64.6) |
| >90 kg | 62.0 | 6.8 | 55.1 (48.7-60.6) |
| BMIa | |||
| Normal (<25 kg/m2) | 76.4 | 17.0 | 58.7 (49.1-66.7) |
| Overweight (≥25 to <30 kg/m2) | 69.2 | 8.4 | 59.5 (52.5-65.6) |
| Obese (≥30 kg/m2) | 60.5 | 5.3 | 55.3 (49.2-60.7) |
| Abbreviations: BMI, body mass index; CI, confidence interval; ICO, ICOTYDE; IGA, Investigator’s Global Assessment score; PBO, placebo. Note: The 95% CI for the difference in proportions was derived using the Miettinen–Nurminen method, applying studyadjusted Mantel–Haenszel weights. aICO, n=1088; PBO, n=465. | |||
- Overall, the least square (LS) mean percent improvement in the Psoriasis Area and Severity Index (PASI) score in the ICOTYDE vs PBO group was 81.9% vs 25.8% (LS mean difference, 56.1% [95% CI, 52.8-59.4]; nominal P<0.001). For more details, see Table: Percent PASI Improvement from Baseline at Week 16 by Weight and BMI.
| % | ICO (n=1047) | PBO (n=451) | LS Mean Difference (95% CI)a |
|---|---|---|---|
| Weight | |||
| ≤72 kg | 83.5 | 34.4 | 49.1 (42.2-56.0) |
| >72 to ≤85 kg | 84.0 | 23.8 | 60.2 (53.2-67.2) |
| >85 to ≤98.8 kg | 81.5 | 22.3 | 59.2 (53.0-65.4) |
| >98.8 kg | 78.1 | 22.9 | 55.2 (48.9-61.4) |
| BMIb | |||
| Normal (<25 kg/m2) | 84.1 | 33.1 | 51.0 (43.8-58.2) |
| Overweight (≥25 to <30 kg/m2) | 83.7 | 23.8 | 59.8 (54.4-65.2) |
| Obese (≥30 kg/m2) | 78.8 | 23.5 | 55.4 (50.3-60.4) |
| Abbreviations: BMI, body mass index; CI, confidence interval; ICO, ICOTYDE; LS, least squares; MMRM, mixed-effect model for repeated measures; PASI, Psoriasis Area and Severity Index; PBO, placebo. aNominal P<0.001 for ICO vs PBO. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established. bICO, n=1046; PBO, n=450. Note: LS means, LS mean differences, and P-values were based on an MMRM model, with treatment group, visit, study, baseline PASI total score, and treatment group by visit interaction as covariates. Patients with missing baseline body weight or BMI were excluded from the analysis. | |||
Safety
- The mean duration of follow-up in the pooled cohort was 15.9 weeks for ICOTYDE and 15.6 weeks for PBO. Safety data are summarized in Table: Pooled Safety Data through Week 16.
Pooled
| n (%) | ICO (n=1088) | PBO (n=465) |
|---|---|---|
| Any AE | 531 (49) | 249 (54) |
| Most common AEs (≥5%) | ||
| Nasopharyngitis | 68 (6) | 28 (6) |
| Upper respiratory tract infection | 53 (5) | 24 (5) |
| Serious AEs | 20 (2) | 10 (2) |
| AEs leading to discontinuation | 20 (2) | 13 (3) |
| Infections | 252 (23) | 125 (27) |
| Serious infections | 2 (<1) | 1 (<1) |
| Gastrointestinal AEs | 71 (7) | 27 (6) |
| Malignancy | 5 (<1) | 1 (<1) |
| Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo. Note: All randomized and treated patients were included in the safety analysis set. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | 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. |