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ICOTYDE™ (icotrokinra)
Medical Information
ICOTYDE - Use in Elderly Patients 65 Years of Age and Older with Plaque Psoriasis
Last Updated: 04/08/2026
- The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
- Please refer to the local labeling for relevant information regarding geriatric use of ICOTYDE.
- The week 16 response rates for ICOTYDE in elderly patients with plaque psoriasis (PsO), based on a pooled analysis of phase 3 studies, are discussed here.1
Elderly (65 Years of Age and Older)
Of the 2367 patients exposed to ICOTYDE in clinical trials for PsO, 240 (10%) were 65 years of age and older, and 36 (1.5%) were 75 years of age or older.2 - No overall differences in safety and effectiveness of ICOTYDE have been observed between patients 65 years and older and younger adult patients.2
Pharmacokinetic Properties
Elderly (65 Years of Age and Older)
- No apparent differences in clearance were observed in patients ≥65 years of age compared to patients <65 years of age, suggesting no dose adjustment is needed for elderly patients.2
CLINICAL DATA
Pooled Analysis of Phase 3 Studies
Gold et al (2026)1 evaluated the consistency of skin clearance with oral ICOTYDE 200 mg once daily in patients with moderate to severe plaque PsO across 3 pooled phase 3 studies (ICONIC-LEAD, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2).
Study Design/Methods
Key Inclusion Criteria
- Age ≥12 years (ICONIC-LEAD)
- Age ≥18 years (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2)
- Plaque PsO ≥26 weeks
- Body surface area (BSA) ≥10%, Psoriasis Area and Severity Index (PASI) score ≥12 and Investigator’s Global Assessment (IGA) score ≥3
- Candidate for phototherapy or systemic treatment for plaque PsO
Randomization
- Patients were randomized to receive oral ICOTYDE 200 mg once daily or placebo (PBO) from week 0 to week 16 across pooled phase 3 studies
- ICONIC-LEAD: N=684 (2:1)
- ICONIC-ADVANCE 1: N=467 (2:1)
- ICONIC-ADVANCE 2: N=404 (4:1)
Outcome Measure at Week 16
- Proportion difference (95% confidence interval [CI]) in IGA 0/1 response between the ICOTYDE and PBO groups.
Results
- Baseline demographic characteristics of the pooled analysis cohort are summarized in Table: Baseline Demographic Characteristics.
- IGA 0/1 response rate at week 16 across different age groups at baseline for ICOTYDE vs PBO are summarized in Table: IGA 0/1 Response Rate Based on Age at Baseline for ICOTYDE and PBO
| ICOTYDE (N=1089) | PBO (N=466) | |
|---|---|---|
| Age, years mean (SD) | 44.8 (14.9) | 45.4 (15.1) |
| ≥12 to <18, n (%) | 44 (4) | 22 (5) |
| ≥18 to <45, n (%) | 505 (46) | 197 (42) |
| ≥45 to <65, n (%) | 435 (40) | 194 (42) |
| ≥65, n (%) | 105 (10) | 53 (11) |
| Abbreviations: PBO, placebo; SD, standard deviation. | ||
| IGA 0/1 Response Rate (%) | Proportion Difference (95% CI) | ||
|---|---|---|---|
| ICOTYDE (N=1089) | PBO (N=466) | ||
| Age, years | |||
| ≥12 to <18 | 84.1 | 27.3 | 56.8 (32.5-74.4) |
| ≥18 to <45 | 68.3 | 9.6 | 58.5 (52.1-64.0) |
| ≥45 to <65 | 63.4 | 6.7 | 55.8 (49.5-61.3) |
| ≥65 | 73.3 | 9.4 | 64.2 (50.6-74.2) |
| Abbreviations: CI, confidence interval; IGA, Investigator’s Global Assessment; PBO, placebo. | |||
Literature Search
A literature search of MEDLINE®
References
| 1 | Gold LS, 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. |
| 2 |