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ICOTYDE™ (icotrokinra)
Medical Information
ICOTYDE - Use in Patients with Plaque Psoriasis and Comorbid Psoriatic Arthritis
Last Updated: 08/26/2026
SUMMARY
- The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
- ICONIC-LEAD, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 are ongoing phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled studies (NCT06095115, NCT06143878, and NCT06220604) evaluating the efficacy and safety of oral ICOTYDE 200 mg once daily in patients with moderate to severe plaque psoriasis (PsO). A subgroup analysis in patients with comorbid psoriatic arthritis (PsA) is described below.1
- 4 - At week 16 in the ICOTYDE group, 47% of patients achieved ≥50% improvement in Patient’s Global Assessment (PtGA) of PsA disease activity and 46% achieved ≥50% improvement in PsA patient pain.1
- At week 16, 47% and 69% of patients treated with ICOTYDE achieved clear or almost clear nail PsO (fingernail Physician’s Global Assessment [f-PGA] 0/1) and scalp PsO (scalp-specific Investigator’s Global Assessment [ss-IGA] 0/1), respectively.
- In pooled safety analyses through week 16 in patients with PsO and PsA, the adverse event (AE) profile was comparable to PBO (any AE: ICOTYDE, 49%; PBO, 51%).
CLINICAL DATA
Pooled analysis (LEAD, ADVANCE 1, AND ADVANCE 2)
McInnes et al (2026)1 reported PsA- and PsO-relevant outcomes and AEs through week 16 from a post-hoc analysis of patients with moderate to severe PsO and a self-reported medical history of PsA (PsO+PsA).
Study Design/Methods
Key study design elements have been summarized in the Figure: Study Design: ICO vs PBO through Week 16 in Select Phase 3 Studies.
Abbreviations: BSA, body surface area; FAS, full analysis set; f-PGA, fingernail Physician's Global Assessment; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; mNAPSI, modified Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsA, psoriatic arthritis; PsO, psoriasis; PtGA, Patient’s Global Assessment; R, randomized; ss-IGA, scalp-specific Investigator’s Global Assessment; QD, once daily; VAS, visual analog scale; W, week.
a
b
c
d
- The safety analysis included AEs through week 16 for pooled ICO and PBO groups.1
Results
Patient Characteristics
- A total of 149 and 67 patients with PsO+PsA were randomized to ICOTYDE and PBO, respectively. Baseline characteristics are described in Table: Select Baseline Demographics and Clinical Characteristics.
| ICO (n=149) | PBO (n=67) | |
|---|---|---|
| Demographics | ||
| Age, years, mean (SD) | 49.6 (12.8) | 49.1 (13.0) |
| Female sex, % | 36 | 45 |
| Race, Asian/Black/White, % | 17/3/77 | 13/3/84 |
| BMI, kg/m2 | 31.3 (7.5) | 30.4 (7.6) |
| PsA Characteristics | ||
| PtGA of PsA disease activitya (0-100), mean (SD) | 48.0 (27.0) | 50.1 (27.1) |
| PsA patient paina (0-100), mean (SD) | 49.3 (27.6) | 53.4 (28.7) |
| PsO Characteristics | ||
| PsO disease duration, years, mean (SD) | 19.1 (12.0) | 20.4 (13.8) |
| % of BSA with PsO, mean (SD) | 24.8 (14.3) | 26.0 (15.0) |
| IGA score, moderate (3)/severe (4), % | 83/17 | 70/30 |
| PASI score (0-72), mean (SD) | 19.4 (6.5) | 20.6 (8.2) |
| High-Impact Site PsO Characteristics | ||
| mNAPSI scoreb (0-130), mean (SD) | 21.0 (18.6) | 21.5 (19.5) |
| f-PGA score,c mild (2)/moderate (3)/severe (4), % | 24/18/3 | 13/18/1 |
| ss-IGA score,c mild (2)/moderate (3)/severe (4), % | 10/61/16 | 13/42/30 |
| Abbreviations: BMI, body mass index; BSA, body surface area; f-PGA, fingernail Physician's Global Assessment; ICO, ICOTYDE; IGA, Investigator’s Global Assessment; mNAPSI, modified Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsA, psoriatic arthritis; PsO, psoriasis; PtGA, Patient’s Global Assessment; SD, standard deviation; ss-IGA, scalp-specific Investigator’s Global Assessment. aICO n=136/PBO n=57. bAmong patients with a baseline f-PGA score >0: ICO N=84/PBO N=33. cICO N=148/PBO N=67. | ||
Efficacy
- At week 16, patients treated with ICOTYDE showed improvements in PsA disease activity and pain. Select endpoints comparing ICOTYDE to PBO are described in Table: PsA-specific Patient Reported Outcomes.
PsA-specific Patient Related Outcomes1
| Week 8 | Week 16 | |||||
|---|---|---|---|---|---|---|
| ICO (n=134) | PBO (n=56) | Difference % (95% CI) | ICO (n=134) | PBO (n=56) | Difference % (95% CI) | |
| LSM change from baselinea,b | ||||||
| PtGA of PsA disease activityb,c | -18.5 | -4.8 | -13.7 (-20.6 to -6.8) Nominal P<0.001c | -19.2 | -0.8 | -18.4 (-26.7 to -10.1) Nominal P<0.001c |
| PsA patient painb,c | -17.1 | -4.6 | -12.5 (-19.4 to -5.5) Nominal P<0.001c | -19.5 | -7.8 | -11.6 (-19.2 to -4.1) Nominal P<0.01c |
| Patients with ≥50% improvement, %a,d | ||||||
| PtGA of PsA disease activity | - | - | - | 47 | 11 | 36.3 (22.6-47.8)d Nominal P<0.001c |
| PsA patient pain | - | - | - | 46 | 16 | 29.0 (14.4-41.4)d Nominal P<0.001c |
| Abbreviations: CI, confidence interval; FAS, full analysis set; ICO, ICOTYDE; LSM, least squares mean; MMRM, mixed-effect model for repeated measures; PBO, placebo; PsA, psoriatic arthritis; PtGA, Patient’s Global Assessment. Note: Among patients in the pooled FAS and with a self-reported medical history of PsA, 213 were evaluable for efficacy. aAmong patients with baseline PtGA of PsA disease activity or PsA patient pain. bLSM, LSM differences, and P-values were based on the MMRM model with treatment group, visit, study, baseline PtGA of PsA disease activity or baseline PsA patient pain, their respective baseline-by-visit interactions, and treatment-by-visit interaction as covariates. cThese endpoints were not controlled for multiple comparisons. Therefore, the P-values are nominal and statistical significance has not been established. dTreatment difference and 95% CI (using Miettinen-Nurminen method) were calculated adjusting for study, baseline weight category for adults, and geographic region using Mantel-Haenszel weights; P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by study, baseline weight category for adults, and geographic region. | ||||||
- Select high-impact site endpoints comparing ICOTYDE to PBO are described in Table: Nail PsO and Scalp PsO Outcomes at Week 16.
| ICO | PBO | Difference % (95% CI) | Nominal P-valuea | |
|---|---|---|---|---|
| Nail PsO | ||||
| (n=81) | (n=31) | |||
| mNAPSI improvement, LSM percent change from baselineb,c | -41.6 | 118.6 | -160.3 (-235.1 to -85.4) | P<0.001 |
| (n=64) | (n=21) | |||
| f-PGA 0/1d, % | 47 | 10 | 35.7 (12.2-52.3)e | P<0.01 |
| f-PGA 0d, % | 19 | 10 | 9.2 (-12.8 to 23.9)f | NR |
| Scalp PsO | ||||
| (n=126) | (n=56) | |||
| ss-IGA 0/1g | 69 | 12 | 55.9 (42.2-66.4)e | P<0.001 |
| ss-IGA 0g, % | 52 | 5 | 46.5 (35.0-56.5)e | P<0.001 |
| Abbreviations: CI, confidence interval; FAS, full analysis set; f-PGA, fingernail Physician’s Global Assessment; ICO, ICOTYDE; LSM, least squares mean; MMRM; mixed-effect model for repeated measures; mNAPSI, modified Nail Psoriasis Severity Index; NR, not reported; PBO, placebo; PsA, psoriatic arthritis; PsO, psoriasis; ss-IGA, scalp-specific Investigator’s Global Assessment. Note: Among patients in the pooled FAS and with a self-reported medical history of PsA, 213 were evaluable for efficacy. aThese endpoints were not controlled for multiple comparisons. Therefore, the P-values are nominal and statistical significance has not been established. bAmong patients with a baseline mNAPSI score >0. cLSM, LSM difference, and P-value were based on the MMRM model with treatment group, visit, study, baseline mNAPSI score, baseline mNAPSI score by visit interaction, and treatment group by visit interaction as covariates. dAmong patients with a baseline f-PGA score ≥2. eTreatment differences and 95% CIs (using Miettinen-Nurminen method) were calculated adjusting for study using Mantel-Haenszel weights; P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by study. fTreatment difference and 95% CI were based on exact method. gAmong patients with a baseline ss-IGA score ≥2. | ||||
Safety through Week 16
- Through week 16, the ICOTYDE AE profile was consistent with that observed for PBO in patients with PsO+PsA (see Table: Pooled Safety in Patients with PsO+PsA through Week 16).
| ICO (n=148) | PBO (n=67) | |
|---|---|---|
| Mean weeks of follow-up | 15.8 | 15.3 |
| Any AE, n (%) | 73 (49) | 34 (51) |
| Most common AEs (≥5%), n (%) | ||
| Headache | 10 (7) | 2 (3) |
| AEs leading to discontinuation, n (%) | 3 (2) | 5 (7) |
| Infection, n (%) | 28 (19) | 17 (25) |
| Most common infection (≥5%), n (%) | ||
| Upper respiratory tract infection | 7 (5) | 2 (3) |
| Gastrointestinal AEs, n (%) | 12 (8) | 4 (6) |
| Malignancy, n (%) | 2 (1) | 1 (1) |
| Abbreviations: AE, adverse event; FAS, full analysis set; ICO, ICOTYDE; PBO, placebo; PsA, psoriatic arthritis; PsO, psoriasis. aAmong patients in the pooled FAS and with a self-reported medical history of PsA. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | McInnes IB, Stein Gold L, Bissonnette R, et al. Icotrokinra, a targeted oral peptide, in participants with moderate-to-severe plaque psoriasis and psoriatic arthritis: results from a pooled analysis of the phase 3 ICONIC-LEAD, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 trials. Poster presented at: European Alliance of Associations for Rheumatology (EULAR); June 3-6, 2026; London. |
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