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ICOTYDE®

(icotrokinra)

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ICOTYDE® (icotrokinra)
Medical Information

ICOTYDE – Occurrence of Infections in Patients with Plaque Psoriasis

Last Updated: 10/15/2026

SUMMARY

  • Please refer to the local labeling for relevant information regarding ICOTYDE (icotrokinra) and occurrence of infections.
  • The safety and efficacy of icotrokinra 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.1-3 
  • The following pooled analysis summarizes the exposure-adjusted incidence rates (EAIR) of infections per 100 patient-years (PY) of follow-up across these studies.4
    • Through week 16 across LEAD, TOTAL, ADVANCE 1, and ADVANCE 2, EAIRs of infections were 91.0/100 PY vs 104.0/100 PY in the icotrokinra vs placebo (PBO) groups.
    • Through week 24 across ADVANCE 1 and ADVANCE 2, the EAIRs of infections were 81.3/100 PY vs 119.0/100 PY in the icotrokinra vs deucravacitinib groups.
    • Through week 52 across LEAD, TOTAL, ADVANCE 1, and ADVANCE 2, the EAIR of infections was 75.8/100 PY in the icotrokinra group.
    • Nasopharyngitis and URTI were the most common infections across all treatment groups and treatment periods.

PRESCRIBING INFORMATION

Warnings and Precautions - Infections 

  • Medicines that interact with the immune system may increase the risk of infection.
  • In the 16-week PBO-controlled trials in patients with moderate to severe plaque PsO, the rate of serious infections for icotrokinra-treated patients was 0.2% compared to 0.4% of patients who received PBO.5
  • Avoid treatment with icotrokinra in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing icotrokinra.5
  • Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection and/or is not responding to standard therapy, monitor the patient closely and discontinue icotrokinra until the infection resolves.5

Adverse Reactions - Infections 


Adverse Reactions that Occurred in ≥1% of Patients in the Icotrokinra Group and More Frequently than in the PBO Group through Week 16a,5
Adverse Reactions
ICO
N=1296
PBO
N=568
Fungal Infectionb, n (%)
14 (1.1)
0 (0)
Abbreviations: ICO, icotrokinra; PBO, placebo.aPercentages based on Cochran-Mantel-Haenszel adjusted proportions.bFungal infection includes tinea pedis (n=4), tinea versicolor (n=2), oral candidiasis (n=2), onychomycosis (n=1), skin candida (n=1), urinary tract candidiasis (n=1), vulvovaginal candidiasis (n=1), fungal skin infection (n=1), genital infection fungal (n=1), ear infection fungal (n=1), laryngitis fungal (n=1). Two patients experienced more than 1 event.

CLINICAL DATA

Pooled Analysis of Phase 3 Clinical Trials

Lebwohl et al (2026)4 evaluated the 1-year safety profile of icotrokinra using pooled data from the ongoing LEAD, TOTAL, ADVANCE 1, and ADVANCE 2 studies.

Study Design/Methods


Overview of Phase 3 Clinical Trials through Week 521-4
LEAD
TOTAL
ADVANCE 1 and
ADVANCE 2
Overview
  • Multicenter, randomized, controlled, double-blind, phase 3 clinical trials
Key inclusion criteria
  • Age ≥12 years
  • IGA ≥3
  • PASI ≥12
  • BSA ≥10%
  • Candidate for phototherapy or systemic treatment
  • Age ≥12 years
  • IGA ≥2
  • BSA ≥1%
  • ≥1 high-impact site with at least moderate PsO
    (ss-IGA ≥3, sPGA-G ≥3, or hf-PGA ≥3)
  • Failed ≥1 topical therapy
  • Candidate for phototherapy or systemic treatment
  • Age ≥18 years
  • IGA ≥3
  • PASI ≥12
  • BSA ≥10%
  • Candidate for phototherapy or systemic treatment
Treatment groups
  • ICO (n=456)
    • ICO 200 mg QD W0-24
    • W24–52: randomized withdrawal and retreatmenta
  • PBO (n=228)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • ICO (n=208)
    • ICO 200 mg QD W0-52
  • PBO (n=103)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • ICO (ADVANCE 1, n=311; ADVANCE 2, n=322)
    • ICO 200 mg QD W0-52
  • PBO (ADVANCE 1, n=156; ADVANCE 2, n=82)
    • PBO QD W0-16
    • ICO 200 mg QD W16-52
  • Deucra (ADVANCE 1, n=307; ADVANCE 2, n=327)
    • Deucra 6 mg QD W0-24
    • ICO 200 mg QD W24-52
Abbreviations: BSA, body surface area; Deucra, deucravacitinib; hf-PGA, Physician’s Global Assessment of hands and feet; ICO, icotrokinra; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsO, psoriasis; QD, once daily; sPGA-G, static Physician’s Global Assessment of Genitalia; ss-IGA, scalp-specific Investigator’s Global Assessment; W, week.aBased on PASI 75 and IGA 0/1 response (adults only; all adolescents continued ICO).

Safety Results


Select Safety Results Across Analysis Periods through Week 524,6
PBO-controlled (W0-16)a
Active-controlled (W0-24)b
Through W52c
ICO
n=1296
PBO
n=568
ICO
n=632
Deucra
n=634
ICO
n=2400
Total PY of follow-up
395
170
285
283
1840
Average weeks of follow-up
15.9
15.6
23.5
23.3
40.0
Infections, EAIR/100 PY (95% CI)d
Infections
91.0
104.0
81.3
119.0
75.8
   Nasopharyngitis
24.7
24.1
20.5
29.2
21.4
   URTI
16.1
17.6
12.2
18.0
13.9
   Serious infections
0.49
(0.30-2.70)
1.09
(0.65-6.54)
1.05
(0.22-3.32)
1.78
(0.65-4.34)
0.65
(0.32-1.09)
   Active TB events
0
(0.00-2.00)
0
(0.00-5.03)
0
(0.00-1.67)
0
(0.00-1.69)
0
(0.00-0.16)
   Latent TB events
0
(0.00-2.00)
0
(0.00-5.03)
0
(0.00-1.67)
0
(0.00-1.69)
0
(0.00-0.16)
   Opportunistic infections excluding TB
0.26
(0.15-2.39)
0
(0.00-5.03)
0
(0.00-1.67)
0.35
(0.00-2.26)
0.05
(0.00-0.26)
Abbreviations: AE, adverse event; CI, confidence interval; Deucra, deucravacitinib; EAIR, exposure-adjusted incidence rate; ICO, icotrokinra; PBO, placebo; PY, patient-years; W, week.aIncludes LEAD, TOTAL, ADVANCE 1, and ADVANCE 2. To account for the different PBO:ICO randomization ratio in ADVANCE 2 vs the other studies, rates were adjusted by the total follow-up from the combined PBO and ICO treatment groups in a study.bIncludes ADVANCE 1 and ADVANCE 2 only.cIncludes data for patients randomized to ICO, data after W16 for patients randomized to PBO who crossed over to ICO, and data after W24 for patients randomized to Deucra who switched to ICO. For the LEAD study, events that occurred during the withdrawal period (on or after W28 and before re-treatment) were excluded for patients who were re-randomized to PBO at W24.dCalculated as (number of patients with AEs/total PY at risk) x 100. CIs for some terms were not reported. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.

Infections

Through week 16 (LEAD, TOTAL, ADVANCE 1, and ADVANCE 2)4
  • Serious infections with icotrokinra included 1 case each of bacterial gastroenteritis and infective exacerbation of chronic obstructive airways disease, while PBO-treated patients reported 1 case each of bacterial arthritis and COVID-19 pneumonia with sepsis.
Through week 24 (ADVANCE 1 and ADVANCE 2)4:
  • Through week 24, 2 additional serious infections (infective exacerbation of chronic obstructive airways disease and pneumonia) were reported in the icotrokinra group.
Through week 52 (LEAD, TOTAL, ADVANCE 1, and ADVANCE 2)4:
  • One patient treated with icotrokinra experienced 2 positively adjudicated fungal laryngitis events (EAIR, 0.05/100 PY) in the presence of potential confounding factors (smoker, inhaled salbutamol, oral prednisone).
  • No treatment-emergent AEs of active TB or LTBI were reported in any treatment group.
  • Among 173 patients with LTBI at or before screening, 17.9% (31/173) did not receive LTBI treatment before or during the study, including 30 patients exposed to icotrokinra.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on
08 September 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 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12):EVIDoa2500155.  
3 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.  
4 Lebwohl MG, Gooderham M, Warren RB, et al. Safety of icotrokinra through 1 year for the treatment of moderate-to-severe plaque psoriasis and psoriasis affecting high-impact sites: pooled results across the ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2 phase 3 trials. [published online ahead of print August 28, 2026]. Dermatol Ther (Heidelb). doi:10.1007/s13555-026-01885-w.  
5 ICOTYDE (icotrokinra) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/ICOTYDE-pi.pdf
6 Data on File. Icotrokinra 120-Day Safety update. Janssen Research & Development, LLC. EDMS-RIM-1606208; 2025.  

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