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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: 03/18/2026

SUMMARY

  • Please refer to the local labeling for relevant information regarding ICOTYDE and occurrence of infections.
  • The safety of ICOTYDE 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. The following summarizes the incidence of infections across these studies.1-6 
    • The incidence of infections reported in the ICOTYDE group was 23% through week 24 in ICONIC-LEAD, 51% through week 52 in ICONIC-TOTAL, and 30% through week 24 in the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 combined safety analysis.
    • Across all trials, nasopharyngitis and upper respiratory tract infection (URTI) were among the most common adverse events (AEs) through week 16.

PRESCRIBING INFORMATION

Warnings and Precautions - Infections7 

  • Medicines that interact with the immune system may increase the risk of infection.
  • In the 16-week placebo (PBO)-controlled trials in patients with moderate to severe plaque psoriasis, the rate of serious infections for ICOTYDE-treated patients was 0.2% compared to 0.4% of patients who received PBO.
  • Avoid treatment with ICOTYDE 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 ICOTYDE.
  • 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 ICOTYDE until the infection resolves.

Adverse Reactions7 


Adverse Reactions that Occurred in ≥1% of Patients in the ICOTYDE Group and More Frequently than in the PBO Group through Week 16a
Adverse Reactions
ICOTYDE
N=1296
PBO
N=568
Fungal Infectionb, n (%)
14 (1.1)
0 (0)
Abbreviations: 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

ICONIC-LEAD

Bissonnette et al (2025)1 and Soung et al (2025)2 evaluated the efficacy and safety of oral ICOTYDE 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO in an ongoing phase 3, multicenter, randomized, double-blind, PBO-controlled study with randomized withdrawal and retreatment (NCT06095115).

  • Through week 16: 
    • The most common AEs were nasopharyngitis (7% in each of the ICOTYDE and PBO groups) and URTI (7% in each group).1
    • There were 107 (23%) and 51 (22%) reports of infection in the ICOTYDE and PBO groups, respectively.1
  • The incidence of infections through week 24 in patients treated with ICOTYDE and PBO is included in the following Table: Incidence of Infections Through Week 24 in ICONIC-LEAD.

Incidence of Infections Through Week 24 in ICONIC-LEAD1 
PBO-Controlled
Active Treatment
ICO
N=456
PBO
N=228
PBO→ICOa
N=213
ICO
N=456
Treatment period
W0-16
W16-24
W0-24
Mean weeks of follow-up
15.9
15.8
8.2
23.6
Total PY of follow-up
139.2
68.9
33.3
206.3
Most common AEs (≥5%)b
Nasopharyngitis, n (%)
31 (7)
15 (7)
5 (2)
37 (8)
URTI, n (%)
30 (7)
16 (7)
6 (3)
34 (7)
Infection, n (%)
107 (23)
51 (22)
21 (10)
131 (29)
    Number/100 PY (95% CI)c
89.2
(72.3–106.2)
85.5
(62.0–109.0)
66.3
(38.0–94.7)
77.6
(64.3–90.9)
Serious infection, n (%)
1 (<1)
0
0
1 (<1)
    Number/100 PY (95% CI)c
0.7
(0.0–4.0)
0.0
(0.0–4.4)
0.0
(0.0–9.0)
0.5
(0.0–2.7)
Active tuberculosis, n (%)
0
0
0
0
Abbreviations: AEs, adverse events; CI, confidence interval; ICO, ICOTYDE; PBO, placebo; PY, patient-years; URTI, upper respiratory tract infection; W, week.aIncludes data after patients transitioned from PBO to ICO at week 16 and continuing through week 24.bList is not all-inclusive.cExposure-adjusted incidence rates were calculated as (number of patients with event/total PY at risk)×100.

Incidence of Infections Through Week 52 in ICONIC-LEAD2 
Active Treatment
(Adults & Adolescents)
ICO Responders Re-Randomized at W24 (Adults)
ICO
N=456
ICOa
N=213
ICO→ICO
N=168
ICO→PBOb N=172
Treatment period
W0-52
W16-52
W24-52
W24-52
Mean weeks of follow-up
43.4
35.3
27.7
27.8
Most common AEs
Nasopharyngitis, n (%)
64 (14)
23 (11)
21 (12)
20 (12)
URTI, n (%)
52 (11)
24 (11)
9 (5)
15 (9)
Serious infection, n (%)
1 (<1)
1 (<1)
0
1 (1)
Active tuberculosis, n (%)
0
0
0
0
Abbreviations: AE, adverse event; ICO, ICOTYDE; PBO, placebo; URTI, upper respiratory tract infection; W, week.
aIncludes data after week 16 for PBO-randomized patients who crossed over to receive ICO.bCombined withdrawal and retreatment group.

ICONIC-TOTAL

Gooderham et al (2025)3 and Lain et al (2025)4 evaluated the efficacy and safety of oral ICOTYDE 200 mg daily in patients ≥12 years of age with moderate to severe plaque PsO affecting special sites (scalp, genitals, and/or palms of the hands and soles of the feet) in an ongoing phase 3, multicenter, randomized, double-blind, PBO-controlled study (NCT06095102).

  • Through week 16:
    • The most common AEs were nasopharyngitis and URTI.3 
    • In the ICOTYDE and PBO groups, the incidence of nasopharyngitis was 12.5% and 10.7%, respectively, and the incidence of URTI was 4.3% and 4.9%, respectively.3 
  • Through week 16, the incidence of active tuberculosis was 0 in each of the ICOTYDE and PBO groups.3 
  • The incidence of infections through week 52 in patients treated with ICOTYDE and PBO in the ICONIC-TOTAL study is included in the following Table: Incidence of Infections Through Week 52 in ICONIC-TOTAL.

Incidence of Infections Through Week 52 in ICONIC-TOTAL4 
PBO-Controlled
Crossover
Active Treatment
ICO
N=208
PBO
N=103
PBO→ICO
N=92
ICO
N=208
ICO Combineda N=300
Treatment period
W0-16
W16-52
W0-52
Mean weeks/total PY of follow-up
16.0/63.6
15.6/30.8
36.2/63.9
49.3/196.4
45.3/260.2
Infection, n (%)
59 (28)
23 (22)
39 (42)
106 (51)
145 (48)
Incidence/100 PY (95% CI)b
110 (82-138)
88 (52-124)
81 (56-106)
81 (66-96)
81 (68-94)
Serious infection,   n (%)
0 (0)
1 (1)
0 (0)
0 (0)
0 (0)
Incidence/100 PY (95% CI)c
0 (0-5)
3 (<1-18)
0 (0-5)
0 (0-2)
0 (0-1)
Abbreviations: CI, confidence interval; ICO, ICOTYDE; PBO, placebo; PY, patient-years; W, week.
aIncludes data for ICO-randomized patients through W52 and for PBO-to-ICO patients from W16 through W52.bCIs were based on a Wald statistic using the normal assumption.cCIs were based on an exact method assuming that the observed number of events follows a Poisson distribution.

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)5 evaluated the efficacy and safety of oral ICOTYDE 200 mg daily in adults with moderate to severe plaque PsO in 2 ongoing, phase 3, multicenter, randomized, double-blind studies comparing ICOTYDE with PBO and deucravacitinib (NCT06143878 and NCT06220604).


Incidence of Infections Through Week 24 in the Combined Safety Analysis Set (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2)5,6 
PBO-Controlled
Active Comparator-Controlled
ICO
N=632
PBO
N=237
Deucra
N=634
ICO
N=632
Deucra
N=634
Treatment period
W0-16
W0-24
Mean weeks of follow-up
15.9
15.5
15.8
23.5
23.3
AEs occurring in ≥5% of patients, n (%)a
Infection
145 (23)
73 (31)
202 (32)
190 (30)
253 (40)
Nasopharyngitis
37 (6)
13 (5)
58 (9)
56 (9)
77 (12)
URTI
23 (4)
8 (3)
33 (5)
32 (5)
49 (8)
Serious infection, n (%)b
1 (<1)
1 (<1)
4 (1)
3 (<1)
4 (1)
Active tuberculosis,
n (%)
0
0
0
0
0
Herpes, n (%)c
5 (1)
6 (3)
13 (2)
6 (1)
18 (3)
Abbreviations: AE, adverse event; Deucra, deucravacitinib; ICO, ICOTYDE; PBO, placebo; URTI, upper respiratory tract infection; W, week.aIn any treatment group. List is not all-inclusive.bSerious infections included bacterial arthritis (PBO group), campylobacter colitis (Deucra group), viral infection (Deucra group), infection exacerbated by chronic obstructive airways disease (ICO group), lower respiratory tract infection (Deucra group), viral upper respiratory tract infection (Deucra group), and pneumonia (ICO group).cIncluded preferred terms genital herpes simplex, herpes simplex, herpes virus infection, herpes zoster, and oral herpes.
Note: The safety analysis set included all randomized and treated patients.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 7 January 2026.

 

References

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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 Soung J, Cui Y, Bissonnette R, et al. Maintenance of response with icotrokinra, a targeted oral peptide, for the treatment of moderate-to-severe plaque psoriasis: randomized treatment withdrawal in adults (weeks 24-52) and continuous treatment in adolescents (through week 52) from the phase 3, ICONIC-LEAD trial. Oral Presentation presented at: European Academy of Dermatology and Venereology (EADV); September 17-20, 2025; Paris, France.  
3 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).  
4 Lain E, Warren RB, Gooderham M, et al. Durability of response to the targeted oral peptide icotrokinra for high-impact site psoriasis: 1-year ICONIC-TOTAL findings. Poster presented at: Fall Clinical Dermatology Conference; October 23-26, 2025; Las Vegas, NV.  
5 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.  
6 Stein Gold L, Armstrong AW, Bissonnette R, et al. Icotrokinra demonstrated superior responses compared with placebo and deucravacitinib in the treatment of moderate-to-severe plaque psoriasis. Oral presentation presented at: European Academy of Dermatology and Venereology (EADV); September 17-20, 2025; Paris, France.  
7 ICOTYDE (icotrokinra) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/ICOTYDE-pi.pdf