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ICOTYDE™

(icotrokinra)

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ICOTYDE™ (icotrokinra)
Medical Information

ICOTYDE - Occurrence of Tuberculosis in Patients with Plaque Psoriasis

Last Updated: 04/22/2026

SUMMARY

  • Please refer to the local labeling for relevant information regarding ICOTYDE and occurrence of tuberculosis (TB).
  • 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 TB across these studies.1-4 
    • The incidence rate of active TB reported in the ICOTYDE group was 0% through week 52 in ICONIC-LEAD, 0% through week 16 in ICONIC-TOTAL, and 0% through week 24 in ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2.1-3 
    • There were no new cases of latent TB infection (LTBI) identified in the overall safety analysis set and no cases of TB reactivation in patients with LTBI at or before baseline who did not receive LTBI treatment.4 

PRESCRIBING INFORMATION

Warnings and Precautions - TB5 

  • Based on clinical judgment, consider evaluating patients for TB infection prior to initiating treatment with ICOTYDE.
  • In patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed, consider anti-TB therapy prior to initiating ICOTYDE.
  • During and after ICOTYDE treatment, monitor patients for signs and symptoms of active TB.
  • Avoid administering ICOTYDE to patients with active TB.

CLINICAL DATA

ICONIC-LEAD

Bissonnette et al (2025)1 and Soung et al (2025)6 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, placebo (PBO)-controlled study with randomized withdrawal and retreatment (NCT06095115).


Incidence of Active TB through Week 52 in ICONIC-LEAD1,6 
PBO-Controlled
(Adults & Adolescents)
Active Treatment
(Adults & Adolescents)
ICO Responders Re-Randomized at W24 (Adults)
ICO
N=456
PBO
N=228
ICO
N=456
ICOa
N=213
ICO→ICO N=168
ICO→PBOb N=172
Treatment period
W0-16
W0-52
W16-52
W24-52
Mean weeks of follow-up
15.9
15.8
43.4
35.3
27.7
27.8
Active TB, n (%)
0
0
0
0
0
0
Abbreviations: ICO, ICOTYDE; PBO, placebo; TB, tuberculosis; W, week.
aIncludes data after week 16 for PBO-randomized patients who crossed over to receive ICO.bCombined withdrawal and retreatment group.
  • There were 48 patients identified with LTBI at or before baseline.1 
    • Based on the investigator’s discretion, 12 patients received concomitant treatment for LTBI (ICOTYDE, n=7; PBO, n=5) and 20 patients did not (ICOTYDE, n=15; PBO, n=5).
    • Eighteen patients were previously treated for LTBI (ICOTYDE, n=11; PBO, n=7).
  • No cases of active or latent TB emerged during the treatment period.

ICONIC-TOTAL

Gooderham 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 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).


Incidence of Active TB through Week 16 in ICONIC-TOTAL2 
ICO
N=208
PBO
N=103
Mean weeks of follow-up
16.0
15.7
Active TB, n (%)
0
0
Abbreviations: ICO, ICOTYDE; PBO, placebo; TB, tuberculosis.
  • There were 21 patients identified with LTBI at or before baseline.
    • Based on the investigator’s discretion, 3 patients received concomitant treatment for LTBI (ICOTYDE, n=3; PBO, n=0) and 11 patients did not (ICOTYDE, n=6; PBO, n=5).
    • Seven patients were previously treated for LTBI (ICOTYDE, n=6; PBO, n=1).
  • No cases of active or latent TB emerged during the treatment period.

ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2

Stein Gold et al (2025)3 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 Active TB through Week 24 in ICONIC-ADVANCE 1 and ICONIC-ADVANCE 23 
PBO-Controlled
Active Comparator-
Controlled
Crossover
ICO
N=632
PBO
N=237
Deucra
N=634
ICO
N=632
Deucra
N=634
PBO→ICO
N=215
Treatment period
W0-16
W0-24
W16-24
Mean weeks of follow-up
15.9
15.5
15.8
23.5
23.3
8.1
Active TB, n (%)
0
0
0
0
0
0
Abbreviations: Deucra, deucravacitinib; ICO, ICOTYDE; PBO, placebo; TB, tuberculosis; W, week.Note: The safety analysis set included all randomized and treated participants.
  • These studies excluded patients with a history of untreated latent TB or positive interferon-γ release assay (within 8 weeks of first study dose).3 
  • Patients with treated latent TB were eligible. Treatment had to be initiated before the first dose of study drug and not prematurely discontinued during the trial.3 
  • There were 49 patients identified with LTBI at or before baseline in ICONIC-ADVANCE 1. Thirty patients received concomitant treatment and 19 were previously treated for LTBI.4 
  • There were 55 patients identified with LTBI at or before baseline in ICONIC-ADVANCE 2. Forty-seven patients received concomitant treatment and 8 were previously treated for LTBI.4 

Pooled Analyses of Phase 3 Studies

Across ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC- ADVANCE 2:

  • There were 31 patients with LTBI at or prior to baseline who did not receive LTBI treatment. There were no cases of TB re-activation in these patients.4 
  • There were no new cases of active or LTBI in the safety analysis set (n=2498).4

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 2 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 Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12).  
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 Data on File. Integrated Summary of Safety v1.0. Janssen Research & Development, LLC. EDMS-RIM-1313216; 2025.  
5 ICOTYDE (icotrokinra) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/ICOTYDE-pi.pdf
6 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.