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icotrokinra

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Icotrokinra – Occurrence of Tuberculosis in Patients with Plaque Psoriasis

Last Updated: 01/29/2026

SUMMARY

  • Icotrokinra (JNJ-77242113) is a targeted oral peptide that selectively binds the interleukin-23 (IL-23) receptor and inhibits IL-23 pathway signaling.1 
  • The safety 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. The following summarizes the incidence of tuberculosis across these studies.1-3 
    • The incidence rate of active tuberculosis reported in the icotrokinra 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.

CLINICAL DATA

ICONIC-LEAD

Bissonnette et al (2025)1 and Soung et al (2025)4 evaluated the efficacy and safety of oral icotrokinra 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 Tuberculosis Through Week 52 in ICONIC-LEAD1,4 
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 tuberculosis, n (%)
0
0
0
0
0
0
Abbreviations: ICO, icotrokinra; PBO, placebo; 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 latent tuberculosis infection (LTBI) at or before baseline.1 
    • Based on the investigator’s discretion, 12 patients received concomitant treatment for LTBI (icotrokinra, n=7; PBO, n=5) and 20 patients did not (icotrokinra, n=15; PBO, n=5).
    • Eighteen patients were previously treated for LTBI (icotrokinra, n=11; PBO, n=7).
  • No cases of active or latent tuberculosis emerged during the treatment period.

ICONIC-TOTAL

Gooderham et al (2025)2 evaluated the efficacy and safety of oral icotrokinra 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 Tuberculosis Through Week 16 in ICONIC-TOTAL2 
ICO
N=208
PBO
N=103
Mean weeks of follow-up
16.0
15.7
Active tuberculosis, n (%)
0
0
Abbreviations: ICO, icotrokinra; PBO, placebo.
  • There were 21 patients identified with LTBI at baseline.
    • Based on the investigator’s discretion, 3 patients received concomitant treatment for LTBI (icotrokinra, n=3; PBO, n=0) and 11 patients did not (icotrokinra, n=6; PBO, n=5).
    • Seven patients were previously treated for LTBI (icotrokinra, n=6; PBO, n=1).
  • No cases of active or latent tuberculosis 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 icotrokinra 200 mg daily in adults with moderate to severe plaque PsO in 2 ongoing, phase 3, multicenter, randomized, double-blind studies comparing icotrokinra with PBO and deucravacitinib (NCT06143878 and NCT06220604).


Incidence of Active Tuberculosis Through Week 24 in the Combined Safety Analysis Set (ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2)3 
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 tuberculosis, n (%)
0
0
0
0
0
0
Abbreviations: Deucra, deucravacitinib; ICO, icotrokinra; PBO, placebo; W, week.Note: The safety analysis set included all randomized and treated participants.
  • These studies excluded patients with a history of untreated latent tuberculosis or positive interferon-γ release assay (within 8 weeks of first study dose).3 
  • Patients with treated latent tuberculosis were eligible. Treatment had to be initiated before the first dose of study drug and not prematurely discontinued during the trial.3 

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. The Lancet. 2025;406(10510):1363-1374.  
4 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.