Icotrokinra maintains high-impact site psoriasis clearance through 2 years in ICONIC-TOTAL

Psoriasis of the scalp, genitals, hands, and feet often resists topical therapy and carries a burden out of proportion to the body surface area it covers. New 2-year data from the phase 3 ICONIC-TOTAL trial indicate that icotrokinra (Icotyde; Johnson & Johnson), a once-daily oral peptide that blocks the interleukin (IL)-23 receptor, sustained clearance at these high-impact sites in adults and adolescents through week 112.¹ The late-breaking results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026.¹

Lesions at these sites "often do not respond to topical creams, limit activity, and degrade mental health," said Richard B. Warren, MD, PhD, professor of dermatology at the University of Manchester, United Kingdom, in the company announcement.¹ Warren characterized the data as supporting durable clearance with a favorable safety profile.¹

ICONIC-TOTAL trial design and 2-year icotrokinra results in scalp, genital, and hand/foot psoriasis

ICONIC-TOTAL (NCT06095102) randomly assigned 311 patients aged 12 years and older with at least moderate scalp, genital, and/or hand/foot psoriasis 2:1 to icotrokinra 200 mg once daily (n = 208) or placebo (n = 103), with placebo recipients switching to icotrokinra at week 16.²,⁴ The primary endpoint was an Investigator's Global Assessment (IGA) score of 0 or 1 with at least a 2-grade improvement at week 16.¹ Overall, 255 patients (82%) completed treatment through week 112.²

Among patients randomized to icotrokinra, IGA 0/1 rates rose from 57% at week 16 to 67% at week 24 and 70% at week 112.¹ At week 112, complete site-specific clearance was reported in 60% of patients with scalp psoriasis (scalp-specific IGA 0), 89% with genital psoriasis (Physician's Global Assessment of Genitalia 0), and 63% with hand and/or foot psoriasis (hand/foot Physician's Global Assessment 0).¹ Mean improvement in the modified Nail Psoriasis Severity Index increased from 33% at week 16 to 62% at week 52 and 71% at week 112.¹

In the placebo-controlled period, scalp clear or almost clear rates at week 16 were 66% with icotrokinra vs 11% with placebo, and genital rates were 77% vs 21%.⁴ Johnson & Johnson reported no new safety signals through week 112 but did not release adverse event rates.¹,²

Burden of high-impact site plaque psoriasis and systemic treatment options

Plaque psoriasis affects an estimated 8 million Americans and more than 125 million people worldwide, and nearly one-quarter of cases are moderate to severe.¹ Disease on visible or sensitive skin, such as the scalp, hands, feet, and genitals, is associated with a greater negative effect on quality of life.¹

Systemic options for moderate-to-severe disease include injectable biologics and oral small molecules. In the phase 3 ICONIC-ADVANCE 1 and 2 trials, icotrokinra demonstrated superior IGA 0/1 and PASI 90 response rates at week 16 vs the oral tyrosine kinase 2 inhibitor deucravacitinib.⁴

Icotrokinra mechanism, FDA approval, and pivotal ICONIC-LEAD data

Icotrokinra selectively binds the IL-23 receptor, a central driver of psoriatic inflammation.³ It is approved in the US for moderate-to-severe plaque psoriasis in patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy, and it is also approved in Europe, Japan, and China.¹ Patients take 1 tablet once daily on waking with water, at least 30 minutes before eating.¹

In the pivotal ICONIC-LEAD trial of 684 adults and adolescents, 65% of icotrokinra recipients vs 8% of placebo recipients achieved IGA 0/1 at week 16, and 50% vs 4% achieved PASI 90 (P < .001 for both).³ At least 1 adverse event occurred in 49% of each group, most commonly nasopharyngitis and upper respiratory tract infection.³

Limitations of 2-year ICONIC-TOTAL icotrokinra data in adults and adolescents

ICONIC-TOTAL enrolled only 6 pediatric patients, which limits conclusions about long-term site-specific response in adolescents.⁴ The announcement also did not describe how the 18% of patients who did not complete treatment were handled in the week 112 analysis.¹

Icotrokinra is being evaluated against ustekinumab in ICONIC-ASCEND and in psoriatic arthritis, ulcerative colitis, and Crohn disease.¹

References

1. Johnson & Johnson announces new ICOTYDE (icotrokinra) data in difficult-to-treat plaque psoriasis with proven durability through 2-years, affirming its use as a powerful first line systemic therapy. News release. Johnson & Johnson; October 2, 2026. Accessed October 2, 2026. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-new-icotyde-icotrokinra-data-in-difficult-to-treat-plaque-psoriasis-with-proven-durability-through-2-years-affirming-its-use-as-a-powerful-first-line-systemic-therapy

2. ICONIC-TOTAL: icotrokinra sustains high-impact site clearance at 2 years. HCPLive. October 2, 2026. Accessed October 2, 2026. https://www.hcplive.com/view/iconic-total-icotrokinra-high-impact-site-clearance-2-years

3. 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. doi:10.1056/NEJMoa2504187

4. FDA approves oral icotrokinra for moderate to severe plaque psoriasis. Rheumatology Advisor. Accessed October 2, 2026. https://www.rheumatologyadvisor.com/news/icotrokinra-fda-approval-plaque-psoriasis/