Icotrokinra sustains skin clearance in patients with plaque psoriasis

Two-year data from the phase 3 ICONIC-LEAD trial indicate that once-daily oral icotrokinra (Icotyde; Johnson & Johnson) maintains high levels of skin clearance in adults and adolescents aged 12 years and older with moderate to severe plaque psoriasis, with no new safety signals through week 112.¹ The findings, presented at the 2026 Fall Clinical Dermatology Conference, extend durability data for the targeted oral peptide, which the FDA approved in March 2026.¹,³

"As plaque psoriasis is a chronic lifelong disease, durable results are essential in therapy selection," said Mark Lebwohl, MD, professor and chair emeritus of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai and an ICONIC-LEAD investigator, in the press release.¹ Lebwohl is a paid consultant for Johnson & Johnson.¹

ICONIC-LEAD trial design and 2-year icotrokinra efficacy in plaque psoriasis

ICONIC-LEAD is a randomized, double-blind, placebo-controlled trial that enrolled 684 participants (456 icotrokinra, 228 placebo), including 66 adolescents.¹,² Eligible patients had psoriasis involving at least 10% of body surface area, a Psoriasis Area and Severity Index (PASI) score of at least 12, and an Investigator's Global Assessment (IGA) score of at least 3.² Participants received icotrokinra 200 mg once daily or placebo through week 16, after which the placebo group transitioned to icotrokinra.² Coprimary end points were IGA 0/1 and PASI 90 response at week 16.²

At week 16, 65% of icotrokinra-treated participants achieved IGA 0/1 vs 8% with placebo, and 50% vs 4% achieved PASI 90 (P < .001 for both).²

In the long-term analysis, at least 72% of icotrokinra-treated patients achieved PASI 90 and at least 70% achieved IGA 0/1 from week 64 through week 112.¹ Complete clearance was also maintained over that period, with at least 44% reaching PASI 100 and at least 46% reaching IGA 0.¹ Clinically meaningful improvement in itch was sustained in 78% of patients.¹

Among PASI 90 responders withdrawn from icotrokinra at week 24, 85% regained PASI 90 within 24 weeks of restarting therapy.¹

Safety findings through week 112 were consistent with the drug's established profile.¹ In a separate pooled analysis of 2400 icotrokinra-treated participants across 4 phase 3 ICONIC trials, exposure-adjusted rates of adverse events, serious adverse events, and infections through week 16 were comparable with placebo and remained consistent through week 52.⁴

Plaque psoriasis burden and oral IL-23 receptor blockade in adolescents

Plaque psoriasis affects an estimated 8 million people in the United States, and nearly one-quarter of cases are considered moderate to severe.¹ Involvement of the scalp, hands, feet, and genitals is associated with a greater negative effect on quality of life.¹

Icotrokinra is an oral peptide that selectively binds the interleukin-23 receptor, blocking a signaling pathway central to psoriatic inflammation.² The FDA approved it on March 18, 2026, for moderate to severe plaque psoriasis in adults and pediatric patients aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy.³ Patients take one 200-mg tablet daily on waking, on an empty stomach with water, at least 30 minutes before eating.¹

For pediatric clinicians, ICONIC-LEAD is notable for enrolling adolescents alongside adults in a registrational trial.² Labeling advises evaluation for tuberculosis before treatment and avoidance of live vaccines during therapy, considerations relevant to adolescent immunization planning.¹

References

1. Johnson & Johnson. New Johnson & Johnson ICOTYDE (icotrokinra) long-term data demonstrate robust 2-year results in the treatment of adults and adolescents with plaque psoriasis. News release. October 9, 2026. Accessed October 9, 2026. https://www.jnj.com/media-center/press-releases/new-johnson-johnson-icotyde-icotrokinra-long-term-data-demonstrate-robust-2-year-results-in-the-treatment-of-adults-and-adolescents-with-plaque-psoriasis

2. 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

3. Johnson & Johnson. FDA approval of ICOTYDE (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. News release. March 18, 2026. Accessed October 9, 2026. https://www.jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide

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. Dermatol Ther (Heidelb). 2026;16(10):5049-5068. doi:10.1007/s13555-026-01885-w