First Oral IL-23 Receptor Antagonist Approved for Moderate-to-Severe Plaque Psoriasis: Daily Dose

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On March 18, 2026, we reported on the FDA approval of icotrokinra (Icotyde; Johnson & Johnson) for the treatment of moderate-to-severe plaque psoriasis in adults and children aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy.

The approval

The decision was supported by data from the phase 3 ICONIC program, which enrolled approximately 2500 participants aged 12 and older across 4 trials. In the placebo-controlled ICONIC-LEAD trial, 65% of icotrokinra-treated participants achieved an Investigator's Global Assessment (IGA) score of 0 or 1 at 16 weeks, compared with 8% in the placebo group. PASI 90 response rates were 50% vs 4%, respectively. Responses deepened with continued treatment: by week 24, 74% reached IGA 0/1 and 65% achieved PASI 90.

The ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 studies evaluated icotrokinra head-to-head against both placebo and deucravacitinib (Sotyktu). Icotrokinra demonstrated superiority to deucravacitinib for skin clearance at both weeks 16 and 24, with adverse event rates numerically lower in the icotrokinra group. ICONIC-TOTAL, which enrolled individuals with moderate or greater involvement of the scalp, genitalia, or hands and feet, showed that 72% of participants with scalp psoriasis and 85% with genital psoriasis achieved clear or almost clear skin at week 52.

Across the full program, rates of adverse reactions with icotrokinra were within 1.1 percentage points of placebo through week 16, and no new safety signals emerged through week 52.

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