- Design
- Two phase 3 randomised, placebo- and active-comparator-controlled trials
- Population
- 1,505 adults with moderate-to-severe plaque psoriasis
- Primary outcome
- Durability of IGA 0/1 and PASI 90 through week 52
- Effect
- About 70 to 75% IGA 0/1 or PASI 90 at weeks 24 to 52; 85 to 90% of week-16 responders maintained
ICONIC-ADVANCE 1 and 2 randomised 1,505 adults with moderate-to-severe plaque psoriasis to icotrokinra 200 mg daily, placebo (switched to icotrokinra at week 16) or deucravacitinib 6 mg (switched at week 24). Icotrokinra is an oral peptide that blocks the IL-23 receptor. It had already beaten placebo and deucravacitinib at weeks 16 and 24.
This report, in BJD, follows patients to week 52. Among those randomised to icotrokinra, about 70 to 75% had clear or almost clear skin (IGA 0/1, PASI 90) and about 50% completely clear skin (IGA 0, PASI 100) from week 24 onwards. Of those clear or almost clear at week 16, about 85 to 90% held that at week 52. Patients switched from placebo or deucravacitinib caught up. No new safety signals appeared, and adverse events were fewer than with deucravacitinib to week 24.
The practical point is that an oral agent is approaching injectable IL-23 inhibitor levels of clearance, which matters for patients who refuse or cannot manage injections. After week 24 these are uncontrolled observations of patients who stayed on drug, and there is no head-to-head comparison with an injectable biologic. Approval status in India and elsewhere is not stated in this report.
- Expect about 7 in 10 patients on icotrokinra to be clear or almost clear at one year, based on these trials.
- Most week-16 responders stayed responders at week 52; a good early response predicts durability.
- Weigh icotrokinra against injectable IL-23 and IL-17 inhibitors for needle-averse patients once it is available to you.
- Check local regulatory status before discussing it; this report does not give approval details.
Why it matters
It is the first oral option that looks close to injectable biologic efficacy in psoriasis.
Don't overread it
After week 24 there is no control arm, and there is no head-to-head trial against an injectable biologic.
The statistics, in plain English
Response rates quoted from week 24 to 52 are among patients who stayed on treatment, so dropouts are not counted as failures unless the analysis method did so; the abstract does not say which method was used for these figures. The controlled comparisons ended at weeks 16 and 24.
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