Johnson & Johnson ICOTYDE delivers durable 2‑year plaque psoriasis results
- At Week 112, ≥72% of ICOTYDE-treated patients achieved PASI 90 and ≥70% achieved IGA 0/1, sustained from Week 64 through Week 112.
- Complete clearance sustained: ≥44% achieved PASI 100 and ≥46% achieved IGA 0 from Week 64 through Week 112.
- Clinically meaningful itch improvement was sustained in 78% of patients from Week 64 to Week 112.
- Among PASI 90 responders withdrawn at Week 24, 85% regained PASI 90 within 24 weeks of retreatment.
Key efficacy results
Two‑year data from the Phase 3 ICONIC‑LEAD study showed high, sustained levels of skin clearance through Week 112: ≥72% of ICOTYDE‑treated patients achieved PASI 90 and ≥70% achieved IGA 0/1 from Week 64 through Week 112. Complete clearance was also durable, with ≥44% reaching PASI 100 and ≥46% reaching IGA 0 over the same interval. Clinically meaningful improvement in itch was sustained in 78% of patients from Week 64 to Week 112.
Durability and retreatment
Among PASI 90 responders who were withdrawn from ICOTYDE at Week 24, 85% regained PASI 90 within 24 weeks after retreatment, indicating a high rate of response recovery following temporary discontinuation.
Safety
Safety findings through Week 112 remained consistent with the established safety profile of ICOTYDE, with no new safety signals identified in the trial data presented.
Study design, mechanism and regulatory status
ICONIC‑LEAD is a Phase 3 randomized controlled trial of 684 participants (ICOTYDE=456; placebo=228) including 66 adolescents, with co‑primary endpoints of PASI 90 and IGA 0/1 plus ≥2‑grade improvement. ICOTYDE is described as the first targeted oral peptide that blocks the IL‑23 receptor, binding with single‑digit picomolar affinity (clinical significance of this binding was noted as unknown). ICOTYDE is approved in the U.S., Europe, Japan and China for adults and adolescents (12 years and older meeting weight criteria) and is taken as a once‑daily 200 mg oral dose on an empty stomach.
Source: J&J