Johnson & Johnson (NYSE: JNJ) reported that at least 72% of patients treated with Icotyde (icotrokinra) achieved a 90% reduction in Psoriasis Area and Severity Index (PASI 90) scores, while at least 70% achieved clear or almost clear skin (Investigator's Global Assessment [IGA] 0/1), sustained from Week 64 through Week 112 of the Phase III ICONIC-LEAD trial. The two-year data were presented at the 2026 Fall Clinical Dermatology Conference.
Icotyde is a once-daily oral peptide that selectively inhibits the interleukin-23 receptor (IL-23R), offering an oral approach to a pathway targeted by established injectable psoriasis biologics. The US FDA approved the drug in March 2026 for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older, followed by European Commission approval in September.
ICONIC-LEAD originally randomized 684 participants to icotrokinra or placebo. In the long-term follow-up, at least 44% of icotrokinra-treated patients achieved complete skin clearance (PASI 100), while at least 46% achieved an IGA score of 0 from Week 64 through Week 112. Clinically meaningful itch improvement was sustained in 78% of patients. Among patients who achieved PASI 90 and were withdrawn from treatment at Week 24, 85% regained that response within 24 weeks of retreatment.
J&J reported no new safety signals through Week 112. The company did not disclose the number of participants included in the two-year efficacy analysis or detailed adverse-event rates in its announcement. The long-term results were not derived from a continuous placebo-controlled comparison.