Johnson & Johnson: Two‑year ICONIC‑TOTAL data show durable ICOTYDE efficacy in high‑impact plaque psoriasis
- ICONIC‑TOTAL two‑year data show sustained efficacy through Week 112 in adults and adolescents with moderate-to‑severe high‑impact site psoriasis.
- Overall IGA 0/1 rates for ICOTYDE rose from 57% at Week 16 to 67% at Week 24 and 70% at Week 112.
- Site‑specific complete clearance at Week 112: scalp ss‑IGA 0 in 60%, genital sPGA‑G 0 in 89%, hands/feet hf‑PGA 0 in 63%; nail mNAPSI improvement reached 71% at Week 112.
- Safety through Week 112 was consistent with the established profile and no new safety signals were identified; ICOTYDE is an oral IL‑23 receptor antagonist approved in the US, Europe, Japan and China.
Two‑year efficacy in high‑impact sites
Late‑breaking results from the Phase 3 ICONIC‑TOTAL trial reported sustained skin clearance with ICOTYDE (icotrokinra) through Week 112 in adults and adolescents with at least moderate involvement of high‑impact sites (scalp, genital, hands/feet). Overall Investigator’s Global Assessment (IGA) 0/1 increased from 57% at Week 16 to 67% at Week 24 and 70% at Week 112.
Site‑specific outcomes
At Week 112, site‑specific complete clearance rates were reported as 60% scalp ss‑IGA 0, 89% genital sPGA‑G 0 and 63% hf‑PGA 0 for hands/feet. Nail disease showed progressive improvement with mean modified NAPSI improvement of 33% at Week 16, 62% at Week 52 and 71% at Week 112.
Trial design and programme
ICONIC‑TOTAL is a randomized, placebo‑controlled study of once‑daily oral ICOTYDE versus placebo in participants with moderate‑to‑severe psoriasis affecting special areas, with placebo‑to‑ICOTYDE transition at Week 16. The pivotal ICONIC programme includes multiple Phase 3 trials and ongoing studies in psoriatic arthritis, ulcerative colitis and Crohn’s disease.
Safety and regulatory status
Safety findings through Week 112 aligned with the established ICOTYDE profile and reported no new safety signals. ICOTYDE is an oral peptide that targets the IL‑23 receptor and is approved for moderate‑to‑severe plaque psoriasis in adults and adolescents in the US, Europe, Japan and China.
Source: J&J