Johnson & Johnson: ICOTYDE improves disease activity in biologic‑naïve psoriatic arthritis
- ICONIC‑PsA 1 (Phase 3) met its primary endpoint: 58% achieved ACR20 with ICOTYDE 200 mg once daily versus 41% with placebo at Week 16.
- ACR50 and ACR70 at Week 16 were 29% and 13% with ICOTYDE versus 16% and 5% with placebo, respectively.
- In patients with qualifying skin involvement, 57% on ICOTYDE achieved IGA 0/1 versus 14% on placebo, and 37% achieved PASI 90 versus 6% (nominal p<0.001).
- Responses continued to rise through Week 24 (ACR20 69%, ACR50 40%, ACR70 18%) and safety through Week 24 showed no new signals.
Key results
In the Phase 3 ICONIC‑PsA 1 study in biologic‑naïve adults with active psoriatic arthritis, ICOTYDE 200 mg once daily met the primary endpoint: 58% of patients achieved an ACR20 response versus 41% on placebo at Week 16. Numerically higher proportions achieved ACR50 (29% vs 16%) and ACR70 (13% vs 5%). Response rates increased through Week 24, reaching ACR20 69%, ACR50 40% and ACR70 18%.
Skin outcomes
Among participants with qualifying baseline skin involvement, 57% receiving ICOTYDE achieved clear or almost clear skin (IGA 0/1) versus 14% with placebo, and 37% achieved PASI 90 versus 6% with placebo (nominal p<0.001). By Week 24 these rates improved to IGA 0/1 64% and PASI 90 56%.
Safety
Safety findings through Week 24 were consistent with ICOTYDE’s established safety profile and no new safety signals were identified.
Mechanism and clinical program
ICOTYDE (icotrokinra) is a targeted oral peptide that precisely blocks the IL‑23 receptor. ICONIC‑PsA 1 is part of the ICONIC Phase 3 program, which also includes additional PsA studies and pivotal trials in moderate‑to‑severe plaque psoriasis, and ongoing investigations in ulcerative colitis and Crohn’s disease.
Source: J&J