Core Insights - Johnson & Johnson announced long-term data from the Phase 3 ICONIC-TOTAL study, showing that icotrokinra, a targeted oral peptide, effectively treats moderate-to-severe plaque psoriasis in adults and adolescents, achieving high rates of skin clearance [1][4][5]. Efficacy and Safety - In the ICONIC-TOTAL study, 72% of patients with scalp psoriasis and 85% with genital psoriasis achieved clear or almost clear skin at Week 52 [1][6]. - Overall, 67% of patients treated with icotrokinra achieved clear or almost clear skin by Week 24, maintaining this through Week 52 [1][4]. - In patients with hand/foot psoriasis, the rate of skin clearance increased from 42% at Week 16 to 62% at Week 52 [3]. Patient Impact - The study highlights the significant distress experienced by patients when psoriasis affects sensitive areas, indicating icotrokinra's potential as a meaningful treatment option for managing moderate-to-severe plaque psoriasis long-term [4][5]. - The treatment demonstrated comparable response rates between patients who received icotrokinra for the full 52 weeks and those who transitioned from placebo at Week 16 [4]. Clinical Development - The ICONIC clinical development program includes multiple studies evaluating icotrokinra's efficacy and safety across various conditions, including plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease [10][11][16]. - Icotrokinra is designed to precisely block the IL-23 receptor, which is crucial in the inflammatory response associated with these diseases [13][16]. Conclusion - The long-term data from the ICONIC-TOTAL study reinforces icotrokinra's potential to set a new standard of treatment for patients with high-impact psoriasis, combining effective skin clearance with a favorable safety profile [5][12].

Core Insights - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for icotrokinra, a first-in-class investigational oral peptide targeting the IL-23 receptor for treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][2][4]. Group 1: Clinical Development and Efficacy - The application is based on data from four Phase 3 studies, including ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2, which met all primary and co-primary endpoints [1][6][8]. - Icotrokinra demonstrated significant skin clearance and a favorable safety profile, achieving co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and Psoriasis Area and Severity Index (PASI) 90 compared to placebo [6][7][13]. - The ICONIC-ADVANCE studies showed superiority of icotrokinra over deucravacitinib in patients with moderate-to-severe psoriasis [1][6][13]. Group 2: Safety Profile - Pooled safety data indicated that 49.1% of patients treated with icotrokinra experienced adverse events, compared to 51.9% in the placebo group, with no new safety signals identified [1][6][8]. - The safety profile of icotrokinra is considered favorable relative to comparators, supporting its potential as a treatment option [2][4]. Group 3: Future Studies and Research - Johnson & Johnson has initiated the Phase 3 ICONIC-ASCEND study, which aims to demonstrate the superiority of icotrokinra compared to the injectable biologic ustekinumab and placebo [4][10]. - Long-term data from the ICONIC development program, including at least 52 weeks of treatment, is being prepared for future presentations [6][8]. Group 4: Market Context - Plaque psoriasis affects approximately 6.4 million people in Europe and over 125 million globally, with nearly one-quarter of cases classified as moderate-to-severe [9][10]. - The burden of plaque psoriasis extends beyond physical symptoms, impacting emotional health and quality of life [9][10].