EXPLORE SKIN CLEARANCE DATA
Review ICOTYDE efficacy results, including IGA 0/1, PASI 90, PASI 100, IGA 0, and mean PASI
Answer: The International Psoriasis Council guidelines advise systemic treatment in patients who meet one or more of the following criteria1:
- BSA >10%
- High-impact site involvement
- NEW 2025 update: After 2 consecutive 4-week topical therapy courses fail*
If the patient fails to respond, transition them to UV phototherapy or systemic therapy, keeping topicals as adjunct treatment for resistant areas.1
*Topical treatment failure defined as the inability to achieve clear/nearly clear skin (BSA ≤1%, PGA 0 or 1).1
Reference: 1. Strober BE, Blauvelt A, van de Kerkhof PCM, et al. Establishing consensus on defining failure of topical therapy in psoriasis: recommendations from the International Psoriasis Council. J Am Acad Dermatol. 2026;94(1):372-375. doi:10.1016/j.jaad.2025.08.116
Answer: ICOTYDE is a peptide and it is metabolized via peptide catabolism into smaller peptides. It is designed to resist enzymatic degradation and acid denaturation within the gastrointestinal tract. Its macrocyclic structure supports gastrointestinal stability and facilitates absorption across the gut, enabling systemic circulation. Following oral administration of ICOTYDE to healthy subjects, approximately 37% to 81% of the dose was recovered in feces within 24 hours as unchanged ICOTYDE, and 0.001% of the dose was recovered in urine as unchanged ICOTYDE.1,2
References: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Knight B, Dallas S. Mardirosian S, et al. ADME profiling of targeted oral peptide JNJ-77242113 (icotrokinra). Poster presented at: American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting; May 28-31, 2025; Washington, DC.
Answer: ICOTYDE is approved for use in patients aged ≥12 years who weigh at least 40 kg (88 lbs). In subgroup analyses across 4 phase 3 clinical trials, age and body weight did not have an impact on response.1
Reference: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
Answer: While no formal drug-drug interaction studies have been conducted, no clinically significant drug interactions have been identified. There was also no identified clinically meaningful effect of antidrug antibodies on pharmacokinetics, safety, or effectiveness of ICOTYDE through Week 52.1
Reference: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
Answer: The safety and effectiveness of ICOTYDE have been established in adolescent patients aged ≥12 years weighing at least 40 kg with moderate to severe plaque psoriasis in 2 multicenter, randomized, 52-week trials (ICONIC-LEAD and ICONIC-TOTAL), which included 72 adolescent subjects aged 12 to 17 years. In the ICONIC-LEAD study, at week 16, 84% of the adolescent patients treated with ICOTYDE achieved clear or almost clear skin with a 2-point grade improvement, and 70% of patients achieved PASI 90.1,2
References: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Bissonnette R, Soung J, Hebert AA, et al. Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795. doi:10.1056/NEJMoa2504187
Answer: Instruct patients to take the missed dose as soon as possible, with a return to the normal dosing schedule the following day.1
Reference: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
Answer: In healthy subjects, coadministration of a single ICOTYDE 200-mg tablet with a high-calorie, high-fat (1000 calories, 50% fat) meal decreased ICOTYDE AUC∞ and Cmax by 43% and 59%, respectively, relative to the fasted state. ICOTYDE should be taken upon waking at least 30 minutes before eating food. Administration of a single ICOTYDE tablet with caffeine resulted in no significant difference in exposure.1
Reference: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
AUC, area under the curve; BSA, body surface area; IGA, Investigator’s Global Assessment; IPC, International Psoriasis Council; PASI, Psoriasis Area and Severity Index; PGA, Physician's Global Assessment; PsO, psoriasis; UV, ultraviolet.