EXPLORE SKIN CLEARANCE DATA
Review ICOTYDE efficacy results, including IGA 0/1, PASI 90, PASI 100, IGA 0, and mean PASI
ICONIC-ADVANCE 1 (N=774) and ICONIC-ADVANCE 2 (N=731): Two phase 3, multicenter, randomized, double-blind, placebo-controlled and active comparator–controlled trials that evaluated the efficacy and safety of ICOTYDE 200 mg orally once daily in adults with moderate to severe plaque psoriasis defined as IGA ≥3, PASI ≥12, and BSA ≥10%. Patients randomized to placebo crossed over to ICOTYDE at Week 16. Patients randomized to deucravacitinib 6 mg orally once daily crossed over to ICOTYDE at Week 24. Patients received open-label ICOTYDE after Week 24 through Week 156. Safety will be assessed through Week 160.1,3
ICONIC-LEAD (N=684): A phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of ICOTYDE 200 mg orally once daily in adult and adolescent patients 12 years and older and weighing at least 40 kg with moderate to severe plaque psoriasis defined as IGA ≥3, PASI ≥12, and BSA ≥10%. Patients randomized to placebo crossed over to ICOTYDE at Week 16. Adults with a treatment response entered randomized withdrawal and retreatment from Week 24 to Week 52. Patients received open-label ICOTYDE from Week 52 to Week 156. Safety will be assessed through Week 160.1,4
ICONIC-TOTAL (N=311): A phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of ICOTYDE 200 mg orally once daily in adult and adolescent patients 12 years and older and weighing at least 40 kg with moderate to severe plaque psoriasis who had a minimum BSA involvement of ≥1% and IGA ≥2 and had failed to respond to ≥1 topical therapies. Patients had at least one of the following baseline conditions: ss-IGA ≥3, sPGA-G ≥3, and/or hf-PGA ≥3. Patients randomized to placebo crossed over to ICOTYDE at Week 16. Efficacy will be assessed through Week 156. Safety will be assessed through Week 160.1,5
Warnings and Precautions include infections, tuberculosis, and immunizations
*Based on safety analysis set. Data were pooled across ADVANCE 1, ADVANCE 2, LEAD, and TOTAL.
†Refers to adverse reactions ≥1% with ICOTYDE and more frequently than placebo.
‡Includes oral candidiasis, onychomycosis, skin candida, urinary tract candidiasis, vulvovaginal candidiasis, fungal skin infection, genital infection fungal, ear infection fungal, laryngitis fungal. Two patients experienced more than 1 event.
§Due to 1 or more adverse events.
WHEN TREATING WITH ICOTYDE
NO
labeled warnings and precautions for
malignancy, IBD, depression, or candidiasis1*
NO
routine lab monitoring1†
NO
reports of new or reactivated latent TB infections to date1,2‡
NO
identified drug–drug interactions1§
*Fungal infection including oral candidiasis (n=2), skin candida (n=1), urinary tract candidiasis (n=1), and vulvavaginal candidiasis (n=1) have been reported with ICOTYDE.
†Consider evaluating patients for TB and instruct patients to report signs and symptoms of infection.
‡As of initial US approval: 2026.
§No formal studies have been conducted and no clinically significant drug interactions have been identified.
BSA, body surface area; hf-PGA, Physician’s Global Assessment of Hands and Feet; IBD, inflammatory bowel disease; IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PsO, psoriasis; sPGA-G, Static Physician’s Global Assessment of Genitalia; ss-IGA, Scalp-Specific Investigator’s Global Assessment; TB, tuberculosis.
References: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. Gold LS, Armstrong AW, Bissonnette R, et al. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025;406(10510):1363-1374. doi:10.1016/S0140-6736(25)01576-4 4. 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 5. Gooderham M, Lain E, Bissonnette R, et al. Targeted oral peptide icotrokinra for psoriasis involving high-impact sites. NEJM Evid. 2025;4(12):EVIDoa2500155. doi:10.1056/EVIDoa2500155