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Durability of response to icotrokinra for high-impact site psoriasis: 1-year ICONIC-TOTAL findings.

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Title: Durability of response to icotrokinra for high-impact site psoriasis: 1-year ICONIC-TOTAL findings.
Authors: Warren RB; Northern Care Alliance NHS Foundation Trust & Division of Musculoskeletal and Dermatological Sciences, Dermatology Centre, Manchester NIHR Biomedical Research Centre, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK., Gooderham M; SKiN Centre for Dermatology, Peterborough, Ontario, Canada.; Department of Medicine, Queen's University, Kingston, Ontario, Canada.; Probity Medical Research, Waterloo, Ontario, Canada., Lain E; Austin Institute for Clinical Research, Sanova Dermatology, Austin, Texas, USA., Bissonnette R; Innovaderm Research, Montreal, Quebec, Canada., Huang YH; Department of Dermatology, Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan City, Taiwan., Ringuet J; Centre de Recherche Dermatologique du Québec Métropolitain, Quebec, Quebec, Canada.; Department of Dermatology, McGill University, Montreal, Quebec, Canada., Hoffmann M; Dermatology Practice Dr Matthias Hoffmann, Witten, Germany., Pinter A; University Hospital Frankfurt am Main, Frankfurt am Main, Germany., Merola JF; Department of Dermatology, UT Southwestern Medical Center and O'Donnell School of Public Health, Dallas, Texas, USA.; Division of Rheumatology, Department of Medicine, UT Southwestern Medical Center and O'Donnell School of Public Health, Dallas, Texas, USA., Rubens JH; Johnson & Johnson, La Jolla, California, USA., Fan D; Johnson & Johnson, Spring House, Pennsylvania, USA., Hsu MC; Johnson & Johnson, West Chester, Pennsylvania, USA., Li S; Johnson & Johnson, Malvern, Pennsylvania, USA., Yang YW; Johnson & Johnson, Horsham, Pennsylvania, USA., DeKlotz CMC; Johnson & Johnson, Spring House, Pennsylvania, USA., Song EJ; Frontier Dermatology, Mill Creek, Washington, USA.
Source: Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2026 May 23. Date of Electronic Publication: 2026 May 23.
Publication Model: Ahead of Print
Publication Type: Journal Article
Language: English
Journal Info: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9216037 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1468-3083 (Electronic) Linking ISSN: 09269959 NLM ISO Abbreviation: J Eur Acad Dermatol Venereol Subsets: MEDLINE
Imprint Name(s): Publication: Oxford : Wiley-Blackwell
Original Publication: Amsterdam ; New York : Elsevier Science Publishers, c1992-
Abstract: Background: High-impact site plaque psoriasis is difficult to treat. Icotrokinra, an oral peptide with high specificity for the interleukin (IL)-23 receptor, demonstrated significantly higher rates of high-impact site psoriasis clearance, versus placebo, with no safety signals, through Week (W)16.
Objectives: Report clinical response rates and safety through 1 year of icotrokinra treatment in participants with high-impact site plaque psoriasis.
Methods: Participants (≥12 years of age; psoriasis body surface area ≥1%; Investigator's Global Assessment [IGA] ≥2) with at least moderate scalp, genital or hand/foot psoriasis were randomized (2:1) to once-daily icotrokinra 200 mg (N = 208) or placebo (N = 103), with placebo-to-icotrokinra transition at W16 (N = 92). Rates (using nonresponder imputation) of achieving clear/almost clear (0/1) or clear (0) overall skin (IGA), genital (static Physician's Global Assessment of genitalia [sPGA-G]), hand/foot (hf-PGA) psoriasis and absent/very mild (0/1) or absent (0) scalp psoriasis (scalp-specific-IGA [ss-IGA]), modified Nail Psoriasis Severity Index (mNAPSI) percent improvement and safety were assessed through W52.
Results: Eighty-eight per cent (275/311) of participants completed treatment through W52. In icotrokinra-randomized participants, response rates increased through W24 and were durable through W52 for overall psoriasis clearance (IGA 0/1 range: 67%-70%) and across high-impact sites (ss-IGA 0/1: 72%-78%; sPGA-G 0/1: 85%-90%; hf-PGA 0/1: 54%-62%); responses were consistent among placebo-randomized participants after transitioning to icotrokinra. High proportions of icotrokinra-randomized participants achieved complete clearance during W24-52 (IGA 0: 44%-51%; ss-IGA 0: 57%-66%; sPGA-G 0: 73%-84%; hf-PGA 0: 44%-58%). Mean mNAPSI improvement increased from W16 (33%) to W52 (62%). Exposure-adjusted rates of participants with ≥1 adverse event (AE) or serious AE through W16 were similar between icotrokinra and placebo, with no increase in AE rates or occurrence of a safety signal through W52.
Conclusions: Icotrokinra demonstrated high and durable rates of psoriasis clearance across high-impact sites, with a favourable safety profile, through 1 year.
(© 2026 The Author(s). Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)
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Grant Information: Johnson & Johnson
Contributed Indexing: Keywords: 1‐year; clinical trials; foot; genitalia; hand; high‐impact sites; icotrokinra; interleukin‐23; nails; oral; psoriasis; randomized controlled trials; scalp; skin; skin diseases
Local Abstract: [plain-language-summary] Psoriasis is a lifelong inflammatory skin disease causing thick, scaly plaques, which may be itchy or painful. Psoriasis can involve special body sites, such as the scalp, genitals, hands/feet and nails, which may be particularly bothersome to patients. Psoriasis is caused by high levels of certain immune proteins, including interleukin (IL)‐23. While many patients prefer oral treatments, current advanced oral therapies for psoriasis are less efficacious than injectable treatments and none specifically target the IL‐23 pathway. Icotrokinra is an oral peptide that targets the IL‐23 receptor with high specificity to inhibit IL‐23 pathway signalling, and it is the first such molecule to gain approval for treatment of plaque psoriasis. Icotrokinra is being evaluated in the ICONIC‐TOTAL phase 3 randomized controlled trial conducted at 90 sites across 11 countries. Reported here are clinical response and safety through 1 year of icotrokinra treatment among 311 study participants with high‐impact site plaque psoriasis (scalp, genital and hand/foot). Previous reports showed icotrokinra had higher rates of psoriasis clearance compared with placebo through 16 weeks of treatment. After the placebo‐controlled period, among icotrokinra‐randomized participants, response rates increased through Week 24 and were durable through Week 52 for overall psoriasis clearance (ranging from 67%–70%) and across high‐impact sites (scalp: 72%–78%; genital: 85%–90%; hand/foot: 54%–62%). Additionally, icotrokinra provided improvements (62%) in nail psoriasis through Week 52. Icotrokinra safety through Week 16 was similar to placebo, with no increase in rates of adverse events through Week 52. Icotrokinra demonstrated high and durable rates of psoriasis clearance at high‐impact sites, with a favourable safety profile, through 1 year of treatment.
Entry Date(s): Date Created: 20260523 Latest Revision: 20260523
Update Code: 20260524
DOI: 10.1111/jdv.70471
PMID: 42175814
Database: MEDLINE
Description
ISSN:1468-3083
DOI:10.1111/jdv.70471