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.
Warren et al. (Sat,) studied this question.