TOPLINE:
Oral icotrokinra yielded high and durable clearance rates at high-impact sites through 1 year in patients with psoriasis, with a safety profile similar to that of placebo in a phase 3 trial.
METHODOLOGY:
- Researchers used data from an ongoing phase 3, multicentre, randomised, double-blind, placebo-controlled trial, including 311 patients (mean age, 44.7 years; 64% male; 78% White) with plaque psoriasis at screening and at least moderate disease at high-impact sites; patients were from 11 countries, and six of them were adolescents (age, 12 to < 18 years).
- All patients were randomly assigned in a 2:1 ratio to receive once-daily oral icotrokinra 200 mg (n = 208) or placebo (n = 103) through week 16, after which patients in the placebo group transitioned to icotrokinra through week 156.
- Researchers evaluated the severity of overall skin psoriasis using the Investigator's Global Assessment (IGA), scalp psoriasis using the scalp-specific IGA (ss-IGA), genital psoriasis using the static Physician's Global Assessment of Genitalia (sPGA-G), hand/foot psoriasis using the hand/foot PGA (hf-PGA), and nail psoriasis using the modified Nail Psoriasis Severity Index (mNAPSI) through week 52.
- A safety profile was also reported for both treatment groups through week 52.
TAKEAWAY:
- The icotrokinra-randomised group had high response rates through week 24, which remained consistent through week 52 for no or very mild overall skin psoriasis (IGA score, 0/1; 67%-70%), scalp psoriasis (ss-IGA score, 0/1; 78%-72%), genital psoriasis (sPGA-G score, 0/1; 90%-85%), and hand/foot psoriasis (hf-PGA score, 0/1; 54%-62%).
- At week 52, complete clearance of overall skin psoriasis was achieved by 44% of patients, scalp psoriasis by 57%, genital psoriasis by 84%, and hand/foot psoriasis by 58%. The placebo-randomised group achieved comparable response rates after transitioning to icotrokinra.
- The mean percent improvement in the mNAPSI score of 33.2% at week 16 increased to 62.0% by week 52 in the icotrokinra-randomised group.
- Exposure-adjusted incidence rates of patients with at least one adverse event did not increase between weeks 0 and 16 (232.8 per 100 patient-years; 95% CI, 188.2-277.3) and between weeks 0 and 52 (168.5 per 100 patient-years; 95% CI, 141.8-195.2) in the icotrokinra-randomised group. Similar results were observed for the placebo group after transitioning to icotrokinra at week 16.
IN PRACTICE:
Given the FDA approval of icotrokinra for treatment of plaque psoriasis, the authors concluded that this oral drug can provide "high rates of overall skin, scalp, genital and hand/foot psoriasis clearance, and improvements in nail psoriasis" and that "the icotrokinra AE [adverse event] profile, which was similar to placebo, remained favourable and no safety signals were identified through 1 year."
SOURCE:
The study was led by Richard B. Warren, Division of Musculoskeletal & Dermatological Sciences, The University of Manchester, Manchester, England. It was published online on May 23, 2026, in Journal of the European Academy of Dermatology and Venereology.
LIMITATIONS:
The study was limited by the small sample size per high-impact site. All placebo-randomised patients transitioned to icotrokinra at week 16, resulting in descriptive findings after week 16 and no control group for comparison.
DISCLOSURES:
This study was funded by Johnson & Johnson and supported by the National Institute for Health and Care Research Manchester Biomedical Research Centre. Several authors reported serving as consultants or speakers, receiving honoraria and/or research grants, and having other ties with multiple pharmaceutical companies, including Johnson & Johnson, AbbVie, Almirall, Alumis, and Amgen. Six authors reported being employees of Johnson & Johnson and possibly owning stock or stock options in the company. Full disclosures are provided in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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