Oral icotrokinra sustained clearance at scalp, genital, hand/foot, and nail sites through Week 112 in ICONIC-TOTAL, with no rise in adverse event rates.
Clearance rates with once-daily oral icotrokinra held steady through 2 years in
These data on icotrokinra were presented as a late-breaking abstract at the
Richard B. Warren, of the University of Manchester, is the abstract's first author, and Melinda Gooderham, MD, of the SKiN Centre for Dermatology and Queen's University, is senior author. Several coauthors are Johnson & Johnson employees.¹
The ongoing multicenter, double-blind trial enrolled patients aged 12 years and older with an Investigator's Global Assessment (IGA) score of 2 or higher, at least 1% body surface area involvement, and at least moderate disease at 1 or more high-impact sites.
Participants were randomized 2:1 to icotrokinra 200 mg daily or placebo, with placebo recipients switching to icotrokinra at Week 16. Qualifying high-impact disease meant a score of 3 or higher on the scalp-specific IGA, the static Physician's Global Assessment of Genitalia, or the hand/foot PGA.¹
Topical therapy was allowed after Week 52. Missing binary data were handled with nonresponder imputation through Week 52 and multiple imputation afterward. Of 311 randomized patients (208 icotrokinra, 103 placebo), 255 (82%) completed treatment through Week 112.¹
Among patients randomized to icotrokinra, the proportion with clear or almost clear skin (IGA 0/1) climbed from 57% at Week 16 to 67% at Week 24, then reached 70% at week 112. Completely clear skin (IGA 0) followed a similar curve, rising from 25% to 45% and then 48% over the same timepoints.¹
Site-specific responses showed comparable durability. Scalp clear or almost clear rates were 66%, 78%, and 74% at the 16, 24, and 112-week marks, respectively, while genital rates were 77%, 90%, and 89%.¹
Hand and foot responses took longer to plateau, increasing from 42% at Week 16 to 62% at Week 52 and 68% at Week 112. At the final timepoint, complete clearance was reported in 60% of patients for scalp, 89% for genital, and 63% for hand and foot psoriasis.¹
Nail involvement improved gradually over time. Percent improvement in the modified Nail Psoriasis Severity Index (mNAPSI) rose from 33% at Week 16 to 62% at Week 52 and 71% at Week 112 among patients randomized to icotrokinra.¹
Patients who crossed over from placebo saw nail improvements of similar magnitude, according to the investigators.¹
Longer exposure did not raise adverse event rates. The exposure-adjusted incidence of patients with at least 1 adverse event was 160 per 100 patient-years (95% CI, 138-182) through Week 52 and 122 per 100 patient-years (95% CI, 106-137) through Week 112.¹
Serious adverse event rates were unchanged at 2.7 per 100 patient-years across both periods (Week 52: 95% CI, 1.1-5.6; Week 112: 95% CI, 1.3-4.1). No deaths occurred.¹ Because topical therapy was permitted after Week 52 and multiple imputation was used beyond Week 52, later response rates may not be directly comparable with those from the first year. The abstract also did not specify which adverse events occurred most often or break down results for adolescents.
Editor’s note: This summary has been edited for grammar and clarity using artificial intelligence tools.
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