Journal of psoriasis and psoriatic arthritis · 2026
Icotrokinra, a Targeted Oral Peptide, in Participants With Moderate-to-Severe Plaque Psoriasis and Self-Reported Psoriatic Arthritis: Results From a Pooled Analysis of the Phase 3 ICONIC-LEAD, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 Trials.
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McInnes Iain B, Stein Gold Linda, Bissonnette Robert, Lebwohl Mark G, Reyes-Servin Ofelia, Cafone Joseph, Yang Ya-Wen, Chakravarty Soumya D, Iaconangelo Charles, Li Shu, Shagroni Tasneam, Lozenski Karissa, Armstrong April W, Merola Joseph F
Аннотация
BACKGROUND: Icotrokinra, a targeted oral peptide that precisely blocks the interleukin-23 receptor, is approved to treat adult and pediatric (≥12 years, ≥40 kg) patients with moderate-to-severe plaque psoriasis (PsO).
OBJECTIVE: Assess psoriatic arthritis (PsA)-specific outcomes through Week (W) 16 in a subgroup of phase-3 study participants with moderate-to-severe plaque PsO and self-reported medical history of PsA (PsO+PsA).
METHODS: Post-hoc analyses pooled data from ICONIC-LEAD and ICONIC-ADVANCE 1 and 2 among PsO+PsA participants randomized to once-daily icotrokinra 200 mg or placebo through W16. PsA-specific outcomes included mean change from baseline and ≥50% improvement in Patient's Global Assessment (PtGA) of PsA disease activity and Patient's Assessment of PsA Pain, and percent change from baseline in modified Nail Psoriasis Severity Index (mNAPSI). P values are nominal.
RESULTS: Analyses included 216 participants (149 icotrokinra, 67 placebo). At W8, icotrokinra-treated participants reported greater improvements vs placebo in PtGA of PsA disease activity (-18.5 vs -4.8; P < 0.001) and PsA Pain (-17.1 vs -4.6; P < 0.001), with improvement sustained at W16 (-19.2 vs -0.8; P < 0.001; -19.5 vs -7.8; P = 0.003). At W16, greater proportions of icotrokinra-treated vs placebo-treated participants achieved ≥50% improvement in PtGA of PsA disease activity (47.0% vs 10.7%; P < 0.001) and PsA Pain (45.5% vs 16.1%; P < 0.001). At W16, icotrokinra improved mNAPSI by 41.6% (vs 118.6% worsening with placebo; P < 0.001). Adverse event rates were similar between icotrokinra and placebo.
CONCLUSIONS: Icotrokinra demonstrated early, substantial improvements in participant-reported PsA activity and PsA Pain, and nail psoriasis, with a favorable safety profile through W16 in participants with PsO+PsA.
OBJECTIVE: Assess psoriatic arthritis (PsA)-specific outcomes through Week (W) 16 in a subgroup of phase-3 study participants with moderate-to-severe plaque PsO and self-reported medical history of PsA (PsO+PsA).
METHODS: Post-hoc analyses pooled data from ICONIC-LEAD and ICONIC-ADVANCE 1 and 2 among PsO+PsA participants randomized to once-daily icotrokinra 200 mg or placebo through W16. PsA-specific outcomes included mean change from baseline and ≥50% improvement in Patient's Global Assessment (PtGA) of PsA disease activity and Patient's Assessment of PsA Pain, and percent change from baseline in modified Nail Psoriasis Severity Index (mNAPSI). P values are nominal.
RESULTS: Analyses included 216 participants (149 icotrokinra, 67 placebo). At W8, icotrokinra-treated participants reported greater improvements vs placebo in PtGA of PsA disease activity (-18.5 vs -4.8; P < 0.001) and PsA Pain (-17.1 vs -4.6; P < 0.001), with improvement sustained at W16 (-19.2 vs -0.8; P < 0.001; -19.5 vs -7.8; P = 0.003). At W16, greater proportions of icotrokinra-treated vs placebo-treated participants achieved ≥50% improvement in PtGA of PsA disease activity (47.0% vs 10.7%; P < 0.001) and PsA Pain (45.5% vs 16.1%; P < 0.001). At W16, icotrokinra improved mNAPSI by 41.6% (vs 118.6% worsening with placebo; P < 0.001). Adverse event rates were similar between icotrokinra and placebo.
CONCLUSIONS: Icotrokinra demonstrated early, substantial improvements in participant-reported PsA activity and PsA Pain, and nail psoriasis, with a favorable safety profile through W16 in participants with PsO+PsA.