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

Abstract

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.