25799 Efficacy and safety of ixekizumab in patients with moderate-to-severe plaque psoriasis with and without psoriatic arthritis at baseline: Results from UNCOVER studies through 5 years

Introduction/objective: Ixekizumab (IXE) demonstrated sustained efficacy and a consistent safety profile in psoriasis through 5 years. We evaluated effects of baseline psoriatic arthritis (PsA) on IXE efficacy and safety in moderate-to-severe psoriasis patients over 5 years in randomized, double-blinded Phase 3 trials. Methods: UNCOVER-1 and -2 patients (integrated) were Week 12 (IXE every 2 weeks [Q2W]) responders who completed maintenance (Week 60) and entered the long-term extension (LTE) period (5 years total) with approved dosing (every 4 weeks). UNCOVER-3 patients received IXE Q2W for 12 weeks and entered the LTE period with approved dosing. Psoriasis Area and Severity Index (PASI) 75/90/100 data include patients entering the LTE period with or without baseline PsA (self-reported), summarized using observed values. Escalated dosing visits during the LTE period were excluded from the analyses. Safety is reported. Results: Clinical response as proportions of patients achieving PASI 75/90/100 with baseline PsA (UNCOVER-1/2: N = 49, UNCOVER-3: N = 74) and without baseline PsA (UNCOVER-1/2: N = 157, UNCOVER-3: N = 288) was sustained through 5 years of treatment. At Week 264, PASI 75/90/100 responses in UNCOVER-1/2 with baseline PsA were 96.9%/81.3%/56.3% and without baseline PsA were 98.0%/88.0%/58.0%, and in UNCOVER-3 with baseline PsA were 97.6%/92.9%/78.6% and without baseline PsA were 97.4%/89.5%/63.2%. The overall IXE safety profile was similar to previous reports in both baseline PsA status groups for UNCOVER-1/2 and UNCOVER-3, with no new safety concerns. Conclusion: IXE demonstrated sustained skin clearance and a consistent safety profile through 5 years among patients with moderate-to-severe psoriasis irrespective of baseline PsA status.