O03 Efficacy and safety of ixekizumab at week 24 in biologic experienced patients with active psoriatic arthritis summary results

Abstract

Background: Psoriatic arthritis is a chronic inflammatory arthritis associated with plaque psoriasis. Here we present data from a dou‐ble‐blind phase 3 trial to assess the safety and efficacy of ixek‐izumab, a monoclonal antibody that inhibits IL‐17A, in patients with active PsA, with inadequate response to TNF inhibitor treatment. Method: Patients were randomised to subcutaneous placebo or ixekizumab 80 mg every two (Q2W) or four weeks (Q4W), following a 160 mg initial dose at w0. Primary endpoint was the proportion of patients achieving an ACR 20 at week 24. Result: 363 patients were randomized: inadequate response to 1‐2 TNF‐inhibitors (204 [56.2%], 128 [35.3%], respectively) or TNF‐intol‐erant (31 [8.5%]) with 87% completing the 24 weeks. At w24, significantly more ixekizumab vs. placebo‐treated patients achieved ACR20 (65 [53.3%], 59 [48.0%] vs. 23 [19.5%]; Q4W, Q2W, placebo, respectively), ACR50 (43 [35.2%], 41 [33.3%] vs. 6 [5.1%]; respec‐tively), ACR70 (27 [22.1%], 15 [12.2%] vs. 0; respectively), MDA (34 [27.9%], 29 [23.6%] vs. 4 [3.4%]; respectively) and reductions in functional disability (HAQ‐DI). Significantly, more ixekizumab‐treated patients with ≥3% BSA achieved PASI75 and more patients achieved an itch numeric rating scale of zero. There was a higher incidence of injection site reactions in the ixekizumab‐treated groups, with the majority being mild otherwise the incidence of TEAEs was similar across groups (83 [68.0%], 90 [73.2%] vs. 76 [64.4%]; Q4W, Q2W, placebo, respectively). Conclusion: Ixekizumab improved arthritis, physical function and psoriasis compared to placebo with no unexpected safety findings in patients with active PsA who had inadequate response with prior TNF‐inhibitors. This study was sponsored by Eli Lilly and Company.