SAT0316 Rapid and sustained improvements in both skin and musculoskeletal symptoms correlates with improved quality of life in patients with active psoriatic arthritis

Background Psoriatic arthritis (PsA) is a chronic, systemic, autoimmune, inflammatory arthritis condition commonly associated with psoriasis. Several biologic therapies exist for the treatment of PsA, with varying degrees of efficacy and onset of action. Objectives The objective of this analysis was to examine whether there is additional value to a patient’s overall quality of life if efficacy is achieved early during treatment and sustained. Methods Data were analysed from an integrated database of 2 double-blind, phase III SPIRIT trials investigating the efficacy and safety of ixekizumab (IXE), a high-affinity monoclonal antibody selectively targeting interleukin-17A, for patients with active PsA. The integrated database consisted of patients who were biologic-naive (SPIRIT-P1, NCT01695239) or who had an inadequate response or were intolerant to tumour necrosis factor inhibitors (SPIRIT-P2; NCT02349295). Patients were randomised to placebo (n=224) or 80 mg IXE every 4 (n=229) or 2 weeks (n=226) after a 160 mg starting dose. Patients included in this post-hoc analysis had baseline ≥3% body surface area (BSA) and at least one visit with a Psoriasis Area and Severity Index (PASI) 75 and American College of Rheumatology (ACR) 20 response; all treatment groups were combined. During the first 24 weeks of the trial, health-related quality of life (HRQoL) was measured by Short Form-36 Health Survey (SF-36) domain scores, the EuroQoL 5 Dimensions Visual Analogue Scale (EQ-5D VAS), and the Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) activity impairment domain. Change in HRQoL at Week 24 was modelled using a response surface model with duration of consecutive PASI and ACR responses and their interaction as independent variables. Missing data were imputed using last observation carried forward and non-responder imputation for continuous and categorical endpoints, respectively. Results Of the 679 placebo- and IXE-treated patients in the SPIRIT trials, 215 (31.7%) had baseline≥3% BSA and≥1 PASI75 and ACR20 response. Longer consecutive ACR20 responses correlated positively with greater HRQoL improvements, as measured by the EQ-5D VAS (figure 1). Patients with a longer consecutive number of both ACR20 and PASI75 responses had the highest improvements in EQ-5D VAS. This was consistent with 7 of 8 SF-36 domains, as well as the WPAI-SHP activity impairment domain (data not shown). Response surface modelling of the contribution of skin and joint improvements to patient HRQoL. (A) Three-dimensional scatterplot of skin (y-axis; PASI – consecutive response in weeks), joint (x-axis; ACR20 – consecutive response in weeks), and HRQoL (z-axis; EQ-5D – change from baseline) improvement at Week 24. A colour spectrum is applied to HRQoL improvements (blue [least improvement] to red [greatest improvement]). (B) Response surface of scatterplot estimated by smoothing spline method. Conclusions Early and sustained improvements in the symptoms of PSA correlated positively with improved HRQoL. The greatest HRQoL improvements were achieved when both skin and musculoskeletal symptoms improved early and were sustained. Disclosure of Interest A. Kavanaugh Consultant for: Eli Lilly and Company, J. Birt Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, C.-Y. Lin Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, O. Benichou Employee of: Eli Lilly and Company, M. Hufford Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, A. B. Gottlieb Grant/research support from: Janssen, Incyte, Consultant for: Janssen Inc.; Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbvie, UCB, Novartis, Incyte, Lilly, Reddy Labs, Valeant, Dermira, Allergan, Sun Pharmaceutical Industries