P182\u2003A systematic literature review and network meta-analysis of the efficacy and safety of ixekizumab versus currently licensed biologics for the treatment of radiographic axSpA

Abstract

\n Background/Aims\u2002\n Patients with radiographic axial spondyloarthritis (rad-axSpA) are often managed using biologic therapies such as TNF-α inhibitors and interleukin-17 inhibitors, including ixekizumab (IXE). Due to a lack of head-to-head trial data, limited evidence exists as to the relative performance of biologic therapies. Therefore, when making evidence-based reimbursement decisions, treatment funding agencies can use network meta-analysis (NMA) to estimate the relative efficacy and safety of each treatment within a network of comparator treatments.\n Objectives: Demonstrate, by means of NMA, the efficacy and safety of IXE 80 mg administered every four weeks (Q4W) against other approved biologic agents used in the treatment of r-axSpA in a biologic-naïve population.\n Methods\u2002\n We conducted a systematic literature review in February 2019 to identify relevant studies for inclusion in the NMA. The NMA was based on Bayesian Mixed Treatment Comparisons in keeping with NICE DSU (Decision Support Unit) technical guidance. The base case for this analysis focused on studies with biologic-naïve populations and assessed endpoints including the Assessment of SpondyloArthritis International Society endpoints (ASAS20 and ASAS40), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at least 50% improvement (BASDAI50), adverse events (AEs), serious adverse events (SAEs) and treatment discontinuation due to AE (DISCAE). Sensitivity analyses explored the robustness of the base case by including studies where the patient’s prior exposure to biologic therapy was unclear, not stated or mixed (treatment naïve and treatment experienced) and examined the impact of IXE starting dose (80mg v 160mg) on outcomes.\n Results\u2002\n In total, the systematic literature review included 78 full papers and 27 conference proceedings. Fixed-effect models were chosen, as they had lower deviance information criteria (DICs) and random effects models frequently did not converge. IXE 80 mg Q4W demonstrated superiority to placebo on the ASAS20 (Odds Ratio: 3.72, 95% CI:2.11,6.68), ASAS40 (Odds Ratio: 6.26, 95% CI:3.37,11.69), BASDAI (Mean difference: -1.72, 95% CI:-2.27,-1.17) and the BASDAI 50 (Odds Ratio: 5.40, 95% CI: 2.91, 10.06) as well as the other efficacy measures investigated. IXE and the comparator treatments demonstrated similar efficacy compared to each other. The rate of AEs, SAEs and DISCAE were in line with the existing literature both for IXE and the comparator treatments.\n Results from the sensitivity analyses were confirmatory for the robustness of the base case results.\n Conclusion\u2002\n This NMA confirms the efficacy and acceptable safety profile of IXE 80 mg Q4W and other biologics in biologic-naïve patients with active rad-axSpA. The NMA can be used to inform evidence-based decision-making in clinical practice and in payer decisions by including all currently marketed agents and dosages.\n Disclosure\u2002\n Y. Schymura: Corporate appointments; Yves Schymura is an employ of Eli Lilly and Company. P. Graham-Clarke: Corporate appointments; Peita Louise Graham-Clarke is an employee of Eli Lilly and Company. Shareholder/stock ownership; Peita Louise Graham-Clarke is a minor shareholder of Eli Lilly and Company. S. Liu-Leage: Corporate appointments; Soyi Liu-Leage is an employ of Eli Lilly and Company. Shareholder/stock ownership; Soyi Liu-Leage is a minor shareholder of Eli Lilly and Comapny.