AB0711 IXEKIZUMAB IMPROVES SIGNS AND SYMPTOMS AND SPINAL INFLAMMATION OF ANKYLOSING SPONDYLITIS/RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS THROUGH ONE YEAR OF TREATMENT IN BIOLOGIC DISEASE MODIFYING ANTI-RHEUMATIC DRUG-NAÏVE PATIENTS

Background During 16 weeks (wks) of blinded treatment, ixekizumab (IXE) and an adalimumab (ADA) active reference arm were superior to placebo (PBO) in improving signs and symptoms of radiographic axial spondyloarthritis (r-axSpA).1 Objectives To assess the safety and efficacy of continuous treatment with IXE through 52 wks in patients (pts) with r-axSpA and to describe clinical response at Wk 52 for pts who switched to IXE following 16 wks of treatment with either aDA or PBO. Methods Participants were biologic disease-modifying anti-rheumatic drug (bDMARD)-naive adult pts with active r-axSpA per assessment of Spondyloarthritis (SpA) international Society (ASAS) criteria (sacroilliitis centrally defined by modified New York criteria and ≥1 SpA feature) and inadequate response or intolerance to non-steroidal anti-inflammatory drugs. Pts were randomized 1:1:1:1 to receive 80 mg IXE every 2 (Q2W) or 4 wks (Q4W), 40 mg adalimumab (ADA) Q2W (active reference arm), or PBO. At Wk 16, pts assigned to IXE continued their assigned treatment and pts receiving PBO or aDA were re-randomized 1:1 to IXE Q2W or IXE Q4W through Wk 52. Results Of 164 pts initially randomized to IXE, 146 (89%) completed Wk 52. IXE Q4W and IXE Q2W led to persistent improvements in disease activity, function, objective inflammation (MRI and C-reactive protein), quality of life, health status, and overall functioning for up to 52 wks (Figure and Table). For pts initially assigned to PBO or aDA, aSAS40 response showed a numerical increase upon switching to IXE (Table). Frequencies of treatment-emergent adverse events (AEs) were similar between IXE dosing regimens. Among pts with ≥1 dose of IXE (N=336), serious aEs occurred in 20 (6%) pts. There were no deaths and 11 (3%) pts discontinued due to aEs. Conclusion Persistent improvements in the signs and symptoms of r-axSpA were observed through Wk 52 in pts who received continuous treatment with IXE. ASAS40 response rates at Wk 52 were numerically similar between pts who received continuous treatment with IXE and pts who switched from aDA to IXE. No unexpected safety signals were observed through 52 wks of treatment. References [1] van der Heijde, et al. Lancet, 2018 Disclosure of interests James Cheng-Chung Wei Grant/research support from: abbvie, BMS, Celgene, Janssen, Novartis, Pfizer, and UCB pharma, Consultant for: TSH Taiwan, Speakers bureau: Janssen, Novartis, Pfizer and TSH, Lianne S. Gensler Grant/research support from: abbvie, amgen, UCB Pharma, Consultant for: Novartis, Lilly, Janssen, Jessica a. Walsh Grant/research support from: abbvie, Pfizer, Consultant for: abbvie, Celgene, Lilly, Novartis, Robert B.M. Landewe: None declared, Tetsuya Tomita Consultant for: abbVie, astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe, Novartis, Takeda, and Pfizer, Speakers bureau: abbVie, astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe, Novartis, Takeda, and Pfizer, Fangyi Zhao Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gaia Gallo Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Hilde Carlier Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, maxime dougados Grant/research support from: Eli Lilly and Company, Pfizer, abbVie, and UCB Pharma, Consultant for: Eli Lilly and Company, Pfizer, abbVie, and UCB Pharma