P187 Safety and efficacy of ixekizumab treatment in patients with axial spondyloarthritis: 3-year results from the COAST programme

Background/Aims Ixekizumab (IXE) has demonstrated efficacy at week (wk) 16 which was maintained through 2 years (yrs) and was associated with a consistent safety profile in patients (pts) with r- and nr-axSpA, who are bDMARD-naïve and TNFi-experienced. We aimed to report safety and efficacy from the COAST programme at 3 yrs: 1 yr of the originating studies (COAST-V/W/X) and 2 yrs of COAST-Y. Methods COAST-Y (NCT03129100) is the phase 3, long-term extension study of the 3 originating studies COAST-V/W/X. Pts continued with the dose received at the end of the originating trial at week (wk) 52, either with 80 mg IXE every 4 wks (Q4W) or every 2 wks (Q2W). Pts assigned to adalimumab (ADA) or placebo (PBO) were re-randomised to IXE Q4W or Q2W at wk 16 in COAST-V and -W. Pts who received PBO for 52 wks in COAST-X were switched to IXE Q4W to continue in COAST-Y. Starting at wk 116 (wk 64 of COAST-Y), pts receiving IXE Q4W could have their dose escalated to Q2W based on investigator's opinion. This analysis focused on pts receiving ≥1 dose of IXE Q4W, observed data while on IXE Q2W dose escalation are excluded. Continuous data are summarised as observed. Safety data while on IXE were analysed for pts who received ≥1 dose of IXE; observed data while on PBO or ADA are excluded. Results A total of 932 pts received ≥1 dose of IXE, 414 received ≥1 dose of IXE Q4W, and 562/932 (60%) pts completed 3 yrs of follow-up (PBO→IXE Q4W, 63/119 (53%); ADA→IXE Q4W, 29/44 (66%); and IXE Q4W→IXE Q4W, 114/251(45%)). Through 3 yrs, the most frequently reported treatment-emergent adverse events were infections [incidence rate (IR) 25.7/100 patient years (PY)] and injection site reactions [IR 7.4/100 PY], the majority of which were mild/moderate in severity. Serious adverse events were reported at an IR of 4.8/100 PY, of which osteoarthritis was the most frequent at 0.4/100 PY. A total of 3 deaths were reported among all pts who received ≥1 dose of IXE [IR 0.1/100 PY]. For all patients, baseline disease activity (Ankylosing Spondylitis Disease Activity Score; ASDAS) was high. A similar improvement in disease activity through 3 yrs was confirmed across additional efficacy endpoints. Conclusion This analysis in COAST-Y demonstrated that the safety profile is consistent with the established safety profile, with no new safety signals observed. Patients on IXE Q4W had sustained improvement through 3 years. Disclosure A. Deodhar: Consultancies; A. Deodhar has served as a speaker and/or consultant for: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos NV, GlaxoSmithKline, Janssen, Novartis, Pfizer, and UCB Pharma. D. Poddubnyy: Shareholder/stock ownership; D. Poddubnyy has served as a speaker and/or consultant for: AbbVie, BIOCAD, Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Samsung Bioepis, and UCB Pharma. Grants/research support; D.P. has received grant and/or research support from: AbbVie, Eli Lilly and Company, Merck Sharp & Dohme, Novartis, and Pfizer. P. Rahman: Consultancies; P. Rahman has served as a speaker for: Abbott, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, and Pfizer. Grants/research support; P.R. has received grant and/or research support from: Janssen and Novartis. R. Bolce: Shareholder/stock ownership; R. Bolce is an employee and shareholder of: Eli Lilly and Company. S. Liu Leage: Shareholder/stock ownership; S. Liu-Leage is an employee and shareholder of: Eli Lilly and Company. A. Kronbergs: Shareholder/stock ownership; A. Kronbergs is an employee and shareholder of: Eli Lilly and Company. C. Johnson: Shareholder/stock ownership; C. Johnson is an employee and shareholder of: Eli Lilly and Company. A. Leung: Corporate appointments; A. Leung is an employee of: Syneos Health; and a contractor for: Eli Lilly and Company. D. van der Heijde: Consultancies; D. van der Heijde has served as a consultant for: AbbVie, Bayer Pharmaceuticals, Bristol Myers Squibb, Cyxone, Eisai, Eli Lilly and Company, Galapagos NV, Gilead Sciences, GlaxoSmithKline, Janssen, Novartis, Pfizer, and UCB Pharma. Other; D. van der Heijde is the director of: Imaging Rheumatology BV. A. Kiprianos (Non-author Presenter): Shareholder/stock ownership; A. Kiprianos is an employee and shareholder in Lilly.