P191 Efficacy and improvement in patient-reported outcomes at weeks 16 and 52 in ixekizumab treated biological naïve patients with radiographic axial spondyloarthritis achieving clinically important pain at night reduction at week 16: results from COAST-V trial
Authors: Ramiro Sofia , Lukas Cédric , Nissen Michael , Schymura Yves , Ng Khai Jing , Bradley Andrew , Doridot Gabriel , Liu-Leage Soyi , Chan Antoni , Wei Cheng-Chung 
Published: April 2023

Abstract

Background/Aims
Ixekizumab (IXE), a monoclonal antibody that selectively targets interleukin IL-17A, has shown efficacy in patients with radiographic axial spondyloarthritis (r-axSpA). Spinal pain, in particular spinal pain at night (SP-N), is a major contributor to the patient burden of r-axSpA.To assess SP-N improvement in patients up to week (W) 52 and to determine the association of SP-N improvement in patients treated with IXE with other patient-reported outcomes (PROs) at W16 and with reaching ASDAS LDA at W52.

Methods
The Phase III COAST-V (NCT02696785) trial investigated the efficacy of IXE in 341 patients with r-axSpA and were biological disease-modifying anti-rheumatic drug (bDMARD)-naïve. Patients were randomised to IXE every 2W (IXEQ2W), IXE every 4W (IXEQ4W), adalimumab (ADA) or placebo (PBO) up to W16. Only approved dose IXEQ4W data are presented here. SP-N was measured at each visit using a numeric rating scale (NRS) (0-10). A clinically relevant improvement in SP-N was defined as &gt; 2 point improvement from baseline. Differences in baseline variables between those achieving versus not achieving &gt;2 improvement in SP-N were tested using Fisher’s exact test (binary variables) and analysis of variance (ANOVA; continuous variables). Associations of SP-N improvement with PROs (BASFI, Fatigue Severity NRS, Jenkins Sleep Evaluation Questionnaire (JSEQ), SF-36 PCS) at W16, and ASDAS LDA at W52 were tested using analysis of covariance (ANCOVA; continuous variables) and logistic regression (binary variables). Missing values were imputed using non-responder imputation (NRI), and modified baseline observation carried forward.

Results
A greater proportion of patients achieved &gt;2 improvement in SP-N with IXE treatment compared to PBO at W16 (63.0% vs. 32.2%, p &lt; 0.001) and improvement was sustained up to W52. Of the 81 patients originally randomised to IXE, those achieving &gt;2 improvement in SP-N (63%) at W16 were younger, more frequently positive for HLA-B27 and had higher disease activity at baseline compared to those that did not achieve &gt;2 improvement. Achieving &gt;2 improvement in SP-N was associated with improvement in PROs including BASFI, Fatigue Severity, JSEQ and SF-36 PCS at W16 and with achieving ASDAS&lt;2.1 at W52 compared to those not achieving &gt;2 improvement in SP-N.

Conclusion
IXE improved SP-N for patients with r-axSpA not previously treated with bDMARDs. Improvements in SP-N were associated with improvements in disease activity, function, fatigue, and quality of life.
Disclosure
S. Ramiro: Consultancies; S. Ramiro has served as a speaker and/or consultant for: AbbVie, Eli Lilly and Company, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and UCB Pharma. Grants/research support; S. Ramiro has received grant and/or research support from: AbbVie, Galapagos NV, Novartis, Pfizer, and UCB Pharma. C. Lukas: Consultancies; C. Lukas has served as a speaker and/or consultant for: AbbVie, Amgen, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly and Company, Galapagos NV, Merck Sharp & Dohme, Novartis, Pfizer, Roche. Grants/research support; C. Lukas has received grant and/or research support from: Eli Lilly and Company, Novartis, Pfizer, and Roche. M. Nissen: Consultancies; M. J. Nissen has served as a speaker and/or consultant for: AbbVie, Celgene, Eli Lilly and Company, Janssen, Novartis, and Pfizer. Y. Schymura: Shareholder/stock ownership; Y. Schymura is a shareholder and employee of: Eli Lilly and Company. K. Ng: Shareholder/stock ownership; K. Ng is a shareholder and employee of: Eli Lilly and Company. A. Bradley: Shareholder/stock ownership; A. Bradley was an employee of: Eli Lilly and Company at the time of the study. G. Doridot: Shareholder/stock ownership; G. Doridot is a shareholder and employee of: Eli Lilly and Company. S. Liu-Leage: Shareholder/stock ownership; S. Liu-Leage is a shareholder and employee of: Eli Lilly and Company. A. Chan: Consultancies; A. Chan has served as a speaker and/or consultant for: AbbVie, Amgen, Biogen, Celgene, Eli Lilly and Company, Janssen, Novartis, and UCB Pharma. C. Wei: Grants/research support; J. C.-C. Wei has received consulting fees and/or grant and/or research support from: AbbVie, Bristol Myers Squibb, Celgene, Chugai Pharmaceutical, Eisai, Eli Lilly and Company, Janssen, Novartis, Pfizer, Sanofi-Aventis, TSH Biopharm, and UCB Pharma.