P278 Baseline characteristics and treatment response to ixekizumab categorised by sex in radiographic and non-radiographic axial spondylarthritis patients through 52 weeks: data from three phase III, randomized, controlled trials. (23rd April 2022)

• Record Type: Journal Article
• Authors: Kiprianos, Allan; van der Horst-Bruinsma, Irene E; Bolce, Rebecca; Hunter, Theresa; Calderon, David Marcelino Sandoval; Zhu, Danting; Geneus, Vladimir; Lisse, Jeffrey R; Liu-Leage, Soyi; Magrey, Marina
• Is Part Of: Rheumatology. Volume 61(2022)Supplement 1
• Publication Date: 2022-04-23
• Subjects: Rheumatism -- Periodicals; Rheumatology -- Periodicals; 616.723005
• DOI: 10.1093/rheumatology/keac133.277
• Languages: English
• ISSNs: 1462-0324

Abstract

Abstract: Background/Aims: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease of the axial skeleton comprising two subtypes within the same spectrum: radiographic (r-axSpA) and non-radiographic (nr-axSpA). Previous studies have shown that clinical presentation and treatment response of males and females may differ despite similar disease burden. Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, has demonstrated superior efficacy to placebo in the treatment of patients with r-axSpA (COAST-V/W [bDMARD-naïve/TNFi-experienced]) and nr-axSpA (COAST-X [bDMARD-naïve]). Here we report baseline characteristics and treatment response to IXE categorised by sex in patients with r-axSpA and nr-axSpA for up to 52 weeks. Methods: Patients fulfilled the ASAS classification criteria for r-axSpA or nr-axSpA. Patients were randomized to receive 80 mg subcutaneous IXE every two weeks (Q2W) or four weeks (Q4W), or to placebo (PBO; 16 weeks COAST-V/W; 52 weeks COAST-X). Baseline characteristics and treatment outcomes were assessed. Patients were categorised by sex; missing data were controlled for using non-responder imputation (NRI) and modified baseline observation carried forward (mBOCF) analysis was conducted on continuous efficacy variables. Results: At baseline, females were older, with significantly higher pain and fatigue scores and peripheral joint symptoms. ASAS40 response rate with IXEQ4W was achieved in 39% of males with r-axSpA by week 16, and 44% by week 52. Females achieved 16.7% at week 16, and 33.3% at week 52. In nr-axSpA, 46% of IXEQ4W males achieved ASAS40 at week 16 and 30% at week 52. 23.9% of females achieved ASAS40 at week 16, increasing to 30.4% at week 52. Conclusion: This analysis demonstrates that, for the axSpA disease spectrum, females present with higher disease burden as reflected by higher scores in fatigue/tiredness, and spinal pain at night. Our findings indicate that males and females respond to IXE; however, females experience this benefit later in their treatment course, with a more prolonged attainment of peak response. Disclosure: A. Kiprianos: None. I.E. van der Horst-Bruinsma: None. R. Bolce: Shareholder/stock ownership; Eli Lilly and Company. T. Hunter: Shareholder/stock ownership; Eli Lilly and Company. D. Marcelino Sandoval Calderon: Shareholder/stock ownership; Eli Lilly and Company. D. Zhu: Shareholder/stock ownership; Eli Lilly and Company. V. Geneus: Shareholder/stock ownership; Eli Lilly and Company. J.R. Lisse: Shareholder/stock ownership; Eli Lilly and Company. S. Liu-Leage: Shareholder/stock ownership; Eli Lilly and Company. M. Magrey: None.