ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0934

Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-Radiographic Axial Spondylarthritis Patients Through 52 Weeks: Data from 3 Phase III, Randomized, Controlled Trials

Irene van der Horst-Bruinsma1, Rebecca Bolce2, Theresa Hunter3, David Sandoval Calderon2, Danting Zhu2, Vladimir Geneus2, Jeffrey Lisse4, Soyi Liu-Leage5 and Marina Magrey6, 1Amsterdam UMC, Amsterdam, Netherlands, 2Eli Lilly and Company, Indianapolis, IN, 3Eli Lilly and Company, Indianapolis, IN, USA, Indianapolis, IN, 4Eli Lilly and Company, Tucson, AZ, 5Eli Lilly and Company, Neuilly sur Seine, France, 6Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, USA, Richfield, OH

Meeting: ACR Convergence 2021

Keywords:

Session Information

Date: Sunday, November 7, 2021

Session Title: Spondyloarthritis Including PsA – Treatment Poster I: Axial Spondyloarthritis (0908–0939)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: 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 differ1 despite similar disease burden.2 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]).3 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 2 weeks (Q2W) or 4 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 was 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 (table 1). 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.

References.

1. van der Horst-Bruinsma IE, et al. Ann Rheum Dis. 2019;78:1550-1558.

2. Zhao SS, et al. Rheumatology. 2019;58:2025-2030.

3. Deodhar A, et al. Lancet. 2020;395:53-64.

Table 1. Baseline Characteristics of Patients Categorised by Sex

Figure 1: COAST-V/W ASAS40 (ITT, NRI) Patients initially randomized to PBO in COAST-V/W switched to IXEQ2W or Q4W at week 16 by study design; PBO data are summarised up to week 16

Disclosures: I. van der Horst-Bruinsma, None; R. Bolce, Eli Lilly and Company, 3, 11; T. Hunter, Eli Lilly and Company, 3, 11; D. Sandoval Calderon, Eli Lilly and Company, 3; D. Zhu, Eli Lilly and Company, 3; V. Geneus, Eli Lilly and Company, 3; J. Lisse, Eli Lilly and Company, 3, 11; S. Liu-Leage, Eli Lilly and Company, 3, 11; M. Magrey, AbbVie, 2, 5, UCB Pharma, 5, Novartis, 2, Eli Lilly, 2, Pfizer, 2, Amgen, 5.

To cite this abstract in AMA style:

van der Horst-Bruinsma I, Bolce R, Hunter T, Sandoval Calderon D, Zhu D, Geneus V, Lisse J, Liu-Leage S, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-Radiographic Axial Spondylarthritis Patients Through 52 Weeks: Data from 3 Phase III, Randomized, Controlled Trials [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/baseline-characteristics-and-treatment-response-to-ixekizumab-categorised-by-sex-in-radiographic-and-non-radiographic-axial-spondylarthritis-patients-through-52-weeks-data-from-3-phase-iii-randomize/. Accessed May 19, 2022.

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