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POS0931 (2022)
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
S. Ramiro1, C. Lukas2, M. J. Nissen3, Y. Schymura4, K. Ng4, A. Bradley4, G. Doridot4, S. Liu Leage4, A. Chan5, J. C. C. Wei6,7,8
1Leiden University Medical Centre, Department of Rheumatology, Leiden, Netherlands
2University of Montpellier, University Hospital Centre Montpellier, Montpellier, France
3Geneva University Hospital, Division of Rheumatology, Geneva, Switzerland
4Eli Lilly and Company, Lilly Corporate Center, Indianapolis, United States of America
5Royal Berkshire Hospital, Department of Rheumatology, Reading, United Kingdom
6Chung Shan Medical University Hospital, Department of Allergy, Immunology and Rheumatology, Taichung, Taiwan, Republic of China
7Chung Shan Medical University, Institute of Medicine, Taichung, Taiwan, Republic of China
8China Medical University, Graduate Institute of Integrated Medicine, Taichung, Taiwan, Republic of China

Background: 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.


Objectives: 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 >2 point improvement from baseline. Differences in baseline variables between those achieving versus not achieving >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, and modified baseline observation carried forward.


Results: A greater proportion of patients achieved >2 improvement in SP-N with IXE treatment compared to PBO at W16 (63.0% vs. 32.2%, p <0.001) and improvement was sustained up to W52 ( Figure 1 ). Of the 81 patients originally randomised to IXE, those achieving >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 >2 improvement ( Table 1 ). Achieving >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<2.1 at W52 compared to those not achieving >2 improvement in SP-N ( Table 1 ).

Baseline demographics, clinical characteristics, and PROs of IXE treated patients achieving vs. not achieving >2 improvement in SP-N at W16.

Achieved >2 Improvement in SP-N at W16 Yes (n=51 ) No (n=30 )
Baseline Characteristics
Age, yrs 38.6 (11.4)* 44.9 (12.4)
Positive for HLA-B27, n (%) 50.0 (98.0)* 25.0 (83.3)
CRP (mg/L) 14.9 (14.9)* 7.6 (8.4)
ASDAS 3.9 (0.8)* 3.5 (0.6)
Spinal Pain at Night 7.4 (1.3)* 6.4 (1.4)
PROs Baseline W16 CFB Baseline W16 CFB
BASFI 6.1 (1.9) -3.4 (2.2)*** 6.0 (1.6) -0.7 (1.5)
Fatigue Severity NRS 6.9 (1.7) -3.5 (2.6)*** 6.3 (1.6) -0.7 (2.0)
JSEQ 7.1 (5.4) -3.2 (4.2)*** 7.2 (5.2) -0.1 (2.7)
SF-36 PCS 32.8 (7.7) 10.9 (7.7)*** 36.1 (6.7) 2.0 (6.5)
ASDAS <2.1 at W52 Response, n (%) 34 (66.7)** 9 (33.3)

Values represent mean (SD) unless otherwise stated. *p<0.05, **p<0.01, ***p<0.001 versus those not achieving >2 improvement in SP-N.

HLA-B27; Human Leukocyte antigen-B27, CRP; C-reactive protein, ASDAS; Ankylosing Spondylitis Disease Activity Score, CFB; change from baseline, BASFI; Bath Ankylosing Spondylitis Functional Index, NRS; Numeric Rating Score, JSEQ; Jenkins Sleep Evaluation Questionnaire, SF-36 PCS; Short-Form 36 physical component score.

Patients achieving meaningful spinal pain at night improvement through W52.


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 of Interests: Sofia Ramiro Speakers bureau: Eli Lilly and Company, MSD, Novartis, UCB, Consultant of: AbbVie, Eli Lilly and Company, MSD, Novartis, Pfizer, UCB, Sanofi, Grant/research support from: AbbVie, Galapagos, Pfizer, Novartis, UCB, Cédric Lukas Speakers bureau: AbbVie, Amgen, Novartis, Pfizer, Galapagos, Consultant of: AbbVie, BMS, Chugai, Roche, Eli Lilly and Cmpany, MSD, Novartis, Pfizer, Amgen, Grant/research support from: Roche, Pfizer, Novartis, Eli Lilly and Company, Michael J. Nissen Speakers bureau: Eli Lilly and Company, Janssen, Novartis, Consultant of: AbbVie, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, Yves Schymura Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Khai Ng Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andrew Bradley Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gabriel Doridot Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Soyi Liu Leage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Antoni Chan Speakers bureau: Novartis, AbbVie, Amgen, UCB, Janssen, Celgene, Biogen, Consultant of: Novartis, Eli Lilly and Company, Janssen, Amgen, UCB, AbbVie, James Cheng-Chung Wei Consultant of: tsh biopharma, Abbvie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, UCB pharma, Grant/research support from: AbbVie, BMS, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB pharma

Citation: , volume 81, supplement 1, year 2022, page 765
Session: Spondyloarthritis - treatment (POSTERS only)