AB1321 PSYCHOMETRIC PROPERTIES OF THE ASAS HEALTH INDEX IN PATIENTS WITH ACTIVE AS/RADIOGRAPHIC AXIAL SPA WHO HAVE PRIOR INADEQUATE RESPONSE/INTOLERANCE TO TNF INHIBITORS IN A PHASE 3 TRIAL. (June 2019)

• Record Type: Journal Article
• Authors: Kiltz, Uta; Heijde, Désirée van der; Boonen, Annelies; Gensler, Lianne S.; Hunter, Theresa; Wyrwich, Kathleen; Dong, Yan; Xiaoqi, LI; Gallo, Gaia; Braun, Juergen
• Is Part Of: Annals of the rheumatic diseases. Volume 78(2019)Supplement 2
• Page Start: 2123
• Page End: 2124
• Publication Date: 2019-06
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2019-eular.1615
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: The Assessment of SpondyloArthritis international Society Health Index (ASAS HI) assesses function, disability, and health in patients with ankylosing spondylitis/radiographic axial spondyloarthritis (AS/r-axSpA). Objectives: To evaluate the psychometric properties of the ASAS HI in patients with active AS/r-axSpA in a placebo-controlled study of ixekizumab, a humanized IL-17A monoclonal antibody (COAST-W, NCT02696798 ). Methods: The ASAS HI questionnaire consists of 17 dichotomous items that yield a total score ranging from 0 (good health) to 17 (poor health). The psychometric properties of the questionnaire, including test-retest reliability, convergent and discriminant validity, and responsiveness, were evaluated using pooled data from three exposure groups (placebo and ixekizumab 80 mg every 2 or 4 weeks). Adults enrolled fulfilled ASAS criteria (sacroiliitis defined centrally by modified New York Criteria and ≥1 SpA feature), had active disease (BASDAI ≥4, back pain ≥4), and either prior inadequate response or intolerance to 1 or 2 TNF inhibitors. Results: Mean baseline ASAS HI score was 9.7 (SD=3.62, n=316). Intraclass correlation (0.78) indicated test-retest reliability of ASAS HI between screening and baseline. ASAS HI score was moderately correlated at baseline (|r|>0.30, Figure [circles]) and strongly correlated at Week (Wk) 16 (|r|>0.50; Figure [crosses]) with BASDAI, BASFI, SF-36 PCS, and spinal pain, and strongly correlated at both baseline and Wk 16 with EQ-5D-5L UK Population-based Index and SF-36 MCS. Greater improvements in disease activity were associated with greater improvements in ASAS HI scores at Wk 16 (Table). Conclusion: The ASAS HI demonstrated reliability, validity, and responsiveness in adults with AS/r-axSpA, supporting its use in clinical trials. Note: An ANCOVA model with change in ASAS HI score as dependent variable and clinical outcome response and baseline ASAS HI as independent variables was applied. Post hoc comparison was conducted using Scheffé's correction. Disclosure of Interests: Uta Kiltz Grant/research support from: AbbVie, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Consultant for: AbbVie, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Désirée van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, Union Chimique Belge, Annelies Boonen: None declared, Lianne S. Gensler Grant/research support from: Abbvie, Amgen, UCB Pharma, Consultant for: Novartis, Lilly, Janssen, Theresa Hunter Employee of: Eli Lilly and Company, Kathleen Wyrwich Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Yan Dong Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Xiaoqi Li Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gaia Gallo Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Juergen Braun Shareholder of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Grant/research support from: Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB, Consultant for: Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB, Consultant for: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, UCB Pharma, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Speakers bureau: Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB