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Abstract Number: 0541

Measurement Properties of Disease Activity Instruments in Peripheral Spondyloarthritis. an Analysis in the CRESPA Trial

Clementina López Medina1, Anna Molto2, Dafne Capelusnik3, Philippe Carron4, Casper Webers5, Filip Van den Bosch6, Annelies Boonen7 and Sofia Ramiro8, 1Reina Sofia University Hospital, Cordoba, Spain, 2Groupe Hospitalier Cochin, AP-HP, Paris, France, 3Tel Aviv Sourasky Medical Center, Ramat Gan, Israel, 4UZ Gent, Gent, Belgium, 5Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, Maastricht, 6Ghent University Hospital, Ghent, Belgium, 7Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center; Care and Public Health Research Institute (Caphri), Maastricht University, Maastricht, Netherlands, 8Leiden University Medical Center, Bunde, Netherlands

Meeting: ACR Convergence 2024

Keywords: Outcome measures, Spondyloarthropathies

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Session Information

Date: Saturday, November 16, 2024

Title: SpA Including PsA – Diagnosis, Manifestations, & Outcomes Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Un
derstanding the best-performing disease activity measure and response criterion in peripheral spondyloarthritis (pSpA) is crucial for the development of future meaningful clinical studies. The aim of this study was to evaluate the construct validity and discriminatory ability of various instruments to assess components of disease activity and response criteria in patients with pSpA.

Methods: This is a post-hoc analysis of the CRESPA randomized controlled trial, which included active adult patients newly diagnosed with early pSpA and fulfilling the ASAS classification criteria for pSpA. Patients were randomized to golimumab (GOL) or placebo (PBO) with a 2:1 ratio. The data of the placebo-controlled part of the trial until week 12 were used. Construct validity (known-group discrimination (SMD) in the baseline population), longitudinal construct validity (i.e., Standardized Response Mean (SRM) and (Guyatt’s) effect size) and trial discrimination (standardized mean difference (SMD)) of several continuous disease activity measure instruments (Table 1) were assessed. As part of trial discrimination, Chi-square test was evaluated for binary outcomes.

Results: A total of 60 patients (40 GOL and 20 PBO) were included. Construct validity was better for composite outcomes (i.e. DAPSA, BASDAI and ASDAS), showing a higher SMD between active and inactive patients. Longitudinal construct validity was consistently good for composite outcomes (e.g. ASDAS and DAPSA) and globals (PGA and PhGA), with some differences across methods. On the other hand, clinical trial discrimination was good for both composites (BASDAI, ASDAS, DAPSA) and global (PGA, PhGA) outcomes, as well as for SJC (Table 1).

Finally, among the binary outcomes, trial discrimination was best for clinical remission (defined as absence of arthritis, enthesitis and dactylitis), BASDAI50, DASPA-LDA and ASDAS-LDA (Table 2).

Conclusion: While both composite and global outcome measurement instruments performed well in pSpA, composite scores like DAPSA, ASDAS and BASDAI additionally showed better construct validity. The definition of clinical remission was the most discriminatory response criterion.

Supporting image 1

Table 1. Summary of the psychometric properties of the continuous outcome measurement instruments reflecting disease activity.

Supporting image 2

Table 2. Discriminatory ability of the dichotomous response criteria


Disclosures: C. López Medina: AbbVie, 2, 5, 6, Eli Lilly, 2, 5, 6, Janssen, 6, MSD, 6, Novartis, 2, 5, 6, UCB Pharma, 2, 5, 6; A. Molto: AbbVie, 2, 5, MSD, 2, 5, Pfizer, 2, 5, UCB, 2, 5; D. Capelusnik: None; P. Carron: None; C. Webers: None; F. Van den Bosch: AbbVie/Abbott, 2, 6, Amgen, 6, Eli Lilly, 2, Fresenius Kabi, 6, Galapagos, 2, Janssen, 6, Novartis, 6, UCB, 6; A. Boonen: AbbVie, 2, 5, 6, Galapagos, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, UCB Pharma, 2, 6; S. Ramiro: AbbVie, 1, 2, 5, 6, Alfasigma, 1, 2, 5, Galapagos, 1, 2, 5, Lilly, 1, 2, 6, MSD, 2, 5, 6, Novartis, 1, 2, 5, 6, Pfizer, 1, 2, 5, 6, UCB, 1, 2, 5, 6.

To cite this abstract in AMA style:

López Medina C, Molto A, Capelusnik D, Carron P, Webers C, Van den Bosch F, Boonen A, Ramiro S. Measurement Properties of Disease Activity Instruments in Peripheral Spondyloarthritis. an Analysis in the CRESPA Trial [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/measurement-properties-of-disease-activity-instruments-in-peripheral-spondyloarthritis-an-analysis-in-the-crespa-trial/. Accessed .
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