BASDAI versus ASDAS in evaluating axial involvement in patients with psoriatic arthritis: a pooled analysis of two phase 3 studies

Xenofon Baraliakos; Dafna D Gladman; Soumya D Chakravarty; Cinty Gong; May Shawi; Emmanouil Rampakakis; Mitsumasa Kishimoto; Enrique R Soriano; Philip J Mease

doi:10.1093/rap/rkae058

BASDAI versus ASDAS in evaluating axial involvement in patients with psoriatic arthritis: a pooled analysis of two phase 3 studies

Rheumatol Adv Pract. 2024 Apr 23;8(2):rkae058. doi: 10.1093/rap/rkae058. eCollection 2024.

Authors

Xenofon Baraliakos¹, Dafna D Gladman², Soumya D Chakravarty^{3

4}, Cinty Gong⁵, May Shawi⁶, Emmanouil Rampakakis^{7

8}, Mitsumasa Kishimoto⁹, Enrique R Soriano^{10

11}, Philip J Mease^{12

13}

Affiliations

¹ Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany.
² Department of Medicine, University of Toronto, Schroeder Arthritis Institute; Krembil, Research Institute; Toronto Western Hospital, Toronto, ON, Canada.
³ Immunology, Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Horsham, PA, USA.
⁴ Division of Rheumatology, Drexel University College of Medicine, Philadelphia, PA, USA.
⁵ Immunology, Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, USA.
⁶ Immunology, Janssen Research & Development, LLC, a Johnson & Johnson company, Titusville, NJ, USA.
⁷ Department of Pediatrics, McGill University, Montreal, Canada.
⁸ Scientific Affairs, JSS Medical Research, Inc, Montreal, Canada.
⁹ Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.
¹⁰ Rheumatology Section, Internal Medicine Service, Department of Medicine, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
¹¹ Department of Medicine, University Institute Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
¹² Rheumatology Research, Providence Swedish Medical Center, Seattle, WA, USA.
¹³ University of Washington School of Medicine, Seattle, WA, USA.

Abstract

Objective: In the absence of axial psoriatic arthritis (axPsA)-specific tools, the BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) are used to assess axial symptoms in patients with PsA. Here, we assessed the performance of BASDAI and ASDAS in patients with PsA.

Methods: Patients with active PsA in DISCOVER-1 and DISCOVER-2 (ClinicalTrials.gov: NCT03162796 and NCT03158285, respectively) with or without axPsA but with available baseline BASDAI information were analysed; those with investigator-identified axial symptoms and imaging-confirmed sacroiliitis comprised the axPsA cohort. Correlations between BASDAI/ASDAS and clinical variables were assessed with Pearson's coefficient (r). Longitudinal effects of enthesitis (Leeds Enthesitis Index [LEI]), swollen joint count and presence versus absence of axPsA on BASDAI/ASDAS (normalized 0-10 scale) were analysed with mixed models for repeated measures.

Results: At baseline in the axPsA (n = 312) and non-axPsA (n = 124) cohorts, BASDAI scores showed no or weak correlation with swollen joint count (0.18-0.20), tender joint count (0.12-0.29), LEI (-0.04 to 0.24) and physician global assessment (0.35-0.43); moderate correlation with fatigue (both -0.56); and strong correlation with patient global assessment of disease activity (0.62-0.69) and patient-reported pain (0.66-0.70). Similar correlations were observed for ASDAS. Axial involvement versus non-involvement was associated with higher BASDAI scores and ASDAS (all β ≥ 0.5), without differences between instruments; longitudinal associations between swollen joint count (β ≤ 0.06)/LEI (β ≤ 0.19) and BASDAI/ASDAS were clinically unimportant.

Conclusion: BASDAI and ASDAS performed similarly in patients with active PsA and axial involvement, independent of peripheral disease involvement, supporting their performance in assessing axial disease activity.

Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT03162796 and NCT03158285.

Keywords: ASDAS; BASDAI; MRI; clinical trials; diagnostic imaging; psoriatic arthritis; spine; spondyloarthropathies.

Associated data

ClinicalTrials.gov/NCT03162796
ClinicalTrials.gov/NCT03158285