Sex differences in patient-reported outcome measures and the association with clinical factors in axial spondyloarthritis patients treated with tumour necrosis factor inhibitors

Pasoon Hellamand, Marleen G.H. Van de Sande, Michael T. Nurmohamed, Ronald F. van Vollenhoven, Rosemary Hollick, Ovidiu Rotariu, Ziga Rotar, Katja Perdan Pirkmajer, Dan Nordström, Anna-Mari Hokkanen, Brigitte Michelsen, Tore K Kvien, Bente Glintborg, Merete L Hetland, Mikkel Østergaard, Anne G Loft, Karel Pavelka, Jakub Závada, Isabel Castrejon, Lucia Otero-VarelaBjorn Gudbjornsson, Olafur Palsson, Tor Olofsson, Johan K Wallman, Adrian Ciurea, Michael J Nissen, Tuba D Yildirim, Fatos Onen, Catalin Codreanu, Corina Mogosan, Maria José Santos, Elsa Vieira-Sousa, Florenzo Iannone, Bruno Frediani, Lykke M Ørnbjerg, Jos W.R. Twisk, Irene E van der Horste-Bruinsma* (Corresponding Author)

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Objectives
To investigate sex differences in patient-reported outcome measures (PROMs) among axSpA patients initiating their first TNFi and identify factors contributing to these disparities over the follow-up.

Methods
Data were included from 15 EuroSpA registries and consisted of axSpA patients initiating their first TNFi, with ≥2 measurements for each analysed PROM (BASDAI and BASFI, scale 0–100) taken at any time point. Linear mixed models were employed to analyse sex differences in PROMs over 24 months and to evaluate how baseline characteristics were related to the observed sex differences.

Results
We analysed 13 102 (38% women) in the BASDAI analyses and 10 623 (38% women) in the BASFI analyses. At follow-up, mean sex differences in BASDAI increased from 4.3 units at baseline (95% CI, 3.5–5.1) to 8.0 (7.2–8.8) at 6 months, and in BASFI from 2.2 (1.4–3.1) to 4.6 (3.6–5.5), with consistently worse scores in women. Baseline characteristics could not substantially account for the observed sex differences over time; however, the magnitude of the sex differences was reduced by HLA-B27 positivity, longer disease duration, and increased CRP levels, but increased by TNFi initiation in later years and peripheral arthritis.

Conclusion
In axSpA patients initiating their first TNFi, baseline sex differences in BASDAI and BASFI increased two-fold after 6 months of treatment and persisted thereafter, with worse scores in women. Several baseline characteristics moderated the sex differences, though none could fully account for them. These findings improve our understanding of sex differences and underscore their importance in axSpA.
Original languageEnglish
Article numberkeae370
Pages (from-to)1853-1863
Number of pages11
JournalRheumatology (United Kingdom)
Volume64
Issue number4
Early online date23 Jul 2024
DOIs
Publication statusPublished - Apr 2025

Data Availability Statement

Data is not available to external researchers for legal and logistical reasons. It would require permissions from each contributing registry, plus access to the secure server in Copenhagen. Queries about the data contained in this manuscript can be addressed by reasonable request to the corresponding author. To support reproducibility and facilitate future research, interested researchers may contact the corresponding author to obtain the R code used in this analysis.

Funding

The EuroSpA Research Collaboration Network was financially supported by Novartis Pharma AG. Novartis had no influence on the data collection, statistical analyses, manuscript preparation or decision to submit the manuscript.

FundersFunder number
Novartis Pharma AG

    Keywords

    • axial spondyloarthritis
    • TNF inhibitors
    • sex differences
    • patient-reported
    • outcome measures
    • tumor necrosis factor inhibitors

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