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. 2025 May 14;27(1):103.
doi: 10.1186/s13075-025-03571-2.

Gender differences in clinical and prescribing characteristics of biologic and targeted synthetic drugs in naïve patients with rheumatoid arthritis: Data from BIOBADASER III registry

Paloma Vela-Casasempere  1 , Lucía Otero-Varela  2 , Silvia Gómez Sabater  3 , Rocío Caño Alameda  3 , Cristina Campos Fernández  4 , Jerusalén Calvo-Gutiérrez  5 , Yanira Pérez-Vera  6 , Sara Manrique Arija  7 , Sagrario Bustabad  8 , Javier Manero Ruiz  9 , María Dolores Ruiz Montesino  10 , Lucía Ruíz Gutiérrez  11 , Antonio Mera Varela  12 , Manuel José Moreno Ramos  13 , Fernando Sánchez-Alonso  14 , Isabel Castrejón  15
Affiliations

Gender differences in clinical and prescribing characteristics of biologic and targeted synthetic drugs in naïve patients with rheumatoid arthritis: Data from BIOBADASER III registry

Paloma Vela-Casasempere et al. Arthritis Res Ther. .

Abstract

Background: Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that can lead to progressive joint damage and irreversible disability when inadequately treated. RA is more common in women than in men. Disease characteristics differ between genders in terms of comorbidities, extra-articular manifestations, quality of life, disease activity and functional scores. There is a possibility that RA may be managed differently depending on gender: under-treated due to professional bias when prescribing advanced therapies, or over-treated due to overestimation of disease activity. Our primary objective was therefore to examine gender differences in the time course from RA diagnosis to initiation of the first biologic disease-modifying antirheumatic drug (bDMARD) or targeted synthetic DMARD (tsDMARD) and to identify factors associated with earlier or later prescribing. We also aimed to assess the differences between men and women in clinical characteristics and disease activity at initiation of the first b/tsDMARD among bio-naïve RA patients.

Methods: We analyzed RA patients from the BIOBADASER III registry who began their first b/tsDMARD between 2000 and 2023, stratified by treatment start year. Clinical characteristics were compared by sex, using linear regression models for DAS28. Kaplan-Meier curves and multivariate Cox regression identified factors influencing treatment initiation timelines.

Results: We included 3,384 patients (78.1% women). Males presented higher cardiovascular risk, females more osteoporosis and Sjögren Syndrome. At treatment start, females had lower mean age (54.8 vs. 57 years, p < 0.001) but longer disease duration (7.3 vs. 6.7 years, p = 0.031); higher DAS28-ESR, but not DAS28-CRP; higher subjective components of DAS28 and ESR but lower CRP and no differences in objective components. Disease duration differed between sexes only in the most recent cohort (≥ 2017, HR 0.9 (95% CI 0.81; 0.99), p = 0.026): female sex, age, and treatment with csDMARDs (other than methotrexate) were associated with later prescribing, whereas tobacco, obesity and treatment with methotrexate or glucocorticoids with earlier.

Conclusions: Later prescribing in women despite higher activity rates merits reflection. Discrepancies between subjective and objective measures of DAS, and ESR and CRP, may reflect the need to establish different cut-off points for men and women, and opens a field of research worth exploring.

Keywords: Arthritis; Biological therapy; Patient reported outcome measures; Rheumatoid.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The project was approved by the Research Ethics Committee of the Hospital Universitario Clinic Barcelona (approval code FER-ADA-2015–01), while the reference committee is the Research Ethics Committee of the Hospital Universitario de Canarias. Informed consent was obtained from all participants. Consent for publication: Not applicable. Competing interests: PVC received grants or contracts from GSK, Abbvie, Roche, Novartis, Lilly, AstraZeneca, Pfizer; consulting fees from GSK; honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, GSK, Lilly; Support for attending meetings and/or travel from Abbvie. YPV received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Amgen; Support for attending meetings and/or travel from Nordic Pharma, Pfizer, Abbvie; Other financial or non-financial interests from GebroPharma. SMA received consulting fees from ABbvie, UCB, Novartis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from ABBVIE, PFIZER, UCB, JASSEN, NOVARTIS, GSK, LILLY, ASTRA ZENECA; Support for attending meetings and/or travel from ABBVIE, PFIZER, UCB, JASSEN, NOVARTIS, GSK, LILLY, ASTRA ZENECA. IC received consulting fees from UCB, Alfasigma; honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Boehringer, Gebro, Pfizer, UCB, GSK, Lilly, BMS; Support for attending meetings and/or travel from Janssen, UCB, Lilly, AbbVie, Pfizer. The other authors declare that they have no relevant financial or non-financial interests to disclose.

Figures

Fig. 1
Fig. 1
Kaplan–Meier curve: time course from RA diagnosis until the first prescription of b/tsDMARD
See this image and copyright information in PMC

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