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This research analyzes how clinical and demographic factors influence the choice between targeted synthetic and biologic DMARDs after recent EMA guidelines on JAK inhibitors.

March 28, 2026European Journal of Internal Medicine2 citationsOpen Access

Shaping rheumatoid arthritis treatment: Clinical and demographic drivers of tsDMARDs versus bDMARDs prescription post-EMA pronouncement on JAK inhibitors. Insights from the AMBI-RA study

RBRiccardo BertolaArcispedale Sant'Anna BMBeatrice MaraniniUniversity of Ferrara CGCarlo GaraffoniArcispedale Sant'Anna

Key Points

This research analyzes how clinical and demographic factors influence the choice between targeted synthetic and biologic DMARDs after recent EMA guidelines on JAK inhibitors.
Ambidirectional study design with retrospective (2019-2022) and prospective cohorts (2023-2024)
Enrollment of patients initiating new b/tsDMARD therapy
Comparison of disease activity and treatment response at 3 and 6 months follow-up
Shift towards tumor necrosis factor inhibitors (TNFis) from 32% to 41.4% after EMA guidelines
Decline in JAK inhibitor prescriptions from 18% to 4.1%, especially in first-line treatments
The benefit of first-line treatment in achieving target outcomes decreased from retrospective to prospective phases

Abstract

Objectives: To evaluate the clinical-demographic drivers of treatment choice among targeted synthetic (ts-) and biologic (b-) disease-modifying anti-rheumatic drugs (DMARDs) and therapeutic outcomes in a cohort of patients with rheumatoid arthritis (RA) before and after the European Medicines Agency (EMA) pronouncement on Janus Kinase Inhibitors (JAKis) in January 2023.Methods: This single-center, ambidirectional study enrolled patients with RA who were initiating a new course of b/tsDMARDs.Retrospective (2019-2022) and prospective cohorts (2023-2024) were compared, and disease activity and treatment response (achievement of remission or low disease activity) were evaluated at 3 and 6month follow-up.Results: The study analyzed 539 treatment courses (300 retrospective, 239 prospective) in 380 patients.Following the EMA guidelines, tumor necrosis factor- inhibitors (TNFis) became the predominant bDMARD (from 32% to 41.4%), whilst JAKis prescriptions declined, particularly in the first-line settings (from 18% to 4.1%).The risk factors proposed by the EMA did not significantly prevent treatment with JAKis.However, we observed that a benefit associated with the first-line treatment in terms of target achievement (adjusted OR for non-response retrospective cohort 0.30, 95%CI 0.14-0.62)was mitigated in the prospective phase (OR 0.82, 95% CI 0.33-2.07). Conclusion:The 2023 EMA pronouncement on JAKis led to a shift in prescription patterns, promoting TNFis versus JAKis.The decline in JAKis prescription did not appear to be driven by EMA-identified baseline risk factors, suggesting a generalized, categorical change.This channeling may have compromised the appropriateness of treatment choices, diminishing effectiveness in the prospective cohort, particularly for first-line therapies.

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Bertola et al. (Sun,) studied this question.

synapsesocial.com/papers/69c771838bbfbc51511e17f1 https://doi.org/https://doi.org/10.1016/j.ejim.2026.106852

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