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Introduction <p>The primary objective was to describe the therapeutic approach to methotrexate (MTX) use at the initiation of the first biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) in the treatment of rheumatoid arthritis (RA). Secondary objectives included characterising participants initiating b/tsDMARD treatment, examining treatment strategies over time, monitoring disease progression, and identifying factors influencing treatment choices.</p> Methods <p>This longitudinal, prospective, non-interventional, multicentre study (STRATEGE2) enrolled adult participants with RA who had been treated with MTX for at least 3&#xa0;months and required b/tsDMARD treatment due to persistent disease activity. Outcomes were assessed at 12&#xa0;months (M12) and 24&#xa0;months (M24) after initiating b/tsDMARD treatment.</p> Results <p>At baseline, 173 participants with RA had a mean (SD) disease duration of 5.6 (7.3) years and a mean Disease Activity Score in 28 joints (DAS28) score of 4.3 (1.2). Approximately two-thirds had been on MTX for over a year, with a mean weekly dose of 18.8 (4.2) mg (median 20.0), and 72.3% received it subcutaneously. MTX was continued at the initiation of b/tsDMARD therapy in 97.7% of participants. By M12, 83.2% of participants remained on MTX, with 39.9% (95%&#xa0;CI 32.5–47.6) maintaining the same dosage and route of administration. Discontinuation of MTX was primarily due to participant choice or adverse events. At M24, the mean change in DAS28 score was − 2.0 (1.3), with 66.0% of participants achieving remission. On the basis of European Alliance of Associations for Rheumatology (EULAR) classification criteria, 65.2% had a good response, 19.1% a moderate response, and 15.6% an inadequate response.</p> Conclusion <p>The STRATEGE2 study investigators adhered to current clinical guidelines by continuing MTX in combination with b/tsDMARD initiation for the management of RA.</p> Trial Registration <p>ClinicalTrials.gov: Therapeutic Strategy Associated with bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis (STRATEGE2), NCT05082805.</p>

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Methotrexate Maintenance After Initiation of Biological or Targeted Synthetic DMARDs in Rheumatoid Arthritis: Results from the 2-Year Longitudinal Prospective Non-interventional STRATEGE2 Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月3日

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  • Cécile Gaujoux-Viala,
  • Emmanuelle Dernis,
  • Eric Senbel,
  • Hélène Herman-Demars,
  • Jennifer Becker,
  • René-Marc Flipo

摘要

Introduction

The primary objective was to describe the therapeutic approach to methotrexate (MTX) use at the initiation of the first biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) in the treatment of rheumatoid arthritis (RA). Secondary objectives included characterising participants initiating b/tsDMARD treatment, examining treatment strategies over time, monitoring disease progression, and identifying factors influencing treatment choices.

Methods

This longitudinal, prospective, non-interventional, multicentre study (STRATEGE2) enrolled adult participants with RA who had been treated with MTX for at least 3 months and required b/tsDMARD treatment due to persistent disease activity. Outcomes were assessed at 12 months (M12) and 24 months (M24) after initiating b/tsDMARD treatment.

Results

At baseline, 173 participants with RA had a mean (SD) disease duration of 5.6 (7.3) years and a mean Disease Activity Score in 28 joints (DAS28) score of 4.3 (1.2). Approximately two-thirds had been on MTX for over a year, with a mean weekly dose of 18.8 (4.2) mg (median 20.0), and 72.3% received it subcutaneously. MTX was continued at the initiation of b/tsDMARD therapy in 97.7% of participants. By M12, 83.2% of participants remained on MTX, with 39.9% (95% CI 32.5–47.6) maintaining the same dosage and route of administration. Discontinuation of MTX was primarily due to participant choice or adverse events. At M24, the mean change in DAS28 score was − 2.0 (1.3), with 66.0% of participants achieving remission. On the basis of European Alliance of Associations for Rheumatology (EULAR) classification criteria, 65.2% had a good response, 19.1% a moderate response, and 15.6% an inadequate response.

Conclusion

The STRATEGE2 study investigators adhered to current clinical guidelines by continuing MTX in combination with b/tsDMARD initiation for the management of RA.

Trial Registration

ClinicalTrials.gov: Therapeutic Strategy Associated with bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis (STRATEGE2), NCT05082805.