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Background <p>TNF-inhibitors like adalimumab (ADA) have been vital for managing rheumatoid arthritis (RA) for over two decades. With the emergence of biosimilars, real-life evidence is crucial to confirm their sustained efficacy after switching from originator drugs. This study aims to provide comprehensive evaluation of the clinical outcomes of transitioning from adalimumab reference product (ADA-RP) to the biosimilar adalimumab–AACF (ADA-AACF) in patients with RA over a 12-month period in a real-world analysis.</p> Methods <p>This observational study included RA patients who had been on ADA-RP for at least three months before switching to ADA-AACF. Disease activity parameters, including DAS28-CRP, CDAI, SDAI, and CRP-levels, were assessed at baseline (T0) and compared at 6 (T6) and 12 months (T12) following the switch.</p> Results <p>Sixteen patients were included, with a mean duration of ADA-RP use of 69.9 months. DAS28-CRP remained stable when comparing T0 to T6 [2.36 (1.92–2.84) vs. 1.83 (1.72–3.16), <i>p</i> = 0.988] and T12 [2.36 (1.92–2.84) vs. 2.54 (2.09–2.86), <i>p</i> = 0.874], with similar results for SDAI and CDAI (<i>p</i> &gt; 0.05). The frequency of low disease activity was consistent during the follow-up: 81.3% at T0; 68.8% at T6 (<i>p</i> = 0.617) and 81.3% at T12 (<i>p</i> = 0.480) for DAS28-CRP &lt; 3.2. The same pattern was observed for CDAI ≤ 10 and SDAI ≤ 11 (<i>p</i> &gt; 0.05). CRP-levels and prednisone doses did not show significant variation (<i>p</i> &gt; 0.05) across time points. The biosimilar retention rate was 87.5%, with two patients discontinuing biosimilar before the 12-month mark.</p> Conclusion <p>This real-world study demonstrates the feasibility and sustained efficacy of transitioning from ADA-RP to ADA-AACF in RA patients, reinforcing its role in long-term disease management. These findings in an ethnically diverse population contribute to the growing global evidence on biosimilar adoption, supporting their integration into routine clinical practice and expanding treatment accessibility.</p>

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Efficacy of switching from originator adalimumab to biosimilar adalimumab-AACF in patients with rheumatoid arthritis: a 12-month observational study

  • 期刊论文

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  • 发表日期：

    2025年10月10日

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  • Fanny Reyes-Neira,
  • Barbara Bayeh,
  • Karina Rossi Bonfiglioli,
  • Nadia Emi Aikawa,
  • Ana Paula Luppino Assad,
  • Renata Miossi,
  • Fernando Henrique Carlos de Souza,
  • Carlos Emilio Insfran,
  • Henrique Ayres Mayrink Giardini,
  • Emily Figueiredo Neves Yuki,
  • Eloisa Bonfa,
  • Carla Gonçalves Schahin Saad,
  • Julio Cesar Bertacini de Moraes,
  • Ana Cristina de Medeiros-Ribeiro,
  • Andrea Yukie Shimabuco

摘要

Background

TNF-inhibitors like adalimumab (ADA) have been vital for managing rheumatoid arthritis (RA) for over two decades. With the emergence of biosimilars, real-life evidence is crucial to confirm their sustained efficacy after switching from originator drugs. This study aims to provide comprehensive evaluation of the clinical outcomes of transitioning from adalimumab reference product (ADA-RP) to the biosimilar adalimumab–AACF (ADA-AACF) in patients with RA over a 12-month period in a real-world analysis.

Methods

This observational study included RA patients who had been on ADA-RP for at least three months before switching to ADA-AACF. Disease activity parameters, including DAS28-CRP, CDAI, SDAI, and CRP-levels, were assessed at baseline (T0) and compared at 6 (T6) and 12 months (T12) following the switch.

Results

Sixteen patients were included, with a mean duration of ADA-RP use of 69.9 months. DAS28-CRP remained stable when comparing T0 to T6 [2.36 (1.92–2.84) vs. 1.83 (1.72–3.16), p = 0.988] and T12 [2.36 (1.92–2.84) vs. 2.54 (2.09–2.86), p = 0.874], with similar results for SDAI and CDAI (p > 0.05). The frequency of low disease activity was consistent during the follow-up: 81.3% at T0; 68.8% at T6 (p = 0.617) and 81.3% at T12 (p = 0.480) for DAS28-CRP < 3.2. The same pattern was observed for CDAI ≤ 10 and SDAI ≤ 11 (p > 0.05). CRP-levels and prednisone doses did not show significant variation (p > 0.05) across time points. The biosimilar retention rate was 87.5%, with two patients discontinuing biosimilar before the 12-month mark.

Conclusion

This real-world study demonstrates the feasibility and sustained efficacy of transitioning from ADA-RP to ADA-AACF in RA patients, reinforcing its role in long-term disease management. These findings in an ethnically diverse population contribute to the growing global evidence on biosimilar adoption, supporting their integration into routine clinical practice and expanding treatment accessibility.