Evidence map›Paper›PMID 41074195›Full record

Observational studyAdvances in rheumatology (London, England)2025

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

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 and 5 more

Abstract readObservational Study
In one paragraph

Observational study in Advances in rheumatology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Fanny Reyes-NeiraRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Barbara BayehRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Karina Rossi BonfiglioliRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Nadia Emi AikawaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Ana Paula Luppino AssadRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Renata MiossiRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Fernando Henrique Carlos de SouzaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Carlos Emilio InsfranRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Henrique Ayres Mayrink GiardiniRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Emily Figueiredo Neves YukiRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Eloisa BonfaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Carla Gonçalves Schahin SaadRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Julio Cesar Bertacini de MoraesRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Ana Cristina de Medeiros-RibeiroRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Andrea Yukie ShimabucoRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. andreashimabuco@gmail.com.ORCID http://orcid.org/0000-0002-8511-5688

Funding

Fundacao de Amparo a Pesquisa do Estado de São Paulo (FAPESP) #2015/03756-4Fundacao de Amparo a Pesquisa do Estado de São Paulo (FAPESPConselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq) #305068/2014-8
6 · The paper itself

Abstract

backgroundTNF-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.

methodsThis 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.

resultsSixteen 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.

conclusionThis 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.

Indexed as

AdalimumabAntirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsDrug SubstitutionAdultAgedFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAdalimumabAntirheumatic AgentsBiosimilar PharmaceuticalsAdalimumabBiosimilarOriginatorRheumatoid arthritisSwitchingTumor necrosis factor inhibitors

Identifiers

PMID41074195
PMCPMC13488660

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.