Evidence map›Paper›PMID 35116080›Full record

ArticleTherapeutic advances in musculoskeletal disease2021

Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis.

Cosimo Bruni, Stefano Gentileschi, Giovanni Pacini, Marco Bardelli, Lorenzo Tofani, Francesca Bartoli, Caterina Baldi, Laura Cometi, Ginevra Fiori, Francesca Nacci and 5 more

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 30% of its field
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

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Switching from Adalimumab Reference Product to and Among Adalimumab Biosimilars Outside the USA: Insights for US Clinicians.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  3. Article
  4. Review
  5. Patient Experience with the SensoReadyPatient preference and adherence · 2024
    Article
  6. Article
  7. Article
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 at 3 institutions in 1 country.

Cosimo BruniDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Via delle Oblate 4, Florence, 50141, Italy.ORCID https://orcid.org/0000-0003-2813-2083
Stefano GentileschiDepartment of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Siena, Italy.
Giovanni PaciniDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.
Marco BardelliDepartment of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Siena, Italy.
Lorenzo TofaniDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.
Francesca BartoliDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.
Caterina BaldiDepartment of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Siena, Italy.
Laura CometiDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.ORCID https://orcid.org/0000-0002-7710-5025
Ginevra FioriDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.
Francesca NacciDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.
Luca CantariniDepartment of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Siena, Italy.ORCID https://orcid.org/0000-0002-7352-1275
Serena GuiducciDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.
Alberto Moggi-PignoneDepartment of Experimental and Clinical Medicine, Division of Internal Medicine Unit III, Azienda Ospedaliera Universitaria Careggi, University of Florence, Florence, Italy.
Bruno FredianiDepartment of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Siena, Italy.
Marco Matucci-CerinicDepartment Experimental and Clinical Medicine & Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, University of Florence, Florence, Italy.
Azienda Ospedaliero-Universitaria Careggi · ITUniversity of Siena · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsMedical and non-medical switching strategies have been adopted in Europe in the last few years. We aimed to investigate persistence on treatment with a SB5 Adalimumab (SB5) biosimilar after switching from Adalimumab (ADA) originator among patients with inflammatory rheumatic musculoskeletal diseases (iRMD), identifying possible predictors of drug interruption and describing adverse events.

methodiRMD patients previously switched to SB5 after at least 6 months of ADA were enrolled. Data on concomitant medications, disease flares, and persistence on SB5 up to the last available follow up were collected retrospectively. Kaplan-Meier and Cox regression models were used.

resultA total of 172 patients (106 females, ADA duration 5.8 ± 3.8 years) were enrolled, including 34 rheumatoid arthritis, 59 psoriatic arthritis, and 61 axial spondyloarthritis patients. In a 10 ± 3 months follow up, 65 (37.8%) patients presented with adverse events, with 46 (26.7%) showing a clinically defined disease flare (no disease activity and patient reported outcomes assessment were available); 24 patients interrupted SB5 permanently (among them, 11 back-switched to ADA and 8 were prescribed a different biological therapy). Probability of persistence on SB5 was 94.7% at 6 months and 85.1% at 12 months. Baseline corticosteroid [hazard ratio (HR) 3.209, 95% confidence interval (CI) 1.193-8.635,

conclusionOur data on persistence of treatment and adverse events are in line with previous reports. Further large cohort studies may confirm baseline corticosteroid and NSAIDs use as predictors of SB5 interruption, helping to identify patients at higher risk of failure after switching.

Indexed as

adalimumabpersistencepredictorrheumatic diseasesSB5switch

Identifiers

PMID35116080
PMCPMC8804457
OpenAlexW3184269183

What OpenQuestion holds

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LicenceCC BY-NC
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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.