Evidence map›Paper›PMID 35887671›Full record

ArticleJournal of personalized medicine2022

Predicting Loss of Efficacy after Non-Medical Switching: Correlation between Circulating TNF-α Levels and SB4 in Etanercept to SB4 Switchers and Naïve Patients with Rheumatic Disease.

Maurizio Benucci, Arianna Damiani, Edda Russo, Francesca Li Gobbi, Valentina Grossi, Amedeo Amedei, Maria Infantino, Mariangela Manfredi

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Journal of personalized medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 50% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Maurizio BenucciRheumatology Unit, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, 50143 Florence, Italy.
Arianna DamianiRheumatology Unit, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, 50143 Florence, Italy.
Edda RussoDepartment of Clinical and Experimental Medicine, University of Florence, 50134 Florence, Italy.ORCID 0000-0003-3141-1091
Francesca Li GobbiRheumatology Unit, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, 50143 Florence, Italy.
Valentina GrossiImmunology and Allergology Laboratory, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, 50143 Florence, Italy.
Amedeo AmedeiDepartment of Clinical and Experimental Medicine, University of Florence, 50134 Florence, Italy.ORCID 0000-0002-6797-9343
Maria InfantinoImmunology and Allergology Laboratory, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, 50143 Florence, Italy.
Mariangela ManfrediImmunology and Allergology Laboratory, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, 50143 Florence, Italy.
Azienda Usl Toscana Centro · ITUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe investigated how the non-medical switching (NMS) between Etanercept (ETN)/originator and SB4/biosimilar affects treatment efficacy in a rheumatic disease (RD) cohort, evaluating some laboratory parameters as loss of efficacy predictors after NMS.

methodsWe enrolled 124 patients with RD (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis): 79 switchers from ETN/originator to SB4 and 45 naïve patients receiving SB4 (first biological treatment). At baseline, 6 (T1), and 12 months (T2), clinical and laboratory parameters were evaluated.

resultsIn naïve patients, TNF-α significantly increased at T1 in responders (NR) and non-responders (NNR). TNF-α was lower in NNR than in NR at T1 and T2. In NR and NNR, drug levels (DL) increased between T1 and T2. However, DLs were lower in NNR than in NR at T1 and T2. TNF-α was higher in switcher responders (SR) than in non-responders (SNR) at T1 and T2. In SNR, DLs were higher at baseline than in SR, but they decreased significantly at T1 and T2.

conclusionsWe observed a decrease in DL and TNF-α levels after NMS in SNR. Moreover, in naïve patients, DL and TNF-α levels were higher in NR than in NNR. Monitoring DL and TNF-α levels may represent a future precision medicine approach to predict loss of efficacy after NMS.

Indexed as

biosimilarsdisease activityEtanercept/SB4loss of efficacynon-medical switchingprecision medicinerheumatic disease

Identifiers

PMID35887671
PMCPMC9316161
OpenAlexW4286222574

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.