Evidence map›Paper›PMID 33133246›Full record

ArticleTherapeutic advances in musculoskeletal disease2020

The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases.

Cosimo Bruni, Stefano Gentileschi, Giovanni Pacini, Caterina Baldi, Marco Capassoni, Lorenzo Tofani, Marco Bardelli, Laura Cometi, Luca Cantarini, Francesca Nacci and 5 more

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.0field-weighted citation impact, top 5% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. 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 4 institutions in 1 country.

Cosimo BruniDepartment of Experimental and Clinical Medicine, Division of Rheumatology, University of Firenze, Via delle Oblate 4, 50141, Firenze, 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, University of Florence, Florence, Italy.
Caterina BaldiDepartment of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Siena, Italy.
Marco CapassoniDepartment Experimental and Clinical Medicine, Division of Rheumatology, University of Florence, Florence, Italy.
Lorenzo TofaniDepartment Experimental and Clinical Medicine, Division of Rheumatology, University of Florence, Florence, Italy.
Marco BardelliDepartment of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Siena, Italy.
Laura CometiDepartment Experimental and Clinical Medicine, Division of Rheumatology, University of Florence, Florence, Italy.
Luca CantariniDepartment of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Siena, Italy.
Francesca NacciDepartment Experimental and Clinical Medicine, Division of Rheumatology, University of Florence, Florence, Italy.
Michele VietriDepartment Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Francesca BartoliDepartment Geriatric Medicine, Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy.
Ginevra FioriDepartment Geriatric Medicine, Division of Rheumatology, Azienda Ospedaliero Universitaria Careggi, Firenze, 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, University of Florence, Florence, Italy.
University of Florence · ITUniversity of Siena · ITAzienda Ospedaliero-Universitaria Careggi · ITRegione Toscana

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSwitching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region.

methodsAdult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up.

resultsA total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN duration 7 ± 4 years) were enrolled, with median follow-up of 12.1 (9.7-15.8) months. A total of 50 patients (22.7%) presented with at least one adverse event, with 36 (16.4%) disease flares and 30 (13.6%: 11 for safety and 19 loss of efficacy) SB4 withdrawals. Cumulative SB4 treatment persistence was 99.1%, 88.6% and 64.6% at 6, 12 and 18 months respectively. Back-switch to ETN was performed in 17/30 cases, the remaining cases were managed with change of biologic disease modifying or conventional synthetic anti-rheumatic drug. Age was the only significant predictor of SB4 interruption at 6 months.

conclusionOur real-life data confirm the safety profile of switching from ETN to SB4, with slightly higher treatment persistence rates compared with other real-life registries.

Indexed as

etanerceptpersistencerheumatic diseasessafetySB4switch

Identifiers

PMID33133246
PMCPMC7576915
OpenAlexW3097044269

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.