Evidence map›Paper›PMID 31950442›Full record

ReviewRheumatology and therapy2020

Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology?

Roy Fleischmann, Vipul Jairath, Eduardo Mysler, Dave Nicholls, Paul Declerck

Abstract readReview
In one paragraph

Review in Rheumatology and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
–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

37 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  16. Patient Experience with the SensoReadyPatient preference and adherence · 2024
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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

5 authors.

Roy FleischmannUniversity of Texas Southwestern Medical Center, Metropleac Clinical Research Center, 8144 Walnut Hill Lane, Dallas, TX, 75231, USA. rfleischmann@arthdocs.com.ORCID http://orcid.org/0000-0002-6630-1477
Vipul JairathDivision of Gastroenterology, Departments of Medicine, Epidemiology and Biostatistics, University Hospital, Western University, Room A10-228, London, ON, Canada.
Eduardo MyslerOrganización Médica de Investigación, Callao 384 Piso 2 Dto 6, CABA, C1022AAQ, Buenos Aires, Argentina.
Dave NichollsCoast Joint Care, University of the Sunshine Coast, Maroochy Waters Shopping Centre, Denna Street, Maroochydore, QLD, 4558, Australia.
Paul DeclerckUniversity of Leuven, Campus Gasthuisberg O&N 2, Herestraat 49, P.B. 820, 3000, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The act of nonmedical switching, defined as switching stable patients who are generally doing well with their current therapy from an originator biologic to its biosimilar, has been endorsed as a reasonable treatment strategy. The safety and efficacy of nonmedical switching have been evaluated in randomized controlled and real-world evidence studies, which have demonstrated that although many patients maintain treatment response after the switch, some patients experience therapy failure, resulting in therapy discontinuation. It has been postulated that the vast majority, if not all, of these treatment failures result from a "nocebo effect", defined as patients' negative expectations toward the therapy change. Reports suggest that the risk of a nocebo effect is higher following a mandated nonmedical switch. Although the nocebo effect is a well-recognized phenomenon in pain studies, evidence is limited in immune-mediated diseases primarily because it is difficult to quantify, especially retrospectively. In spite of this, numerous biosimilar studies in patients with immune-mediated diseases have concluded that nonmedical switching failures are due to a nocebo effect. The objective of this narrative review was to explore the reasons for nonmedical switch failure or discontinuation and the role of the nocebo effect among patients with inflammatory rheumatic and gastrointestinal diseases who switched from an originator biologic to its biosimilar.

Indexed as

BiosimilarNoceboNonmedical switchTNF inhibitor

Identifiers

PMID31950442
PMCPMC7021884

What OpenQuestion holds

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LicenceCC BY-NC
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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.