Evidence map›Paper›PMID 28652703›Full record

ReviewDrug design, development and therapy2017

CT-P13: design, development, and place in therapy.

Tommaso Gabbani, Simona Deiana, Vito Annese

Abstract readReview
In one paragraph

Review in Drug design, development and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  9. Review
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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

3 authors.

Tommaso GabbaniGastroenterology Unit, Morgagni-Pierantoni Hospital, AUSL Romagna, Forlì.
Simona DeianaDivision of Gastroenterology, AOU Careggi University Hospital, Florence, Italy.
Vito AnneseGastroenterology Department, Valiant Clinic, Dubai, UAE.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016. The Phase I and Phase III clinical trials conducted in ankylosing spondylitis and rheumatoid arthritis have demonstrated pharmacokinetic and efficacy equivalence with comparable safety and immunogenicity to IFX. For these reasons, the use of CT-P13 has been extrapolated also to inflammatory bowel disease. There have been some initial concerns regarding the use of CT-P13 in inflammatory bowel disease patients, because of the lack of randomized controlled trials. However, emerging real-world data have further confirmed the comparability between CT-P13 and its reference product in terms of efficacy, safety, and immunogenicity, in patients naïve to the anti-tumor necrosis factor alpha agents and after switching from IFX, and will be summarized in this review.

Indexed as

Drug DesignAnimalsAntibodies, MonoclonalAnti-Inflammatory AgentsAntirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsColitis, UlcerativeCrohn DiseaseDrug SubstitutionHumansInflammatory Bowel DiseasesInfliximabJoint DiseasesProduct Surveillance, PostmarketingSpondylitis, AnkylosingAntibodies, MonoclonalAnti-Inflammatory AgentsAntirheumatic AgentsBiosimilar PharmaceuticalsCT-P13Infliximabbiologic therapybiosimilarCrohn’s diseaseCT-P13infliximabulcerative colitis

Identifiers

PMID28652703
PMCPMC5472432

What OpenQuestion holds

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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.