Evidence map›Paper›PMID 35168291›Full record

ArticleHematological oncology2022

The safety and clinical effectiveness of rapid infusion with CT-P10 in patients with non-Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non-interventional post-authorization safety study in Europe.

Mark Bishton, Scott Marshall, Jatinder Harchowal, Gilles Salles, Camille Golfier, Alessandra Tucci, Alicia Rodriguez Fernández, Jose Javier Sanchez Blanco, Monica Bocchia, SooKyoung Kim and 2 more

Open access · hybridAbstract read
In one paragraph

Article in Hematological oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 63% 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. Review
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

12 authors at 10 institutions in 5 countries.

Mark BishtonNottingham City Hospital, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Scott MarshallSunderland Royal Hospital, South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.
Jatinder HarchowalThe Royal Marsden NHS Foundation Trust, London, UK.
Gilles SallesCentre Hospitalier Lyon Sud - Service d'Hématologie Clinique, Lyon, France.
Camille GolfierCentre Hospitalier Lyon Sud - Service d'Hématologie Clinique, Lyon, France.
Alessandra TucciHematology Department, ASST Spedali Civili di Brescia, Brescia, Italy.
Alicia Rodriguez FernándezHematology Department, Hospital Universitario Virgen de la Macarena, Seville, Spain.
Jose Javier Sanchez BlancoHematology Department, Hospital Morales Meseguer de Murcia, Murcia, Spain.
Monica BocchiaU.O.C Ematologia, Azienda Ospedaliero-Universitaria Senese - Policlinico Santa Maria alle Scotte, Siena, Italy.
SooKyoung KimCelltrion Healthcare Co. Ltd., Incheon, Republic of Korea.
Young Nam LeeCelltrion Healthcare Co. Ltd., Incheon, Republic of Korea.
Pier Luigi ZinzaniIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.ORCID https://orcid.org/0000-0002-2112-2651
Celltrion (South Korea) · KRHôpital Lyon Sud · FRAzienda Ospedaliera Universitaria Senese · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITHospital General Universitario Morales Meseguer · ESHospital Universitario Virgen Macarena · ESIstituto di Ematologia di Bologna · ITNottingham University Hospitals NHS Trust · GBRoyal Marsden NHS Foundation Trust · GBSunderland Royal Hospital · GB

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Celltrion HealthcareNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Rapid infusion (RI) of the rituximab biosimilar CT-P10 is currently only an approved treatment regimen for the treatment of rheumatoid arthritis. Although both CT-P10 and reference rituximab are known to be frequently administered using a RI regimen (≤90 min) in clinical practice, published data on the safety of RI of CT-P10 in patients with NHL and CLL are limited. Hence, this study collected real-world safety and effectiveness data on RI-CT-P10 from the medical records of 196 patients with NHL or CLL in 10 European centers, 6 months after the date of the first RI (index date); the infusion-related reaction (IRR) rate was compared to previously published data. Ten percent (95% confidence interval 6%-15%; n = 20/196) of patients experienced an infusion-related reaction (IRR) on day 1-2 post-index, which was not significantly different (p = 0.45) to the IRR rate for rituximab described in a previous meta-analysis (8.8%). During the observation period, 2% of patients experienced grade 3-5 IRRs and 85% (n = 166) experienced an adverse event (non-IRR). The most common reason for discontinuation of first-line CT-P10 was planned treatment completion (81%; n = 158). Complete response and partial response to CT-P10 was observed in 74% (n = 142/192) and 22% (n = 42/192) of patients, respectively. The results of this real-world study demonstrate that the safety and effectiveness profile of RI-CT-P10 is similar to RI of reference rituximab and therefore support the current use of RI-CT-P10 in patients with NHL and CLL.

Indexed as

Biosimilar PharmaceuticalsDrug-Related Side Effects and Adverse ReactionsLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinAntibodies, Monoclonal, Murine-DerivedHumansRetrospective StudiesRituximabTreatment OutcomeAntibodies, Monoclonal, Murine-DerivedBiosimilar PharmaceuticalsCT-P10Rituximabbiosimilar pharmaceuticalschronicinfusionintravenouslymphocytic leukemialymphomanon-Hodgkinrituximab

Identifiers

PMID35168291
PMCPMC9545983
OpenAlexW4213198937

What OpenQuestion holds

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LicenceCC BY
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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.