Evidence map›Paper›PMID 33863352›Full record

Trial reportArthritis research & therapy2021

Comparative efficacy of subcutaneous (CT-P13) and intravenous infliximab in adult patients with rheumatoid arthritis: a network meta-regression of individual patient data from two randomised trials.

Bernard Combe, Yannick Allanore, Rieke Alten, Roberto Caporali, Patrick Durez, Florenzo Iannone, Michael T Nurmohamed, Mondher Toumi, Sang Joon Lee, Taek Sang Kwon and 3 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 2021. 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
1.1field-weighted citation impact, top 23% 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, 16 citations in OpenAlex.

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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

13 authors at 10 institutions in 6 countries.

Bernard CombeDepartment of Rheumatology, CHU Montpellier, Montpellier University, Montpellier, France.
Yannick AllanoreRheumatology Department, Hôpital Cochin, Paris Descartes University, Paris, France.
Rieke AltenDepartment of Internal Medicine and Rheumatology, Schlosspark-Klinik Charité, University Medicine Berlin, Berlin, Germany.
Roberto CaporaliDepartment of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, University of Milan, Milan, Italy.
Patrick DurezRheumatology, Cliniques Universitaires Saint-Luc - Universite Catholique De Louvain - Institut De Recherche Experimentale Et Clinique (IREC), Brussels, Belgium.
Florenzo IannoneRheumatology Unit, Department of Emergency and Organ Transplantation, Università Degli Studi Di Bari Aldo Moro, Bari, Italy.
Michael T NurmohamedDepartment of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, The Netherlands.
Mondher ToumiDepartment of Public Health, Aix-Marseille University, Marseille, France.
Sang Joon LeeCelltrion Inc., Incheon, Republic of Korea.
Taek Sang KwonCelltrion Healthcare Co., Ltd, Incheon, Republic of Korea.
Jiwon NohCelltrion Healthcare Co., Ltd, Incheon, Republic of Korea.
Gahee ParkCelltrion Inc., Incheon, Republic of Korea.
Dae Hyun YooDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea. dhyoo@hanyang.ac.kr.ORCID 0000-0002-0643-4008
Celltrion (South Korea) · KRAix-Marseille Université · FRCliniques Universitaires Saint-Luc · BEHanyang University Seoul Hospital · KRReade · NLSchlosspark-Klinik · DEUniversité de Montpellier · FRUniversité Paris Cité · FRUniversity of Bari Aldo Moro · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA subcutaneous (SC) formulation of infliximab biosimilar CT-P13 is approved in Europe for the treatment of adult patients with rheumatoid arthritis (RA). It may offer improved efficacy versus intravenous (IV) infliximab formulations.

methodsA network meta-regression was conducted using individual patient data from two randomised trials in patients with RA, which compared CT-P13 SC with CT-P13 IV, and CT-P13 IV with reference infliximab IV. In this analysis, CT-P13 SC was compared with CT-P13 IV, reference infliximab IV and pooled data for both reference infliximab IV and CT-P13 IV. Outcomes included changes from baseline in 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI), and rates of remission, low disease activity or clinically meaningful improvement in functional disability per Health Assessment Questionnaire-Disability Index (HAQ-DI).

resultsThe two studies enrolled 949 patients with RA; pooled data for 840 and 751 patients were evaluable at weeks 30 and 54, respectively. For the CT-P13 SC versus pooled IV treatment arm comparison, differences in changes from baseline in DAS28-CRP (- 0.578; 95% confidence interval [CI] - 0.831, - 0.325; p < 0.0001), CDAI (- 3.502; 95% CI - 5.715, - 1.289; p = 0.002) and SDAI (- 4.031; 95% CI - 6.385, - 1.677; p = 0.0008) scores at 30 weeks were statistically significant in favour of CT-P13 SC. From weeks 30 to 54, the magnitude of the differences increased and remained statistically significant in favour of CT-P13 SC. Similar results were observed for the comparison of CT-P13 SC with CT-P13 IV and with reference infliximab IV. Statistically significant differences at week 30 favoured CT-P13 SC over the pooled IV treatment arms for the proportions of patients achieving EULAR-CRP good response, American College of Rheumatology (ACR) 50 and ACR70 responses, DAS28-CRP-defined remission, low disease activity (DAS28-CRP, CDAI and SDAI criteria) and clinically meaningful HAQ-DI improvement.

conclusionsCT-P13 SC was associated with greater improvements in DAS28-CRP, CDAI and SDAI scores and higher rates of clinical response, low disease activity and clinically meaningful improvement in functional disability, compared with CT-P13 IV and reference infliximab IV.

trial registrationEudraCT, 2016-002125-11 , registered 1 July 2016; EudraCT 2010-018646-31 , registered 23 June 2010.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAdultAntibodies, MonoclonalEuropeHumansInfliximabSeverity of Illness IndexTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsCT-P13InfliximabCT-P13Disease activityIndirect treatment comparisonIndividual patient dataInfliximabIntravenousNetwork meta-regressionRheumatoid arthritisSubcutaneousTumour necrosis factor inhibitor

Identifiers

PMID33863352
PMCPMC8051052
OpenAlexW3155463134

What OpenQuestion holds

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LicenceCC BY
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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.