Evidence map›Paper›PMID 34377890›Full record

ArticleRheumatology advances in practice2021

Real-life drug persistence in patients with rheumatic diseases treated with CT-P13: a prospective observational cohort study (PERSIST).

Peter C Taylor, Robin Christensen, Shahrzad Moosavi, Pamela Selema, Ruffy Guilatco, Heather Fowler, Markus Mueller, Katherine F Liau, Boulos Haraoui

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Rheumatology advances in practice, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02605642 (PERSIST), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 96% 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.

NCT02605642 completednot on this map

Persist: prospective observational cohort study to assess persistence of ct-p13 (infliximab) in patients with rheumatoid diseases who are either naive to biologics or switched from stable remicade(r) (infliximab)

TypeobservationalSponsorPfizerRan2015 to 2018Enrolled351ConditionsRheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic ArthritisArmsCT-P13
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Observational
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

9 authors at 6 institutions in 5 countries.

Peter C TaylorNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID https://orcid.org/0000-0001-7766-6167
Robin ChristensenSection for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen.
Shahrzad MoosaviWorldwide Safety and Risk Management, Pfizer Inc., New York, NY, USA.
Pamela SelemaWorldwide Safety and Risk Management, Pfizer Inc., New York, NY, USA.
Ruffy GuilatcoGlobal Biometrics & Data Management, Global Product Development, Pfizer Inc., Manila, Philippines.
Heather FowlerClinical Development & Operations, Global Product Development, Pfizer Inc., London, UK.
Markus MuellerMedical Affairs, Pfizer Pharma GmbH, Berlin, Germany.
Katherine F LiauBiosimilars, Pfizer Inc., La Jolla, CA, USA.
Boulos HaraouiClinical Research Unit in Rheumatology, Institut de rhumatologie de Montréal, Montreal, QC, Canada.
Pfizer (United States) · USMontreal Clinical Research Institute · CANuffield Orthopaedic Centre · GBPfizer (Germany) · DEPfizer (United Kingdom) · GBUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim was to report results from PERSIST, a real-life, observational, prospective cohort study of CT-P13, an infliximab (IFX) biosimilar, for treatment of patients with RA, AS or PsA who were biologic naïve or switched from an IFX reference product (IFX-RP; Remicade).

methodsAdult patients were recruited during usual care at 38 sites in Europe and Canada and enrolled by their physicians after meeting eligibility criteria according to the country-approved label for CT-P13. Primary outcomes were to determine drug utilization and treatment persistence and to assess safety. Patients were followed for up to 2 years. Data were analysed and reported descriptively.

resultsOf 351 patients enrolled, 334 were included in the analysis (RA, 40.4%; AS, 34.7%; PsA, 24.9%). The safety analysis set comprised all 328 patients treated with CT-P13. The majority (58.2%) of patients received CT-P13 monotherapy, most (72.6%) by dosing every 6 or 8 weeks. The mean treatment persistence was 449.2 days; 62.3% of patients completed 2 years of treatment. In all, 214 treatment-emergent adverse events (TEAEs) were reported in 38.4% of patients. Most TEAEs were of mild or moderate intensity; 13 were severe. The most commonly reported TEAEs were drug ineffective (9.5%) and infusion-related reactions (5.2%). The most frequently reported infection-related TEAEs were upper respiratory tract infections (3.0%), nasopharyngitis (2.1%) and bronchitis (1.5%). No patients experienced tuberculosis.

conclusionDrug utilization and treatment persistence with CT-P13 were consistent with historical reports of IFX-RP in this patient population. Safety findings did not identify new concerns for CT-P13 in the treatment of patients with RA, AS or PsA.

trial registrationClinicalTrials.gov: NCT02605642.

Indexed as

biosimilarCT-P13infliximabobservationalPERSISTpersistencereal liferheumatic diseasessafety

Identifiers

PMID34377890
PMCPMC8346696
OpenAlexW3163292931

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.