Evidence map›Paper›PMID 32476277›Full record

Trial reportInternational journal of rheumatic diseases2020

A comparative study of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderate to severe active rheumatoid arthritis: A subgroup analysis.

Hideto Kameda, Eishi Uechi, Tatsuya Atsumi, Carlos Abud-Mendoza, Kazumasa Kamei, Tsugumi Matsumoto, Dario Ponce de Leon, Muhammad I Rehman, Min Zhang, Sebastiao C Radominski

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of rheumatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 38% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Review
  6. 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

10 authors at 7 institutions in 4 countries.

Hideto KamedaDivision of Rheumatology, Department of Internal Medicine, Toho University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-4330-5782
Eishi UechiDivision of Rheumatology, Tomishiro Central Hospital, Okinawa, Japan.
Tatsuya AtsumiDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Carlos Abud-MendozaRheumatology Research Unit, Faculty of Medicine, Central Hospital Dr. Ignacio Morones Prieto, Universidad Autónoma de San Luis Potosí, San Luis, Mexico.
Kazumasa KameiInflammation and Immunology Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.
Tsugumi MatsumotoInflammation and Immunology Medical Affairs, Pfizer Japan Inc, Tokyo, Japan.
Dario Ponce de LeonInflammation and Immunology, Latin America Medical Affairs, Pfizer Inc, Lima, Peru.
Muhammad I RehmanClinical Development, Pfizer Inc, Andover, MA, USA.
Min ZhangGlobal Biometrics and Data Management, Pfizer Inc, La Jolla, CA, USA.
Sebastiao C RadominskiRheumatology Service, Clinical Hospital, Universidade Federal do Paraná, Curitiba, Brazil.
Pfizer (Japan) · JPPfizer (United States) · USAutonomous University of San Luis Potosí · MXHokkaido University · JPHospital de Clínicas Universidade Federal do Paraná · BRToho University · JPTomishiro Central Hospital · JP

Funding

Pfizer
6 · The paper itself

Abstract

aimPF-06438179/GP1111 (PF-SZ-IFX) is a biosimilar of reference infliximab (Remicade

methodsPatients with rheumatoid arthritis were randomized 1:1 to PF-SZ-IFX (n = 324) or IFX-EU (n = 326); study drug (3 mg/kg) was administered intravenously at weeks 0, 2, and 6, then every 8 weeks thereafter. Subgroup analyses of efficacy endpoints such as American College of Rheumatology criteria for ≥20% clinical improvement (ACR20), change in high-sensitivity C-reactive protein (hs-CRP), and change in Disease Activity Score in 28 joints, four components based on hs-CRP (DAS28-CRP) at weeks 14 and 30 were performed by age, gender, race, region, immunogenicity status, and treatment history.

resultsOverall, ACR20 response rates as well as changes in DAS28-CRP and hs-CRP at week 14 were similar between PF-SZ-IFX and IFX-EU within the subgroups of age, gender, race, region, treatment history, and immunogenicity status. Results to week 30 support overall similarity in efficacy between the two treatment arms in all subgroups.

conclusionOverall, PF-SZ-IFX and IFX-EU were similar in efficacy within the analyzed subgroups of age, gender, race, region, treatment history, and immunogenicity status. The efficacy results from these subgroup analyses were aligned with the previously described results for the overall population up to week 30.

Indexed as

AdultAgedAntirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsDouble-Blind MethodFemaleHumansInfliximabMaleMiddle AgedRemission InductionSeverity of Illness IndexTherapeutic EquivalencyTime FactorsTreatment OutcomeAntirheumatic AgentsBiosimilar PharmaceuticalsGP1111Infliximabarthritis - rheumatoidbiosimilar pharmaceuticalsinfliximabJapanLatin America

Identifiers

PMID32476277
PMCPMC7496806
OpenAlexW3030935860

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.