Evidence map›Paper›PMID 32328979›Full record

ArticleClinical drug investigation2020

A 5-year Retrospective Analysis of Drug Survival, Safety, and Effectiveness of the Infliximab Biosimilar CT-P13 in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis.

Tae-Hwan Kim, Shin-Seok Lee, Won Park, Yeong Wook Song, Chang-Hee Suh, SooKyoung Kim, Young Nam Lee, Dae Hyun Yoo

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical drug investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.4field-weighted citation impact, top 19% 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, 20 citations in OpenAlex.

  1. Review
  2. Observational
  3. Article
  4. Article
  5. Review
  6. Article
  7. Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. 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

8 authors at 6 institutions in 1 country.

Tae-Hwan Kim *Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-3542-2276
Shin-Seok Lee *Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Republic of Korea.ORCID http://orcid.org/0000-0001-6810-7355
Won ParkSchool of Medicine, Inha University, Incheon, Republic of Korea.ORCID http://orcid.org/0000-0002-0004-8034
Yeong Wook SongRheumatology, Seoul National University Hospital, Seoul National University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-5384-3437
Chang-Hee SuhRheumatology, Ajou University School of Medicine, Suwon, Republic of Korea.ORCID http://orcid.org/0000-0001-6156-393X
SooKyoung KimCelltrion Healthcare Co. Ltd., Incheon, Republic of Korea.ORCID http://orcid.org/0000-0003-4099-3249
Young Nam LeeCelltrion Healthcare Co. Ltd., Incheon, Republic of Korea.ORCID http://orcid.org/0000-0003-2776-4708
Dae Hyun YooDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea. dhyoo@hanyang.ac.kr.ORCID http://orcid.org/0000-0002-0643-4008
Celltrion (South Korea) · KRHanyang University Seoul Hospital · KRAjou University · KRChonnam National University Hospital · KRInha University · KRSeoul National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe infliximab biosimilar CT-P13 has widely received regulatory approval in all indications of reference infliximab, including rheumatoid arthritis (RA) and ankylosing spondylitis (AS).

objectiveThis retrospective analysis investigated drug survival and long-term safety and effectiveness of CT-P13 in patients with RA or AS in the Republic of Korea.

methodsThis non-interventional, retrospective, multicenter analysis collected medical record data for adult patients with RA or AS who received CT-P13 treatment at five Korean referral hospitals (2012-2017). Drug survival and long-term safety were primary outcomes. The secondary outcome was long-term effectiveness, assessed by disease activity measures.

resultsOverall, 491 patients were treated with CT-P13 (154 patients with RA [135 infliximab-naïve; 19 switched from reference infliximab]; 337 patients with AS [219 infliximab-naïve; 118 switched from reference infliximab]). Drug survival was similar in naïve and switched patients. Treatment-emergent adverse events (TEAEs) occurred in 31.8% and 29.4% of patients with RA and AS, respectively; incidence was similar in naïve and switched groups. Upper respiratory tract infection, influenza-like illness, and urticaria were the most common TEAEs. Overall, nine (1.8%) patients experienced serious adverse events (SAEs) deemed potentially drug-related; SAEs led to permanent CT-P13 discontinuation in five (1.0%) patients, including three with tuberculosis. Disease activity decreased over time.

conclusionUp to 5 years of CT-P13 treatment was safe and effective in patients with RA and AS, based on drug survival, incidence of TEAEs, and disease activity. Drug survival and safety were similar in naïve patients and switched groups, supporting switching from reference infliximab to CT-P13.

Indexed as

AdultAntibodies, MonoclonalAntirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsDrug SubstitutionFemaleHumansMaleMiddle AgedRepublic of KoreaRetrospective StudiesSpondylitis, AnkylosingTreatment OutcomeAntibodies, MonoclonalAntirheumatic AgentsBiosimilar PharmaceuticalsCT-P13

Identifiers

PMID32328979
OpenAlexW3018053945

What OpenQuestion holds

Textmetadata
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.