Evidence map›Paper›PMID 29294598›Full record

Trial reportThe Korean journal of internal medicine2018

Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis.

Young Mo Kang, Young-Eun Park, Won Park, Jung-Yoon Choe, Chul-Soo Cho, Seung-Cheol Shim, Sang Cheol Bae, Chang-Hee Suh, Hoon-Suk Cha, Eun Mi Koh and 8 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Korean journal of internal medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 37% 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Piggybacked by PEGylation?The Korean journal of internal medicine · 2018
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 16 institutions in 3 countries.

Young Mo KangDivision of Rheumatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
Young-Eun ParkDivision of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
Won ParkDivision of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, Korea.
Jung-Yoon ChoeDepartment of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea.
Chul-Soo ChoDivision of Rheumatology, Department of Internal Medicine, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
Seung-Cheol ShimDivision of Rheumatology, Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea.
Sang Cheol BaeDepartment of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.
Chang-Hee SuhDivision of Rheumatology, Department of Internal Medicine, Ajou University Hospital, Suwon, Korea.
Hoon-Suk ChaDivision of Rheumatology, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Suwon, Korea.
Eun Mi KohDivision of Rheumatology, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Suwon, Korea.
Yeong-Wook SongDivision of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Bin YooDivision of Rheumatology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Shin-Seok LeeDivision of Rheumatology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
Min-Chan ParkDivision of Rheumatology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Sang-Heon LeeDivision of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, Seoul, Korea.
Catherine ArendtUCB Pharma, Brainel'Alleud, Belgium, USA.
Willem KoetseUCB Pharma, Raleigh, NC, USA.
Soo-Kon LeeDivision of Rheumatology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Chonnam National University Hospital · KRSungkyunkwan University · KRAjou University Hospital · KRChungnam National University Hospital · KRDaegu Catholic University Medical Center · KRHanyang University Seoul Hospital · KRInha University Hospital · KRKyungpook National University · KRPusan National University Hospital · KRSeoul National University Hospital · KRSeverance Hospital · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRUCB Pharma (Belgium) · BEUCB Pharma (United States) · USUlsan College · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsThe objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity.

methodsIn this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX.

resultsAt week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ≥ 1.2 (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate.

conclusionCZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

Indexed as

AdolescentAdultAgedAntirheumatic AgentsArthritis, RheumatoidCertolizumab PegolDisability EvaluationDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMethotrexateMiddle AgedRecovery of FunctionRemission InductionAntirheumatic AgentsCertolizumab PegolMethotrexateCertolizumabClinical trialMethotrexateRheumatoid arthritisTumor necrosis factor inhibitor

Identifiers

PMID29294598
PMCPMC6234400
OpenAlexW2781625326

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.