Evidence map›Paper›PMID 26472043›Full record

Trial reportModern rheumatology2016

Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis.

Tsutomu Takeuchi, Kazuhiko Yamamoto, Hisashi Yamanaka, Naoki Ishiguro, Yoshiya Tanaka, Katsumi Eguchi, Akira Watanabe, Hideki Origasa, Mariko Kobayashi, Toshiharu Shoji and 3 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Modern rheumatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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, 1 synthesis or guideline pooled it.

  1. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
    Pooled it
  2. Review
  3. Article
  4. Immunogenicity of biologics in inflammatory bowel disease.Therapeutic advances in gastroenterology · 2018
    Article
  5. 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

13 authors.

Tsutomu Takeuchia Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Shinjuku-ku , Tokyo , Japan .
Kazuhiko Yamamotob Department of Allergy and Rheumatology , Graduate School of Medicine, The University of Tokyo , Bunkyo-ku , Tokyo , Japan .
Hisashi Yamanakac Institute of Rheumatology, Tokyo Women's Medical University , Shinjuku-ku , Tokyo , Japan .
Naoki Ishigurod Department of Orthopedic Surgery , Nagoya University Graduate School and Faculty of Medicine , Nagoya , Aichi , Japan .
Yoshiya Tanakae The First Department of Internal Medicine , University of Occupational and Environmental Health , Japan, Kitakyushu , Fukuoka , Japan .
Katsumi Eguchif Rheumatic and Collagen Disease Center, Sasebo Chuo Hospital , Sasebo , Nagasaki , Japan .
Akira Watanabeg Research Division for Development of Anti-Infectious Agents , Institute of Development, Aging and Cancer, Tohoku University , Sendai , Miyagi , Japan .
Hideki Origasah Division of Biostatistics and Clinical Epidemiology , The University of Toyama Graduate School of Medicine , Toyama , Japan .
Mariko Kobayashii UCB Pharma , Shinjuku-ku , Tokyo , Japan .
Toshiharu Shojii UCB Pharma , Shinjuku-ku , Tokyo , Japan .
Osamu Togoi UCB Pharma , Shinjuku-ku , Tokyo , Japan .
Nobuyuki Miyasakaj Tokyo Medical and Dental University , Bunkyo-ku , Tokyo , Japan , and.
Takao Koikek Sapporo Medical Center NTT EC , Sapporo , Hokkaido , Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies.

methodsData from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies.

resultsIn both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]).

conclusionsDespite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile.

Indexed as

AdultAntirheumatic AgentsArthritis, RheumatoidCertolizumab PegolDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedTreatment OutcomeAntirheumatic AgentsCertolizumab PegolCertolizumab pegolLoading doseRandomized controlled trialRheumatoid arthritisTumor necrosis factor-alpha inhibitor

Identifiers

PMID26472043
PMCPMC4898155

What OpenQuestion holds

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Registered trials

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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.