Evidence map›Paper›PMID 37055803›Full record

ArticleArthritis research & therapy2023

Efficacy and pharmacokinetics of ozoralizumab, an anti-TNFα NANOBODY

Tsutomu Takeuchi, Yukihiro Chino, Masafumi Kawanishi, Megumi Nakanishi, Hirotaka Watase, Yoko Mano, Yuri Sato, Saeko Uchida, Yoshiya Tanaka

Abstract read
In one paragraph

Article in Arthritis research & therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–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

14 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Single-Domain Antibodies-Novel Tools to Study and Treat Allergies.International journal of molecular sciences · 2024
    Review
  11. Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Review
  12. Article
  13. Review
  14. 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

9 authors.

Tsutomu TakeuchiKeio University School of Medicine, Tokyo, Japan. tsutake@z5.keio.jp.ORCID 0000-0003-1111-8218
Yukihiro ChinoTaisho Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID 0000-0001-6484-4673
Masafumi KawanishiTaisho Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID 0000-0003-4104-8548
Megumi NakanishiTaisho Pharmaceutical Co., Ltd., Tokyo, Japan.
Hirotaka WataseTaisho Pharmaceutical Co., Ltd., Tokyo, Japan.
Yoko ManoTaisho Pharmaceutical Co., Ltd., Tokyo, Japan.
Yuri SatoTaisho Pharmaceutical Co., Ltd., Tokyo, Japan.
Saeko UchidaTaisho Pharmaceutical Co., Ltd., Tokyo, Japan.
Yoshiya TanakaUniversity of Occupational and Environmental Health, Japan, Kitakyushu, Japan.ORCID 0000-0002-0807-7139

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOzoralizumab (OZR), a tumor necrosis factor alpha (TNFα) inhibitor, is a NANOBODY

methodsEfficacy data were analyzed from the OHZORA trial, in which OZR 30 or 80 mg was administered to Japanese patients with RA at 4-week intervals for 52 weeks in combination with methotrexate (MTX; n = 381), and the NATSUZORA trial, in which OZR 30 or 80 mg was administered without concomitant MTX (n = 140). Effects of patient baseline characteristics and anti-drug antibodies (ADAs) on the PK and efficacy of OZR were investigated, and a post hoc analysis of PK effects on drug efficacy was performed.

resultsThe maximum plasma concentration (C

conclusionsOZR showed a long half-life and favorable PK properties. A post hoc analysis suggested sustained efficacy independent of trough concentration by subcutaneous administration of OZR 30 mg at 4-week intervals for 52 weeks.

trial registrationJapicCTI, OHZORA trial: JapicCTI-184029, registration date July 9, 2018; NATSUZORA trial: JapicCTI-184031, registration date July 9, 2018.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidAntibodies, MonoclonalDouble-Blind MethodDrug Therapy, CombinationHumansMethotrexateRetrospective StudiesTreatment OutcomeTumor Necrosis Factor-alphaAntibodies, MonoclonalAntirheumatic AgentsMethotrexateTumor Necrosis Factor-alphaAntirheumatic agentArthritis rheumatoidOzoralizumabPharmacodynamicsPharmacokineticsTumor necrosis factor alpha inhibitor

Identifiers

PMID37055803
PMCPMC10099673

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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.