Evidence map›Paper›PMID 35659282›Full record

ArticleArthritis research & therapy2022

Intravenous tocilizumab for the treatment of giant cell arteritis: a phase Ib dose-ranging pharmacokinetic bridging study.

Christophe Schmitt, Laura Brockwell, Mylène Giraudon, Mauro Zucchetto, Lisa Christ, Bettina Bannert, Thomas Daikeler, Peter M Villiger

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Arthritis research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03923738 (A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 21% 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.

NCT03923738 phase1completednot on this map

A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis

TypeinterventionalSponsorHoffmann-La RocheRan2019 to 2020Enrolled24ConditionsGiant Cell ArteritisArmsTocilizumab
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Observational
  4. Review
  5. Tocilizumab for Non-Infectious Uveitis: A Systematic Review.Journal of inflammation research · 2025
    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

8 authors at 4 institutions in 2 countries.

Christophe SchmittDepartment of Clinical Pharmacology, F. Hoffmann-La Roche AG, Grenzacherstrasse 124, 4070, Basel, Switzerland. christophe.schmitt@roche.com.ORCID 0000-0001-8001-5584
Laura BrockwellF. Hoffmann-La Roche Ltd, Welwyn Garden City, UK.
Mylène GiraudonDepartment of Clinical Pharmacology, F. Hoffmann-La Roche AG, Grenzacherstrasse 124, 4070, Basel, Switzerland.
Mauro ZucchettoParaxel International, Milan, Italy.
Lisa ChristDepartment of Rheumatology and Immunology, Inselspital, University Hospital Bern, Bern, Switzerland.
Bettina BannertDepartment of Rheumatology, USB - University Hospital Basel, Basel, Switzerland.
Thomas Daikeler *Department of Rheumatology, USB - University Hospital Basel, Basel, Switzerland.
Peter M Villiger *Medical Center Monbijou, Bern, Switzerland.
Roche (Switzerland) · CHUniversity Hospital of Basel · CHRoche (United Kingdom) · GBUniversity Hospital of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSubcutaneous tocilizumab (TCZ SC) is approved globally for giant cell arteritis (GCA). This phase Ib study investigated the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of intravenous (IV) TCZ 6 and 7 mg/kg in patients with GCA. This study explored an IV dose resulting in a minimum exposure level within the range of effective trough concentrations achieved with TCZ SC dosing in GCA and not exceeding the exposure of the well-tolerated 8 mg/kg IV every 4 weeks (Q4W) in rheumatoid arthritis (RA).

methodsPatients with GCA who had received ≥ 5 doses of TCZ IV 8 mg/kg Q4W and achieved remission were enrolled. Patients received 5 doses of TCZ IV 7 mg/kg Q4W in period 1 and, if still in remission, 5 doses of 6 mg/kg Q4W in period 2. Pharmacokinetic endpoints were maximum concentration (C

resultsIn 24 patients, the median (range) age was 65.5 (57-90) years, and 62.5% were female. TCZ exposures (C

conclusionsBoth doses of TCZ IV Q4W were generally well tolerated in patients with GCA. The C

trial registrationClinicalTrials.gov , NCT03923738.

Indexed as

Arthritis, RheumatoidGiant Cell ArteritisAgedAged, 80 and overAntibodies, Monoclonal, HumanizedBlood SedimentationFemaleHumansMaleTreatment OutcomeAntibodies, Monoclonal, HumanizedtocilizumabGiant cell arteritisIntravenousPharmacodynamicsPharmacokineticsSafetyTocilizumab

Identifiers

PMID35659282
PMCPMC9166308
OpenAlexW4281685641

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.