Evidence map›Paper›PMID 31658377›Full record

ArticleBritish journal of clinical pharmacology2020

Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients.

Gerard Bruin, Hans-Ulrich P Hockey, Phillip La Stella, Bárdur Sigurgeirsson, Rong Fu, Manmath Patekar, Pascal Charef, Ralph Woessner, Bruno Boutouyrie-Dumont

Open access · hybridAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

12 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. A Review of the Safety of Interleukin-17A Inhibitor Secukinumab.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
  10. Article
  11. Article
  12. Article
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 at 5 institutions in 5 countries.

Gerard BruinNovartis Institutes for BioMedical Research, Basel, Switzerland.ORCID 0000-0002-8773-0705
Hans-Ulrich P HockeyBiometrics Matters Ltd, Hamilton, New Zealand.
Phillip La StellaTKL Research Inc, Fair Lawn, NJ, USA.
Bárdur SigurgeirssonDepartment of Dermatology, Faculty of Medicine, University of Iceland, Reykjavik, Iceland.ORCID 0000-0002-9733-9742
Rong FuNovartis Pharma, Shanghai, China.
Manmath PatekarNovartis Pharma, Basel, Switzerland.
Pascal CharefNovartis Pharma, Basel, Switzerland.
Ralph WoessnerNovartis Institutes for BioMedical Research, Basel, Switzerland.
Bruno Boutouyrie-DumontNovartis Institutes for BioMedical Research, Basel, Switzerland.
Novartis (Switzerland) · CHNovartis (China) · CNTKL Research · USUniversity of Iceland · ISZimmer Biomet (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of the study was to compare the pharmacokinetics (PK), safety and tolerability of secukinumab with different devices for subcutaneous (s.c.) administration of 2 mL.

methodsA phase 1 study in healthy subjects with 6 devices to administer 2 mL injection volumes was conducted to evaluate the serum PK, safety and tolerability of secukinumab following single s.c. injection of 300 mg in the abdomen (either side) or in the thigh (either leg). Primary PK endpoints were maximum observed serum concentration and area under the serum concentration-time curve. The impact of device, site and side of injection on serum exposure was evaluated. In a phase 3 study in psoriasis patients, PK of secukinumab was evaluated following multiple s.c. injections of 300 mg by either 2 × 1-mL prefilled syringe or 1 × 2-mL prefilled syringe.

resultsMean serum concentration-time profiles for administration as 2 × 1 mL injections or as 1 × 2 mL injections were similar. With an injection volume of 2 mL, perceived injection pain was not different from 2 × 1 mL injections. A nonclinically significant difference in PK endpoints was observed between thigh and abdomen. Results with a 2 mL prefilled syringe in a 1-year phase 3 study in patients confirmed PK results observed in the phase 1 study.

conclusionCollective evidence from both studies demonstrated that 2-mL injections of secukinumab into the abdomen or thigh using different devices resulted in comparable PK characteristics and were all well tolerated without noticeable local reactions.

Indexed as

Antibodies, Monoclonal, HumanizedPsoriasisHealthy VolunteersHumansInjections, SubcutaneousAntibodies, Monoclonal, Humanizedsecukinumabinjection deviceprefilled syringepsoriasissecukinumabsubcutaneous administrationtherapeutic monoclonal antibody

Identifiers

PMID31658377
PMCPMC7015744
OpenAlexW2982689367

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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.