Evidence map›Paper›PMID 27500949›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2017

Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administration using a prefilled syringe or an autoinjector in patients with moderate-to-severe plaque psoriasis (UNCOVER-A).

K Callis Duffin, J Bagel, M Bukhalo, I J Mercado Clement, S L Choi, F Zhao, A Gill, B Pangallo, C Shuler, L Mallbris and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01777191 (Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis), which is not on this map. Cited by 17 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 5 pooled it
3.6field-weighted citation impact, top 7% 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.

NCT01777191 phase3completednot on this map

Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis

TypeinterventionalSponsorEli Lilly and CompanyRan2013 to 2015Enrolled204ConditionsPlaque PsoriasisArmsIxekizumab Auto-Injector, Ixekizumab Prefilled Syringe
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017
    Trial
  9. Article
  10. Article
  11. Review
  12. Autoinjector - A smart device for emergency cum personal therapy.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2021
    Review
  13. Article
  14. Article
  15. Article
  16. Role of IL-17 in plaque psoriasis: therapeutic potential of ixekizumab.Therapeutics and clinical risk management · 2017
    Review
  17. 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

11 authors at 6 institutions in 3 countries.

K Callis DuffinDepartment of Dermatology, University of Utah, Salt Lake City, UT, USA.
J BagelPsoriasis Treatment Center of Central New Jersey, Windsor, NJ, USA.
M BukhaloAltman Dermatology Associates, Arlington Heights, IL, USA.
I J Mercado ClementLilly-NUS Centre for Clinical Pharmacology, Singapore City, Singapore.
S L ChoiLilly-NUS Centre for Clinical Pharmacology, Singapore City, Singapore.
F ZhaoEli Lilly and Company, Indianapolis, IN, USA.
A GillEli Lilly and Company, Indianapolis, IN, USA.
B PangalloEli Lilly and Company, Indianapolis, IN, USA.
C ShulerEli Lilly and Company, Indianapolis, IN, USA.
L MallbrisEli Lilly and Company, Indianapolis, IN, USA.
K JacksonEli Lilly and Company, Windlesham, UK.
Eli Lilly (United States) · USEli Lilly (Singapore) · SGArlington Dermatology · USEli Lilly (United Kingdom) · GBUniversity of Utah · USVA New Jersey Health Care System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of ixekizumab, an anti-interleukin-17A (anti-IL-17A) monoclonal IgG4 antibody, was demonstrated in moderate-to-severe psoriasis patients when administered via prefilled syringe (PFS).

objectiveTo evaluate the effect of two drug delivery devices on the pharmacokinetics (PK) of ixekizumab as well as efficacy and safety with both devices.

methodsIn the first 12 weeks of an open-label, phase 3 study, moderate-to-severe psoriasis patients were randomized to ixekizumab delivery via PFS or autoinjector device. Randomization was stratified by weight (<80 kg, 80-100 kg, >100 kg), injection assistance (yes/no) and injection site (arm, thigh or abdomen). Following a 160-mg initial dose at week 0, patients received subcutaneous 80-mg ixekizumab as a single injection every 2 weeks for 12 weeks. Blood samples were collected following the initial 160-mg dose on days 2, 4, 7, 10 and 14 for PK analysis. Primary PK parameters were maximum concentration (C

resultsOf 204 randomized patients, 192 were included in the PK analysis (PFS: 94; autoinjector: 98). The PFS and autoinjector showed similar geometric mean C

conclusionThe PK, efficacy and safety of ixekizumab administered subcutaneously by PFS and autoinjector were similar. Clinicaltrials.gov number: NCT01777191 https://clinicaltrials.gov/ct2/show/NCT01777191.

Indexed as

Antibodies, Monoclonal, HumanizedHumansInjections, SubcutaneousPsoriasisSeverity of Illness IndexAntibodies, Monoclonal, Humanizedixekizumab

Identifiers

PMID27500949
PMCPMC5215575
OpenAlexW2494759158

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.