Evidence map›Paper›PMID 29116597›Full record

Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2017

Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants.

Elisa V Gomez, Jessie L Bishop, Kimberley Jackson, Talia M Muram, Diane Phillips

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02543918 (Vaccination Response Following Administration of Ixekizumab to Healthy Subjects), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 25% 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.

NCT02543918 phase1completednot on this map

Vaccination Response Following Administration of Ixekizumab to Healthy Subjects

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2015Enrolled84ConditionsHealthyArmsIxekizumab, Boostrix®, Pneumovax®23
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.

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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

5 authors at 2 institutions in 2 countries.

Elisa V GomezEli Lilly and Company, Indianapolis, IN, USA.
Jessie L BishopEli Lilly and Company, Indianapolis, IN, USA.
Kimberley JacksonEli Lilly and Company, Windlesham, UK.
Talia M MuramEli Lilly and Company, Indianapolis, IN, USA.
Diane PhillipsEli Lilly and Company, Indianapolis, IN, USA. phillips_diane_l@lilly.com.ORCID http://orcid.org/0000-0001-7299-1075
Eli Lilly (United States) · USEli Lilly (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIxekizumab (IXE) is an interleukin (IL)-17A antagonist approved for the treatment of adults with moderate-to-severe psoriasis.

objectiveThe objective of this study was to determine if the immune response to tetanus and pneumococcal vaccines in healthy subjects administered IXE was noninferior to control.

methodsIn a randomized, open-label, parallel-group study, adult subjects received vaccinations alone (N = 42, control) or in combination with 160 mg IXE subcutaneously 2 weeks prior to vaccination and 80 mg IXE on the day of vaccination (N = 41, IXE). Response to tetanus vaccination was defined as anti-tetanus antibodies ≥ 1.0 IU and a ≥ 1.5-fold increase if baseline was ≤ 1.0 IU or a ≥ 2.5-fold increase if baseline was > 1.0 IU. Response to pneumococcal vaccination was defined as a ≥ 2-fold increase from baseline in anti-pneumococcal antibodies against > 50% of the 23 serotypes. The primary outcomes were the percentages of patients with a response to the tetanus and pneumococcal vaccines 4 weeks after vaccination. A noninferiority analysis of IXE to control using a 40% margin was evaluated for the primary outcomes. Safety and pharmacokinetics were also assessed.

resultsIXE (38 completers) was noninferior to control (41 completers) based on the difference in the proportion of responders to tetanus [1.4%; 90% confidence interval (CI) - 16.6 to 19.2] and pneumococcal (- 0.8%; 90% CI - 12.9 to 11.0) vaccines. Twenty subjects (14 IXE, six control) reported 43 mild treatment-emergent adverse events.

conclusionIXE does not suppress the humoral immune response to non-live vaccines and was well tolerated in healthy subjects. ClinicalTrial.gov identifier: NCT02543918.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedDermatologic AgentsHealthy VolunteersHumansMiddle AgedPneumococcal VaccinesTetanus ToxoidTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedDermatologic AgentsixekizumabPneumococcal VaccinesTetanus Toxoid

Identifiers

PMID29116597
PMCPMC5696443
OpenAlexW2767463706

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.