Evidence map›Paper›PMID 39215351›Full record

ArticleAllergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology2024

Exploratory pharmacodynamics and efficacy of PF-06817024 in a Phase 1 study of patients with chronic rhinosinusitis and atopic dermatitis.

Spencer I Danto, Nikolaos Tsamandouras, Padma Reddy, Steven A Gilbert, Jessica Y Mancuso, Karen Page, Jean S Beebe, Elena Peeva, Michael S Vincent

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02743871 (A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE AND/OR MULTIPLE INTRAVENOUS AND/OR SUBCUTANEOUS DOSES OF PF-06817024 IN HEALTHY SUBJECTS WHO MAY BE MILDLY ATOPIC, SUBJECTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS, AND SUBJECTS WITH MODERATE-SEVERE ATOPIC DERMATITIS), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT02743871 phase1completednot on this map

A phase 1, randomized, double-blind, third-party open, placebo-controlled, dose escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and/or multiple intravenous and/or subcutaneous doses of pf-06817024 in healthy subjects who may be mildly atopic, subjects with chronic rhinosinusitis with nasal polyps, and subjects with moderate-severe atopic dermatitis

TypeinterventionalSponsorPfizerRan2016 to 2021Enrolled97ConditionsHealthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic DermatitisArmsPF-06817024, Placebo for PF-06817024
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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.

Spencer I DantoPfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA. spencer.i.danto@pfizer.com.ORCID http://orcid.org/0000-0002-0587-5274
Nikolaos TsamandourasPfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA.
Padma ReddyPfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA.
Steven A GilbertPfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA.
Jessica Y MancusoPfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA.
Karen PagePfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA.
Jean S Beebe *Pfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA.
Elena PeevaPfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA.
Michael S VincentPfizer Inc, 1 Portland Street, Cambridge, MA, 02151, USA.

Funding

Pfizer Inc Pfizer Inc
6 · The paper itself

Abstract

PF-06817024 is a humanized antibody against interleukin-33 that has the potential to inhibit type 2 inflammation. An exploratory analysis of the pharmacodynamics and clinical effects of single and repeat doses of PF-06817024 was assessed in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and patients with moderate-to-severe atopic dermatitis (AD), respectively, as part of a Phase 1, first-in-human study. Rhinosinusitis symptoms were improved, and nasal polyps were decreased in size following treatment with PF-06817024 in patients with CRSwNP. In patients with AD, PF-06817024, in aggregate, reduced disease severity and improved symptoms, as demonstrated by greater percentage decrease from baseline in Eczema Area and Severity Index (EASI) scores and reduced pruritus numerical rating scores, compared with placebo. The efficacy in AD appeared to be bimodal with a sub-group of participants exhibiting high levels of improvement (EASI75 and EASI90) for a sustained period of time after dosing. In patients with CRSwNP, a consistent trend of decrease in eosinophil levels was observed in the PF-06817024 group, compared with placebo. Further research would be needed to confirm the clinical benefit and safety of PF-06817024 as a treatment for allergic diseases. Trial registration ClinicalTrials.gov, NCT02743871. Registered 15 April 2016, https://clinicaltrials.gov/study/NCT02743871?term=NCT02743871&rank=1 .

Indexed as

Anti-IL-33 antibodyAtopic dermatitisBiomarkersChronic rhinosinusitis with nasal polypsEfficacyPharmacodynamicsPhase 1

Identifiers

PMID39215351
PMCPMC11365161

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.