Evidence map›Paper›PMID 41461999›Full record

Trial reportAdvances in therapy2026

Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic Rhinosinusitis with Nasal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2.

Daniel J Jackson, Arnaud Bourdin, Allison Blackorby, Anna Leslie, Anna Vichiendilokkul, Peter Howarth, Natalia Karkoszka, Shigeharu Fujieda, Marjolein Cornet

4 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT04718103 phase3completednot on this map

A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

TypeinterventionalSponsorGlaxoSmithKlineRan2021 to 2024Enrolled397ConditionsAsthmaArmsGSK3511294, Placebo
NCT04719832 phase3completednot on this map

A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

TypeinterventionalSponsorGlaxoSmithKlineRan2021 to 2023Enrolled395ConditionsAsthmaArmsGSK3511294 (Depemokimab), Placebo
NCT05274750 phase3completednot on this map

A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)

TypeinterventionalSponsorGlaxoSmithKlineRan2022 to 2024Enrolled276ConditionsNasal PolypsArmsDepemokimab (GSK3511294), Placebo
NCT05281523 phase3completednot on this map

A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-2 (depemokimAb iN CHrOnic Rhinosinusitis)

TypeinterventionalSponsorGlaxoSmithKlineRan2022 to 2024Enrolled264ConditionsNasal PolypsArmsDepemokimab (GSK3511294), Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
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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

9 authors.

Daniel J JacksonDepartment of Pediatrics, Division of Allergy, Immunology and Rheumatology, University of Wisconsin, School of Medicine and Public Health, K4/936 CSC, 600 Highland Avenue, Madison, WI, 53792, USA. djj@medicine.wisc.edu.
Arnaud BourdinDépartement de Pneumologie et Addictologie, Phy Med Exp, CHU Montpellier, Université de Montpellier, Montpellier, France.
Allison BlackorbyStatistics, Respiratory Unit, GSK, Durham, NC, USA.
Anna LeslieClinical Development, Respiratory, Immunology and Inflammation Research Unit, GSK, London, UK.
Anna VichiendilokkulGlobal Medical Affairs, GSK, Collegeville, PA, USA.
Peter HowarthGlobal Medical Affairs, Respiratory Specialty Care, GSK, London, UK.
Natalia KarkoszkaSpecialty Safety, GSK, Warsaw, Poland.
Shigeharu FujiedaDepartment of Otorhinolaryngology, Head and Neck Surgery, University of Fukui, Fukui, Japan.
Marjolein CornetDepartment of Otorhinolaryngology, Alrijne Hospital, Leiderdorp, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDepemokimab, the first ultra-long-acting respiratory biologic, is under investigation for diseases with underlying type 2 (T2) inflammation. Subcutaneous depemokimab 100 mg was efficacious in patients with T2 asthma characterized by blood eosinophil count and in chronic rhinosinusitis with nasal polyps (CRSwNP) when administered twice-yearly in four Phase III randomized, double-blind, placebo-controlled studies (SWIFT-1/-2 and ANCHOR-1/-2, respectively). This pooled analysis examined the safety and tolerability of subcutaneous depemokimab 100 mg versus placebo in patients with T2 asthma and in CRSwNP.

methodsAdverse event (AE) frequency, severity, time-to-onset, duration, and relative risk (RR) were evaluated for depemokimab 100 mg and placebo administered subcutaneously every 26 weeks for 52 weeks using pooled SWIFT-1/-2 and ANCHOR-1/-2 data. The impact of immunogenicity on safety was also evaluated.

resultsOverall, 1290 patients from the four studies were included in the safety analysis population (773 [60%] received depemokimab; 517 [40%] received placebo). On-treatment AEs were reported by 73% and 78% of patients in the depemokimab and placebo groups, respectively; the majority were mild or moderate in intensity and transient, with similar durations between treatment groups. Serious AEs (SAEs; 5% and 10%, with depemokimab and placebo, respectively), and discontinuations due to AEs (< 1% and 1%, respectively) were infrequent. No fatal AEs or treatment-related SAEs (per investigator assessment) were reported. RRs (vs. placebo) were similar for all common on-treatment AEs except asthma and back pain, which occurred less frequently in the depemokimab group compared with the placebo group. Antidrug antibodies and neutralizing antibodies occurred infrequently, and no association between antidrug antibody status and depemokimab efficacy was identified.

conclusionsIn these studies, twice-yearly depemokimab 100 mg was generally well tolerated by patients with T2 asthma or CRSwNP over the 52-week treatment period, supporting the safety of the first ultra-long-acting biologic for these diseases. CLINICAL TRIAL IDENTIFIER(S): NCT04719832/NCT04718103/NCT05274750/NCT05281523.

Indexed as

Antibodies, Monoclonal, HumanizedAsthmaNasal PolypsRhinitisSinusitisAdultAgedChronic DiseaseDouble-Blind MethodDrug Administration ScheduleFemaleHumansInjections, SubcutaneousMaleMiddle AgedRhinosinusitisAntibodies, Monoclonal, HumanizedAnti-IL-5AsthmaChronic rhinosinusitis with nasal polypsDepemokimabSafetyTolerability

Identifiers

PMID41461999
PMCPMC12909322

What OpenQuestion holds

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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.