Evidence map›Paper›PMID 34750553›Full record

Trial reportNature medicine2021

Fenebrutinib in H

Martin Metz, Gordon Sussman, Rémi Gagnon, Petra Staubach, Tonny Tanus, William H Yang, Jeremy J Lim, Holly J Clarke, Joshua Galanter, Leslie W Chinn and 6 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 3 pooled it
14.8field-weighted citation impact, top 1% 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

60 citing papers in PubMed, 3 syntheses or guidelines pooled it, 125 citations in OpenAlex.

  1. European S2k Guideline on Chronic PruritusActa dermato-venereologica · 2025
    Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Emerging Therapies for Anaphylaxis.Immunology and allergy clinics of North America · 2026
    Review
  13. Review
  14. Article
  15. Review
  16. Emerging IgE and non-IgE targeted therapies for chronic urticaria.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2026
    Review
  17. [Advances in targeted therapies for chronic spontaneous urticaria].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2026
    Review
  18. Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond.The journal of allergy and clinical immunology. In practice · 2026
    Review
  19. Review
  20. 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

16 authors at 7 institutions in 3 countries.

Martin MetzDermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0002-4070-9976
Gordon SussmanDivision of Allergy and Clinical Immunology, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.
Rémi GagnonService d'Allergie et Immunologie, Département de Médecine, Centre Hospitalier Universitaire de Québec, Quebec City, Québec, Canada.
Petra StaubachDepartment of Dermatology, University Medical Center Mainz, Mainz, Germany.
Tonny TanusKern Allergy Medical Clinic Inc., Bakersfield, CA, USA.
William H YangOttawa Allergy Research Corporation, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Jeremy J LimGenentech, Inc., South San Francisco, CA, USA.
Holly J ClarkeGenentech, Inc., South San Francisco, CA, USA.
Joshua GalanterGenentech, Inc., South San Francisco, CA, USA.
Leslie W ChinnGenentech, Inc., South San Francisco, CA, USA.
Tom ChuGenentech, Inc., South San Francisco, CA, USA.
Anastasia TeterinaHoffman-LaRoche Limited, Missisauga, Ontario, Canada.
Tracy BurgessGenentech, Inc., South San Francisco, CA, USA.
D James HaddonGenentech, Inc., South San Francisco, CA, USA.
Timothy T LuGenentech, Inc., South San Francisco, CA, USA.
Marcus MaurerDermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany. marcus.maurer@charite.de.ORCID http://orcid.org/0000-0002-4121-481X
Fraunhofer Institute for Translational Medicine and Pharmacology · DECentre hospitalier universitaire de Québec · CAJohannes Gutenberg University Mainz · DEKern Medical Center · USRoche (Canada) · CASt. Michael's Hospital · CAUniversity of Ottawa · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bruton's tyrosine kinase (BTK) is crucial for FcεRI-mediated mast cell activation and essential for autoantibody production by B cells in chronic spontaneous urticaria (CSU). Fenebrutinib, an orally administered, potent, highly selective, reversible BTK inhibitor, may be effective in CSU. This double-blind, placebo-controlled, phase 2 trial (EudraCT ID 2016-004624-35 ) randomized 93 adults with antihistamine-refractory CSU to 50 mg daily, 150 mg daily and 200 mg twice daily of fenebrutinib or placebo for 8 weeks. The primary end point was change from baseline in urticaria activity score over 7 d (UAS7) at week 8. Secondary end points were the change from baseline in UAS7 at week 4 and the proportion of patients well-controlled (UAS7 ≤ 6) at week 8. Fenebrutinib efficacy in patients with type IIb autoimmunity and effects on IgG-anti-FcεRI were exploratory end points. Safety was also evaluated. The primary end point was met, with dose-dependent improvements in UAS7 at week 8 occurring at 200 mg twice daily and 150 mg daily, but not at 50 mg daily of fenebrutinib versus placebo. Asymptomatic, reversible grade 2 and 3 liver transaminase elevations occurred in the fenebrutinib 150 mg daily and 200 mg twice daily groups (2 patients each). Fenebrutinib diminished disease activity in patients with antihistamine-refractory CSU, including more patients with refractory type IIb autoimmunity. These results support the potential use of BTK inhibition in antihistamine-refractory CSU.

Indexed as

AdolescentAdultAgammaglobulinaemia Tyrosine KinaseAngioedemaAutoimmunityChronic UrticariaDouble-Blind MethodDrug ResistanceFemaleHistamine H1 AntagonistsHistamine ReleaseHumansImmunoglobulin EMaleMast CellsMiddle AgedAgammaglobulinaemia Tyrosine KinasefenebrutinibHistamine H1 AntagonistsImmunoglobulin EPiperazinesPlacebosPyridonesReceptors, IgETransaminases

Identifiers

PMID34750553
PMCPMC8604722
OpenAlexW3212896089

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.