Evidence map›Paper›PMID 35939785›Full record

ArticleBlood advances2022

Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies.

Rebecca Kruse-Jarres, Flora Peyvandi, Johannes Oldenburg, Tiffany Chang, Sammy Chebon, Michelle Y Doral, Stacy E Croteau, Thierry Lambert, Christine L Kempton, Steven W Pipe and 9 more

4 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Blood advances, 2022. 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 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 2% 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.

NCT02622321 phase3completednot on this map

A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors

TypeinterventionalSponsorHoffmann-La RocheRan2015 to 2020Enrolled113ConditionsHemophilia AArmsEmicizumab, rFVIIa, aPCC
NCT02795767 phase3completednot on this map

A Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Administration of Emicizumab in Hemophilia A Pediatric Patients With Inhibitors

TypeinterventionalSponsorHoffmann-La RocheRan2016 to 2020Enrolled88ConditionsHemophilia AArmsEmicizumab
NCT02847637 phase3completednot on this map

A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients Without Inhibitors

TypeinterventionalSponsorHoffmann-La RocheRan2016 to 2022Enrolled152ConditionsHemophilia AArmsEmicizumab, Factor VIII (FVIII)
NCT03020160 phase3completednot on this map

A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks (Q4W) in Patients With Hemophilia A

TypeinterventionalSponsorHoffmann-La RocheRan2017 to 2022Enrolled48ConditionsHemophilia AArmsEmicizumab
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Haemophilia Prophylaxis in the Age of Innovation: Exploring Opportunities for Personalized Treatment.Haemophilia : the official journal of the World Federation of Hemophilia · 2025
    Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
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  15. Article
  16. Article
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  19. Article
  20. Simoctocog alfa (NuwiqTherapeutic advances in hematology · 2024
    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

19 authors at 10 institutions in 6 countries.

Rebecca Kruse-JarresWashington Center for Bleeding Disorders, Seattle, WA.ORCID 0000-0001-6547-5240
Flora PeyvandiFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia, Milan, Italy.ORCID 0000-0001-7423-9864
Johannes OldenburgUniversity Clinic Bonn, Bonn, Germany.
Tiffany ChangGenentech, Inc., South San Francisco, CA.
Sammy ChebonF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Michelle Y DoralGenentech, Inc., South San Francisco, CA.
Stacy E CroteauBoston Hemophilia Center, Boston Children's Hospital, Boston, MA.ORCID 0000-0001-6112-6166
Thierry LambertHaemophilia Care Centre, Bicêtre AP-HP Hospital, Faculté de Médecine Paris XI, Paris, France.
Christine L KemptonDepartment of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA.ORCID 0000-0002-2391-2016
Steven W PipeUniversity of Michigan, Ann Arbor, MI.ORCID 0000-0003-2558-2089
Richard H KoGenentech, Inc., South San Francisco, CA.
Benjamin TrzaskomaGenentech, Inc., South San Francisco, CA.
Christophe DhalluinF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Nives Selak BienzF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Markus NiggliF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Michaela LehleF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Ido Paz-PrielGenentech, Inc., South San Francisco, CA.
Guy YoungChildren's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, CA.ORCID 0000-0001-6013-1254
Víctor Jiménez-YusteLa Paz Hospital, Autónoma University, Madrid, Spain.ORCID 0000-0003-3937-3499
Roche (Switzerland) · CHBoston Children's Hospital · USEmory University · USUniversidad Autónoma de Madrid · ESUniversité Paris-Saclay · FRUniversity Hospital Bonn · DEUniversity of Michigan · USUniversity of Milan · ITUniversity of Southern California · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many people with hemophilia A (PwHA) undergo surgery in their lifetime, often because of complications of their disease. Emicizumab is the first bispecific monoclonal antibody prophylactic therapy for PwHA, and its efficacy and safety have been previously demonstrated; however, there is a need to build an evidence base on the management of PwHA on emicizumab undergoing surgery. Data from the HAVEN 1-4 phase 3 clinical trials were pooled to provide a summary of all minor and major surgeries in PwHA with or without factor VIII (FVIII) inhibitors who were receiving emicizumab prophylaxis. Overall, 233 surgeries were carried out during the HAVEN 1-4 trials: 215 minor surgeries (including minor dental and joint procedures, central venous access device placement or removal, and endoscopies) in 115 PwHA (64 with FVIII inhibitors) and 18 major surgeries (including arthroplasty and synovectomy) in 18 PwHA (10 with FVIII inhibitors). Perioperative hemostatic support was at the discretion of the treating physician. Overall, the median (interquartile range [IQR]) age was 33.5 (13.0-49.0) years and the median (IQR) emicizumab exposure time before surgery was 278.0 (177.0-431.0) days. Among the 215 minor surgeries, 141 (65.6%) were managed without additional prophylactic factor concentrate, and of those, 121 (85.8%) were not associated with a postoperative bleed. The majority (15 of 18 [83.3%]) of major surgeries were managed with additional prophylactic factor concentrate. Twelve (80.0%) of these 15 surgeries were associated with no intraoperative or postoperative bleeds. The data demonstrate that minor and major surgeries can be performed safely in PwHA receiving emicizumab prophylaxis. These trials are registered at www.clinicaltrials.gov as #NCT02622321, #NCT02795767, #NCT02847637, and #NCT03020160.

Indexed as

Hemophilia AAdultAntibodies, BispecificAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicFactor VIIIHemorrhageHumansMiddle AgedTreatment OutcomeAntibodies, BispecificAntibodies, Monoclonal, HumanizedemicizumabFactor VIII

Identifiers

PMID35939785
PMCPMC9768240
OpenAlexW4290725216

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.