Evidence map›Paper›PMID 36397934›Full record

ArticleResearch and practice in thrombosis and haemostasis2022

Safety and efficacy of long-term emicizumab prophylaxis in hemophilia A with factor VIII inhibitors: A phase 3b, multicenter, single-arm study (STASEY).

Víctor Jiménez-Yuste, Flora Peyvandi, Robert Klamroth, Giancarlo Castaman, Chandrakala Shanmukhaiah, Savita Rangarajan, Jaime García Chavez, Raul Martinez, Gili Kenet, Hazaa Alzahrani and 5 more

Open access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
7.4field-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.

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

25 citing papers in PubMed, 49 citations in OpenAlex.

  1. Trial
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  3. Emicizumab dose up-titration in case of suboptimal bleeding control in people with haemophilia A.Haemophilia : the official journal of the World Federation of Hemophilia · 2023
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  5. Observational
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  11. Review
  12. Evaluation of Safety and Efficacy of Emicizumab Prophylaxis in Egyptian Pediatric Patients with Hemophilia ATurkish journal of haematology : official journal of Turkish Society of Haematology · 2024
    Article
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  14. Article
  15. Review
  16. Article
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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

15 authors at 10 institutions in 10 countries.

Víctor Jiménez-YusteHospital Universitario La Paz Autónoma University Madrid Spain.ORCID https://orcid.org/0000-0003-3937-3499
Flora PeyvandiIRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center Milan Italy.ORCID https://orcid.org/0000-0001-7423-9864
Robert KlamrothComprehensive Care Haemophilia Treatment Centre, Vivantes Klinikum Berlin Germany.ORCID https://orcid.org/0000-0003-4194-8183
Giancarlo CastamanCareggi University Hospital Florence Italy.ORCID https://orcid.org/0000-0003-4973-1317
Chandrakala ShanmukhaiahDepartment of Haematology Seth GS Medical College and King Edward Memorial Hospital Mumbai India.
Savita RangarajanClinical Trials & Research Unit K J Somaiya Superspeciality Hospital & Research Centre Mumbai India.
Jaime García ChavezUnidad de Investigación en Enfermedades Hematologicas, Hospital de Especialidades CMN La Raza, IMSS Mexico City Mexico.
Raul MartinezUMAE Hospital De Especialidades CMNSXXI Mexico City Mexico.
Gili KenetNational Hemophilia Center, Sheba Medical Center Tel Hashomer Israel.ORCID https://orcid.org/0000-0003-3494-9823
Hazaa AlzahraniKing Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia.
Susan RobsonF. Hoffmann-La Roche Ltd Basel Switzerland.
Christophe SchmittF. Hoffmann-La Roche Ltd Basel Switzerland.
Anna KiialainenF. Hoffmann-La Roche Ltd Basel Switzerland.
Oliver MeierF. Hoffmann-La Roche Ltd Basel Switzerland.
Margareth OzeloHemocentro UNICAMP University of Campinas Campinas Brazil.
Roche (Switzerland) · CHHospital de Especialidades · MXHospital Universitario La Paz · ESAzienda Ospedaliero-Universitaria Careggi · ITKing Edward Memorial Hospital and Seth G.S. Medical College · INKing Faisal Specialist Hospital & Research Centre · SATel Aviv University · ILUniversidade Estadual de Campinas (UNICAMP) · BRUniversity of Milan · ITVivantes Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The bispecific monoclonal antibody emicizumab bridges activated factor IX and factor X, mimicking the cofactor function of activated factor VIII (FVIII), restoring hemostasis. Objectives: The Phase 3b STASEY study was designed to assess the safety of emicizumab prophylaxis in people with hemophilia A (HA) with FVIII inhibitors. Methods: People with HA received 3 mg/kg emicizumab once weekly (QW) for 4 weeks followed by 1.5 mg/kg QW for 2 years. The primary objective was the safety of emicizumab prophylaxis, including incidence and severity of adverse events (AEs) and AEs of special interest (thrombotic events [TEs] and thrombotic microangiopathies). Secondary objectives included efficacy (annualized bleed rates [ABRs]). Results: Overall, 195 participants were enrolled; 193 received emicizumab. The median (range) duration of exposure was 103.1 (1.1-108.3) weeks. Seven (3.6%) participants discontinued emicizumab. The most common AEs were arthralgia ( Conclusions: The safety profile of emicizumab prophylaxis was confirmed in a large population of people with HA with FVIII inhibitors and no new safety signals occurred. The majority of participants had zero treated bleeds.

Indexed as

antibodyblood coagulation factorsclinical trialhemophilia Ahemostasis

Identifiers

PMID36397934
PMCPMC9663319
OpenAlexW4308962120

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.