Evidence map›Paper›PMID 39134043›Full record

Trial reportThrombosis and haemostasis2025

Final Analysis Results from the AGEHA Study: Emicizumab Prophylaxis for Acquired Hemophilia A with or without Immunosuppressive Therapy.

Midori Shima, Nobuaki Suzuki, Hidekazu Nishikii, Kagehiro Amano, Yoshiyuki Ogawa, Ryota Kobayashi, Ryoto Ozaki, Koichiro Yoneyama, Narumi Mizuno, Emiko Sakaida and 7 more

Abstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Thrombosis and haemostasis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–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.

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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Outcomes of Emicizumab in Acquired Hemophilia Patients: A Systematic Review.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
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  4. Non-Factor Therapies in Haemophilia: The Era of Factor VIII Mimetics and Targeted Rebalancing Agents.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026
    Review
  5. Acquired hemophilia A: an illustrated review based on the French National Guidelines.Research and practice in thrombosis and haemostasis · 2026
    Review
  6. A Jehovah's Witness with Acquired Hemophilia A Who Successfully Avoided Blood Transfusions by Receiving Emicizumab.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026
    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

17 authors.

Midori ShimaThrombosis and Hemostasis Research Center, Nara Medical University, Kashihara, Japan.
Nobuaki SuzukiDepartment of Transfusion Medicine, Nagoya University Hospital, Nagoya, Japan.
Hidekazu NishikiiDepartment of Hematology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Kagehiro AmanoDepartment of Laboratory Medicine, Tokyo Medical University Hospital, Tokyo, Japan.
Yoshiyuki OgawaDepartment of Hematology, Gunma University Graduate School of Medicine, Maebashi, Japan.
Ryota KobayashiChugai Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID 0000-0002-5204-2064
Ryoto OzakiChugai Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID 0000-0002-1142-4162
Koichiro YoneyamaChugai Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID 0000-0001-8166-6522
Narumi MizunoChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Emiko SakaidaDepartment of Hematology, Chiba University Hospital, Chiba, Japan.
Makoto SaitoBlood Disorders Center, Aiiku Hospital, Sapporo, Japan.
Takashi OkamuraDepartment of Hematology, St. Mary's Hospital, Kurume, Japan.
Toshihiro ItoDepartment of Infectious Diseases, National Hospital Organization Sendai Medical Center, Sendai, Japan.
Norimichi HattoriDivision of Hematology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Satoshi HigasaDepartment of Hematology, Hyogo College of Medicine Hospital, Nishinomiya, Japan.
Yoshinobu SekiDepartment of Hematology, Uonuma Institute of Community Medicine, Niigata University Medical and Dental Hospital, Minami-uonuma, Japan.
Keiji NogamiDepartment of Pediatrics, Nara Medical University, Kashihara, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Primary analysis of the phase III AGEHA study suggested a favorable benefit-risk profile for emicizumab prophylaxis in patients with acquired hemophilia A (PwAHA); however, only patients undergoing immunosuppressive therapy (IST; Cohort 1) were included.To present final analysis results of AGEHA, including data on IST-ineligible patients (Cohort 2) and on long-term prophylaxis with emicizumab.For patients in both Cohorts 1 and 2, emicizumab was administered subcutaneously at 6 mg/kg on Day 1, 3 mg/kg on Day 2, and 1.5 mg/kg once weekly from Day 8 onward.Twelve patients (Cohort 1) and two patients (Cohort 2) were enrolled. Duration of emicizumab treatment was 8 to 639 days (median: 44.5 days) in Cohort 1 and 64 and 450 days in Cohort 2. In both cohorts, no major bleeds were observed after initial emicizumab administration. Six patients started their first rehabilitation sessions during emicizumab treatment and no rehabilitation-related bleeds occurred. Twenty-three surgeries were performed under emicizumab prophylaxis and there were no bleeds related to surgeries. Although asymptomatic deep vein thrombosis was reported in one patient in the primary analysis, no other thrombotic events occurred thereafter. Two patients developed anti-emicizumab antibodies, one of whom showed accelerated emicizumab clearance. Tailored IST approaches (delayed initiation, no use, or reduced dose) were successfully executed in three patients undergoing emicizumab prophylaxis.These results suggest that emicizumab prophylaxis has a favorable benefit-risk profile in PwAHA regardless of eligibility for IST.

Indexed as

Antibodies, BispecificAntibodies, Monoclonal, HumanizedHemophilia AImmunosuppressive AgentsAdultAgedDrug Administration ScheduleFactor VIIIFemaleHemorrhageHumansMaleMiddle AgedTime FactorsTreatment OutcomeYoung AdultAntibodies, BispecificAntibodies, Monoclonal, HumanizedemicizumabFactor VIIIImmunosuppressive Agents

Identifiers

PMID39134043
PMCPMC12040431

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.