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

• Type of Material: Article
• Authors: Rebecca Kruse-Jarres, Washington Center for Bleeding Disorders; Flora Peyvandi, Fdn IRCCS Ca Granda Osped Maggiore Policlin; Johannes Oldenburg, University Clinic Bonn; Tiffany Chang, Genentech Inc; Sammy Chebon, F. Hoffmann-La Roche Ltd; Michelle Y Doral, Genentech Inc; Stacy E Croteau, Boston Childrens Hospital; Thierry Lambert, Bicêtre AP-HP Hospital; Christine Kempton, Emory University; Steven W Pipe, University of Michigan; Richard H Ko, Genentech Inc; Benjamin Trzaskoma, Genentech Inc; Christophe Dhalluin, F. Hoffmann-La Roche Ltd; Nives Selak Bienz, F Hoffmann La Roche Ltd; Markus Niggli, F Hoffmann La Roche Ltd; Michaela Lehle, F Hoffmann La Roche Ltd; Ido Paz-Priel, Genentech Inc; Guy Young, University of Southern California; Víctor Jiménez-Yuste, Autónoma University
• Language: English
• Date: 2022-12-27
• Publisher: ELSEVIER
• Publication Version: Final Published Version
• Copyright Statement: © 2022 by The American Society of Hematology.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1182/bloodadvances.2022007458
• Title of Journal or Parent Work: BLOOD ADVANCES
• Volume: 6
• Issue: 24
• Start Page: 6140
• End Page: 6150
• Grant/Funding Information: The HAVEN studies were funded by F. Hoffmann-La Roche Ltd. and Chugai Pharmaceutical Co., Ltd.
• Keywords: Hematology; INHIBITORS; Life Sciences & Biomedicine; Science & Technology; ELECTIVE ORTHOPEDIC-SURGERY; MANAGEMENT
• Research Categories: Health Sciences, Oncology

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.