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. 2021 Jan;27(1):90-99.
doi: 10.1111/hae.14212. Epub 2020 Nov 27.

Management of people with haemophilia A undergoing surgery while receiving emicizumab prophylaxis: Real-world experience from a large comprehensive treatment centre in the US

Magdalena Lewandowska  1 , Nicole Randall  1 , Nihal Bakeer  1 , Jennifer Maahs  1 , Jeanne Sagar  1 , Anne Greist  1 , Amy D Shapiro  1
Affiliations

Management of people with haemophilia A undergoing surgery while receiving emicizumab prophylaxis: Real-world experience from a large comprehensive treatment centre in the US

Magdalena Lewandowska et al. Haemophilia. 2021 Jan.

Abstract

Introduction: Surgery is frequently required in persons with haemophilia A (PwHA). Emicizumab, a bispecific, humanized monoclonal antibody, bridges activated factor (F) IX and FX. Management of patients undergoing surgery while receiving emicizumab is of clinical interest due to paucity of data.

Aim: Review real-world experience of PwHA with/without FVIII inhibitors who required surgery while receiving emicizumab prophylaxis.

Methods: Data regarding peri-operative management, including type of surgery, haemostatic agent use and bleeding complications, were collected for PwHA receiving emicizumab undergoing surgery between 25/10/18 and 31/12/19 at the Indiana Hemophilia and Thrombosis Center. Analyses were exploratory and descriptive.

Results: Twenty minor and five major surgeries were performed in 17 and five patients, respectively. Overall, 9/20 minor surgeries were planned to occur with emicizumab as the sole haemostatic agent; of these, four required additional coagulation factor (2 due to haematomas following port removals, 1 due to oozing at port removal site, 1 due to bleeding following squamous cell carcinoma removal). Three of the 11 minor surgeries with planned additional coagulation factor resulted in non-major bleeds; all were safely managed with additional coagulation factor. All five major surgeries were planned with additional haemostatic agents; there was 1 bleed in a patient undergoing elbow synovectomy with nerve transposition, likely triggered by physical/occupational therapy. There were no major bleeds, thrombotic events or deaths.

Conclusions: Additional haemostatic agent use is safe in PwHA undergoing surgery while receiving emicizumab. Additional data are needed to determine the optimal dosing/length of treatment of additional haemostatic agents to lower bleeding risk.

Keywords: emicizumab; haemophilia; real-world evidence; surgery.

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Conflict of interest statement

All authors report funding from F. Hoffmann‐La Roche Ltd for writing support for the development of this manuscript; JM reports funding for consultation/advisory role for Novo Nordisk and Takeda and speakers’ bureaus for Genentech, Inc., and Novo Nordisk; JS reports research funding from Genentech, Inc.; ADS reports speakers’ bureau and research funding from Genentech, Inc.

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