Surgical Experience from Four Phase III Studies (HAVEN 1-4) of Emicizumab in Persons with Haemophilia A (PwHA) with or without FVIII Inhibitors
ISTH Academy. Santagostino E. 07/09/19; 273889; OC 60.1 Topic: Hemophilia - Clinical
Elena Santagostino
Elena Santagostino
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OC 60.1

Surgical Experience from Four Phase III Studies (HAVEN 1-4) of Emicizumab in Persons with Haemophilia A (PwHA) with or without FVIII Inhibitors

E. Santagostino1, J. Oldenburg2, T. Chang3, J. Xu3, S. Chebon4, M. Doral3, V. Jiménez-Yuste5, R. Liesner6, S. Croteau7, T. Lambert8, C. Kempton9, S. Pipe10, C. Dhalluin4, N. Selak Bienz4, C. Vignal4, M. Lehle4, G. Young11, R. Kruse-Jarres12
1Fondazione IRCCS Ca'Granda, Ospedale Maggiore Policlinico, Milan, Italy, 2University Clinic Bonn, Bonn, Germany, 3Genentech Inc., South San Francisco, United States, 4F. Hoffmann-La Roche Ltd, Basel, Switzerland, 5Hospital Universitario La Paz, Autonoma University, Madrid, Spain, 6Great Ormond Street Hospital, London, United Kingdom, 7Boston Hemophilia Centre, Boston Children's Hospital, Boston, United States, 8Haemophilia Care Centre, Bicêtre AP-HP Hospital and Faculté de Médecine Paris XI, Paris, France, 9Emory University School of Medicine, Department of Hematology and Medical Oncology,, Atlanta, United States, 10University of Michigan, Ann Arbor, United States, 11Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, United States, 12Bloodworks Northwest, Seattle, United States

Main Topic: Hemophilia and Bleeding (including Transfusion)
Category: Hemophilia - Clinical

Background: Emicizumab is a subcutaneously administered, bispecific, humanized monoclonal antibody that bridges FIXa and FX to restore the function of missing FVIIIa in PwHA.
Aims: To present our experience of surgical procedures in pooled data from four phase III studies: HAVEN 1, 2, 3 and 4 (NCT02622321, NCT02795767, NCT02847637 and NCT03020160, respectively).
Methods: The studies enrolled PwHA of all ages, with or without FVIII inhibitors. Participants requiring minor or unplanned major surgery were managed per the investigator's discretion. We analysed perioperative use of prophylactic coagulation factor (FVIII or bypassing agents), as well as the frequency and management of post-operative bleeds.
Results: Across the HAVEN studies, 214 minor and 19 major surgeries were performed in 113 and 19 participants, respectively. The majority of minor surgeries were dental and central venous access device (CVAD) procedures
(Figure 1). The majority of minor surgeries (n=141; 65.9%) were managed without use of prophylactic coagulation factor; of these, 128 (90.8%) did not result in treated post-operative bleeds. Of the 73 (34.1%) procedures managed with prophylactic coagulation factor, 64 (87.7%) did not result in treated post-operative bleeds. Treated post-operative bleeds occurred most commonly following dental procedures, managed either with (5/22) or without (9/41) prophylactic coagulation factor.
Of the 19 major surgeries, 16 (84.2%) were managed with prophylactic coagulation factor; only one of which resulted in a treated post-operative bleed. Of the three major surgeries managed without prophylactic coagulation factor, no post-operative bleeding occurred. A summary of prophylactic coagulation factors used is provided in Table 1. Importantly, no procedure resulted in death, thrombosis, FVIII inhibition, or unexpected bleed.
Conclusions: Emicizumab alone provides good haemostatic coverage for patients undergoing minor surgeries. The majority of minor procedures were performed without prophylactic coagulation factor, and of these, >90% did not result in a treated post-operative bleed.

[Figure 1]

[Table 1]

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