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Thank you for attending THSNA 2026. The virtual meeting is now closed.
Thank you for attending THSNA 2026. The virtual meeting is now closed.
Presentation Details
| Exploratory Analysis from HAVEN 1–4 to Further Contextualize Injection-Site Reactions Among People with Hemophilia A Receiving Emicizumab Maya Bloomberg1, Katherine Eakle2, Markus Niggli3, Christophe Dhalluin3, Lucy Lee2, Elise Lim2, Shannon L.Carpenter4. 1Sylvester Comprehensive Cancer Center, Miami, FL, USA.2Genentech, Inc., South San Francisco, CA, USA.3F.Hoffmann-La Roche Ltd, Basel, Switzerland.4Children’s Mercy Hospital, Kansas City, MT, USA |
Abstract
Background: Long-term data from the Phase III HAVEN 1–4 studies (NCT02622321, NCT02795767, NCT02847637, NCT03020160) showed that subcutaneous emicizumab prophylaxis in people with hemophilia A (PwHA) with or without factor (F)VIII inhibitors maintained low bleed rates and was well tolerated (Callaghan MU, et al. Blood 2021). The most common treatment-related adverse events were injection-site reactions (ISRs). Objectives: Here, we further contextualize ISRs across HAVEN 1–4, informing on the tolerability of emicizumab injections. Methods: PwHA in the safety populations of HAVEN 1–4 were included. Clinic visiting schedules were similar across all studies until Week 49 (HAVEN 2) or Week 73 (HAVEN 1, 3, and 4). Follow-up visits then occurred every 12 (HAVEN 1, 2, and 4) or every 24 weeks (HAVEN 3). The proportion of participants with ISRs over time and the proportion of ISRs by total emicizumab injections are reported. Results: Overall, 399 PwHA were included (data cut-off: May 15, 2020). The median (range) emicizumab duration was 130.3 (3.4–221.1) weeks. In total, 112 participants (28.1%) had ≥1 ISR; the median (range) number of ISRs per participant was 0 (0–23). The proportion of participants experiencing ISRs declined over time (23.7% at 1–24 weeks; 4.9% at 25–48 weeks; 2.8% at 49–72 weeks; 1.8% at 73–96 weeks; 0.5% at 97–120 weeks [Figure 1]). Out of >42,000 injections, 317 ISRs occurred, corresponding to 0.75% of injections being associated with a reported ISR. The proportion of ISRs by total injections was 0.42% in HAVEN 1, 0.98% in HAVEN 2, 0.65% in HAVEN 3, and 3.29% in HAVEN 4 (Figure 2). No participant discontinued emicizumab because of an ISR. Erythema, pain, and swelling were the most reported ISR-associated symptoms, occurring in 46.4% (52/112), 16.1% (18/112), and 14.3% (16/112) of participants with ISRs, respectively. ISR-associated symptoms trended down over time across all studies and were similar irrespective of dosing regimen. Conclusions: Overall, <1% of emicizumab injections were associated with an ISR and the proportion of participants experiencing ISRs declined over time; however, changes in visit schedules beyond the main study period may introduce a reporting bias. These results expand our understanding of the tolerability of emicizumab injections.
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No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.