Publications about HEMLIBRA and haemophilia A
This page contains links to external guidance documents and the latest sponsored congress presentations from Roche/Chugai/Genentech. Additionally, you will find links to published manuscripts, containing clinical study data and safety information, for HEMLIBRA in haemophilia A.
Please note that these lists are not exhaustive. For further information, or to request access for any previous Roche/Chugai sponsored congress poster or presentation or document that is not available on open access, please contact Roche medicinal information on 0800 328 1629 or via this form.
The following links are to external resources, generated independently of Roche/Chugai.
Treatment of bleeding episodes in haemophilia A complicated by a Factor VIII inhibitor in patients receiving emicizumab. Interim guidance from UKHCDO Inhibitor Working Party and Executive Committee
(open access) Collins PW et al. Haemophilia 2018;24:344–47.
Guidelines on the use of prophylactic factor replacement for children and adults with haemophilia A and B
(open access) Rayment R et al. Br J Haem 2020;190:684–95.
Recent poster presentations from or supported by Roche/Chugai (ASH and NHF, 2020)
Links to Roche/Chugai sponsored posters from the American Society of Hematology (ASH) Annual Meeting and the National Hemophilia Foundation (NHF) Conference, both held in 2020.
ASH 2020:866. Real-world persistence with and adherence to emicizumab prophylaxis in persons with hemophilia A: a secondary claims database analysis
Mahajerin A et al.
1786. A phase IV, multicenter, open-label study of emicizumab prophylaxis in persons with hemophilia A with or without FVIII inhibitors undergoing minor surgical procedures
Escobar M et al.
1793. Analysis of hemophilia A outcomes and treatment patterns using real-world data from the Canadian Hemophilia Bleeding Disorder RegistryLee A et al.
1800. Safety and efficacy of emicizumab in persons with hemophilia A with or without FVIII inhibitors: pooled data from four phase III studies (HAVEN 1–4)Callaghan MU et al.
2532. Problem joints and their clinical and humanistic burden in children and adults with moderate and severe hemophilia A: CHESS Paediatrics and CHESS IIMcLaughlin P et al.
2685. Real-world safety of emicizumab: the first interim analysis of the European Haemophilia Safety Surveillance (EUHASS) databaseShang A et al.
3449. An insight into the impact of hemophilia A on daily life according to disease severity: a preliminary analysis of the CHESS II studyNoone D et al.3457. Impact of hemophilia A inhibitor on joint health and health-related quality of life from the Hemophilia Utilization Group Studies Part VIII in the U.S.Ullman MM et al.
Manuscripts for the HEMLIBRA clinical studies (HAVEN)
Emicizumab prophylaxis in hemophilia A with inhibitors
(open access) Oldenburg J et al. N Engl J Med 2017;377:809–18.
Emicizumab prophylaxis in patients who have hemophilia A without inhibitors
(open access) Mahlangu J et al. N Engl J Med 2018;379:811–22.
A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors
(open access) Young G et al. Blood 2019;134:2127–38.
Efficacy, safety and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study
(not open access) Pipe SW et al. Lancet Haematol 2019;6:e295–e305.
Manuscripts assessing mortality in congenital haemophilia A
Mortality in congenital hemophilia A – a systematic literature review
(open access) Hay CRM et al. J Thromb Haemost 2021;19:6–20.
Establishment of a framework for assessing mortality in persons with congenital hemophilia A and its application to an adverse event reporting database
(open access) Pipe SW et al. J Thromb Haemost 2021;19:21–31.
Application of a hemophilia mortality framework to the Emicizumab Global Safety Database
(open access) Peyvandi F et al. J Thromb Haemost 2021;19:32–41.
Manuscripts discussing HEMLIBRA safety data
In vitro studies show synergistic effects of a procoagulant bispecific antibody and bypassing agents
(open access) Hartmann R et al. J Thromb Haemost 2018;16:1580–91.
Emicizumab and thrombosis: the story so far
(open access) Makris M et al. J Thromb Haemost 2019;17:1269–72.
Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: experience from the HAVEN clinical program
(open access) Levy GG et al. J Thromb Haemost 2019;17:1470–77.
Spotlight on emicizumab in the management of hemophilia A: Patient selection and special considerations.
(open access) Yada K & Nogami K. J Blood Med 2019;10:171–81.
Emicizumab prophylaxis in patients with haemophilia A with and without inhibitors
(open access) Ebbert PT et al. Haemophilia 2020;26:41–46.
Invasive procedures in patients with haemophilia: review of low-dose protocols and experience with extended half-life FVIII and FIX concentrates and non-replacement therapies
(open access) Hermans C et al. Haemophilia 2020;00:1–7. DOI: 10.1111/hae.13978.
Concomitant use of rFVIIa and emicizumab in people with hemophilia A with inhibitors: current perspectives and emerging clinical evidence
(open access) Linari S & Castaman G. Ther Clin Risk Manag 2020;16:461–9.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing firstname.lastname@example.org or calling +44 (0)1707 367554. As HEMLIBRA® is a biological medicine, healthcare professionals should report adverse reactions by brand and batch number.
ASH, American Society of Hematology; FDA, Food and Drug Administration; FVIII, Factor VIII; rFVIIa, activated recombinant Factor VII; NHF, National Hemophilia Foundation; UKHCDO, United Kingdom Haemophilia Centre Doctors’ Organisation.
- HEMLIBRA SPC.
Date of preparation: January 2021