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 welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554.
HEMLIBRA delivered sustained protection with long-term efficacy across HAVEN 1–41,3,4
The HAVEN studies were four multicentre, open label, phase III clinical trials that evaluated HEMLIBRA in patients with haemophilia A, classified as severe or with FVIII inhibitors.3–6 HAVEN 1 and HAVEN 3 were randomised trials,3,4 HAVEN 2 and HAVEN 4 were non-randomised trials.5,6
All data presented on this page are from a non-cumulative analysis of HAVEN 1–4, which evaluated annualised bleed rate (ABR) over each 24 week interval, with median duration of treatment 120 weeks (IQR, 89–164). These pooled data demonstrated the long-term efficacy of HEMLIBRA prophylaxis.2
Long-term efficacy2
Across HAVEN 1–4, pooled analysis showed:
- Treated ABR was maintained in patients receiving HEMLIBRA over intervals of 24 weeks, up to 192 weeks duration
- The model-based, mean treated ABR was 1.4 (95% CI, 1.1–1.7) over the median 120 week duration of exposure
Model-based, mean treated ABR, by HAVEN study, over intervals of 24 weeks
Zero treated bleed rates7
The proportion of patients receiving HEMLIBRA with zero treated bleeds was maintained over intervals of 24 weeks, up to 144 weeks duration, across the HAVEN studies.
Patients with 0 or 1–3 treated bleeds, by HAVEN study, over intervals of 24 weeks (pooled analysis)
-
Spontaneous treated bleed rates⁷
The proportion of patients receiving HEMLIBRA with zero treated spontaneous bleeds was maintained over intervals of 24 weeks, up to 144 weeks duration, across the HAVEN studies.
Patients with 0 or 1–3 treated spontaneous bleeds, over intervals of 24 weeks (pooled analysis)
Spontaneous bleeds based on calculated ABRs for bleeds treated with coagulation factors.
-
Over 95% of target joints resolved²
Across HAVEN 1–4, pooled analysis showed that overall, target joints resolved in 95.1% of patients receiving HEMLIBRA vs. baseline (510/536 target joints resolved; n=226).2
Patients with 0 or 1–3 treated joint bleeds, over intervals of 24 weeks (pooled analysis)7
Target joints were defined as major joints (hip, elbow, wrist, shoulder, knee and ankle) with ≥3 bleeding events over the prior 24 weeks. Target joint resolution was defined as ≤2 spontaneous bleeding events over 52 weeks, in a joint previously defined as a target joint.
ABR, annualised bleed rate; CI, confidence interval; IQR, interquartile range; MOA, mechanism of action; NE, not estimable; RCT, randomised controlled trial.
Treated bleeds defined as a bleed that was directly followed by a haemophilia medication reported to be a “treatment for bleed”, regardless of the time between the treatment and the preceding bleed. ABR based on Negative Binomial Regression Model, which takes into account number of bleeds, different treatment and follow-up times.
References:
- HEMLIBRA SPC.
- Callaghan MU et al. ASH 2020:1800 [Poster Presentation].
- Oldenburg J et al. New Eng J Med 2017;377:809–18.
- Mahlangu J et al. New Eng J Med 2018;379:811–22.
- Young G et al. Blood 2019;134:2127–38.
- Pipe S et al. Lancet Haematol 2019;6:e295–305.
- Callaghan MU et al. ASH 2020:1800 [Abstract].
M-GB-00004679
Date of preparation: September 2021
