Adults

Prophylaxis is the gold standard of care in adults with severe haemophilia A1 with the aim to enable healthy and active lives, and it should be personalised to the needs of the individual patient.2 The NuPreviq study demonstrated the efficacy and safety of a patient-tailored personalised prophylaxis approach with Nuwiq® (simoctocog alfa), a rFVIII protein produced in a human cell-line and without modification or protein fusion, in adult previously treated patients with severe haemophilia A.3

Breakthrough bleeding events may still occur in haemophilia A patients on prophylaxis which will require FVIII treatment2, as breakthrough bleeds can contribute to joint damage, pain, disability and reduced quality of life.4

Perioperative prophylaxis with FVIII is used in patients with haemophilia A who undergo surgery, as these patients are at a high risk for bleeding complications during and after such interventions.5

The NuPOWER and NuDIMENSION studies are prospective clinical trials evaluating the perioperative efficacy and safety of Nuwiq®: NuPOWER focusing on individuals receiving emicizumab undergoing major surgery, and NuDIMENSION addressing the underrepresented population of women and girls with mild to moderate haemophilia A.6,7

simoctocog-img

Personalised prophylaxis with Nuwiq®

can lead to significantly more patients with zero bleeds

65 haemophilia A patients underwent 6 months of personalised prophylaxis3

  • adults who received
    personalised prophylaxis with
    Nuwiq® had zero spontaneous
    bleeds3

  • were dosed twice a week or less3

    the dose was decreased compared with
    standard prophylaxis3

NuPreviq Study results

Personalised prophylaxis with Nuwiq®

can lead to significantly more patients experiencing zero bleeds compared to prophylaxis with other extended half-life rFVIII products

A higher percentage of patients had zero bleeds while on personalised prophylaxis with Nuwiq® in a matching-adjusted indirect comparison with extended half-life rFVIII products 8, 9

Percentage of patients with zero bleeds:
  • Nuwiq®
    n=65     75%vs45%Efmoroctocog alfa
    n=118 (p<0.001)
  • Nuwiq®
    n=64     77%vs38%Damoctocog alfa pegol
    n=110 (p<0.001)
  • Nuwiq®
    n=55     78%vs42%Rurioctocog alfa
    
pegol 1–3%, n=57 (p<0.001)
  • Nuwiq®
    n=65     64%vs56%Efanesoctocog alfa
    n=128 (p=0.291)

Personalised prophylaxis with Nuwiq®

can lead to significantly more patients experiencing zero bleeds compared to prophylaxis with the bispecific monoclonal antibody emicizumab

A significantly higher percentage of patients had zero bleeds while on personalised prophylaxis with Nuwiq® in a matching-adjusted indirect comparison with emicizumab10

Percentage of patients with zero bleeds:
  • Nuwiq®
    n=65     74%vs47%Emicizumab
    administered every
    week, n=99 (p<0.001)
  • Nuwiq®
    n=65     70%vs40%Emicizumab
    administered every 2
    weeks, n=35 (p=0.003)
  • Nuwiq®
    n=65     82%vs29%Emicizumab
    administered every 4
    weeks, n=41 (p<0.001)

Personalised prophylaxis with Nuwiq®

reduced the annualised bleeding rate compared with on-demand treatment in adults, irrespective of the type of bleed11

Compared with on-demand treatment (n=22), patients on Nuwiq® prophylaxis (n=32) showed11

  • reduction in spontaneous
    bleeds

  • reduction in traumatic bleeds

Prophylaxis with Nuwiq® in children

Personalised prophylaxis with Nuwiq®

can lead to significantly more patients with zero bleeds

65 haemophilia A patients underwent 6 months of personalised prophylaxis3

  • adults who received
    personalised prophylaxis with
    Nuwiq® had zero spontaneous
    bleeds3

  • were dosed twice a week or less3

    the dose was decreased compared with
    standard prophylaxis3

NuPreviq Study results

A higher percentage of patients had zero bleeds while on personalised prophylaxis with Nuwiq® in a matching-adjusted indirect comparison with extended half-life rFVIII products8,9

Percentage of patients with zero bleeds:
  • 75% Nuwiq®
    n=65
    vs
    45%Efmoroctocog
    alfa n=118
    (p<0.001)
  • 77%Nuwiq®
    n=64
    vs
    38%Damoctocog
    alfa pegol n=110
    (p<0.001)
  • 78%Nuwiq®
    n=55
    vs
    42%Rurioctocog
    alfa 
pegol 1–3%, n=57
    (p<0.001)
  • 64%Nuwiq®
    n=65
    vs
    56%Efanesoctocog
    alfa, n=128
    (p=0.291)
The MAIC analyses followed best practice guidance and used stringent statistical criteria. However, there are inherent limitations when comparing treatments with this methodology. It was not possible to match all baseline variables known to impact bleeding outcomes. Some differences in populations could not be addressed due to unavailable data or very small patient numbers in certain groups. Additionally, the relatively small sample sizes limited the ability to incorporate many baseline characteristics into the matching process. Another potential limitation is the variation in personalized treatment durations across the studies.

Personalised prophylaxis with Nuwiq®

can lead to significantly more patients experiencing zero bleeds compared to prophylaxis with the bispecific monoclonal antibody emicizumab

A significantly higher percentage of patients had zero bleeds while on personalised prophylaxis with Nuwiq® in a matching-adjusted indirect comparison with emicizumab 10

Percentage of patients with zero bleeds:
  • 74% Nuwiq®
    n=65
    vs
    47%Emicizumab
    administered
    every week,
    n=99 (p<0.001)
  • 70%Nuwiq®
    n=65
    vs
    40%Emicizumab
    administered
    every 2 week,
    n=35 (p<0.003)
  • 82%Nuwiq®
    n=65
    vs
    29%Emicizumab
    administered
    every 4 week,
    n=41 (p<0.001)
Compared with on-demand treatment (n=22), patients on Nuwiq® prophylaxis (n=32) showed11

  • reduction in spontaneous
    bleeds

  • reduction in traumatic bleeds

Nuwiq® demonstrates effective management

of breakthrough bleeds in patients during on-demand treatment

In adult PTPs receiving on-demand treatment with Nuwiq®11 

of 986 bleeds were treated with only 1 infusion

985 bleeds were evaluated in adult PTPs receiving on-demand treatment with Nuwiq®11

of bleeds were successfully treated with an excellent or good rated efficacy

PTP: previously treated patient

Nuwiq® provides haemostatic efficacy

during surgery in patients of all ages

antigenic-img antigenic-img antigenic-img

Haemostatic efficacy of
Nuwiq® was rated as
excellent or good in 98% (51 of 52) rated surgeries in
PTPs aged 3–55 years5

Surgical clinical efficacy and
safety data have been
expanded to include the
combination of Nuwiq® with
non-factor therapies in the
NuPOWER trial9, as well as data
focused exclusively on women
in the NuDIMENSION study10

Nuwiq ® offers convenient and
flexible dosing with a large
range of vial sizes, all with an
infusion volume of 2.5 mL 

haemostatic-img-0

Haemostatic efficacy of
Nuwiq® was rated as
excellent or good in 98% (51 of 52) rated surgeries in
PTPs aged 3–55 years5

Surgical clinical efficacy and
safety data have been
expanded to include the
combination of Nuwiq® with
non-factor therapies in the
NuPOWER trial9, as well as data
focused exclusively on women
in the NuDIMENSION study10

haemostatic-img-1
haemostatic-img-2

Nuwiq ® offers convenient and
flexible dosing with a large
range of vial sizes, all with an
infusion volume of 2.5 mL 

Nuwiq® has a well-established safety profile

evaluated in 201 PTPs across seven studies12

infusions

patients developed FVIII inhibitors

References

  • 1

    Makris M et al. Blood Transfus 2012; 10:165-8;​

  • 2

    Srivastava A et al. Haemophilia 2020; 26:1-158;​

  • 3

    Lissitchkov T et al. Haemophilia 2017; 23:697-704;​

  • 4

    Mazepa MA et al. Blood 2016; 127:3073-81;​

  • 5

    Zozulya N et al. Haemophilia 2018; 24:70-6;​

  • 6

    ClinicalTrials.gov, NCT05935358;​

  • 7

    ClinicalTrials.gov, NCT05936580;​

  • 8

    Kessler C et al. Eur J Haematol 2023; 111:757-67;​

  • 9

    Kessler C et al. Blood 2023; 142(Suppl. 1):5473;

  • 10

    Kessler C et al. Blood 2023; 142(Suppl. 1):5482;​

  • 11

    Tiede A et al. Haemophilia 2016; 22:374-80;​​

  • 12

    Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471.​

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