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Physical health
Change observed in Haem-A-QoL Physical Health Score from 37.0 at baseline to 29.7 at Week 52*
Hero image of a hypothetical patient with hemophilia A mountain biking with friends
Factor VIII levels at 44%, 4 days after infusion
Hypothetical
patient and scenario
patient and scenario
ALTUVIIIO is a once-weekly, first-in-class, Factor VIII replacement therapy
The only once-weekly
prophylaxis factor infusion
Longer half-life, in a separate study with EHL and SHL therapies*
In a Phase 1 study, ALTUVIIIO had a 3‑4x longer half-life than EHL and SHL therapies*
*This is information from a study of 13 previously treated adults with severe hemophilia A that had the goal of comparing how long ALTUVIIIO, Adynovate® [Antihemophilic Factor (Recombinant), PEGylated], and Advate® [Antihemophilic Factor (Recombinant)] stayed in the body after 1 dose. Half-life was 43 hours for ALTUVIIIO, 15 hours for Adynovate, and 11 hours for Advate.
Adynovate and Advate are registered trademarks of Baxalta Incorporated, a Takeda company.
EHL=extended half-life; SHL=standard half-life.
In the XTEND-1 study, average Factor VIII levels
Stayed above
for most
of the week
(near-normal to normal range)
Stayed above
on average for
adults, for the
entire week
Average trough levels were 9% for adolescents aged 12 years to under 18 years.
Average trough levels were 9% for adolescents aged 12 years to under 18 years.
In the XTEND-Kids study, average trough levels
- Were 10% for children aged 6 years to under 12 years, and 7% for children aged 1 year to under 6 years
How was ALTUVIIIO studied?
ALTUVIIIO was studied in XTEND-1
159
=
133
+
26
159
Adults and Adolescents
158 males and 1 female with severe hemophilia (aged 12 years and older)
133
People in Group 1
switched to ALTUVIIIO prophylaxis from prior prophylaxis therapy. Efficacy of prophylaxis was evaluated in 128 of these patients.
Included 1 female participant
26
People in Group 2
switched from prior on‑demand therapy to ALTUVIIIO on‑demand for 26 weeks, and finally to ALTUVIIIO prophylaxis for another 26 weeks
1 YEAR: total
length of study
length of study
Finding people’s mean annualized bleed rate was the primary goal of the study
Children under 12 years were enrolled in XTEND-Kids, an ongoing pediatric study. XTEND-Kids enrolled 67 male previously treated patients <12 years of age with severe hemophilia A. Of the 67 enrolled subjects, all received at least 1 dose of ALTUVIIIO. Efficacy of prophylaxis was evaluated in 23 of these patients.
Proven Bleed Protection with ALTUVIIIO Prophylaxis
Median bleeds
per year*
(median annualized
bleed rate)
Mean bleeds
per year*
(mean annualized
bleed rate)
PRIMARY OUTCOME
Median joint
bleeds per year*
(median annualized
joint bleed rate)
PRIMARY OUTCOME
In the pediatric study, routine prophylaxis with ALTUVIIIO resulted in a mean ABR of 0.5* and a median ABR of 0.*
How were bleeds and joint bleeds measured in the trials?
- Median ABR was the middle number of all ABRs, when everyone’s ABR was ordered from least to greatest
- Mean ABR was the average number based on everyone’s ABR
Significant improvement in bleed protection with ALTUVIIIO prophylaxis
In Group 1:
133 people aged 12 years and older had prior prophylaxis therapy and switched to ALTUVIIIO. 78 of those people participated in a separate study to measure their ABRs on their prior prophylaxis. Comparing the results of the 78 people who participated in both studies showed:
People went from
3 bleeds to less than 1 bleed a year (mean ABR 0.7)
3 bleeds to less than 1 bleed a year (mean ABR 0.7)
That’s a 77% reduction in yearly bleeds (mean)*
Over 52 weeks on prophylaxis
64% of people had
zero bleeds* vs 42%
on prior prophylaxis
zero bleeds* vs 42%
on prior prophylaxis
*Data based on treated bleeds.
ABR=annualized bleed rate.
Know your joints
are protected
are protected
Over 52 weeks on prophylaxis
72%
of people had zero joint bleeds after switching to ALTUVIIIO*
72% of people had zero joint bleeds after switching to ALTUVIIIO*
- A mean change of -1.5 (-2.7, -0.3) from starting point was observed in Hemophilia Joint Health Score (HJHS) total score
- HJHS is a validated tool used to measure joint health function. The study was designed so the investigators knew the patients were taking ALTUVIIIO, which may have impacted their assessment of the patients’ HJHS score
100%
Target joint resolution
- Target joints are 3 or more spontaneous bleeds in a major joint in a consecutive 6-month period
- Target joints were considered resolved if 2 or fewer bleeds occurred in a target joint in 12 months
*Data based on treated bleeds.
Demand fewer yearly bleeds
In Group 2:
26 people aged 12 years and older were treated on-demand with ALTUVIIIO, then switched to ALTUVIIIO prophylaxis for 26 weeks.
On average…
People who switched from ALTUVIIIO on-demand to ALTUVIIIO prophylaxis went from 21 bleeds to less than 1 bleed a year (mean ABR 0.7)
That’s a 97% reduction in yearly bleeds (mean)*
and
Over 26 weeks on prophylaxis
77% of people had zero bleeds*
81% of people had zero joint bleeds*
*Data based on treated bleeds.
Switch it up from on‑demand to prophylaxis
with ALTUVIIIO
Pain and physical health outcomes
In people on once-weekly ALTUVIIIO who switched from prior prophylaxis in XTEND-1
Pain intensity
Reduction observed in PROMIS Pain Intensity 3a Score from 2.5 at baseline to 2.2 at Week 52*
A lower score represents an overall improvement in these measures.
The XTEND-1 study was designed so patients and their doctors knew they were taking ALTUVIIIO, which may have impacted these findings. The study was a single-arm study, so all participants in the trial were treated with ALTUVIIIO and there was no other treatment to compare, which may impact the ability to assess the effect of ALTUVIIIO on these patient-reported outcomes. The PROMIS tool was not specifically developed for use in hemophilia patients.
*Patient-reported outcomes of pain intensity and physical-health scores were evaluated in patients receiving ALTUVIIIO prophylaxis in Group 1. The PROMIS Pain intensity 3a instrument was used to assess pain, specifically the first question that rates the worst pain experienced during the last 7 days. Physical-health scores were assessed in patients 17 years and older using the Physical Health Score of Haem-A-QoL, which evaluated factors such as painful swellings, presence of joint pain, pain with movement, difficulty walking far, and needing more time to get ready.
Haem-A-QoL=haemophilia quality of life questionnaire for adults; PROMIS=Patient-Reported Outcome Measurement Information System.
One infusion, a powerful* response
In the clinical trial, of 362 bleeds that occurred
were treated with 1
infusion†
*Based on the number of infusions needed to treat an active bleed.
†
In the XTEND-1 study, 350 out of 362 bleeds that occurred were resolved with only one infusion.
ALTUVIIIO safety was well studied
Learn more about the safety profile.
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