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Discover a treatment that could change how you manage your hemophilia A

admin May 28, 2023

This is a paid public announcement from Sanofi and does not constitute an endorsement of products or services. When you click on the links in this blog entry, you will be directed to a Sanofi website. LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

If your life has been touched by hemophilia A, you know it can be full of unknowns. Bleeds can be painful, happen without warning, and limit physical activity, which is why it’s critical to stay on top of them. Sanofi launched ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]—a hemophilia A Factor VIII replacement therapy that provides proven bleed protection.

Here are 4 reasons to consider ALTUVIIIO:

1. HIGHER FACTOR LEVELS THAT LAST LONGER
With just one weekly ALTUVIIIO infusion, factor levels remain in the near-normal to normal range (>40%) for most of the week and stay above 18%,* on average, in adults.

*Average trough levels were 18% for adults 18 years and older, 9% for adolescents aged 12 years to under 18 years, 10% for children aged 6 years to under 12 years, and 7% for children aged 1 year to under 6 years.

‡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.
 

ALTUVIIIO offers not only weekly prophylaxis use, but also on-demand bleed control and perioperative management. Regardless of how you use it, you can expect the same infusion process.

2. STUDIED—AND PROVEN—BLEED PROTECTION
Before we dig into the numbers, it’s helpful to know how ALTUVIIIO was studied and to understand its safety profile.

For one year, the XTEND-1 study looked at treatment in 159 adults and adolescents. Participants were divided into 2 groups. Both groups used mean and median annualized bleed rates (ABRs) to evaluate the efficacy of ALTUVIIIO. Finding people’s mean ABR was the primary goal of the study.

Safety evaluated in 159 people taking ALTUVIIIO in the XTEND-1 study showed that:

  • 21% of people had headache (33 people)
  • 16% of people had joint pain (26 people)
  • 6% of people had back pain (9 people)

In 67 children taking ALTUVIIIO in the ongoing XTEND-Kids study:

  • 1% of children had headache (1 child)

In XTEND-1 and XTEND-Kids, people taking ALTUVIIIO had:

  • 0 inhibitors
  • 0 serious allergic reactions

Although no inhibitors were found, and no serious allergic reactions occurred in clinical studies, inhibitors and serious allergic reactions are possible with ALTUVIIIO.

Group 1
This group consisted of 133 people aged 12 years and older who had prior prophylaxis therapy and switched to ALTUVIIIO weekly prophylaxis. This group included 1 female participant. Efficacy of prophylaxis was evaluated in 128 of these patients.

The primary outcome showed a mean of <1 (0.7) bleeds per year (the median ABR was 0).‡

Here’s a look at how the study measured bleed rates:

  • Median ABR was the middle number of all ABRs, when ABRs were ordered from least to greatest
  • Mean ABR was the average number based on everyone’s ABRs

It’s also worth noting that 78 of the people in Group 1 participated in a separate study to measure their ABRs on their prior prophylaxis. These 78 people went from 3 bleeds to less than 1 bleed a year. That’s a 77% reduction in yearly bleeds!‡

Group 2
People in this group (28 participants) switched to ALTUVIIIO on demand from prior on-demand therapy for 26 weeks, and then were treated with ALTUVIIIO prophylaxis for another 26 weeks.

This group also saw striking results. 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% mean reduction in yearly bleeds.‡

And over the 26 weeks on ALTUVIIIO prophylaxis, 77% of people had 0 bleeds.‡

Both groups showed significant improvement in bleed protection with ALTUVIIIO prophylaxis.

‡Data based on treated bleeds.

3. FEEL CONFIDENT YOUR JOINTS ARE PROTECTED

The XTEND-1 study also examined target joint bleeds. When evaluating joint results at 52 weeks in the 128 people who participated in the XTEND-1 study, 72% of people had 0 joint bleeds‡ on prophylaxis after switching to ALTUVIIIO. 100% of target joints were resolved.

Target joints:

  • Are 3 or more spontaneous bleeds in a major joint within a period of 6 consecutive months
  • Were considered resolved if 2 or fewer bleeds occurred in the target joint within 12 months

4. THE FEWEST WEEKLY INFUSIONS AMONG FACTOR VIII PROPHYLAXIS TREATMENTS

While most people with hemophilia grow accustomed to infusing, fewer infusions are generally preferred. In studies, ALTUVIIIO clearly outlasted other Factor VIII replacement therapies, meaning ALTUVIIIO takes longer to be reduced by half in the body, and therefore lasts for a longer period.

So instead of needing up to 4 infusions a week with other treatments, patients on ALTUVIIIO infused only once per week.

ALTUVIIIO offers the fewest weekly infusions among Factor VIII prophylaxis treatments.

†This is information from a study in 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.
§Doses and dosing intervals may be adjusted.
Adynovate and Advate are registered trademarks of Baxalta Incorporated, a Takeda company.

Now that you’ve learned about a few of the ways ALTUVIIIO protects you from bleeds, you may be considering a conversation with your doctor about your treatment plan. Our Doctor Discussion Guide can help. It offers a list of helpful questions to help you jump-start the conversation. You can also connect with your local Sanofi Community Relations and Education (CoRe) Manager, who can share additional resources and provide education.

INDICATION
ALTUVIIIO™ [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is an injectable medicine that is used to control and reduce the number of bleeding episodes in people with hemophilia A (congenital Factor VIII deficiency).

Your healthcare provider may give you ALTUVIIIO when you have surgery.

IMPORTANT SAFETY INFORMATION

What is the most important information I need to know about ALTUVIIIO?
Do not attempt to give yourself an injection unless you have been taught how by your healthcare provider or hemophilia center. You must carefully follow your healthcare provider’s instructions regarding the dose and schedule for injecting ALTUVIIIO so that your treatment will work best for you.

Who should not use ALTUVIIIO?
You should not use ALTUVIIIO if you have had an allergic reaction to it in the past.

What should I tell my healthcare provider before using ALTUVIIIO?
Tell your healthcare provider if you have had any medical problems, take any medications, including prescription and non-prescription medicines, supplements, or herbal medicines, are breastfeeding, or are pregnant or planning to become pregnant.

What are the possible side effects of ALTUVIIIO?
You can have an allergic reaction to ALTUVIIIO. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called “inhibitors” against ALTUVIIIO. This can stop ALTUVIIIO from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

The common side effects of ALTUVIIIO are headache, joint pain, and back pain.

These are not the only possible side effects of ALTUVIIIO. Tell your healthcare provider about any side effect that bothers you or does not go away.

Please see full Prescribing Information.

© 2023 Genzyme Corporation. All rights reserved.
ALTUVIIIO and Sanofi are trademarks of Sanofi or an affiliate.

MAT-US-2209658-v1.0-05/2023

New Survey Spotlights Ongoing Concerns for People Living with Hemophilia B

admin April 30, 2023

This is a paid public announcement from CSL Behring and does not constitute an endorsement of products or services. When you click on the links in this blog entry, you will be directed to the CSL Behring website. LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

Carefully controlled schedules. Undercurrents of uncertainty. Persistent pain. People who are living with hemophilia B, and those who love them, face a lifetime of managing the complexities of this condition.

While significant advancements have been made in the treatment of hemophilia B, there is still a desire for new treatment options to address unmet needs for people with moderate to severe forms of the condition.

In fact, a recent CSL Behring-sponsored survey on the burdens of living with hemophilia B found that even with treatment, people with hemophilia B are still experiencing spontaneous bleeds and joint pain, and would consider switching to a new therapy that may be more effective. The online survey conducted by CSL Behring in partnership with the Coalition for Hemophilia B included 110 people with the rare bleeding disorder who are on either short-term or long-term prophylactic treatment.* The survey revealed that during a six-month period, respondents reported an average of 4.2 spontaneous bleeds and 2.2 joints bleeding three or more times.

Additionally, 87% of respondents reported experiencing joint pain at least a few times a month. 

“The survey really highlighted the concerns and challenges that people with hemophilia B still face,” said Kim Phelan, Chief Operating Officer of The Coalition for Hemophilia B. “Spontaneous bleeds, joint damage and joint pain are just a few of the burdens that some in the hemophilia B community must live with.

With up to 156 intravenous infusions per year, people with hemophilia B are also at risk for vein collapse.

The life-long effects of living with and managing hemophilia B however aren’t just physical. More than 40% of people living with hemophilia B experience depression, anxiety, or other psychological disorders.

As new treatments become available to potentially address the unmet needs within the hemophilia B community, discussion with healthcare professionals on treatment goals is essential. It’s time to ask, “Is there a better treatment option for me?”

*Short-term prophylaxis is prolonged treatment following a bleed until full recovery and prophylaxis prior to physical activity. Long-term prophylaxis is regular preventative injections. Of the 110 people surveyed, 29 were being treated with short-term prophylaxis only, 74 were being treated with long-term prophylaxis only, and 7 were being treated with both short-term and long-term prophylaxis.

©2023 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA

www.CSLBehring.com USA-HGX-0330-APR23

New Episodes of the Infusion Squad Take Kids with Hemophilia B on a Mission into the Bloodstream

admin July 17, 2022

This is a paid public announcement from Sanofi and does not constitute an endorsement of products or services. When you click on the links in this blog entry, you will be directed to a Sanofi website. LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

Two new episodes of the Infusion Squad are now available from Sanofi to take kids with Hemophilia B on an audio adventure through the bloodstream.

Anyone who deals with children knows that getting them to sit still for more than a few minutes can be mission impossible. This can be especially challenging for children with hemophilia B who may receive regular infusions of Factor IX therapy that helps them manage their hemophilia. 

For entertainment and education during the infusion process for children and their caregivers, Sanofi launched the audio adventure series, Infusion Squad, available as an Amazon Alexa voice skill for patients in the U.S. The now ten-episode series is designed for children aged 12 and younger but is fun for any age.

Part educational and part entertaining, each episode takes a team of “Infusionauts” and the children on a mission into the bloodstream. Along the way, children learn more about infusion and the role that factor IX plays in hemophilia B. 

The series was created based on patient research and focus groups that found it can be challenging for children to stay still during the infusion process. They also expressed the need for educational materials to help families learn about hemophilia B and infusing. 

Available in English, the Infusion Squad skill can be enabled on the Alexa app, Alexa Skills store, or on any Alexa-enabled device. Just ask Alexa to “enable Infusion Squad” and you’ll be dropped right into numerous episodes of hands-free adventure.

To learn more about the Infusion Squad or a treatment option for Hemophilia B, visit https://bit.ly/30mc6fE . You can also contact your local Sanofi Community Relations and Education Manager here.

© 2022 Genzyme Corporation. All rights reserved. Sanofi is a registered trademark of Sanofi or an affiliate. Amazon, Alexa and all related logos are trademarks of Amazon.com, Inc. or its affiliates.

MAT-US-2204695-v1.0-06/2022

3 Ways to Get Motivated and Protect Joint Health

admin June 26, 2022

Sponsored content by Sanofi

As we move into the summer season, now is the perfect time to go outside, grab some fresh air, and get moving! Maintaining healthy joints is important for everyone, especially people living with hemophilia. Nearly 80% of bleeds in hemophilia occur in the joints, and prioritizing joint health can help lead to a higher quality of life. Exercise and physical activity can protect joint health, but sometimes we all need a little extra motivation. Below are three ways to put a little pep in your step and stay on the path to strong and healthy joints.

  1. Choose an activity you enjoy

Some people are workout warriors, jumping at any opportunity to go for a long run or participate in a competitive sport. But there are many ways to get active at varying levels of intensity. Choosing an activity, or range of activities, that you find fun can help you start and stick to a lifestyle that incorporates exercise.

Not a marathon maven? Not a problem. If you’re the outdoorsy type, you can go for a hike in your local state park, start a garden in your backyard, run a few errands on foot, or take a dip at the local pool. More of an inside person, or weather not cooperating? Take a yoga class, lift some weights at home or at the gym, or get active in your living room by walking in place, stretching, or doing a Pilates video. Even routine work around your house and yard is a great way to get moving and accomplish a task at the same time.

Whatever your interests and preferences, there’s a way to work them into an active lifestyle for healthier joints. Just make sure to work with your healthcare team to choose activities that are suitable for you and your condition.

  1. Get in the habit

Establishing a routine is another great way to get and stay motivated. When an activity becomes a part of your daily or weekly routine, you may not even have to think about it to make it happen. For example, get used to taking the stairs instead of the elevator at work. Park farther away from the grocery store. Start taking walks over your lunch break. Walk in place or do strength exercises while watching TV in the evenings. The more you get used to staying active, the easier it can be to maintain a regimen. And if you miss a day, don’t fret. Go easy on yourself and take breaks as needed, getting back in the saddle as soon as you’re ready. Just remember to work with your healthcare team when starting any new exercise routine.

  1. Enlist a buddy

Carving out solo time to stay active can be a great form of self-care and an opportunity to check in with yourself. But sometimes finding a partner can make active time more fun and interesting while raising accountability. You and your exercise partner can motivate each other, even sparking a little friendly competition. Your buddy may introduce you to a new activity you wouldn’t otherwise have tried, expanding your horizons for exercise options. And finally, a friend or family member can help you stay consistent, because when someone else’s time is on the table, you’ll want to make sure you show up and stay on track.

To learn more, visit The Joint Movement, hemjointmovement.com, a Sanofi website dedicated to empowering
people living with hemophilia to be more active. The Joint Movement is for people of all mobility levels and provides resources and inclusive community workshops that promote joint health. Let’s get out there and get moving!

Young friends on a hiking trip, in the mountains, at sunrise

MAT-US-2204096-v1.0-06/2022

Boost Mental Well-Being with Empowerment

admin April 24, 2022

Sponsored content by Sanofi

May is Mental Health Awareness Month. Since it is not uncommon for people with hemophilia to experience higher rates of mental health issues, this is an important topic for the bleeding disorders community. If you or someone you care for has hemophilia, it can be a time to be mindful of mental health and consider taking empowering steps toward improved well-being.

Studies have shown that nearly four out of 10 adults living with hemophilia met the criteria for depression,¹ and that people with hemophilia and depression are less likely to adhere to a proper treatment regimen.² Withdrawing from friends, family, and the community can also happen over time, all of whom may help with maintaining a well-rounded and connected life.

Mental health not only affects a person emotionally, but also influences physical well-being. “There
is no health without mental health,” said Debbie de la Riva, CEO of Mental Health Matters Too.
“When someone is struggling with a mental health disorder, he/she is less likely to engage in
healthy self-care behavior, such as getting enough exercise. This can have a lasting, negative
impact on their joints and increase the risk of bleeds.”

If you are struggling with your mental health, it is important to talk to someone about it and
possibly seek treatment. Recognizing and acknowledging your condition is critical to managing
mental health. Visit the National Alliance on Mental Illness to learn about the signs and symptoms
of common mental health conditions, such as depression and anxiety, and to better recognize them in
yourself or a loved one. Through honest, open conversation, you can help yourself and others by
breaking down stigmas associated with mental health.

“I encourage people to recognize what mental health conditions look like and how to have that
conversation,” de la Riva says. “It’s time we break the stigma and educate ourselves.”

Another way to potentially improve mental well-being is by taking steps toward a greater sense of

empowerment. Empowerment allows patients and caregivers to have a sense of control over mindsets
and the confidence to make choices and solve challenges that arise. Some steps you can take to help
increase your sense of empowerment include:

  • Embracing uniqueness
    What traits make you special? Think about characteristics like creativity, gratitude, and bravery.
    These are strengths that can help you navigate difficult situations.
  • Engaging in self-advocacy
    Self-advocacy means understanding your needs and speaking up for yourself in order to have those
    needs met.
  • Creating empowering partnerships
    Partners in empowerment support you in your decisions. They can be friends, family, a care team,
    others with hemophilia, and other people in your life who believe in you and your abilities.

Empowerment is an active process that can be nurtured, practiced, and developed over time. One way
to practice empowerment is through visualization. The activity below can be used to help you
visualize the situations, behaviors, and people who give you confidence in navigating life:

  1. On a piece of paper, write a word that describes a situation where you feel in control of your surroundings and empowered to speak about and make decisions regarding your hemophilia. Make that word so large it fills as much of the space as possible.
  2. Fill in the space around your big word with actions you take in that situation that make you
    feel confident.
  3. Write down the names of people who support you, continuing to fill in as much space as you
    can. Post this somewhere you will see it often as a reminder of what makes you feel empowered.
    Sanofi is committed to empowering people with hemophilia. If you’d like to learn more, you can also connect with your local Sanofi Community Relations and Education, or CoRe, Manager, who can provide
    education and share resources for additional information.

¹https://pubmed.ncbi.nlm.nih.gov/22642565/#:~:text=Adult%20patients%20with%20haemophilia%20have,h ealth%20outcomes%20and%20treatment%20adherence
²https://www.dovepress.com/interrelationship-between-depression-anxiety-pain-and-treatment-adhere-pe er-r eviewed-fulltext-article-PPA

MAT-US-2201856-v1.0-03/2022

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