STRENSIQ IMPROVES BONE HEALTH

By addressing the underlying cause of hypophosphatasia (HPP), STRENSIQ® (asfotase alfa) improves bone health. Healthier bones can lead to improved mobility and strength in people living with HPP.

Woman with boy holding walker
Jump Btn

STUDIED IN ALL AGES

STRENSIQ was studied in children and adults, but only in those with signs and symptoms that appeared before 18 years of age.

Select secondary endpoint presented on this page is in bold in the chart below.

Clinical studies chart
Clinical studies chart

Abbreviations: PLP, pyridoxal 5'-phosphate; PPi, inorganic pyrophosphate.

*HPP is when your body lacks sufficient alkaline phosphatase (ALP) enzyme; as a result, you develop weak or “soft” bones, which may lead to skeletal deformities, tooth loss or pain, or other related symptoms.

PPi and PLP are substances found in blood that are related to ALP activity and bone health.

Growth refers to changes in body size based on age over time.

§Mobility is a person’s ability to walk.

ALP is an enzyme, which is needed to “mineralize” bones. ALP frees phosphate so it can combine with calcium and form the building blocks needed to make bone.

STRENSIQ IMPROVES SKELETAL HEALING

Study 1 and 2 primary endpoints

Improvements in HPP-related bone health/mineralization

Study 1 included patients up to 3 years of age with signs and symptoms that appeared before 6 months of age. At 6 months, 90% (9 out of 10) of patients responded to treatment, which was sustained at 7 years (n=7).

Study 2 included patients up to 5 years of age with signs and symptoms that appeared before 6 months of age. At 6 months, 63% (40 out of 64) of patients responded to treatment, which was sustained at 6 years (n=2).

The primary endpoint is the outcome that establishes a medication’s effectiveness and safety when it goes through testing. The secondary endpoints demonstrate additional effects after success on the primary endpoint.

Study 1

90%
90%

AFTER 6 MONTHS OF STRENSIQ

treatment achieved complete or substantial bone healing

100%

AFTER 7 YEARS OF STRENSIQ

treatment achieved complete or substantial bone healing

Study 2

63%
63%

AFTER 6 MONTHS OF STRENSIQ

treatment achieved complete or substantial bone healing

100%

AFTER 6 YEARS OF STRENSIQ

treatment achieved complete or substantial bone healing

SKELETAL HEALING

Study 3 primary endpoint

Improvements in HPP-related bone health/mineralization

Study 3 included patients aged 6 to 12 with signs and symptoms that appeared before 18 years of age.

At 6 months, 69% (n=13) of patients responded to treatment, which was sustained at 7 years (n=12).

  • 1 child did not complete this study

 

69%
69%

AFTER 6 MONTHS OF STRENSIQ

treatment achieved complete or substantial bone healing

100%

AFTER 7 YEARS OF STRENSIQ

treatment achieved complete or substantial bone healing

IMPROVEMENTS IN MOBILITY AND 6-MINUTE WALK TEST

Study 3 select secondary endpoints

Mobility

Six-minute walk test was conducted in 11 out of 13 children aged 6 to 12 with HPP during the study. In the 11 children, the percent of their predicted walking distance reached the normal range after 6 months of treatment and improvements were sustained over 7 years.
Watch the 6-minute walk test for children
Mobility and 6-minute walk test graph for children

*This refers to the percentage of the distance a healthy person of similar age, gender, and height would be expected to walk in 6 minutes.

A baseline is information captured at the beginning of a study. It's used for comparison with later data.

Representations of efficacy are consistent with results seen from typical patients in the study. Individual results may vary.

During the 6-minute walk test, a person is asked to walk as far as they can for 6 minutes. This test is helpful when determining if someone has trouble with mobility.

CHANGE IN PLASMA PPi* AND PLP

Study 4 design

  • Study 4 spanned 5 years and included adolescents and adults aged 13 to 65 years with signs and symptoms of HPP that appeared before 18 years of age (for 18 of the 19 study patients)
  • The primary endpoints of this study were to measure reductions of PPi and PLP, which are substances found in the blood that are related to ALP enzyme activity and bone health. If PPi and PLP are high, ALP activity is generally low
  • The most frequently reported adverse events were injection-site reactions
  • These data are not included in the FDA-approved Prescribing Information
  • Over the initial duration of the study, STRENSIQ was administered at lower doses than the FDA-approved dose (weight-based dose of 6 mg/kg per week)
Study for primary endpoints

IMPROVEMENTS IN MOBILITY AND 6-MINUTE WALK TEST

Study 4 select secondary endpoint

Mobility

Improvement in the 6-minute walk test was observed as early as 6 months and sustained through 5 years.
Watch the 6-minute walk test for adults
Mobility and 6-minute walk test graph for adolescents and adults

*PPi is a substance important in the process of bone mineralization and making bones stronger.

PLP is also known as vitamin B6.

This refers to the percentage of the distance a healthy person of similar age, gender, and height would be expected to walk in 6 minutes.

Enroll in OneSource™ to get personalized patient support from Alexion:

READY TO GET STARTED?

Once your doctor prescribes STRENSIQ, Alexion and OneSource will be there to guide you on your STRENSIQ treatment journey. See the resources available as you start treatment with STRENSIQ.

REQUEST A STARTER KIT
× +
IMPORTANT SAFETY INFORMATION & INDICATION

STRENSIQ may cause serious side effects, including

  • Serious allergic (hypersensitivity) reactions happened in some people who use STRENSIQ. Stop using STRENSIQ and go to the nearest hospital emergency room right away if you or your loved one have any of the signs and symptoms of a serious allergic reaction, including
    • Difficulty breathing
    • Swelling of your eyes, lips, or tongue
    • Hives
    • Feeling faint
    • Nausea or vomiting
    • Dizziness
    • Itching of your lips, tongue, or throat
    • Choking sensation
  • Skin thickening or pits at the injection site (lipodystrophy) has happened several months after using STRENSIQ.
  • Calcium buildup in the eyes and kidneys can occur if you or your loved one have HPP. Your healthcare provider should check the eyes and kidneys while you or your loved one use STRENSIQ.
  • Decreased efficacy. Contact your healthcare provider if you or your loved one notice STRENSIQ is no longer working or experience worsening symptoms of HPP (e.g., increased respiratory support, increased difficulty walking, new fractures).

The most common side effects of STRENSIQ include local skin injection-site reactions (red skin patches, bruising, color change, pain, itching, thinning, swelling, pits, and bumps) and calcium buildup in your eyes and kidneys.

Strensiq may affect other lab test results, therefore it is important that you present your Medical Alert Card to your healthcare team so they are aware that you are being treated with an alkaline phosphatase (ALP) replacement therapy which may cause incorrect results on certain laboratory tests.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

These are not all the possible side effects of STRENSIQ. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1‑800‑FDA‑1088.

INDICATION
What is STRENSIQ?
Strensiq is a prescription medicine used to treat people with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

Please see STRENSIQ full Prescribing Information, including Patient Information and Instructions for Use.
IMPORTANT SAFETY INFORMATION & INDICATION

STRENSIQ may cause serious side effects, including

  • Serious allergic (hypersensitivity) reactions happened in some people who use STRENSIQ. Stop using STRENSIQ and go to the nearest hospital emergency room right away if you or your loved one have any of the signs and symptoms of a serious allergic reaction, including
    • Difficulty breathing
    • Swelling of your eyes, lips, or tongue
    • Hives
    • Feeling faint
    • Nausea or vomiting
    • Dizziness
    • Itching of your lips, tongue, or throat
    • Choking sensation
  • Skin thickening or pits at the injection site (lipodystrophy) has happened several months after using STRENSIQ.
  • Calcium buildup in the eyes and kidneys can occur if you or your loved one have HPP. Your healthcare provider should check the eyes and kidneys while you or your loved one use STRENSIQ.
  • Decreased efficacy. Contact your healthcare provider if you or your loved one notice STRENSIQ is no longer working or experience worsening symptoms of HPP (e.g., increased respiratory support, increased difficulty walking, new fractures).

The most common side effects of STRENSIQ include local skin injection-site reactions (red skin patches, bruising, color change, pain, itching, thinning, swelling, pits, and bumps) and calcium buildup in your eyes and kidneys.

Strensiq may affect other lab test results, therefore it is important that you present your Medical Alert Card to your healthcare team so they are aware that you are being treated with an alkaline phosphatase (ALP) replacement therapy which may cause incorrect results on certain laboratory tests.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

These are not all the possible side effects of STRENSIQ. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1‑800‑FDA‑1088.

INDICATION
What is STRENSIQ?
Strensiq is a prescription medicine used to treat people with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

Please see STRENSIQ full Prescribing Information, including Patient Information and Instructions for Use.