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For US Healthcare Professionals

Discover results with ENSPRYNG® for Thyroid Eye Disease (TED)

ENSPRYNG was studied in two clinical trials

Discover more details on the results from Study 2 below

See the difference in yourself with improvement in eye bulging

In Study 2, after 6 months, around 1 in 2 people saw a reduction in eye bulging with ENSPRYNG vs around 1 in 4 people taking a placebo.

Out of the people with active TED.

In both studies, the key goal was to measure how effective ENSPRYNG was in reducing eye bulging (or proptosis) compared to placebo. One of the studies (Study 1) did not meet this goal, meaning ENSPRYNG did not show a significant benefit compared to placebo.

Bring what you love into focus by improving double vision

In Study 2, after 6 months, more than 6 in 10 people on ENSPRYNG saw improvements in double vision vs just over 1 in 4 people taking a placebo.*

Out of the people with active TED.

*Double vision (also known as diplopia) was a secondary goal measured in the study.

In Study 2, after 6 months, around 7 in 10 people on ENSPRYNG had little to no signs of active inflammation vs just over 4 in 10 people taking a placebo.

Out of the people with active TED.

In Study 2, the levels of inflammation in people with TED were recorded using their Clinical Activity Score (CAS), which is a tool that doctors use to assess TED symptoms.

CAS evaluates for the presence of 7 symptoms in the eyes and surrounding area: pain that happens for no apparent reason, pain due to looking at something for too long, eyelid swelling, eyelid redness, redness of the eye itself, swelling of the eye, and inflammation in the inner corner of the eye. The higher the CAS number (from 0 to 7), the more serious the impact of TED.

Each of the 7 symptoms is counted equally toward a single overall score, even though that may not reflect the impact to the individual patient. For example, if a patient has eye redness and eye pain, but is only really bothered by the eye pain, each symptom still adds to the overall score by 1.

How was ENSPRYNG studied?

Two clinical trials were done to study the safety and effectiveness of ENSPRYNG in TED.

258 adults were enrolled and and treated in Study 1 and Study 2 for 6 months. To participate in the studies, adults had to have a confirmed diagnosis of active or chronic inactive TED.

Across both trials, there were:

Icon - Representing different patient ethnicities

Patients from 19 countries around the world with diverse backgrounds, including White, Asian, Black, and Hispanic populations.

A balanced number of patients with various ages and a wide range of symptoms - from early flare-ups to long-term eye changes.

Icon - Representing different patient genders

Both men and women participated, with a larger proportion of women enrolled to match how TED affects people in real life.

CAS=Clinical Activity Score; TED=thyroid eye disease.

Safety

Discover a well-established safety profile.

Learn more
Next: Safety profile

Important Safety Information & Indication

What is ENSPRYNG® (satralizumab-mwge)?

ENSPRYNG is a prescription medicine used to treat:

  • thyroid eye disease (TED) no matter how severe it is or how long a person has had it.

It is not known if ENSPRYNG is safe and effective in children.

Who should not receive ENSPRYNG?

Do not take ENSPRYNG if you:

  • are allergic to ENSPRYNG or any of the ingredients in ENSPRYNG.
  • have an active hepatitis B infection.
  • have active or untreated inactive (latent) tuberculosis.
What is the most important information I should know about ENSPRYNG?

ENSPRYNG may cause serious side effects including:

  • Infections. ENSPRYNG can increase your risk of serious infections, some of which can be life-threatening. Talk to your healthcare provider if you are being treated for an infection, or call them right away if you think you have signs of an infection, with or without a fever, such as:
    • chills, feeling tired, muscle aches, cough that will not go away or a sore throat
    • skin redness, swelling, tenderness, pain or sores on your body
    • diarrhea, belly pain, or feeling sick
    • burning when you urinate or urinating more often than usual
  • Your healthcare provider will check if you have an infection and treat it if needed before you start or continue to take ENSPRYNG.
  • Your healthcare provider should test you for hepatitis and tuberculosis (TB) before you start taking ENSPRYNG.
  • All required vaccinations should be completed before starting ENSPRYNG. People using ENSPRYNG should not be given ‘live’ or ‘live-attenuated’ vaccines. ‘Live’ or ‘live-attenuated’ vaccines should be given at least 4 weeks before you start ENSPRYNG. Your healthcare provider may recommend that you get a ‘non-live’ (inactivated) vaccine, such as some of the seasonal flu vaccines. If you plan to get a ‘non-live’ (inactivated) vaccine, it should be given, whenever possible, at least 2 weeks before you start ENSPRYNG.
  • Increased liver enzymes.
    Your healthcare provider should order blood tests to check your liver enzymes before and while you are taking ENSPRYNG. Your healthcare provider will tell you how often you will need to have these blood tests. Make sure you get all of your follow-up blood tests as ordered by your healthcare provider. Your healthcare provider will tell you if you need to wait to start ENSPRYNG if your liver enzymes are increased.
  • Low neutrophil count.
    ENSPRYNG can cause a decrease in your neutrophil counts in your blood. Neutrophils are white blood cells that help the body fight off bacterial infections. Your healthcare provider should order blood tests to check your neutrophil count while you are taking ENSPRYNG.
  • Serious allergic reactions.
    Serious allergic reactions that may be life-threatening have happened with other medicines like ENSPRYNG. Tell your healthcare provider before taking your next dose if you had hives, rash, or flushing after your injection. Seek medical attention right away if you have any symptoms of a serious allergic reaction, such as:
    • shortness of breath or trouble breathing
    • dizziness or feeling faint
    • swelling of your lips, face, or tongue
    • moderate or severe stomach (abdominal) pain or vomiting
    • chest pain

Before you take ENSPRYNG, tell your healthcare provider about all of your medical conditions, including if you:

  • have or think you have an infection. See "What is the most important information I should know about ENSPRYNG?"
  • have liver problems.
  • have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • have had or have been in contact with someone with tuberculosis.
  • have had a recent vaccination or are scheduled to receive any vaccination.
  • are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if ENSPRYNG will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ENSPRYNG passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ENSPRYNG.

Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of ENSPRYNG?

The most common side effects of ENSPRYNG include:

  • sore throat, runny nose (nasopharyngitis)
  • rash
  • fatigue
  • extremity pain
  • headache
  • upper respiratory tract infection
  • nausea
  • inflammation of the stomach lining (gastritis)
  • joint pain (arthralgia)

These are not all the possible side effects of ENSPRYNG.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

For more information, call 1-844-NSPRYNG.

For additional safety information, please see the full Prescribing Information and Medication Guide.

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