Clinical Trial Results
THE TENDER STUDY
In a clinical trial called the TENDER study, ACTEMRA was tested in a number of children living with systemic JIA (SJIA). This study showed that for many children:
ACTEMRA works fast
Nearly 9 out of 10 children saw at least a 30% improvement in the signs of symptoms of their SJIA, also called a JIA ACR30 response, and saw no signs of fever at 12 weeks of treatment.* "No signs of fever" was defined as no temperature at or above 37.5°C in the preceding 7 days.
*After 12 weeks, 85% of patients taking ACTEMRA showed an ACR30 response with an absence of fever compared to just 24% of patients receiving placebo alone.
ACTEMRA may lessen the need for steroids
ACTEMRA helps control fever
Out of the children who had fevers at the start of the
study, 85% taking ACTEMRA showed no sign
of fever at 12 weeks, compared to just 21% taking
- In the study, controlled fever was defined as no temperature at or above 37.5°C in the preceding 14 days
Some children in the study also saw noticeable reductions in:
- Number of joints affected
- Number of joints with limited movement
Important Side Effect Information | Hepatitis B infection
If your child is a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while he or she uses ACTEMRA. Tell your child’s healthcare provider if your child has symptoms of a possible hepatitis B infection such as feeling very tired, vomiting, chills, dark urine, skin or eyes look yellow, clay-colored bowel movements, stomach discomfort, skin rash, little or no appetite, fevers, or muscle aches.
Before reading more, please see the Important Side Effect Information for ACTEMRA
This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
Important Side Effect Information
After reading about ACTEMRA, please talk to your healthcare provider if you have any questions.
- Available by medical prescription only
- For adults with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate, that did not provide enough relief
- For adults with giant cell arteritis (GCA)
- For people with active PJIA ages 2 and above
- For people with active SJIA ages 2 and above
ACTEMRA is not approved for subcutaneous use in people with PJIA or SJIA.
It is not known if ACTEMRA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.
ACTEMRA can cause serious side effects
ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have died from these infections.
Before taking ACTEMRA, tell your healthcare provider if you have:
- An infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Infection signs, with or without a fever, include:
- Sweating or chills
- Shortness of breath
- Warm, red or painful skin or sores on your body
- Feel very tired
- Muscle aches
- Blood in phlegm
- Diarrhea or stomach pain
- Weight loss
- Burning when you urinate or urinating more often than normal
- Any of the following conditions that may give you a higher chance of getting infections. These include: diabetes, HIV, or a weak immune system
- Tuberculosis (TB) or have been in close contact with someone who has TB. Your healthcare provider should test you for TB before starting ACTEMRA and during treatment with ACTEMRA
- Lived in or currently live in parts of the United States known for fungal infections. These parts include the Ohio and Mississippi River Valleys and the Southwest
- Hepatitis B or have had hepatitis B
Be sure to contact your healthcare provider or nurse if you see any signs of these side effects.
If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking ACTEMRA.
Some people taking ACTEMRA may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
Tell your healthcare provider right away if you see any of these side effects:
- Stomach-area pain that does not go away
- Change in your bowel habits
Changes in blood test results
Your healthcare provider should do blood tests before you start receiving ACTEMRA. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA) your healthcare provider should do blood tests 4 to 8 weeks after you start receiving ACTEMRA and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA) you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA) you will have blood tests done every 2 to 4 weeks during treatment. These blood tests are to check for the following side effects of ACTEMRA:
Low neutrophil count: neutrophils are white blood cells that help the body fight infection
Low platelet count: platelets are blood cells that help with clotting, which stops bleeding
Increase in liver function test levels
Increase in blood cholesterol levels
You should not receive ACTEMRA if your neutrophil and platelet counts are too low or your liver function test levels are too high. These may cause your healthcare provider to stop your ACTEMRA treatment for a time or change your dose. Your cholesterol levels should be checked 4 to 8 weeks after the start of your treatment, and then every 6 months after that.
Increased risk of cancer
ACTEMRA may increase your risk of certain cancers by changing the way your immune system works.
Hepatitis B infection
If you have hepatitis B, a virus that affects the liver, or are a carrier of the virus, ACTEMRA can cause the virus to become active. Your healthcare provider should test you for hepatitis B before starting treatment. Tell your healthcare provider right away if you see any signs of these symptoms:
- Feeling very tired
- Dark urine
- Skin or eyes look yellow
- Clay-colored bowel movements
- Stomach discomfort
- Skin rash
- Little or no appetite
- Muscle aches
Serious allergic reactions
Serious allergic reactions, including death, can happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If you had hives, a rash, or experienced flushing after injecting, you should tell your healthcare provider or nurse before your next injection.
Contact 911 immediately, as well as your healthcare provider or nurse, if you experience any of these reactions:
- Shortness of breath or trouble breathing
- Swelling of lips, tongue, or face
- Chest pain
- Feeling dizzy or faint
- Moderate or severe abdominal pain or vomiting
Nervous system problems
While rare, multiple sclerosis has been diagnosed in some people taking ACTEMRA.
Most common side effects
Tell your healthcare provider if you have these or any other side effect that bothers you or does not go away:
Upper respiratory tract infections (like common cold and sinus infections)
Increased blood pressure (also called hypertension)
Injection site reactions
ACTEMRA & pregnancy
Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your healthcare provider should decide if you will take ACTEMRA or breast-feed. You should not do both. If you are pregnant and taking ACTEMRA, join the pregnancy registry. The purpose of this registry is to check the health of the pregnant mother and her baby. To learn more, call 1-877-311-8972 or talk to your healthcare provider to register.
Reporting side effects
Tell your healthcare provider right away if you are experiencing any side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also call Genentech at 1-888-835-2555.