What Is Simponi, and Why Does It Matter?
The FDA has approved Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kilograms (33 pounds). Simponi is a lab-made antibody (biologic medicine) that works by blocking a protein called tumor necrosis factor-alpha (TNF-alpha), whose excessive levels cause long-term inflammation and damage in several autoimmune diseases.
Simponi is already approved for the treatment of several conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and UC, in adults.
UC is a long-term autoimmune disease in which the immune system mistakenly attacks healthy cells lining the colon (large intestine), leading to inflammation and symptoms such as frequent or bloody diarrhea, stomach pain, tiredness, weight loss, and loss of appetite. UC affects more than 1 million people in the U.S., and about 20% of them are children.
This approval matters because unlike other biologic treatments that may require frequent doses or an intravenous (IV) infusion, Simponi is a once-monthly shot under the skin given as a maintenance treatment for children with UC. This first-of-its-kind medicine provides more convenient home-based care, making it easier for families to manage and continue their child's treatment.
Why Was It Approved?
Simponi was approved based on clinical studies that showed that it can help reduce symptoms and improve the daily life of children with moderately to severely active UC ages 2 years and older.
In a clinical study, about one-third of children went into remission (their symptoms disappeared) after six weeks of treatment. Among those in remission, over half (57%) stayed in remission through week 54 (about a year after the start of treatment). The safety results in children were similar to those seen in adults using Simponi.
The most common symptoms include colds, flu-like symptoms, and swelling, itching, pain, bruising, or tingling reactions where the shot is given. Some people may also get viral infections such as cold sores or the flu. More serious risks include infections such as tuberculosis or fungal infections, low blood cell counts, immune or nervous system issues, and certain cancers such as lymphoma or skin cancer. Rare but life-threatening side effects include new or worsening heart failure, liver failure, and severe allergic reactions.
What Do I Need to Know?
Simponi is given as a shot under the skin. It comes in a prefilled syringe or an autoinjector. Children ages 12 years and older may be able to give the shot themselves using the syringe after getting trained by their health care provider on how to prepare and inject Simponi correctly. Only adults should use the autoinjector. The first dose should always be given under medical supervision.
For children, the dose depends on body weight. Children who weigh more get a higher starting dose, followed by monthly shots. Those who weigh less get a lower dose on the same schedule.
Your health care provider will test your child for tuberculosis and hepatitis B before starting Simponi. Your child will also be monitored for signs of infection while using it. You shouldn't give Simponi to your child if they have an active infection or are getting treated for one. Let your provider know if your child has an infection that doesn't go away or keeps coming back or has had close contact with someone who has tuberculosis.
Inform your health care provider if your child has a weak immune system, lymphoma or any other cancer, skin problems, liver disease, heart failure, or nervous system problems. Be sure to tell them about all medicines your child takes, including over-the-counter products, herbal remedies, vitamin supplements, or other TNF-alpha blockers, to avoid possible interactions. Simponi should not be used along with other medicines that affect your child's immune system. Let your health care provider know if your child is allergic to rubber or latex, as the needle cover of the syringe and autoinjector contains dry natural rubber.
Let your health care provider know if your child is scheduled for any vaccinations. Your child should not receive certain types of vaccines while using Simponi.
Contact your health care provider right away if your child has a fever or any other signs of infection, a rash, new muscle or joint pain, dark urine, yellow skin or eyes, pain in the right side of the stomach area (abdomen), hives, trouble breathing, chest pain, or a swollen face; complains of vision changes or weakness or numbness in any part of the body; or bruises or bleeds easily.