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FDA Approves Infliximab to Treat Ulcerative Colitis in Children 6 Years and Older

The U.S. Food and Drug Administration approved infliximab to treat moderately to severely active ulcerative colitis (UC) in children 6 years and older who have had inadequate response to conventional therapy.

Infliximab reduces signs and symptoms of UC and induces and maintains clinical remission in these patients.

UC is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine (colon) and rectum. Symptoms of UC include abdominal pain, diarrhea, rectal bleeding, weight loss and fever. Between 50,000 and 100,000 children in the United States have IBD; of these, 40 percent have UC. 

"With the approval of Infliximab, children with moderately to severely  active  ulcerative colitis who have not had an adequate response to conventional treatment now have an FDA-approved treatment option,” said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “However, there are serious risks associated with its use. Patients and their families should always discuss with their physician the risks and benefits of using a medication before deciding to start treatment.”

Infliximab belongs to a class of drugs called tumor necrosis factor (TNF) blockers. TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to autoimmune diseases. In addition to being approved for UC, Infliximab is approved for the treatment of other autoimmune diseases such as Crohn’s disease in adults and children 6 years and older, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), psoriatic arthritis (joint pain associated with psoriasis), and plaque psoriasis in adults. 

The safety and efficacy of Infliximab was supported by a multi-center, randomized, open-label study in 60 children ages 6 years to 17 years with moderately to severely active UC. All had failed to respond to or tolerate conventional treatment.

Infliximab carries a Boxed Warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and infections caused by viruses, fungi or bacteria. There have been cases of unusual cancers reported in adolescent and young adult patients using TNF-blocking agents, including a rare and fatal type of cancer called Hepatosplenic T-cell Lymphoma.

Children should have all of their vaccines brought up to date before starting treatment with Infliximab and should not receive live vaccines while taking Infliximab. The most common side effects of Infliximab are worsening of UC, upper respiratory infections, infusion-related reactions, and headache. 

 

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