The FDA has approved Remicade (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in children 6 years and older who have had inadequate response to conventional therapy. Remicade was found to reduce 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.
Remicade 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, Remicade 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 pelvis), psoriatic arthritis (joint pain associated with psoriasis), and plaque psoriasis in adults.
The safety and efficacy of Remicade was backed by a multi-center, randomized, open-label study in 60 children aged 6 to 17 years with moderately to severely active UC. All had failed to respond to or tolerate conventional treatment.
Remicade comes with a Boxed Warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and viral, fungal or bacterial infections. 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 Remicade and should not receive live vaccines while taking Remicade. The most common side effects of Remicade are worsening of UC, upper respiratory tract infections, infusion-related reactions, and headache.
Remicade is manufactured by Janssen Biotech Inc. in Malvern, Pa.