Expanded Approval of Adalimumab for UC

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In September 2012, the U.S. Food and Drug Administration (FDA) approved adalimumab (Humira) to treat moderate or severe ulcerative colitis in adults with the condition. This medication also is approved, alone or in combination with other therapies, for the treatment of moderate-to-severe rheumatoid arthritis (RA), psoriasis and psoriatic arthritis, Crohn's disease, ankylosing spondylitis, and juvenile idiopathic arthritis in children over the age of 4.

Adalimumab—a tumor necrosis factor (TFN) blocker administered as an injection—can reduce the inflammation and abnormal immune system responses that cause symptoms of ulcerative colitis. It is approved for use when other medications to treat UC have not been effective, and has been show to help get ulcerative colitis symptoms under control and help keep the disease in remission. In clinical trials, about 16–18 percent of patients experienced UC remission with adalimumab, and about 9 percent of these patients achieved sustained remission of symptoms.

To treat moderate-to-severe ulcerative colitis, adalimumab is usually administered as follows:

  • Initial dose of 160 mg
  • Second dose (2 weeks after the first) of 80 mg
  • Maintenance doses of 40 mg every other week in patients who experience clinical remission by 8 weeks of treatment

Side effects of Humira include injection site reactions (redness, itching, swelling, bruising), rash, headache, nausea and upper respiratory infections. TFN blockers, which can impair the immune system’s ability to fight infections, increase the risk for serious infections, including tuberculosis (TB), as well as certain types of cancer.

Talk to your health care provider about your medical history before starting treatment with this medication and notify your doctor immediately if you develop severe side effects or new symptoms, including:

  • Abnormal bleeding or bruising
  • Chest pain
  • Cough
  • Dark urine or stool
  • Difficulty breathing, shortness of breath
  • Dizziness
  • Fatigue
  • Hives
  • Joint pain
  • Muscle aches or weakness
  • Pallor (pale skin)
  • Stomach pain
  • Swelling of the face or lower legs
  • Vision loss
  • Vomiting
  • Weight loss or sudden weight gain
  • Yellowing of the skin or eyes

Source: U.S. Food and Drug Administration

Publication Review By: the Editorial Staff at Healthcommunities.com

Published: 11 Oct 2012

Last Modified: 13 Nov 2014