Humira reported to help ulcerative colitis patients not responsive to other treatments

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Oct 1 2012 - 1:38pm
ulcerative colitis, Humira, adalimumab, Crohn's disease, FDA

Approximately 620,000 individuals in the United States suffer from ulcerative colitis, an inflammatory disease of the large intestine. A newly-approved medication may benefit people with moderate to severe ulcerative colitis who have not responded to corticosteroids and other immunosuppressant medicines.

On September 28, the Food and Drug Administration (FDA) announced that it had expanded the approved use of Humira (adalimumab) to include treatment of the condition in in adults. The drug is an anti-tumor necrosis factor (TNF) that blocks proteins, which play an important role in abnormal inflammatory and immune responses. The FDA notes that it should be used in individuals who have not been helped by immunosuppressant medicines such as corticosteroids, azathioprine, and 6-mercaptopurine have not worked.

Ulcerative colitis is a chronic disease that causes inflammation and ulcers in the inner lining of the large intestine. Ulcerative colitis and Crohn’s disease are the two major forms of chronic inflammatory bowel disease.

“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” explained Donna Griebel, MD, director of the Division of Gastroenterology and Inborn Errors Products in FDA’s Center for Drug Evaluation and Research. She added, “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”

Humira is manufactured by Abbott Laboratories, based in North Chicago, Illinois.The FDA previously approved Humira to treat rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn’s disease (2007), plaque psoriasis (2008), and juvenile idiopathic arthritis (2008). To aid in the assessment of the condition, people with ulcerative colitis are normally evaluated for stool frequency, rectal bleeding, endoscopic findings, and a physician’s assessment, which combined provide a score ranging from 0 to 12. This scoring system is commonly referred to as the Mayo score.

Humira’s safety and effectiveness for ulcerative colitis were established in two clinical studies. A total of 908 patients who had never been treated with a TNF-blocker, or who lost response to or were intolerant to TNF-blockers participated in the studies. All patients enrolled in the studies had a Mayo score of 6 to 12 and an endoscopy subscore of 2 to 3. Patients were randomly assigned to receive Humira or a placebo. The researchers designed the study to measure the percentage of patients whose Mayo score decreased to 2 or less with no individual subscore of more than 1 after eight weeks of treatment. Patients who obtained such reductions in the Mayo score were determined to have achieved clinical remission.

Results from both studies reported that 16.5-18.5% of patients treated with Humira achieved clinical remission, compared with 9.2-9.3% of patients receiving placebo. Furthermore, in the second study, 8.5% of patients treated with Humira had a clinical remission, compared with 4.1 percent of patients treated with placebo. The effectiveness of Humira has not been established in patients with ulcerative colitis who have lost response to or were intolerant to TNF blockers.

The FDA-approved dosing regimen for Humira for ulcerative colitis begins with an initial dose of 160 milligrams, a second dose two weeks later of 80 mg, and a maintenance dose of 40 mg every other week, thereafter. The drug should only continue to be used in patients who have shown evidence of clinical remission by eight weeks of therapy. No new side effects were identified during clinical studies. Common side effects of Humira include infections, reactions at the injection site, headache, and rash.

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The cause of ulcerative colitis is unknown. It may affect any age group; however,there are peaks at ages 15 - 30 and then again at ages 50 - 70. The disease usually begins in the rectal area and may eventually extend through the entire large intestine. Repeated swelling (inflammation) leads to thickening of the wall of the intestine and rectum with scar tissue. Death of colon tissue or sepsis (severe infection) may occur with severe disease. The symptoms vary in severity and may start slowly or suddenly. Many factors can lead to attacks, including respiratory infections or physical stress.

Risk factors include a family history of ulcerative colitis, or Jewish ancestry. Common symptoms are:

  • Abdominal pain and cramping that usually disappears after a bowel movement
  • Abdominal sounds (a gurgling or splashing sound heard over the intestine)
  • Diarrhea, from only a few episodes to very often throughout the day (blood and mucus may be present)
  • Fever
  • Tenesmus (rectal pain)
  • Weight loss

Other symptoms that may occur with ulcerative colitis include the following:

  • Gastrointestinal bleeding
  • Joint pain
  • Nausea and vomiting

Signs and tests:

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