FDA approves Humira to treat ulcerative colitis

October 1, 2012
From staff reports

FDA has approved adalimumab (Humira, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.

FDA has approved adalimumab (Humira, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.

Adalimumab works by inhibiting tumor necrosis factor-alpha (TNF-α). The UC approval represents the seventh indication for this treatment in the United States and makes adalimumab the first and only self-administered biologic treatment approved for use in this disease. It is not known if adalimumab is effective in people with moderate to severe UC who have lost response to or could not tolerate anti-TNF medicines. Adalimumab can be self-administered after proper injection training is received and with proper physician monitoring.

"There is significant unmet medical need in this patient population, which has not seen a new treatment approved in more than seven years," William J. Sandborn, MD, division chief, gastroenterology, University of California, San Diego, said in an Abbott press release. "This FDA approval is good news for patients and health care professionals who are seeking another option to manage the disease."

UC is a chronic disease that is marked by inflammation and ulceration in the lining of the colon or large intestine. It is estimated that approximately 700,000 people in the United States have UC. On average, people are diagnosed with UC in their mid-30s, though the disease can occur at any age. Symptoms include abdominal cramping, rectal bleeding, diarrhea, and urgency and frequency to have a bowel movement. The symptoms of UC tend to come and go, with periods of remission between flare-ups. Treatment may include medication and surgery.

It is also important that UC patients properly manage their nutrition because fluids, nutrients and electrolytes can be lost due to rectal bleeding and diarrhea. Additionally, 25% of UC patients will require surgery during the course of the disease.

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).

Abbott's submission for Humira was supported by results from 2 phase 3 studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (ie, corticosteroids, azathioprine, or 6-mercaptopurine).

The primary end point of both studies was the proportion of patients achieving clinical remission at specified time points (week 8 in ULTRA 1 and weeks 8 and 52 in ULTRA 2). Remission was defined as a Mayo score of ≤ 2 and no individual subscore > 1. The Mayo score is calculated based on subscores of stool frequency, rectal bleeding, physician's global assessment, and endoscopy. In the FDA-approved dose, both studies achieved their primary end points. The safety results from both studies were consistent with the known safety profile of adalimumab and no new safety signals were identified.

Adalimumab is a TNF blocker medicine that affects the immune system and can lower the ability to fight infections. Serious infections have happened in people taking adalimumab. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before adalimumab use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with adalimumab should not be started in a person with an active infection, unless approved by a doctor. Adalimumab should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB, hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including adalimumab, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including adalimumab, the chance of getting 2 types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life threatening if treated.

Common side effects of adalimumab include injection-site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

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