Posts Tagged ‘Infliximab’

Fistulizing Crohns Disease

02.19.10

Fistulas are common in Crohns disease. A population-based study has shown a cumulative risk of 33% after 10 years and 50% after 20 years. Perianal fistulas were the most common (54%). Medical therapy is the main option for perianal fistula once abscesses, if present, have been drained, and should include antibiotics (both ciprofloxacin and metronidazole) and immunomodulators.

Infliximab should be reserved for refractory patients. Surgery is often necessary for internal fistulas. The appropriate treatment of patients with fistulas in the setting of Crohns disease requires a knowledge of the specific medical and surgical literature of fistulizing Crohn’s. The patient with symptomatic fistulizing Crohns disease may respond differently to specific medical therapy than a patient with symptomatic obstructing Crohns disease.

Certain medications that are useful for the treatment of patients with obstructive Crohns disease may not be helpful in the treatment of fistulas in patients with fistulizing Crohns disease (e.g., corticosteroids and mesalamine); in fact, some medications are believed to be detrimental (e.g., corticosteroids). Few studies have been performed to assess the efficacy of specific medications on fistulas directly.

To date, there has been only one published prospective randomized controlled trial that was designed to assess the efficacy and safety of a specific medication on fistulas in patients with Crohns disease; it showed clinical efficacy over placebo in a statistically significant manner. The judicious use of surgery remains an integral part of the management of certain presentations of fistulizing Crohns disease, and the appropriate integration of surgical and medical therapy is of paramount importance in the management of these patients.

This review provides an overview of pertinent medical and surgical literature as it pertains to management of patients with fistulizing Crohns disease. Remicade was also shown to be effective in reducing the number of open, draining fistulas, a painful complication of Crohns disease in which deep openings burrow from the bowel wall through the surface of the skin, causing drainage of mucous and/or fecal material. Remicade is the first product documented to reduce the number of open fistulas in a controlled clinical trial.

In a clinical study of 94 patients with fistulizing Crohns disease (42 patients had single fistula and 52 patients had multiple fistulas), 68 percent of those treated at the recommended dose of Remicade experienced closure of at least 50 percent of fistula(s) for four weeks or more compared with 26 percent of placebo-treated patients. More than one-half (55 percent) of patients with single or multiple fistula(s) treated with Remicade experienced a clinical effect demonstrated clinical response to treatment with Remicade developed an abscess in the area of the fistula between eight and 16 weeks after the last infusion.

“Remicade represents a significant advance in the treatment of Crohns disease,” said Stephen Hanauer, M.D., University of Chicago Medical Center, department of gastroenterology, and a principal investigator in the clinical trials. “These patients suffer terribly and we physicians now have an important option available to treat them.”

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New Treatment for Crohns Disease

11.21.09

Until now, treatment for Crohn’s has relied on surgery and anti-inflammatory and other drugs also used to treat other conditions. In August 1998, the Food and Drug Administration licensed the first treatment specifically for Crohn’s disease, an incurable and sometimes debilitating inflammation of the bowel.

Remicade (infliximab) is a genetically engineered antibody that blocks inflammation caused by a protein called tumor necrosis factor. After clinical trials showed benefit from Remicade treatment within a two-to-four week period following a single dose, FDA approved the drug for patients with moderate to severe Crohn’s disease who have not found relief with other treatments. The Food and Drug Administration (FDA) today approved Humira (adalimumab) to treat adult patients with moderately to severely active Crohn’s disease, a chronic inflammatory disease of the intestines, which affects an estimated one million Americans. Humira is a human-derived, genetically-engineered monoclonal antibody (a protein that can be produced in large quantities in a manufacturing plant). The product acts to reduce excessive levels of human tumor necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses.

The labeling includes a boxed warning about potential serious adverse events. Crohn’s disease is a chronic, incurable, inflammatory bowel disease that causes diarrhea, cramping and abdominal pain, and in some cases, abnormal connections (fistulas) leading from the intestine to the skin. “Humira has been shown to reduce signs and symptoms, and to induce and maintain clinical remission of Crohn’s disease in patients who have had an inadequate response to conventional therapy, and in those patients who did not benefit from treatment, or who were intolerant to previous treatment with Remicade (infliximab) therapy,” said Dr. Douglas Throckmorton, Deputy Director of FDA’s Center for Drug Evaluation and Research. “Today’s approval provides patients and their health care providers with a new treatment option.”

The product has been studied in 1,478 patients with Crohn’s disease in four clinical trials comparing the drug to a placebo (contains no active ingredient) and two longer term extension studies. The labeling of Humira includes a boxed warning, the strongest type of label warning, that use of this product has been associated with serious, sometimes fatal, infections, including cases of tuberculosis, opportunistic infections, and sepsis.

Before initiating Humira treatment, patients should be evaluated for tuberculosis risk factors and tested for latent tuberculosis infection. Other serious adverse events reported by Humira users include lymphoma, a type of cancer. The most frequent adverse events included upper respiratory infections, sinusitis, and nausea. Humira requires subcutaneous injections (under the skin) to initiate treatment for Crohn’s disease, and maintenance treatment is administered as one injection every other week.

Humira was previously approved for the treatment of three autoimmune diseases: rheumatoid arthritis, a chronic inflammation of the joints; psoriatic arthritis, which causes joint swelling and scaly skin; and ankylosing spondylitis, a systemic rheumatic disease that affects the spine and sacroiliac joints. Humira is manufactured by Abbott Laboratories, Abbott Park, Ill.

Crohns Disease Cure

09.30.09

Mild to moderate cases are usually treated with oral medications called aminosalicylates that can relieve inflammation and keep Crohns in remission.More serious cases are treated with corticosteroids such as Prednisone, and medications such as Remicade and Humira that can reduce inflammation and heal fistulas.

Due to the potential side effects of these medications, many people opt for natural anti inflammatories such as fish oil. It has been proven to be beneficial in intestinal health, and can be as effective as prescription drugs as a Crohns treatment.

If you have Crohns disease, you will usually be seen regularly by a specialist team. Treatment will aim to increase your quality of life as much as possible, but there is no cure. If you have Crohns disease it’s important that you eat a healthy, balanced diet with a high fibre content, unless you are prone to blockages.

This is especially true when your symptoms flare up, as you will need to replace lost nutrients, although you may not feel like it. If you can eat a normal diet, you should continue to do so. However, you may find that certain foods disagree with you or that you need to eat more of particular types of food such as starchy carbohydrates (eg potatoes, bread and pasta).

When your Crohns disease is active, your doctor may recommend that you have a liquid diet, made up of simple forms of protein, carbohydrates and fats. This is called an elemental diet and is commonly used to treat children.

Many people with Crohns disease find that treatment with medicines is effective. Medicines used to treat Crohns disease include:
•    corticosteroids (eg prednisolone) to reduce inflammation
•    medicines to suppress your immune system (eg methotrexate or azathioprine)
•    a medicine called infliximab – your doctor may recommend this if you have severe Crohns disease that hasn’t responded to other medicines

During flare-ups you may consider taking painkillers, but your GP may advise you not to take certain medicines such as ibuprofen (eg Nurofen) as they can make Crohns disease worse. It’s usually fine to take paracetamol as a painkiller, but check with your GP first. It’s not a good idea to take antidiarrhoeal medicines all the time as they may cover up signs that your disease has become more severe. Speak to your GP if diarrhoea is a problem.

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Crohns Disease Drugs

09.21.09

Thirty-two years ago Ginger Gray walked into her doctor’s office complaining of abdominal pain, diarrhea, severe weight loss, and overwhelming joint pain. At 19, she hadn’t grown an inch since the sixth grade. But her doctor said there was nothing physically wrong with her, and even suggested she seek psychiatric counseling.

Fortunately for Gray, she sought another physician’s opinion.

Based on tests he conducted, the doctor recommended the 4-foot-11-inch Pennsylvania resident begin full-time treatment for Crohns disease.”Crohns disease robbed me of my stamina,” Gray says. “It took two years for me to fully regain my strength and weight so that I could begin working again.”Until now, treatment for Crohn’s has relied on surgery and anti-inflammatory and other drugs also used to treat other conditions.

In August 1998, the Food and Drug Administration licensed the first treatment specifically for Crohns disease, an incurable and sometimes debilitating inflammation of the bowel.Remicade (infliximab) is a genetically engineered antibody that blocks inflammation caused by a protein called tumor necrosis factor. After clinical trials showed benefit from Remicade treatment within a two-to-four week period following a single dose, FDA approved the drug for patients with moderate to severe Crohns disease who have not found relief with other treatments.

“We recognized that [Remicade] had such a dramatic effect on patients,” says Barbara Matthews, M.D., a medical officer in FDA’s Center for Biologics Evaluation and Research, “that it was given accelerated approval.”Remicade, which is taken intravenously, can decrease the amount of inflammation along the lining of the intestine.

Clinical trials also show that Remicade is effective in closing fistulas (abnormal passages or sores between the bowel and skin). Although not a cure, the drug reduces the symptoms in patients who have not responded well to traditional treatments.”This is an exciting development for two reasons,” says R. Balfour Sartor, M.D., professor of medicine, microbiology and immunology at the University of North Carolina, and chairman of the National Scientific Advisory Committee for the Crohn’s & Colitis Foundation of America (CCFA). “It is the first therapy for Crohns disease derived by molecular techniques, and it has the possibility of improving the quality of life for [Crohn's] patients.”

But Sartor also cautions that the long-term toxic effects of Remicade are unknown and that the drug is not needed by every Crohns disease patient. “Two-thirds of the people will have near immediate results,” he says, “but only those patients who do not respond to other therapies” are eligible to take the drug. The next step is to maintain a patient’s remission after the drug’s initial effect has worn off.

Currently, studies are being done to better define the risks and longer-term benefits of Remicade because drug reactions and potential adverse effects from suppressing tumor necrosis factor require further clarification. Crohns disease is one of two major types of inflammatory bowel diseases (IBD)–the general term for diseases that cause inflammation in the intestines–and has no cure and a high rate of recurrence following treatment.

It usually occurs in the lowest portion of the small intestine (ileum), and the large intestine (colon or bowel), but it can occur in other parts of the digestive tract. Crohn’s usually involves all layers of the intestinal wall.

The disease can be difficult to diagnose because its symptoms, which include chronic diarrhea, crampy abdominal pain, loss of appetite, and weight loss, often mimic those of the other IBD type–ulcerative colitis–which affects only the colon. (See “Is It Crohn’s Disease?”)

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