“We are very encouraged by the findings of this study and look forward to larger prospective studies,” says researcher Konstantinos A. Papadakis, MD, with the Inflammatory Bowel Disease Center at Cedars-Sinai Medical Center in Los Angeles, in a news release. His paper appears in the current issue of American Journal of Gastroenterology.
Crohn's disease is a serious chronic and inflammatory disease of the intestinal tract (search), causing diarrhea, cramping, stomach pain, weight loss, and in some cases rectal bleeding. These symptoms wax and wane, with periods of active inflammation and disease followed by periods of inactivity. There is no cure for Crohn’s disease, but Remicade has helped to greatly reduce symptoms of this lifelong disease.
Remicade, a drug that works by blocking a part of the immune system know as TNF, is currently the only FDA-approved “biologic” treatment of this kind for the treatment of Crohn's disease. The drug lessens the symptom flare-ups and helps keep people in remission for long periods of time. It also helps people avoid developing fistulas (search), a common complication in people with Crohn's disease. Fistulas are openings of the intestine into other organs or on to the skin, such as around the anus -- which can seriously affect quality of life, and often requires surgery.
However, Remicade has its problems. The drug has been linked with serious and sometimes fatal infections, such as tuberculosis (search). It has also been linked to a rare but deadly liver reaction. Also, some studies have shown that the drug loses its effectiveness over time.
Crohn’s Disease vs. Humira
In his study, Papadakis tested Humira, a similar drug that suppresses the immune system and is FDA-approved for treatment of rheumatoid arthritis (search).
His study involved 13 patients with Crohn’s disease. All had been taking Remicade, but were no longer getting any relief from it. In the six-month study, they got an initial 80-milligram injection of Humira, then 40-milligram injections every two weeks. Researchers tracked their symptom relief.
Of the 13 patients, seven had complete symptom relief, four had partial relief, and two got no relief. Six of the patients required a boost in their dosage to maintain symptom relief.
Almost three quarters of the patients (73 percent) were able to discontinue or significantly decrease their concurrent dose of steroids.
All patients tolerated Humira without any allergic reactions; two patients had a skin reaction at the injection site.
Overall, the study shows that Humira is a strong option for Crohn’s disease patients -- when Remicade no longer works, writes Papadakis.
SOURCES: News release, Abbott Laboratories. Papadakis, K. American Journal of Gastroenterology, Jan. 2005. WebMD Medical News: “Remicade Fights Crohn’s Disease Complications.” WebMD Medical News: “New Remicade Warning.” WebMD Medical News: “FDA Issues New Warnings for Remicade.” WebMD Medical News: “Lymphoma Warning Added to Remicade.”