New Hope for Crohn's Patients
By Michael Lasalandra
Beth Israel Deaconess Medical Center Correspondent
Scott Gramstorff was diagnosed with Crohn's disease 19 years ago. Over the years, he has suffered numerous episodes of severe abdominal pain, and has had to be hospitalized frequently. Eleven years ago, he had a section of his small intestine removed. It helped for a number of years, but eventually the pain returned.
Gramstorff, now 37, had been on anti-inflammatory pills since his diagnosis, but the drug started losing its effectiveness after a number of years. He tried a different medication four years ago, but had a bad reaction and had to go off it.
Nine months ago, after yet another hospitalization for an abdominal blockage, Gramstorff, a Methuen resident who works in financial services, tried a brand new medication, one of three newly approved by the FDA for Crohn's.
The drug, Humira (generic name adalimumab) is known as a blocker of Tumor Necrosis Factor (TNF), a protein involved in the inflammatory process. It was previously used to treat rheumatoid arthritis but last year got approved for Crohn's as well. It is injected by the patient at home every two weeks.
"So far, so good," says Gramstorff. "I've been feeling great since I've been on it. I haven't had any problems, no reactions to it. I feel like I am in complete remission. I'm encouraged."
Dr. Adam Cheifetz, clinical director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center, says the drug and two others are offering Crohn's patients new hope.
"In the last year, there have been three new medications approved for treatment of Crohn's," he says. "They are making a huge difference for patients who have not responded to other drugs. And it gives physicians and patients more options. Some offer more convenience for the patient."
Crohn's is a type of inflammatory bowel disease in which the lining of the digestive tract becomes inflamed, causing severe pain and other symptoms, including diarrhea. When the inflammation spreads into the layers of affected tissue, it can be debilitating and may even lead to life-threatening complications.
Most patients start out on one of a number of anti-inflammatory medications. Steroids are also used to try and keep the condition under control. Until recently, there had been only one biologic medication, Remicade, approved for Crohn's. Like Humira, Remicade (generic name infliximab) also blocks TNF-alpha, but a number of patients lose response to the drug over time or develop a bad reaction. The drug is given by infusion every eight weeks.
Besides Humira, the two other newly approved biologic drugs for Crohn's are Cimzia (generic name certolizumab pegol) and Tysabri (generic name natalizumab). Cimzia is also a TNF blocker and is given by injection, but a health care provider must do the injection every four weeks. Tysabri was originally approved for use against Multiple Sclerosis. It is a monoclonal antibody and works by preventing white blood cells called lymphocytes from leaving the bloodstream, thus preventing them from causing the debilitating symptoms associated with the disease.
Tysabri is given by monthly infusion, but patients must be closely monitored as the drug was associated with a severe side effect - a brain infection - in three MS patients and was once pulled from the market as a result of this complication. It is approved only for patients with active Crohn's disease who have failed to respond to other therapies, including the TNF-alpha inhibitors.
Cheifetz said patients who have been doing well on Remicade are generally staying on the drug. But those who lose response to it are switching to one of the new drugs. A number of new patients who have not been on any of the biologics are choosing Humira as or Cimzia as they are easier to administer, he says.
The drugs are not a cure, however. "When these drugs work, patients go from being sick to being in remission and that's our goal," Cheifetz says. "We want them feeling healthy and normal again."
Above content provided by Beth Israel Deaconess Medical Center. For advice about your medical care, consult your doctor.
Posted March 2009