New Drug for Crohn's Patients

Stomach issues may decrease with new antibody treatment

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Maybe this is the end of long-term stomach aches and pains, at least for patients with Crohn's disease who don't respond to the common treatment.

An antibody that can treat other immune system problems may help ease Crohn's symptoms, a new study has found.

"Talk to your doctor about antibody treatment."

Ustekinumab, an antibody that treats dry skin in patients with psoriasis, showed it can help decrease the diarrhea, weight loss, and intestinal bleeding that comes with Crohn's, an inflammatory bowel disease.

Researchers, led by William Sanborn, MD, chief of the Division of Gastroenterology at the University of California San Diego School of Medicine, looked at 526 patients in 12 countries with moderate to severe Crohn's.

Patients were at least 18-years-old and had the disease for at least three months.

They were randomly assigned to receive 1, 3, or 6 mg per kilogram of their body weight for 36 weeks. The received a shot of the antibody at the beginning of the study and then one every eight weeks.

Patients who had a response to the antibody at week 6 were then assigned to receive another dose to maintain their therapy. Half received 90 mg of the antibody or a fake injection at weeks 8 and 16.

At week 6, about 37 percent of the group given 1 mg of the antibody per kilogram had some response.

For the groups receiving 3 and 6 mg, 34.1 percent and almost 40 percent of patients respectively had a response.

At 22 weeks, almost 70 percent of those given the additional antibody to maintain their therapy responded to treatment. Further, almost 42 percent were completely clear of any Crohn's symptoms. 

By the end of the study, five patients reported having a serious infection. Another had basal-cell carcinoma, a form of skin cancer, but no one died.

The research will be continued in two other stages to see how patients respond to the antibody when given over the course of a year.

“Our goal is to increase clinical response and put the disease in remission to improve the patient’s quality of life," Dr. Sandborn said.

The new findings are very encouraging, according to Maxwell Chait, MD, a gastroenterologist with the ColumbiaDoctors Medical Group and dailyRx Contributing Expert.

"It may also be potentially tried before TNF inhibitors among people with Crohn’s disease," Dr. Chait said.

"There is always room for another good drug to help tailor therapy in each patient. The more drugs doctors have with which to treat Crohn's disease, the better it is for Crohn’s disease patients."

The study was funded by Janssen Research and Development.

The study is published in the October 18 issue of the New England Journal of Medicine. 

Reviewed by: 
Review Date: 
October 17, 2012
Last Updated:
October 20, 2012