Johnson & Johnson Crohn's Disease Drug is Superior in Its Study

An injected Johnson & Johnson biologic drug used to treat several immune diseases controlled Crohn's disease, a difficult-to-treat bowel disorder, better than a widely used pill, a study found.

Run by J&J's biotech unit, Centocor Inc., and funded by the company, the study showed that patients getting its Remicade, either alone or in combination with azathioprine pills, brought disease remission in far more patients than in a group getting just the pills.

The data are to be presented Tuesday at an American College of Gastroenterology conference.

The study included 508 adults with moderate or severe Crohn's disease who had suffered with the debilitating disorder for just over two years on average. Caused by an immune system-gone-awry that attacks the intestinal lining like a foreign body, it strikes about 500,000 Americans.

Symptoms include abdominal pain, frequent diarrhea, rectal bleeding, weight loss and fever. There's no cure, and in most patients increasing complications over the years lead to repeated surgeries to remove damaged bowel segments.

In the study, one-third of the patients got Remicade injections periodically over 30 weeks, along with dummy pills; one-third got those injections plus daily azathioprine pills, and the rest got daily azathioprine pills and dummy injections.

After six months, 57 percent of patients getting both treatments found their symptoms were gone and they were able to stop using steroids — immune-system suppressors that are commonly used in the short term but cause a host of side effects. In the group getting just Remicade, 44 percent of patients fared as well, compared with 31 percent getting azathioprine alone.

The patients also underwent a colonoscopy to see whether the lining of the bowel had healed: It had in 44 percent getting both treatments, 30 percent getting Remicade and 17 percent getting azathioprine.

Patients getting Remicade had slightly fewer side effects, which included serious infections, one case of tuberculosis and two patients on azathioprine alone developing colon cancer.

"There's such a great need for improvement" over standard treatments, said Dr. William Sandborn, one of the lead investigators for Centocor and an inflammatory bowel disease expert at the Mayo Clinic. "These data, I think, give us some hope."

Sandborn, a consultant to Centocor and some competitors, said the study patients will be followed a year longer to see whether Remicade prevents the need for bowel surgery.

Currently, he said, patients diagnosed with Crohn's disease usually start on steroids or older drugs called amino-salicylates that don't suppress the immune system but aren't very effective. As the condition worsens, patients often are prescribed azathioprine or related drugs that suppress the entire immune system, leaving the patient vulnerable to infections and other serious side effects.

Remicade and a couple similar biologic drugs — those grown in living cells — instead target just one part of the immune system, a protein called tumor necrosis factor that causes inflammation. Remicade was approved in 1998 for treating Crohn's disease, but only after standard therapies have failed, and Centocor's study aimed to show that using it earlier improves outcomes.

However, Remicade has caused fatal infections and cancers in a small number of patients and the cost, while generally covered by insurance, averages about $19,000 per year, many times that of azathioprine and generic steroids. Sandborn said that could be somewhat offset by preventing hospitalizations and surgeries.