October 6, 2008 / 12:22 PM / 11 years ago

UPDATE 1-Remicade tops azathioprine in Crohn's disease study

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By Bill Berkrot

NEW YORK, Oct 6 (Reuters) - Crohn’s disease patients taking Johnson & Johnson’s (JNJ.N) Remicade either alone or with azathioprine experienced steroid-free remission in significantly greater numbers than those taking azathioprine alone, according to results of a clinical trial.

Patients who received Remicade in the study also had greater mucosal healing — the healing of ulcers in the bowel caused by Crohn’s — researchers said.

Remicade, a blockbuster rheumatoid arthritis and psoriasis treatment given by intravenous infusion, is already approved to treat moderate to severe Crohn’s in patients who have not responded well to other therapies. It had sales of $1.9 billion for the first half of the year, and greater and earlier use in Crohn’s would further boost revenue.

After 26 weeks of treatment, 57 percent of patients receiving Remicade combination therapy and 44 percent of patients receiving Remicade alone achieved steroid-free remission compared with 31 percent of patients receiving azathioprine alone, researchers said.

The results were considered statistically significant.

“I think this really is a very important result that probably should change our practice,” said Dr William Sandborn, an inflammatory bowel disease specialist at the Mayo Clinic and a principal investigator of the study.

Forty-four percent of patients receiving Remicade combination therapy and 30 percent who got Remicade alone achieved mucosal healing — a secondary goal of the trial — compared with just 17 percent of azathioprine patients.

“That’s a very objective measure of efficacy, which past trials haven’t done,” said Sandborn, who will present results of the 30-week trial of 508 patients with moderate to severe Crohn’s at the American College of Gastroenterology meeting in Orlando, Florida, this week.

Crohn’s disease is a chronic and often debilitating inflammatory disease of the colon and large intestine that affects some 500,000 people in the United States and leads to frequent hospitalizations and surgery.

Crohn’s patients are typically first treated with a class of drugs called aminosalicylates and/or steroids before moving on to azathioprine. A biologic medicine such as Remicade, known chemically as infliximab, has been the third or fourth option.

“It’s increasingly unclear whether they’re effective,” Sandborn said of aminosalicylates. And long-term steroid therapy presents a host of complications and adverse side effects, he said.

“Steroid-free is a big deal,” Sandborn said of the primary goal of the study sponsored by J&J’s Centocor unit.

Azathioprine, an immunosuppressant, is not approved for Crohn’s in the United States but is nevertheless widely used by U.S. physicians treating Crohn’s.

“This is such a miserable disease,” Sandborn said. “The data are really definitive that once you’ve failed first-line therapy, an infliximab-based strategy is superior to azathioprine.”

The safety profile for Remicade was similar to that of azathioprine in the study with fewer serious side effects, researchers said.

At week 30, 24 percent of patients receiving azathioprine monotherapy experienced one or more serious adverse events compared with 16 and 14 percent of patients receiving Remicade monotherapy and Remicade with azathioprine, respectively.

That includes two patients receiving azathioprine who developed colon cancer and one patient who died following a colectomy and one patient receiving Remicade combination therapy who was diagnosed with tuberculosis. Eight azathioprine patients developed serious infections compared with four on Remicade. (Editing by Dave Zimmerman)

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