# Abbott Labs Humira possible for Crohn's



## overitnow (Nov 25, 2001)

By Deena Beasley (Reuter's)LOS ANGELES, May 22 (Reuters) - A trial of Abbott Laboratories Inc.'s rheumatoid arthritis drug Humira shows it can keep symptoms of Crohn's disease from flaring for a year in patients who respond to the drug, the company said on Monday.The trial enrolled 854 patients with moderate to severe forms of the chronic inflammatory disorder of the digestive tract, but 76 dropped out and another 279 were not included in the analysis because they did not benefit from Humira in the first month of treatment.The study found that 46 percent of patients given Humira weekly had achieved remission from Crohn's disease at week 26, and 36 percent of those treated every other week maintained remission from Crohn's disease after 56 weeks.For patients treated with a placebo, 12 percent maintained remission after 56 weeks."The results are proof that this is a drug that works not only for induction, but also for maintenance," said Dr. David Rubin, trial investigator and director of clinical education for gastroenterology at the University of Chicago.The most common side effects were injection site reactions, but Humira, like other drugs that suppress the immune system, makes patients more susceptible to infections and can activate latent tuberculosis, Rubin said."We always test for that," and the TB can be treated before the patient is started on Humira, he explained.Abbott said it plans to file by the end of this year for U.S. Food and Drug Administration approval of the drug as a treatment for Crohn's disease.Currently, the only biologic drug approved to treat the bowel disease is Johnson & Johnson's Remicade, another of the group of drugs that suppress tumor necrosis factor-alpha, a protein that plays a key role in inflammation.Belgian biotech company UCB SA filed in March for FDA approval of its anti-TNF drug Cimzia for Crohn's.Abbott said the Humira trial also showed that up to 29 percent of patients taking Humira were able to stop using steroids, which have side effects like infectious complications and weight gain, and maintain their remission, compared to 6 percent on placebo.Also, one-third of patients with "draining cutaneous fistulas," the abnormal connections that form between the intestine and the skin in patients with Crohn's disease, had their fistulas closed, compared with 13 percent of placebo patients.The trial data was presented at the Digestive Disease Week annual meeting in Los Angeles.


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