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Abbott's Humira tames Crohn's in 29 pct of patients

Wed May 21, 2008 2:17pm EDT

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By Ransdell Pierson

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NEW YORK, May 21 (Reuters) - Abbott Laboratories Inc (ABT.N) said on Wednesday its Humira medicine has maintained maximum effectiveness for a year or longer among roughly 29 percent of Crohn's disease patients treated in two previously reported studies.

Abbott said it obtained the new long-term effectiveness data by following patients who had already completed the two trials and continued to receive treatment.

One of those earlier studies, called Charm, involved 854 patients with moderate to severe Crohn's disease, including ones who had never been treated and patients who had received earlier treatment for the often dangerous inflammatory bowel disease.

About 36 percent of patients taking Humira were found to be in remission after 56 weeks, meaning they achieved the highest level of relief according to a standard scale of symptoms. Results from the study were reported in 2006.

The latest data show that 77 percent of patients whose symptoms had gone into remission maintained clinical remission for an additional year, Abbott said.

That means about 29 percent of all patients who began treatment with Abbott's $18,000-a-year biotech drug in the Charm study were in remission two years later.

Jeffrey Kent, Abbott's global head of immunology, said Humira is the first biotech drug for Crohn's to establish sustained relief two years after treatment begins.

"Remicade's data only goes out to one year in published literature," Kent said in an interview, referring to Johnson & Johnson's (JNJ.N) older blockbuster treatment for the inflammatory bowel disease believed to affect more than 500,000 Americans.

Although fewer than a third of Crohn's patients who began Humira treatment achieved remission in the two trials, Kent said some patients achieve lesser degrees of relief for symptoms that include abdominal pain that can severely restrict daily activities.

When asked if Humira's high cost was warranted given the limited number of patients achieving remission, Kent said: "It's a chronic and devastating lifelong condition that destroys lives, so the ability to help restore normalcy is a worthwhile endeavor."

A shorter, previously completed Humira trial called Gain involved 325 patients who were no longer benefiting from Remicade treatment or were intolerant to it.

An estimated 21 percent of patients taking Humira in that trial were in remission at week four compared with 7 percent taking a placebo. Results from the study were also reported in 2006.

Patients, including those who had been on a placebo, continued taking Humira and were followed for another year.

Kent said an estimated 29 percent of all patients treated during the study and one-year follow-up period were in remission 13 months after the trial began.

First-quarter sales of Humira, Abbott's flagship product that also is used to treat rheumatoid arthritis, soared almost 54 percent to $878 million despite competition from Remicade. (Editing by Toni Reinhold)



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