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Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission
Date:5/21/2008

th moderate to severe Crohn's disease to study the safety and efficacy of HUMIRA in maintaining clinical remission up to 56 weeks. After week four, 778 patients were randomized to placebo, HUMIRA 40 mg every other week (EOW) or 40 mg weekly (EW) in blinded fashion. At or after week 12, patients with flares or non-responders could receive open-label 40 mg EOW and 40 mg EW for continued flare or nonresponse.

The co-primary endpoints evaluated the maintenance of clinical remission at weeks 26 and 56 for each HUMIRA group compared to those on placebo. A significantly greater percentage of patients treated with HUMIRA maintained clinical remission at one year compared to placebo.

About the GAIN Trial

In the GAIN (Gauging Adalimumab effectiveness in Infliximab Nonresponders) study, a four-week induction trial of 325 patients who lost response or were intolerant to infliximab, three times as many patients taking HUMIRA achieved clinical remission at week four versus placebo (21 percent versus 7 percent, respectively).

"HUMIRA's ability to effectively treat the chronic symptoms of Crohn's disease makes it an important option for gastroenterologists and patients looking for improved disease management," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.

HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

The recommended HUMIRA dose regimen for adult patients with Crohn's disease is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15).
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