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Abbott Announces Three-Year Long-Term Data Evaluating Efficacy With HUMIRA® (Adalimumab) For Patients With Moderately To Severely Active Ulcerative Colitis

About ULTRA 1ULTRA 1 was an eight week, multi-center, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of HUMIRA for the induction of clinical remission per Mayo score in 390 anti-TNF naive adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (i.e., corticosteroids, azathioprine, or 6-mercaptopurine). 

Mayo score is a measure of disease activity that ranges from 0 to 12 and includes stool frequency, rectal bleeding, endoscopic findings and physician's global assessment.  Patients were randomized to treatment with HUMIRA 160/80 mg (160 mg, week zero; 80 mg, week two; 40 mg, weeks four and six), HUMIRA 80/40 mg (80 mg, week zero; 40 mg; weeks two, four and six) or placebo.  Patients, including those randomized to placebo, continued conventional therapy such as corticosteroids, aminosalicylates and immunosuppressants.  The primary efficacy endpoint was clinical remission (defined as a Mayo score of two or less, with no individual subscore greater than one) at week eight.                 

At week eight, 18 percent of 130 patients in the HUMIRA 160/80 group (p=0.031 vs. placebo) and 10 percent of the 130 in the HUMIRA 80/40 group (p=0.833 vs. placebo) compared with 9 percent of the 130 patients in the placebo group were in clinical remission.  The safety results were consistent with the known safety profile of HUMIRA and no new safety signals were observed.

About ULTRA 2ULTRA 2 was a 52-week, double-blind, randomized, placebo-controlled phase 3 trial of 494 adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (i.e., corticosteroids, azathioprine, or 6-mercaptopurine).  Patients were randomized 1:1 to placebo or HUMIRA (160 mg, week zero; 80 mg, week two; 40 mg every other week starting at week four).  Patients, including those randomized to placebo, continued concurrent therapy such as corticosteroids, aminosalicylates and immunosuppressants.  Co-primary endpoints were the proportion of patients with clinical remission at week eight and clinical remission at week 52.  Clinical remission was defined as a Mayo score of two or less with no individual subscore greater than one.

Of the 248 patients treated with HUMIRA in ULTRA 2,17 percent achieved clinical remission compared to 9 percent on placebo at week eight (p<0.05).  At week 52, 17 percent achieved clinical remission compared to 9 percent on placebo (p<0.05). These results were statistically significant compared to placebo. The safety results from ULTRA 2 were consistent with the known safety profile of HUMIRA and no new safety signals were identified.

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