Abbott announced that the FDA has approved Humira (adalimumab) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP).
Abbott’s submission for Humira was supported by results from two Phase 3 studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (eg, corticosteroids, azathioprine, or 6-mercaptopurine).
The primary endpoint of both studies was the proportion of patients achieving clinical remission at specified time points (Week 8 in ULTRA 1 and Weeks 8 and 52 in ULTRA 2). Remission was defined as a Mayo score of <2 and no individual subscore >1. The Mayo score is calculated based on subscores of stool frequency, rectal bleeding, physician’s global assessment and endoscopy. In the FDA-approved dose, both studies achieved their primary endpoints.
The effectiveness of using Humira for ulcerative colitis has not been established in patients who have lost response to or were intolerant to tumor necrosis factor-alpha (TNF) blockers.
Humira, a tumor necrosis factor blocker, is available as a subcutaneous injection. Humira is indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, chronic plaque psoriasis, and psoriatic arthritis in adults. Humira is also indicated for the treatment of polyarticular juvenile idiopathic arthritis in children ≥4 years of age.
For more information call (847) 937-6100 or visit www.abbott.com.