Abbott (NYSE: ABT) today announced results from an analysis of three-year long-term data from an ongoing open-label extension of the HUMIRA® (adalimumab) ULTRA 1 and ULTRA 2 studies. Adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to certain other medications and were treated with HUMIRA were evaluated for symptom improvement for up to three years. In this long-term analysis, ulcerative colitis activity was assessed using the Partial Mayo score, which does not include endoscopic findings. Results showed:
A reduction in observed mean Partial Mayo score (a measure of disease activity that ranges from 0 to 9) from 5.9 at the time of first dose of HUMIRA to 1.4 at week 172 of HUMIRA therapy.
A 55.3 percent remission rate, per Partial Mayo score at week 60 of the extension study (reflecting 112 weeks from lead-in study baseline), as assessed in the intent-to-treat patients who enrolled in the open-label study extension.
The data were presented this week at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nevada, and the United European Gastroenterology Week (UEGW) Annual Meeting in Amsterdam, The Netherlands.
"We know ulcerative colitis can be a long-term, disruptive and difficult-to-treat disease," said lead investigator Jean-Frederic Colombel, M.D., professor of gastroenterology and hepatogastroenterology, director of the Department of Hepatogastroenterology, Hopital Huriez, Lille, France. "These results provide valuable information and insight to further study the long-term use of adalimumab in the treatment of ulcerative colitis."
UC is an inflammatory bowel disease marked by ulcers in the colon and may lead to life-threatening complications. It is estimated that 25 percent of patients with UC may undergo surgical removal of the colon during their lifetimes, leaving patients with a permanent colostomy or ileal pouch.
These results are encouraging, as they follow the recent regulatory approvals in the U.S. and Europe of HUMIRA for inducing and sustaining clinical remission in adult patients with moderately to severely active UC who demonstrated an inadequate response to immunosuppressant therapy," said John Medich, Ph.D., divisional vice president, clinical development, Immunology, Abbott. "Abbott is committed to further investigate the long-term use, efficacy and safety of HUMIRA in these patients."