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."
Study Details The analysis of the ULTRA 1 and ULTRA 2 trials and the ongoing, multicenter open-label extension evaluated the long-term treatment of HUMIRA in patients with moderately to severely active UC for up to three years (172 weeks). Partial Mayo score (PMS), which evaluates stool frequency, rectal bleeding, and physician's global assessment, was collected at every study visit during the trials and the open-label extension. Mean PMS over time from first dose of HUMIRA was assessed using observed case method and decreased over time through 172 weeks of treatment from 5.9 (n=992) to 1.4 (n=136).
Of the 588 patients in the intent-to-treat population, 55.3 percent achieved clinical remission (defined as Partial Mayo score of two or less, with no individual subscore greater than one) at week 60 of the open-label extension (n=325). These results were observed for up to three years. Of the 588 patients who entered the open-label extension trial, 141 were receiving HUMIRA 40 mg weekly. An additional 100 patients began receiving HUMIRA 40 mg weekly during the open-label phase due to flare or non-response. The recommended dose of HUMIRA for adult patients with UC is 160 mg on Day 1, followed by 80 mg on Day 15, following two weeks later (Day 29) with 40 mg every other week by subcutaneous injection. In the open-label extension, both the investigator and patient knew that they were receiving HUMIRA. Additionally, open-label extension data may be enriched as patients who remain in the study long-term tend to do better than those who drop out. The results from the placebo-controlled, phase 3 trials demonstrated statistically significant percentages of clinical remission per Mayo score at eight and 52 weeks in HUMIRA-treated patients compared to placebo. The safety results were consistent with the known safety profile of HUMIRA and no new safety signals were observed.