Abbott’s HUMIRA® (adalimumab) Shows Long-Term Improvement In Fistula Response and Healing Rates In Difficult-to-Treat Patients With Crohn’s Disease

Two Sub Analyses from the CHARM Trial Evaluated Fistula Closure and Quality Of Life in Patients with Fistulas from Crohn’s Disease

Abbott announced today the first two-year data for Crohn’s disease patients with fistulas, which show that more than half of patients receiving HUMIRA® (adalimumab) had continued fistula healing. These data were presented at the European Crohn’s and Colitis Organization (ECCO) Annual Meeting in Lyon, France. Fistulas are tunnels that form between the intestine and other parts of the body and are considered one of the most painful complications of Crohn’s disease. Fistula healing in these studies was defined as complete cessation of fistula drainage.

“Fistulas are a serious complication of Crohn’s disease that can lead to invasive surgery,” said Jean-Frédéric Colombel, M.D., professor, Gastroenterology, Hôpital Huriez, Lille, France. “Medical treatments that can promote fistula healing are important for gastroenterologists and patients suffering from fistulizing Crohn’s disease – a very difficult-to-treat patient population.”

The results were taken from two sub-analyses of fistula patients from Abbott’s 854-patient, one-year Phase III CHARM trial for HUMIRA. Patients were followed through a second year of therapy into a non-placebo controlled, ongoing open-label extension (OLE) trial. Results showed:

* Fistula healing was sustained with HUMIRA treatment. More than half of patients (60 percent) experienced fistula healing at one year with HUMIRA treatment, and 76 percent had continued fistula healing one more year.
* Seventy-one percent (50 of 70 patients) had at least a 50 percent reduction in the number of draining fistulas after treatment with HUMIRA.
* Adverse event rates among patients with fistulas were consistent with those seen in previous trials of HUMIRA in rheumatoid arthritis and Crohn’s disease.
* More than half had a high quality-of-life score that correlates to clinical remission over two years. This was measured with an Inflammatory Bowel Disease Questionnaire (IBDQ), a quality-of-life tool that assesses the impact of chronic medical illness on physical, emotional, and social well-being. Specifically, 54 percent had IBDQ scores greater than 170 at 56 weeks (26 of 48 patients) and 60 percent at 116 weeks (29 of 48 patients).
* An IBDQ score greater than 170 correlates with clinician remission, which is measured by the Crohn’s Disease Activity Index (CDAI) and defined as a CDAI score of less than 150.

“HUMIRA’s ability to heal, and keep healed, a majority of fistulas among patients studied reinforces that HUMIRA is an effective and convenient treatment option for severe and active Crohn’s disease,” said Rebecca Hoffman, M.D., divisional vice president, HUMIRA clinical development, Abbott.