Abbott’s HUMIRA® (adalimumab) Data Shows Fistula Healing for Up to Three Years in Patients with Moderate to Severe Crohn’s Disease

Additional Data Presented at United European Gastroenterology Week Show Fistula Healing in Difficult-to-Treat Patients

Vienna. — New data showed that Abbott’s HUMIRA® (adalimumab) provided long-term treatment of fistulas, with more than half of patients with moderate to severe Crohn’s disease experiencing fistula healing at three years, according to clinical research presented today at the United European Gastroenterology Week (UEGW) congress in Vienna. Data also showed response to HUMIRA in difficult-to-treat patients — those with fistulas who had failed to respond, lost response to, or were intolerant of infliximab.

Fistulas are tunnels that form between the intestine and other parts of the body. They develop in up to one-third of people with Crohn’s disease and are considered one of the most disabling complications of the disease. In these studies, fistula healing was defined as the absence of drainage from all fistulas, either spontaneously or with gentle compression.

“Fistulas can affect a patient’s lifestyle due to discharge, bleeding and fecal incontinence, and can also lead to invasive surgery,” said Jean-Frédéric Colombel, M.D., professor, Gastroenterology, Hôpital Huriez, Lille, France. “Treatments that promote fistula healing are important — particularly for difficult-to-treat patients.”



Study Results

Results from an open-label extension of the CHARM study, Abbott’s one-year, Phase III trial, showed the effect of HUMIRA on fistula healing for up to three years.

* More than half of patients (58 percent, 29/50) who had fistulas at baseline experienced fistula healing at the one-year completion of CHARM, and this was maintained through year one of the open-label extension. After a total of two years of treatment, the majority (59 percent, or 22/37) experienced fistula healing.
* About two-thirds of patients (68 percent, 21/31 patients) who continued treatment through year two of the open-label extension (three total treatment years) experienced fistula healing.

A sub-analysis of the CHOICE trial, Abbott’s open-label, single-arm study, assessed HUMIRA in treating patients with moderate to severe Crohn’s disease who had failed infliximab. A total of 83 of the 88 patients with fistulas at baseline had data available at their last physician visit. Last visits ranged from week four to week 36.

* Results showed that 41 percent of HUMIRA patients (34/83) had fistula healing at their last physician visit.
* 42 percent of the 71 initial responders — those who had developed intolerance or lost response to infliximab — had complete fistula healing.
* Four of the 12 patients who were infliximab primary non-responders experienced complete fistula healing.

“These data presented at UEGW represent the first time we have analyzed results of studies on fistula healing in HUMIRA patients who were primary non-responders to infliximab,” said Rebecca Hoffman, M.D., divisional vice president, Global Pharmaceutical Research and Development, Abbott. “We are encouraged by these results and will continue to study HUMIRA in patients with Crohn’s disease.”



About CHARM

CHARM (Crohn’s Trial of the Fully Human Antibody Adalimumab for Remission Maintenance) was a 56-week trial that enrolled 854 patients with moderate to severe Crohn’s disease and evaluated HUMIRA for the maintenance of clinical remission. Following a four-week, open-label induction period, the 778 patients still participating in the trial were randomized to either HUMIRA (40 mg every other week or weekly), or placebo. The co-primary endpoints evaluated the maintenance of clinical remission at weeks 26 and 56 for the HUMIRA 40 mg every other week and 40 mg every week groups compared to those on placebo. A significantly greater percentage of patients treated with HUMIRA maintained clinical remission at one year compared to placebo.

The observed data included patients from CHARM who were followed for an additional two years in an ongoing open-label extension. The data analyzed both HUMIRA doses and evaluated the subgroup of patients from CHARM who had fistulas at baseline and enrolled into the open-label extension for further evaluation.

The analysis reported the percentage of patients with healed fistulas and percentage with greater than or equal to 50 percent fistula response up to three years.