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Title: Long-Term Therapy With Infliximab Proves Effective and Safe in Inflammatory Bowel Disease: Presented at UEGW
URL: http://www.pslgroup.com/dg/22F356.htm
Doctor's Guide
October 21, 2008


By Judith Moser, MD

VIENNA, Austria -- October 21, 2008 -- Treatment with infliximab for more than 1 year results in prolonged response or remission, a steroid-sparing effect, and mucosal healing in a majority of patients with Crohn's disease or ulcerative colitis, according to a study presented here at the 16th United European Gastroenterology Week (UEGW).

Remission can be maintained for 1 year with infliximab in about 40% of patients with inflammatory bowel disease (IBD). However, evidence is lacking for treatment beyond 1 year, so there are no clear rules for infliximab discontinuation.

The study, presented by Alessandro Armuzzi, MD, Department of Internal Medicine, Catholic University Rome, Rome, Italy, analysed retrospectively the clinical efficacy of long-term scheduled infliximab therapy in patients with IBD. Dr. Armuzzi presented the findings on October 21.

Dr. Armuzzi and colleagues analysed the medical records of consecutive patients treated with infliximab for more than 1 year (equal to 9 or more infusions) at their institution.

They identified 105 patients with IBD who received an average of 17 infliximab infusions and were followed for a mean of 38 months.

Patients were randomly divided into 2 treatment arms: continued infliximab therapy for up to 4 years or discontinuation of infliximab. All patients received infliximab for at least 15 months.

Among the 63 patients with Crohn's disease, 36.5% suspended infliximab. In 18 cases, this was due to prolonged remission and in 5 cases due to loss of response.

After discontinuation, 67% of the patients maintained remission during a follow-up of 21 months.

All the patients who continued therapy (63.5%) either showed prolonged response (30%) or prolonged remission (70%); 89% discontinued steroids; and 59% had mucosal healing.

Among the 42 patients with ulcerative colitis, 40.5% suspended infliximab, 13 due to prolonged remission and 4 due to loss of response.

Eighty-four percent of these patients maintained remission after 13 months of follow-up. In those patients who continued therapy (59.9%), a prolonged response was achieved in 28% and a prolonged remission in 72%; 82% discontinued steroids; and 60% showed mucosal healing.

Mucosal healing was significantly associated with maintenance of remission after infliximab discontinuation.

Adverse events were seen in 10.5% of patients and led to discontinuation in 4.8%; the most common were infections (4.8%). "The majority of adverse events occurred in the first year of therapy," Dr. Armuzzi said.

Dose flexibility was required in about 25% of patients.

"When infliximab is discontinued after prolonged remission, a high percentage of patients maintain remission on immunomodulators," Dr. Armuzzi summarised. "Therefore, if prolonged remission and mucosal healing are achieved, physicians can be quite sure that most patients will develop no relapse within 1 year after treatment discontinuation."


[Presentation title: Long-Term Scheduled Therapy With Infliximab in Inflammatory Bowel Disease. Abstract PO174]

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