A multi-center research team conducted the first large-scale trial of infliximab - also known as 'Remicade' - as maintenance therapy.
After 30 weeks of the study, patients receiving infusions of infliximab every 8 weeks were twice as likely to be in remission as those who were not receiving the drug.
The results of the trial, known as ACCENT-I, were revealed at the Digestive Disease Week meeting in Atlanta, United States.
Infliximab was approved by the Food and Drug Administration 3 years ago for short-term treatment of moderate to severe Crohn's disease and is the only non-steroidal medication indicated for the treatment of fistulas.
The study's director, Dr Stephen Hanauer, a Professor of Medicine at the University of Chicago, said it was the first therapy that truly allowed the disease to be managed over time.
"Ongoing treatment with infliximab decreased disease activity, prevented sudden attacks, and enabled patients to reduce - or, in many cases, completely eliminate - steroids," he commented.
|Proportion of patients in remission at Week 30:|
Placebo group: 21%
Infliximab, Group II: 39%
Infliximab, Group III: 45%
|Digestive Disease Week|
Almost 600 patients with moderate to severe Crohn's disease were involved in the study at 55 centers in North America, Europe, and Israel.
All patients received an initial dose of infliximab. The 335 patients (59%) who responded to the initial dose were randomized to one of 3 treatment groups.
All three groups received infusions at Weeks 2, 6, 14, 22, and 30 of the study. Group I received placebo (an infusion containing no medication), Group II received 5 mg/kg of infliximab, and Group III received 5 mg/kg of infliximab at Weeks 2 and 6, followed by 10 mg/kg at Weeks 14, 22, and 30.
By Week 30, patients in Groups II and III were twice as likely to be in remission as patients in Group I who received only the placebo.
Dr Hanauer said that almost 21% of the patients who received placebo had no symptoms at 30 weeks, but nearly 39% of those on the lower dose of infliximab, and 45% of those on the higher dose, were in complete remission.
He said infliximab also helped patients reduce their reliance on steroids; and patients reported higher quality-of-life scores at Week 30 than patients receiving the placebo.
"It would make a real difference for patients if we had alternatives to steroids, or better ways to reduce the steroid dose," said Hanauer.
However, infliximab has also been found to increase the risk of serious infection because it suppresses part of the immune response.
There are also reports of serious infusion reactions with hives, difficulty breathing, and low blood pressure, and in rare cases, people with de-myelinating disease who were treated with infliximab have seen their symptoms intensify.
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