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UCB says monthly Cimzia dose effective for Crohn's disease
By Elaine Rigoli
Tampa, Fla., May 22 - Biopharmaceutical company UCB released new phase 3 trial data suggesting that when compared with a placebo, a significantly greater proportion of moderate-to-severe Crohn's disease patients achieved clinical response with subcutaneous once-monthly Cimzia (certolizumab pegol, CDP870), a new type of antitumor necrosis factor therapy.
"The Precise 1 results indicate that Cimzia, administered subcutaneously with a simple and stable once-monthly dose following an induction phase requiring only one additional administration at week 2, was a highly potent and effective therapy for patients with moderate to severe Crohn's disease," said William J. Sandborn, a professor of medicine at the Mayo Clinic College of Medicine and lead investigator for the clinical trial.
"These significant results were demonstrated using a demanding design in which, for the first time, all eligible Crohn's disease patients were randomized to either Cimzia or a placebo at study baseline without pre-selecting responders from an unblinded treatment induction period and treated for a period longer than four weeks," he said.
Trial results confirmed that both co-primary endpoints were met with statistical significance, and demonstrate that compared to a placebo, a statistically greater percentage of Cimzia, patients achieved a clinical response, according to a news release.
Additionally, the percentage of patients who experienced remission at week four and separately at week 26 was statistically significant with Cimzia (week 4: 19.5% Cimzia vs. 11.3% placebo; week 26: 29.5% Cimzia vs. 18.3% placebo), the release said.
UCB, located in Brussels, Belgium, develops pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology.
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