According to new results from the WELCOME trial, exploratory data analyzing the impact of treatment with CIMZIA(®) (certolizumab pegol) - the only PEGylated anti-TNF (alpha) (Tumor Necrosis Factor alpha) - administered either every two weeks or every four weeks, showed that the majority of Crohn's disease patients in both dosing groups experienced no hospitalizations and surgical procedures during the course of the 26-week study. These exploratory data from the WELCOME trial, which studied patients who had been on the anti-TNF therapy infliximab, but failed or developed a hypersensitivity to the treatment, will be presented this week at the American College of Gastroenterology (ACG) Annual Meeting.
CIMZIA is indicated for reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. The recommended initial adult dose of CIMZIA is 400mg at Weeks 0, 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.
In the WELCOME trial, which evaluated moderate to severe Crohn's disease patients who were intolerant to or no longer responding to infliximab therapy, more than 60 percent (329 out of 539 patients enrolled) responded to a 6-week, open label, induction phase with CIMZIA (400 mg subcutaneously at weeks 0, 2, and 4). Patients were then randomized at week 6 to receive CIMZIA (400 mg) every two (q2w) or four (q4w) weeks until week 26 in a double-blind, maintenance comparison phase. Responders were defined as those with a decrease in CDAI score greater than or equal to 100 points from baseline at week 6. The number and length of hospitalizations, number of emergency room visits, and number of medical procedures were recorded during the WELCOME study. The post-hoc analysis of the WELCOME trial evaluated CIMZIA's impact on the incidence of hospitalization and surgical procedures during hospital stays. The majority of patients (86 percent) in both groups>
"The data suggest that the recommended 400mg q4w dosing works as well as the accelerated dosing interval in this refractory population, adding to the extensive results from the WELCOME trial," said study investigator Douglas Wolf, M.D., Atlanta Gastroenterology Associates, Atlanta, Ga. "Treatment with CIMZIA may impact the number of hospital visits and related surgeries based on these findings."