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"Data from the UCB clinical trials program including the WELCOME andPRECiSE studies has demonstrated that certolizumab pegol is effective ininducing and sustaining clinical response in a broad range of patients withmoderate to severe Crohn's disease," said David G. Binion, M.D., director, IBDCenter and professor of medicine at the Medical College of Wisconsin inMilwaukee, Wis. "The addition of Cimzia(R) into our pharmacologicarmamentarium to control chronic intestinal inflammation is an importantadvance for patients who suffer from Crohn's disease."
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Cimzia(R) is the first and only PEGylated anti-TNFa (Tumor Necrosis Factoralpha) antibody approved for reducing signs and symptoms of Crohn's diseaseand maintaining clinical response in adult patients with moderate to severeactive disease who have an inadequate response to conventional therapy.Cimzia(R), manufactured by UCB, was approved by the U.S. Food and DrugAdministration (FDA) on April 22, 2008. The approval was based on safety andefficacy data from clinical trials in more than 1,500 patients with Crohn'sdisease.
The response rates in this study, measured by a decrease (greater than orequal to 100 points from baseline) in the Crohn's Disease Activity Index(CDAI) score, were comparable to those in an earlier study, the PRECiSE 2trial, where 64 percent of patients in the overall population achievedresponse to Cimzia(R).
Cimzia(R) was consistently effective across all patient groups,demonstrating similar results in patients who were and were not receivingconcomitant immunosuppressants or steroids. The most common adverse eventswere headache, nasopharyngitis, nausea, vomiting, pyrexia and arthralgia. Theincidence of serious adverse events (SAEs) was seven percent and the mostfrequent SAEs involved gastrointestinal disorders (five percent) andinfections and infestations (2 percent). No unexpected safety concerns wereidentified during this study.
About WELCOME
The WELCOME study is a 539 patient Phase IIIb multicenter 26-Week trialEvaluating the clinical benefit and tolerability of certoLizumab pegolinduCtiOn and Maintenance in patients suffering from Crohn's disease withprior loss of response or intolErance to infliximab. It consists of anopen-label induction phase (400 mg of Cimzia(R) sub-cutaneously at Weeks 0, 2and 4) and a double-blind maintenance period (400 mg of Cimzia(R) every 2 or 4weeks from Week 6). The primary endpoint was defined as the rate of response(defined as a decrease in CDAI score greater than or equal to 100 points frombaseline) at Week 6. Remission was defined as a CDAI score of less than orequal to 150 points. After the induction period, 62.2 percent of patientsachieved response and 39.3 percent achieved remission. One-third of patientshad responded to treatment by Week 2 (33.2 percent) and more than fortypercent (43.8 percent) had responded by Week 4.
About Crohn's Disease
Crohn's disease is a chronic, progressive, destructive disorder thatcauses inflammation of the gastrointestinal (GI) tract, most commonly at theend of the small intestine (the ileum) and beginning of the large intestine(the colon). If not effectively treated, it results in the need for surgery.Crohn's disease has been estimated to affect as many as half a millionAmericans. People with Crohn's can experience an ongoing cycle of flare-up andremission throughout their lives. Together with ulcerative colitis, Crohn'sdisease is
