Advertisement
"The long-term Cimzia(R) data provide very important information forclinical practitioners treating people with Crohn's disease," said studyinvestigator Gary R. Lichtenstein, M.D., professor of medicine, University ofPennsylvania School of Medicine, Philadelphia, Pa. "In clinical trials,Cimzia(R) showed remarkable and sustainable long-term results without the needfor dose escalation. Further, patients can achieve long-term symptom reliefand remission regardless of the magnitude and rapidity of onset of the initialresponse."
Advertisement
Cimzia(R) is the first and only PEGylated anti-TNF (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) was approved by the U.S. Food and Drug Administration (FDA) on April22, 2008.
UCB, the manufacturer of Cimzia(R), presented analyses of the PRECiSE 3and 4 open-label extension studies, which demonstrated the long-term efficacyof Cimzia(R) in treating Crohn's disease. PRECiSE 3 data showed that eight outof ten patients who were in remission at six months stayed in remission for upto 18 months. Furthermore, 35 percent of patients who had relapsed duringPRECiSE 2 but were treated with one additional dose of Cimzia(R) (PRECiSE 4),achieved and maintained remission at six and 12 months with maintenance dosingevery 4 weeks and no dose escalation. [Abstract #T1133]
"The DDW meeting marks an exciting time to announce additional long-termdata for Cimzia(R), given its recent approval by the FDA," said Olav Hellebo,Senior Vice President and President of Inflammation Operations, UCB. "UCBremains committed to providing healthcare professionals with effectivetherapies to improve the lives of patients suffering from this debilitatingdisease.
In a related analysis of PRECiSE 2 and 3, the durability of long-termmaintenance of response and remission proved not to be related to the rapidityor magnitude of response or remission following induction of Cimzia(R),demonstrating that patients can go on to experience positive response andremission rates regardless of the magnitude and speed of the initial response.[Abstract #T1126]
The pooled data also shows that the PRECiSE Phase 2 and Phase 3 clinicaltrials showed no unexpected safety findings and no increase in the rate ofcommon adverse events with sustained exposure to Cimzia(R). Results alsodemonstrate stable dosing in patients taking the medication for more than sixmonths. [Abstract #469]
About the PRECiSE Clinical Trial Program
PRECiSE, one of the largest, most comprehensive development programs foran anti-TNF for Crohn's disease is composed of two placebo-controlled studiesand two open-label safety follow-up studies.In 2007, the two former studies were published in the New England Journal ofMedicine (NEJM). The studies demonstrated that patients with moderate tosevere Crohn's disease achieved and sustained clinical response with Cimzia(R)for up to six months, compared to placebo. The safety and tolerability ofCimzia(R) was consistent with that expected of an anti-TNF agent. In the firstfollow-up study, patients completing both initial studies are to be givenCimzia(R)
