Cimzia was approved in the United States in 2008 for the reduction of symptoms associated with Crohn’s disease, as well as maintaining clinical responses in adults with a moderate to severely active condition. The treatment is indicated for patients who do not respond to conventional treatment methods and is currently the only Fc-free, PEGylated anti-Tumor Necrosis Factor (TNF) treatment approved for patients with Crohn’s disease.
“UCB is committed to supporting ongoing research that generates new clinical insights into our immunological treatments,” explained Chief Medical Officer and Executive Vice President at UCB, Iris Loew Friedrich. “Research on Cimzia after its initial US approval in 2008 has spanned seven years and these latest results contribute to the body of evidence supporting its important role as a treatment for Crohn’s disease.”
UCB is conducting a PEGylated antibody fragment clinical assessment of the safety and efficacy of Cimzia involving patients with Crohn’s disease in a study entitled PRECiSE. The study is among the largest and most comprehensive clinical studies focused on an anti-TNF to treat the disease, and is comprised of two placebo-controlled studies, as well two open-label safety follow-up studies.
PRECiSE 1 and 2 were designed to evaluate the FDA-approved treatment, with a primary efficacy endpoint being the clinical response Crohn’s disease patients treated with Cimzia, measured according to the Crohn’s Disease Activity Index (CDAI) and defined as a decrease in CDAI score of ≥ 100 points. Previous studies had already demonstrated the drug’s efficacy in achieving and maintaining clinical response for up to six months in comparison with a placebo.
At the DDW, seven posters were dedicated to Cimzia for the treatment of Crohn’s disease, including “The Effect of Anti-Drug Antibodies on Adverse Events Profile in Patients with Crohn’s Disease Treated with Certolizumab Pegol: Results of an Integrated Safety Analysis from Clinical Trials,” as well as “Serious Infectious Complications in Patients Treated with Certolizumab Pegol: A Pooled Analysis of 15 Crohn’s Disease Global Clinical Trials.”
“Safety of Certolizumab Pegol in 2570 Crohn’s Disease Patients with 4378 Patients Years at Risk: Integrated Data from the Global Clinical Program,” was also discussed at the conference, alongside with the “Evaluation of Real-World Risk of Malignancies in Crohn’s Disease Patients Treated with Certolizumab Pegol: Results from the SECURE Registry,” and “Remission Rates In Crohn’s Disease Patients Treated With A Re-Induction Regimen Of Certolizumab Pegol After Experiencing Disease Exacerbation: 7 Year Results From The PRECiSE 4 Study.”
In addition, “Early Remission Status as a Predictor of Long-Term Outcome in Crohn’s Disease Patients Treated With Certolizumab Pegol: Results of an Analysis from the PRECiSE 3 Study” was also addressed. The use of Cimzia in pregnant women was explored in another poster entitled, “Pregnancy Outcomes after Exposure to Certolizumab Pegol: Updated Results from Safety Surveillance.”
AbbVie also presented abstracts regarding its gastroenterology and hematology programs at this year’s DDW. Among the abstracts, AbbVie featured data on clinical studies conducted by the company to assess the safety and efficacy of HUMIRA (adalimumab), a treatment for both Crohn’s disease and ulcerative colitis.