ACG Monthly Cimzia Controls Symptoms of Crohn's for 24 Weeks

Monthly injections of an investigational biologic for Crohn's Disease appear to offer relief from symptoms and may induce remission, according to results of a phase III trial presented here today that compared the agent with placebo.

In the study, known as PRECiSE-2, a significantly higher proportion of patients who responded to an open-label induction regimen of 400 mg Cimzia (certolizumab pegol), a humanized anti-TNF PEGylated Fab' fragment, were able to maintain a clinical response and achieve a remission by week 24, a Mayo-led team reported at the American College of Gastroenterology meeting here.

PRECiSE-2 stands for Pegylated antibody fRagment Evaluation in Crohn's Disease: Safety and Efficacy. To be eligible, patients had to have moderate to severe disease, as defined as a Crohn's Disease Activity Index (CDAI) of 220 to 450 points. CDAI measures the disease severity by taking into account the intensity of symptoms, medication and general well-being.

The primary endpoint was the percentage of patients at week 26 with a C-reactive protein of more than 10 mg/L who maintained a clinical response after successful induction. Major secondary endpoints included remission (CDAI of less than 150) in those with a CRP level of more than 10mg, and response and remission in the overall treatment population.

William J. Sandborn, M.D., of the Mayo Clinic and colleagues gave 668 patients with Crohn's the induction dose at weeks 0, two, and four. At week six, the investigators randomized the 428 responders (64%), who had a decrease in baseline CDAI of at least 100 points, to receive monthly maintenance injections of either Cimzia or placebo every four weeks through week 24. Of those continuing on maintenance, 216 received Cimzia and 212 received placebo.

Crohn's disease is a chronic autoimmune disease that can affect any part of the gastrointestinal tract but most commonly occurs in the ileum (the area where the small and large intestine meet).

Causes, incidence, and risk factors

Autoimmune disorders occur when the immune system attacks the body's own cells. In Crohn's disease, these rogue immune cells attack the gastrointestinal system. The cause is unknown, but genetic factors seem to play a role.

Inflammation frequently occurs at the end of the small intestine that joins the large intestine, but the condition may affect any area of the digestive tract. As a result of the immune attack, the intestinal wall becomes thick, and deep ulcers may form.

Among the 213 patients with CRPs of at least 10 mg/L, 61.6% in the treatment group had a sustained response in the maintenance phase, compared with 33.7% of those receiving placebo (p<0.001). Among patients in this stratum, 42.0% in the treatment arm experienced remission, compared with 25.7% of those on placebo (p<0.01).