Source: DGNews  |  Posted 2 years ago

By Bruce Sylvester

SAN DIEGO -- October 26, 2009 -- The first results from a post-approval safety study of adalimumab for Crohn’s disease (CD), mandated by the US Food and Drug Administration, show no new safety signals. This finding was presented here October 25 at the American College of Gastroenterology (ACG) 74th Annual Scientific Meeting.

“These are the first reported findings from this 5-year observational study, and our most important finding is that for this anti-TNF [tumour necrosis factor] treatment, no unexpected safety issues emerged,” said presenter and lead investigator Edward Loftus, MD, Mayo Clinic, Rochester, Minnesota.

PYRAMID (Productivity, Safety and Efficacy: Long-Term Results in Adalimumab-Treated Patients With Crohn’s Disease) is an international registry study started in September of 2007. Adalimumab-treated patients with moderate-to-severe Crohn’s disease are eligible to participate.

Dr. Loftus and his colleagues reported on the primary endpoint of safety for 1,705 patients enrolled as of November 30, 2008, and on the secondary endpoint of efficacy for 1,003 adalimumab-naive patients enrolled as of March 10, 2009. The mean duration of disease was 10.9 years.

Clinical evaluations were suggested for every 3 months in the first year of treatment, and every 6 months thereafter for the duration of the 5 years.

For the primary endpoint of safety, the most frequent treatment-related serious adverse events (SAEs) were CD flare (n = 23, 1.3%), abdominal pain (n = 5, 0.3%), and anal fistula (n = 5, 0.3%). The rates for these SAEs did not exceed expectations above those already known for anti-TNF/adalimumab therapy in CD.

There were no new safety signals in the reported adverse events of interest (AEIs), especially opportunistic infections or malignancies.

For the secondary endpoint of efficacy at 3 months in newly-initiating adalimumab patients, the authors reported mean improvements from baseline in all assessment categories, including the Physician’s Global Assessment (-3.2), the Short Inflammatory Bowel Disease Questionnaire (+10), and Work Productivity and Activity Impairment Questionnaire (-9 for absenteeism, -20 for presenteeism, -20 for total work productivity, and -19 for total activity impairment).

“In real-practice conditions worldwide, 3 months of adalimumab therapy in newly initiating patients with Crohn’s disease was effective in improving patient-reported outcomes,” the investigators wrote.

The study was sponsored by Abbott Laboratories, Abbott Park, Ill.

[Presentation title: Results From an Observational Study of Adalimumab in Crohn’s Disease: The PYRAMID Registry. Abstract 308]