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PYRAMID REGISTRY: AN OBSERVATIONAL STUDY OF ADALIMUMAB IN CROHN'S DISEASE: RESULTS AT YEAR 3
G D'Haens1, W Reinisch2, J Satsangi3, E Loftus4, R Panaccione5, D Tokimoto6, Y Wang6, K Lomax61Academic Medical Centre, Amsterdam, The Netherlands, and Imelda GI Clinical Research Center, Bonheiden, Belgium; 2Medical University of Vienna, Vienna, Austria; 3Western General Hospital, Edinburgh, United Kingdom; 4Mayo Clinic, Rochester, Minnesota, USA; 5University of Calgary, Calgary, AB; 6Abbott Laboratories, Abbott Park, IL, USA
Aims: Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody, is approved as treatment for Crohn's disease (CD) and has been shown to induce and maintain remission in CD patients. Our objective was to assess the long-term safety of adalimumab as prescribed according to local product labels in PYRAMID, an ongoing observational CD registry in 24 countries, now at year 3.
Methods: PYRAMID has a planned six-year study duration for each enrolled patient. Study visits are scheduled every three months through year 1, then every six months thereafter. Safety data is collected including all serious adverse events (SAEs) and adverse events of special interest (AEIs), including serious infections, intestinal obstructions, malignancies, and demyelinating diseases.
Results: Of the 5080 enrolled patients, 3866 (76.1%) were ongoing as of December 1, 2010 (mean age, 38 years; 57% female; 96% white) with a cumulative adalimumab exposure of 9249 patient-years including exposure from prior adalimumab trials. Twenty-four percent of patients have discontinued from the registry, most frequently due to lack of efficacy or occurrence of an AE. 51% of patients had been previously treated with biologics, 36% were treated with concomitant immunosuppressants at enrollment and 30% with concomitant corticosteroids at enrollment. Twenty percent of patients experienced at least 1 treatment-emergent SAE, the most frequent being worsening of CD (5.9%) and small intestinal obstruction (1.4%). AEIs are listed in the table.
Conclusions: At the 3-year timepoint, there were no new clinical concerns regarding incidence of SAEs, or AEIs; no new safety signals were observed. These findings are in line with the results from earlier timepoints of PYRAMID.