BACKGROUND: To evaluate the long-term safety of adalimumab (ADA), up to 5 years (yrs), as it is used in routine clinical practice in patients (pts) with moderately to severely active Crohn's disease (CD) from the observational registry PYRAMID.
METHODS: All pts entering the multicenter, non-interventional registry PYRAMID were to be followed for up to 6 yrs. Adverse events (AEs) were collected from the first dose up to 70 days after the last dose of ADA or through the 01 Dec 2012 cut-off. Rates of AEs were assessed per 100 patient-yrs (PY).
RESULTS: A total of 5061 pts (57% female, mean age 37.8 yrs, median duration of CD 8.2 yrs) have enrolled in PYRAMID, totaling 13,914.2 PY of exposure, including prior exposure in CD ADA clinical trials. As of 01 December 2012, 3197 pts (63.2%) were still participating and 397 pts (7.8%) had up to 5 years of ADA exposure. Of the 2600 pts (51%) who received biologic therapy prior to enrollment, 98% were infliximab-experienced. Concomitant corticosteroids (CS), immunosuppressants (IMM) and IMM + CS were used by 30%, 36%, and 12% of pts, respectively. More pts receiving ADA combination therapy with IMM and/or CS experienced serious infections than pts receiving ADA monotherapy (10.7%/10.2% versus 7.3%, P < 0.02). Standardized mortality ratios, calculated using the most recent country-specific mortality rates in a general population through 2006, were 0.90 (95% confidence interval [CI] 0.64-1.24) overall, 1.10 (95% CI 0.65-1.74) for females, and 0.77 (95% CI 0.46-1.20) for males. There were 37 treatment-emergent deaths reported; 6 of the 37 were considered possibly related to ADA. The table shows an overview of exposure-adjusted registry treatment-emergent AEs for years 3 and 5.
CONCLUSIONS: At the 5-year timepoint, long-term ADA exposure continues to be well-tolerated in pts with moderately to severely active CD. No new safety signals have been identified. AE rates have remained stable over time.
(C) Crohn's & Colitis Foundation of America, Inc.