Loftus, Edward V.

Abstract Background PYRAMID was an international multicenter, noninterventional, postmarketing registry assessing long-term safety and effectiveness of adalimumab (Humira), as used in routine clinical practice. Methods Adult patients with moderately to severely active Crohn’s disease with or without prior adalimumab experience were enrolled in the registry and followed for up to 6 years. Effectiveness measurements included the Physician’s Global Assessment (PGA, a composite of Harvey Bradshaw Index [HBI] and rectal bleeding score), clinical remission (HBI < 5), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported for adalimumab-naïve patients and analyzed by baseline immunomodulator use and disease duration. Results This study evaluated 2057 adalimumab-naïve patients. Mean PGA improved from 7.5 (baseline) to 3.9 (year 1) and 3.3 (year 6). The proportion of patients in HBI remission increased from 29% (573 of 1969; baseline) to 68% (900 of 1331; year 1) and 75% (625 of 831; year 6). Patients stratified by baseline immunomodulator use had similar HBI remission rates; patients with disease duration <2 years achieved numerically higher HBI remission rates than patients with longer disease duration. Patient-reported SIBDQ and WPAI scores improved at year 1; all WPAI subscore improvements were clinically meaningful (≥7% point change) at year 1 and maintained through year 6. Serious infections were reported in 11.1% of patients; incidence rates of malignancies, lymphoma, and demyelinating disorders were low. Conclusion Adalimumab therapy, as used in routine clinical practice, improved physician-reported and patient-reported disease outcomes and remission rates for up to 6 years. No new safety signals were observed.

Background: Although inflammatory bowel disease (IBD) has been more predominant in white populations, an increasing incidence of IBD in nonwhites has been reported. We sought to evaluate the incidence rates and temporal trends of IBD by race and ethnicity. Methods: The resources of the Rochester Epidemiologic Project were used to identify 814 county residents newly diagnosed with IBD from 1970 through 2010. Race was categorized into whites and nonwhites. Ethnicity was categorized into Hispanic and non-Hispanic. Incidence rates were estimated and adjusted for age and sex to the 2010 United States (US) population. Trends in incidence rates were evaluated by Poisson regression. Results: The adjusted annual incidence rate of IBD for whites was 21.6 cases per 100,000 person-years [95% confidence interval (CI), 20.0–23.1] and for nonwhites it was 13 per 100,000 (95% CI, 8.3–17.5). The incidence rates for whites and nonwhites increased by 39% and 134%, respectively, from 1970 through 2010. The adjusted annual incidence rate of IBD for Hispanics was 15 cases per 100,000 person-years (95% CI, 6.3–23.6) and for non-Hispanics was 20 per 100,000 (95% CI, 18.5–21.6). The incidence rate for Hispanics decreased by 56%, while the rate for non-Hispanics increased by 33%, from 1985 through 2010. In a Poisson regression, white race ( p < 0.0001), a later year of diagnosis ( p < 0.001), male sex ( p < 0.001) and younger age ( p = 0.009) were significantly associated with a higher incidence rate of IBD. Conclusions: There were significant racial and ethnic differences in the incidence and temporal trends of IBD over the last four decades in this US population-based cohort.