TY - JOUR
AU - Mulani, P
AB - Purpose Adalimumab, a fully human anti-tumor necrosis factor monoclonal antibody, is an effective treatment for Crohn's disease (CD). After induction therapy, adalimumab 40 mg is usually used as every-other-week dosing for maintenance therapy. In a large clinical trial, 27% of patients increased their adalimumab dosage to weekly within 1 year.1 Our objective was to determine the dosage pattern of adalimumab in real-world clinical practice in the United States by using data from a large specialty pharmacy-dispensing database and to identify predictors for dosage increase to a weekly regimen in patients with CD. Methods From March 2007 to July 2008, we studied patients with CD (International Classification of Diseases, 9th Revision [ICD-9]: 555) whose first dose of adalimumab was on or after March 1, 2007. New users of adalimumab were included. Adalimumab maintenance therapy was defined as ≥3 dispensing events of adalimumab within 1 year. A weekly dosage regimen of adalimumab was defined as ≥2 consecutive weekly doses after the first dispensing event. Descriptive weekly dosing rates were determined by calculating the ratio of patients with weekly dosing to the total sample of adalimumab-treated patients. To control for the impact of variable follow-up times, Kaplan-Meier analysis was used to estimate the weekly dosing rate for a 12-month period. To identify possible predictors for weekly dosing, a Cox proportional hazards regression model was developed to examine the impact of age, sex, geographic region, and use of a 160-/80-mg induction regimen on the weekly dosing rate. Results Of 1,335 patients with CD who received adalimumab as maintenance therapy, 11.3% (n= 151) had weekly dosing at any time during the study period. The 12-month cumulative risk of weekly dosing was 15.5% (Kaplan-Meier analysis). The Cox proportional hazards model demonstrated that geographic region and not starting on 160/80 mg for induction therapy were significant predictors for weekly adalimumab use. Patients who received 160/80 mg as induction therapy were approximately half as likely to receive weekly dosing as those who didn't start with 160/80 mg (hazards ratio [HR]=0.48, 95% confidence interval [CI]=0.33-0.69, non-160/80-mg user as reference group, p<0.0001). The western and southern regions of the United States had significantly lesser rates of weekly dosing than did the northeastern region (HR= 0.50, 95% CI= 0.27-0.90 and HR= 0.46, 95% CI= 0.31-0.69, respectively, with northeast as reference group; both p<0.05). Conclusions The 12-month adalimumab weekly dosing rate in a real-world, clinical practice setting was relatively low and less than that observed in clinical trials. Patients who received 160-/80-mg induction therapy were significantly less likely to receive weekly dosing, and geographic variation in weekly adalimumab dosing rates was observed. References 1. Sandborn WJ, et al.   J Crohn Colitis . 2008; 2(Suppl): 29. Copyright © 2009 Crohn's & Colitis Foundation of America, Inc.
TI - P-0059: Patterns and predictors of dosage increase in patients treated with Adalimumabfor Crohn's Disease in the United States
JO - Inflammatory Bowel Diseases
DO - 10.1097/00054725-200912002-00067
DA - 2009-12-01
UR - https://www.deepdyve.com/lp/oxford-university-press/p-0059-patterns-and-predictors-of-dosage-increase-in-patients-treated-H5czOiWT3v
SP - S24
EP - S24
VL - 15
IS - suppl_2
DP - DeepDyve
ER -