MAINTENANCE INFLIXIMAB DOSING AND ADMINISTRATION PATTERNS IN PATIENTS WITH CROHN'S DISEASE

Author(s)

Bailey R1, Waters H1, Ernst FR2, Johnson B2, McKenzie RS11Centocor Ortho Biotech Services, LLC, Horsham, PA, USA, 2Premier, Inc, Charlotte, NC, USA

OBJECTIVES: U.S. Food and Drug Administration (FDA)-approved prescribing information recommends infliximab (IFX) administration at 0, 2, 6 and every 8 weeks with potential dose escalation based on patient response in Crohn’s Disease (CD) patients.  Minimal real world dosing data are available in this population.   This study describes IFX dosing patterns in patients with CD treated in an outpatient hospital setting. METHODS: A retrospective longitudinal analysis using the Premier PerspectiveTM Database, a U.S.-based hospital database, was conducted.  Inclusion criteria were an outpatient hospital discharge CD diagnosis between July 1, 2000 and March 31, 2008, IFX-naïve (received no IFX in the prior 180 days), and ≥ 3 IFX doses within ≤ 56 days of the index infusion.  Exclusion criteria included patients with other selected inflammatory diseases.  Treatment duration was defined as the time between the index and last IFX dose.  Hospital outpatient dosing schedules were analyzed for the 4th through 15th IFX dose, representing the first two years of IFX maintenance treatment. RESULTS: A total of 1439 IFX-treated patients with CD were identified.  Mean (SD) age was 42.8 (15.4) years; 59% were female.  Mean (SD) treatment duration was 415 (425) days.  Patients received a mean (SD) of 8.4 (7.5) IFX administrations. Mean (SD) index IFX dose was 429 (152) mg.  During the initial two years of maintenance IFX administration, the highest observed mean IFX dose represented a 10% increase during the maintenance period and a 13% increase compared to the index IFX dose.   Median time between administrations was 56 days for all maintenance infusions. CONCLUSIONS: The mean IFX dose remained between 439 and up to 483 mg throughout the maintenance treatment.  Administration schedule was consistent with FDA-approved prescribing information.  These data suggest that IFX dosing patterns in CD patients remain relatively stable with minimal dose escalation occurring when administered in real world outpatient hospital settings.

Conference/Value in Health Info

2010-05, ISPOR 2010, Atlanta, GA, USA

Value in Health, Vol. 13, No. 3 (May 2010)

Code

PSY57

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Treatment Patterns and Guidelines

Disease

Systemic Disorders/Conditions

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