Infliximab Dosing and Administration Patterns in Patients With Crohn's Disease in a Hospital Outpatient Setting
Objectives: Infl iximab is a biologic agent used to treat Crohn’s disease (CD), but minimal real-world data regarding its dosing exist. This study describes infl iximab dosing patterns in patients with CD treated in hospital outpatient settings.
Study Design: Retrospective longitudinal analysis.
Methods: Using the Premier Perspective Database, hospital outpatient dosing schedules were analyzed for infl iximab doses 4 through 16, representing the fi rst 2 years of maintenance treatment. Inclusion criteria were: an outpatient hospital discharge CD diagnosis between July 1, 2000, and March 31, 2008; infl iximab-naïve; and >3 doses within 56 days of index infusion. Exclusion criteria included patients with ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. Treatment duration extended from index to last dose.
Results: Overall, 1439 infl iximab-treated patients with CD were identified. Mean (standard deviation [SD]) age was 42.8 (15.4) years, and 58.9% were female. Mean (SD) treatment duration was 333 (236) days. Patients received a mean (SD) of 7.0 (4.3) infliximab administrations. Mean (SD) index dose was 429 (152)mg. During the initial 2 years of administration, the highest observed dose represented an 11% increase in mean dose during maintenance treatment and a 14% increase from index dose. Median time between administrations was 56 days.
Conclusions: The mean dose remained stable throughout maintenance treatment. Administration schedules were consistent with United States Food and Drug Administration–approved prescribing information. These data suggest that minimal infliximab dose escalation occurs when administered in real-world outpatient hospital settings.
(Am J Pharm Benefits. 2011;3(6):e121-e126)
Study Design: Retrospective longitudinal analysis.
Methods: Using the Premier Perspective Database, hospital outpatient dosing schedules were analyzed for infl iximab doses 4 through 16, representing the fi rst 2 years of maintenance treatment. Inclusion criteria were: an outpatient hospital discharge CD diagnosis between July 1, 2000, and March 31, 2008; infl iximab-naïve; and >3 doses within 56 days of index infusion. Exclusion criteria included patients with ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. Treatment duration extended from index to last dose.
Results: Overall, 1439 infl iximab-treated patients with CD were identified. Mean (standard deviation [SD]) age was 42.8 (15.4) years, and 58.9% were female. Mean (SD) treatment duration was 333 (236) days. Patients received a mean (SD) of 7.0 (4.3) infliximab administrations. Mean (SD) index dose was 429 (152)mg. During the initial 2 years of administration, the highest observed dose represented an 11% increase in mean dose during maintenance treatment and a 14% increase from index dose. Median time between administrations was 56 days.
Conclusions: The mean dose remained stable throughout maintenance treatment. Administration schedules were consistent with United States Food and Drug Administration–approved prescribing information. These data suggest that minimal infliximab dose escalation occurs when administered in real-world outpatient hospital settings.
(Am J Pharm Benefits. 2011;3(6):e121-e126)
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