Search in the Abstract Database

Search Abstracts 2011

* = Presenting author

P252. Dose escalation of adalimumab subcutaneous injections for Crohn's disease in the real life clinical setting

S. Rajagopalan1, T. Fan2, M. Panagiotis2

1Med Data Analytics Inc., Williamsville, NY, United States; 2Merck & Co., Inc, Whitehouse Station, NJ, United States

Introduction: Biologic therapies are now more extensively prescribed in the treatment of Crohn's disease (CD). Adalimumab was approved for the treatment of moderately to severely active CD. The recommended dosing of adalimumab for Crohn's disease is an induction dose of 160 mg with an 80 mg dose at week two, followed by maintenance dose of 40 mg every other week beginning at week four. However, emerging evidence suggested potential does escalations of adalimumab in the real life practice setting, due to insufficient clinical response or insufficient duration of response. Higher doses of adalimumab use may lead to potential increased risks to patients and substantial medication costs implications.

Objective: This study evaluated prescription patterns of adalimumab and level of adherence to adalimumab maintenance therapy in clinical practice among patients diagnosed with Crohn's Disease.

Methods: A retrospective cohort study was conducted among patients diagnosed with Crohn's disease who were treated with adalimumab subcutaneous injections. Patients' demographic information, medical, and pharmacy claims records were extracted from the Ingenix health claims database, a database containing about 14 million patient records. The study period was January 2006 to June 2010. Patients who were included had an ICD-9-CM diagnosis of CD, at least one prescription claim of adalimumab between January 1, 2007 and December 31, 2008, and had continuous enrollment for 12 months before and after index date. Patients who had diagnosis of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriasis, psoriatic arthritis/psoriatic arthropathy or ankylosing spondylitis were excluded. Total dose for each prescription was calculated based on the quantity dispensed and the NDC code fields on the pharmacy claim and total dose and days' supply from pharmacy claims. Dose escalation was measured using two approaches (1) Average actual dose versus recommended dose and (2) the time-trend method, i.e. reporting at each two week interval, the percentage of patients whose dose exceeded the recommended dose by any amount at that interval. Time to treatment discontinuation from beginning of maintenance therapy was calculated.

Results: Seven hundred and eleven patients were found eligible for the study based on above inclusion criteria. Only 0.28% had at least one dose of other biologics during prior 6 months to first adalimumab prescription. In contrast, majority of the patients (87.4%) of eligible patients who had at least one dose of non-biologic therapies for Crohn's disease during prior 6 months to first adalimumab Rx. The proportion of patients who experienced adalimumab dose escalation was 21.5% over one year period.

Conclusion: This analysis based on a US claim database revealed that most patients who received adalimumab had not been treated with other biologics prior to treatment, and a significant proportion of them experienced dose escalation.