Background ■ Inflammatory bowel disease (IBD), which includes Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic autoimmune inflammatory condition involving the gastrointestinal tract 1 ■ The Food and Drug Administration (FDA)-approved dosing regimen for infliximab (IFX) among adult patients with moderately to severely active CD or UC is 5 mg/kg at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter. Among CD patients, patients who initially respond but then later lose their response may benefit from increasing the dose to 10 mg/kg. 2 ■ There are limited data available characterizing the utilization of IFX within an alternate site of care setting Objective ■ To examine IFX dosing patterns among patients with IBD receiving therapy in an alternate site of care setting (i.e., ambulatory infusion centers) Methods ■ A retrospective analysis of drug utilization data from nine ambulatory infusion centers (AIC) in the southeastern United States was conducted ■ Inclusion criteria included: — ≥3 IFX infusions administered at an AIC during the measurement period (6/2008–3/2010) — aged ≥18 upon first IFX infusion within the AIC facility — ≥2 ICD-9 codes for CD (555.x) or UC (556.x) ■ Both “new” patients (those receiving their first IFX dose within the AIC) and “existing” patients (those receiving IFX doses at another site prior to the AIC) were included in the analysis ■ Available data included demographic information, diagnosis fields, and IFX infusion information ■ Patient weight was available, thus allowing for direct calculation of IFX dose ■ Dosing intervals were calculated as the number of days between infusions ■ Mean and median infusion intervals and IFX doses were compared to FDA prescribing information ■ To measure possible within-patient interval and dose changes over time, repeated-measures analyses of variance (ANOVA) were conducted ■ Since both CD and UC patients were included in the IBD sample, possible infusion variable differences between these groups were also explored. A diagnosis variable was created for the IBD sample (flagging the two diagnosis groups of CD or UC), which was entered into the same repeated measures ANOVA models that examined dose and interval changes over time. Results ■ A total of 167 patients with IBD were included in the analysis (Crohn’s disease=107, Ulcerative colitis=60) (Figure 1) Figure 1. Total Number of IBD Patients Ulcerative Colitis n=60 Crohn's Disease n=107 n=167 ■ Of these patients, 84 were new patients, and 83 were existing patients (Table 1) ■ Approximately 56% of the new patients were male, mean age was 45 years, mean weight was 82 kg, and mean number of infusions during the measurement period was seven (Table 1) ■ Among existing patients, 45% were male, mean age was 40 years, mean weight was 74 kg, and mean number of infusions during the study period was eight (Table 1) Table 1. Patient Demographics New Patients Existing Patients Patients, n 84 83 Gender (male), % 56% 45% Mean age, yrs 45 40 Mean weight, kg 82 74 Mean number of infusions 7 8 New Patients ■ Approximately 94% of new patients (n=79/84) received a starting IFX dose of 5 mg/kg (Table 2) ■ Over the first eight infusions, the mean IFX dose ranged from 4.94 mg/kg to 5.18 mg/kg (Table 2) ■ The median number of days between the 1st and 2nd infusion was 14 days, and between the 2nd and 3rd infusion was 28 days. For the 3rd through 8th infusions, the median number of days between infusions ranged from 55 to 56 days. (Table 2) Table 2. IFX Infusion Dose and Frequency Among New Patients New Patients (n=84) Patients with starting dose of 5 mg/kg, n (%) 79 (94%) Mean dose for first 8 infusions, mg/kg 4.94–5.18 Median days between infusions 1st to 2nd infusion 14 2nd to 3rd infusion 28 3rd to 8th infusion 55–56 ■ Based on ANOVA results, there was no evidence of a systematic change in dose or infusion interval over time — Results of the planned ANOVAs did not reveal a significant within-patients effect for either interval or dose (p>.05), indicating no systematic change in treatment over time — In addition, ANOVA models including the diagnosis flag failed to produce a statistically significant between-patients effect (p’s>.05), indicating similar treatment patterns across new CD and UC patients Existing Patients ■ The mean IFX dose ranged from 5.52 mg/kg to 5.77 mg/kg over the first eight infusions received within the AIC setting (Table 3) ■ Among existing patients, the median number of days between the first eight infusions ranged from 50 to 56 days (Table 3) Table 3. IFX Infusion Dose and Frequency Among Existing Patients Existing Patients (n=83) Mean dose for first 8 infusions, mg/kg 5.52–5.77 Median days between first 8 infusions 50–56 ■ Based on ANOVA results, there was no evidence of a systematic change in dose or infusion interval over time — Results of the planned ANOVAs did not reveal a significant within-patients effect for either interval or dose (p>.05), indicating no systematic change in treatment over time — In addition, ANOVA models including the diagnosis flag failed to produce a statistically significant between-patients effect (p’s>.05), indicating similar treatment patterns across existing CD and UC patients Conclusions ■ Among IBD patients receiving IFX infusions in an AIC, dose and infusion intervals were consistent with FDA prescribing information. There was no evidence of systematic dose or interval change over time. ■ IFX utilization patterns within the AIC setting, as identified in this analysis, appear to be consistent with the in-office infusion setting described in other studies 3 ■ Evaluation of other factors, such as patients’ preferences, may be useful in further characterizing this site of care and supporting optimal site of care decision-making References 1. Loftus EV. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004;126(6):1504-1517. 2. REMICADE ® (infliximab) Prescribing Information, Janssen Biotech, Inc., 2011. 3. Waters H, Vanderpoel J, McKenzie S, et al. Stability of infliximab dosing in inflammatory bowel disease: Results from a multicenter US chart review. J Med Econ . 2011;14(4):397-402. This study was supported by Janssen Scientific Affairs, LLC Infliximab Utilization Patterns Within an Alternate Site of Care Setting Among Patients With Inflammatory Bowel Disease J. Vanderpoel, 1 J.H. Lofland, 1 S.C. Bolge, 1 B. Schenkel, 1 S. Mody, 1 J. Tkacz, 2 C.A. Kassed, 2 L. Nicholls, 3 C. Reutsch, 2 J. Tanner 4 1 Janssen Scientific Affairs, LLC, Horsham, PA, USA; 2 Health Analytics, Columbia, MD, USA; 3 Lancer Solutions, LLC, New Milford, CT, USA; 4 InfuScience, Gurnee, IL, USA