Background/Purpose: AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis) is an ongoing Phase 4 comparator study designed to provide a real-world assessment of intravenous golimumab (GLM) and infliximab (IFX) in patients (pts) with rheumatoid arthritis (RA). Although the primary objective of AWARE is to compare the proportion of GLM and IFX pts with an infusion reaction, RA medication utilization patterns and biologic infusion times are collected for purposes of conducting dosing and cost analyses.  Although cost and managed care coverage are frequently cited by practicing rheumatologists as variables involved in therapeutic choices, data is lacking in the published literature. Here we report on GLM and IFX drug utilization patterns from an interim analysis (IA) of the ongoing AWARE study.

Methods: AWARE is a prospective, noninterventional, observational, multicenter 3-year study conducted at 100 sites in the US. RA pts (1,200 adults) will be enrolled at the time of initiating treatment with either GLM or IFX. All treatment decisions including prescribed dose, administered drug amount and dosing interval are made at the discretion of the treating rheumatologist. Infusion duration was reported by the site. Data shown are mean ± standard deviation.

Results: 421 GLM pts and 326 IFX pts were included in the IA. GLM pts were 61.0 ±12.97 years and IFX pts were 57.2 ±13.02 years. Body weight of GLM pts was 85.3 ± 24.6 kg and body weight of IFX pts was 85.5 ± 23.3kg. BMI of GLM pts was 32.2 ± 13.4 kg/m² and BMI of IFX pts was 31.7 ± 9.5 kg/m². Of GLM pts, 34.7% were bionaïve and 49.7% of IFX pts were bionaïve. The % of GLM and IFX pts with prior exposure to 1 or 2 biologics was similar (data not shown), however exposure to ≥3 biologics was 19.2% of GLM pts compared to 9.8% of IFX pts. GLM and IFX were infused at a rheumatologist practice (95.0% and 96.3%, respectively). GLM pts received 1434 infusions at 2.00 ± 0.08 mg/kg, and IFX pts received 1328 infusions at 3.71 ± 1.21 mg/kg. The duration of GLM infusions was 0.65 ± 0.23 hours and IFX infusions was 2.0 ± 0.46 hours. There was a significant (p<0.0001) difference in the % of pts with a reported dose increase from baseline between GLM and IFX (2.6% vs 32.2%, respectively).

Conclusion: This IA of the AWARE study, reported on drug and administration utilization characteristics of GLM and IFX. While the dose of GLM was not reported to change over the course of the first 7 infusions, among pts with 7 infusions the mean dose of IFX increased by approximately 152% between the first and seventh dose. IFX dose escalation was evident at the third dose. These data provide evidence that in a real-world rheumatology practice setting, the dose of GLM remains constant, whereas the dose of IFX is more variable and the mean infusion time of GLM was consistently shorter compared to IFX.  The AWARE study will utilize these data to assess the relative cost effectiveness of GLM relative to IFX.