Background/Purpose:  AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis) is a Phase 4 comparator study designed to provide a real-world evidence (RWE) based assessment of intravenous golimumab (G-IV) and infliximab (IFX) in patients (pts) with rheumatoid arthritis (RA). Assessments include medical history, RA disease history, prior biologic RA therapies, clinical outcomes, infusion reactions, cost effectiveness, and safety. Here we report on prior biologic use patterns of an early cohort of AWARE pts.

Methods: This is a prospective, noninterventional, observational multicenter study being conducted in the United States, with 2-year study enrollment period and 3-year study duration. 1,200 adult RA pts will be enrolled to initiate treatment with either G-IV or IFX. All treatment decisions are made at the discretion of the treating rheumatologist; patient (pt) visits occur as per usual clinical practice. The primary objective is to compare the proportion of pts with an infusion reaction in RA pts treated with G-IV vs IFX. Secondary objectives include effectiveness assessments, cost effectiveness and patient reported outcomes (PROMIS-29, Pain Interference SF6b, Fatigue SF7a, SF36) and a novel Treatment Satisfaction Questionnaire for Medication–Intravenous, which assesses patient satisfaction with an infusion therapy.

Results:  Mean (±SD) age of pts (n=114) was 59.7 (±12.02) years, with a mean body weight of 85.95 kg, 82.5% of pts were female. A total of 74 pts were administered G-IV and 40 pts were administered IFX. Overall, 69.0% of pts reported to have received at least 1 biologic prior to enrolling. Proportion of bionaive patients among G-IV users and IFX users were 23.3% and 45.0%, respectively. Concomitant methotrexate (MTX) use was reported in 54.1% of G-IV pts and 70.0% of IFX pts. Among all non-bionaïve pts, the most frequently used biologic was adalimumab (31.6%). A similar proportion of G-IV and IFX pts had prior adalimumab (32.4% and 30.0%, respectively), prior etanercept was reported in 29.7% of G-IV pts and 10.0% of IFX pts. Of the G-IV pts, 39.2% had prior exposure to IFX, and 15.0% of IFX pts had prior exposure to G-IV. Subcutaneous golimumab was used in 5.0% of IFX pts, and 2.7% of the G-IV pts. Abatacept was previously used in 18.9% of G-IV pts and 0% of IFX pts. 10.8% of G-IV pts had prior exposure to tocilizumab, 2.5% of IFX pts had prior exposure to that drug. Baseline CDAI scores were 33.67 (±14.8) in G-IV pts and 35.14 (±16.1) in IFX pts.

Conclusion:  In this Phase 4 study, early evaluation of patient demographics confirms published data of current patients treated with biologic agents who have RA. Early analysis of previous biologic use in this RWE study exploring potential differences between G-IV and IFX, indicates that there may be differences in the extent of prior biologic experience of pts treated with either one of these drugs. Patients started on G-IV appeared to have had more extensive prior biologic experience and less concomitant MTX use compared to IFX pts. Greater MTX use by IFX pts may be related to the greater proportion of bionaïve pts in the IFX group. Such differences may have relevance in terms of ultimate efficacy, safety, and cost effectiveness in managing RA pts.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-united-states-based-clinical-experience-with-prior-biologic-use-among-first-time-golimumab-intravenous-and-infliximab-treated-rheumatoid-arthritis-patients/