Effectiveness and Safety of Intravenous Golimumab With and Without Concomitant Methotrexate in Patients With Rheumatoid Arthritis in the Prospective, Noninterventional AWARE Study

Abstract

Abstract Background: Biologic therapies are often prescribed for patients with rheumatoid arthritis (RA) who have an inadequate response to or are intolerant to methotrexate (MTX) and patients with poor prognostic indicators. This post hoc analysis evaluated the effectiveness and safety of intravenous golimumab+MTX vs golimumab monotherapy in RA patients. Methods: AWARE, a real-world, prospective and pragmatic, Phase 4 study, compared the effectiveness and safety of golimumab and infliximab in biologic-naïve and biologic-experienced patients. All treatment decisions were at the discretion of the treating rheumatologist. Effectiveness was evaluated by mean change in CDAI scores at Months 6 and 12; last observation carried forward was utilized for missing data. Safety was monitored through approximately 1 year.Results: Among 685 golimumab-treated patients, 420 (61%) received concomitant MTX during the study and 265 (39%) did not receive MTX after enrollment; 63% and 72%, respectively, discontinued the study. Relative to golimumab monotherapy, golimumab+MTX patients had shorter mean disease duration (8.7 vs 10.0 years) and a lower proportion received prior biologics (60% vs 72%); mean±standard deviation (SD) baseline CDAI scores were similar (30.8±15.1 and 32.6±15.4). Mean±SD changes from baseline in CDAI scores at Months 6 and 12, respectively, were similar with golimumab+MTX (-10.2±14.2 and -10.8±13.8) and golimumab monotherapy (-9.6±12.9 and -9.9±13.1). The incidence of adverse events/100 patient-years(PY) (95% confidence interval [CI]) was 155.6 (145.6, 166.1) for golimumab+MTX and 191.2 (176.2, 207.1) golimumab monotherapy; infections were the most common type. The incidence of infusion reactions/100PY (95% CI) was 2.1 (1.1, 3.6) with golimumab+MTX vs 5.1 (2.9, 8.3) with golimumab monotherapy; none were considered serious. For golimumab+MTX vs golimumab monotherapy, rates/100PY (95% CI) of serious infections, opportunistic infections, and malignancies were 2.6 (1.5, 4.3) vs 7.0 (4.4, 10.6), 0.9 (0.28, 2.03) vs 2.6 (1.1, 5.0), and 3.0 (1.7, 4.7) vs 1.0 (0.20, 2.79), respectively. Conclusions: Changes in CDAI score with golimumab monotherapy was generally similar to that of golimumab+MTX through 1 year, regardless of prior biologic therapy. Adverse events were consistent with the known IV golimumab safety profile. These results provide real world evidential data that may assist healthcare providers and patients with RA in making informed treatment decisions.Trial registration: clinicaltrials.gov NCT02728934 05/04/2016</jats:p