Improvement in disease activity among patients with rheumatoid arthritis who switched from intravenous infliximab to intravenous golimumab in the ACR RISE registry

Abstract

Infliximab and golimumab are intravenously (IV) administered tumor necrosis factor inhibitors approved to treat moderate-to-severe rheumatoid arthritis (RA) with concomitant methotrexate. Owing to differences in biologic construct, patients with IV-infliximab treatment failure may benefit from switching to IV-golimumab. Utilizing the ACR's Rheumatology Informatics System for Effectiveness (RISE), a large electronic health records registry based in the USA, we assessed RA disease activity in patients switching from IV-infliximab to IV-golimumab. This retrospective, longitudinal, single-arm study included adults (≥ 18 years) with ≥ 1 RA diagnosis code between 2014 and 2018 and ≥ 1 IV-infliximab prescription within 6 months of a new IV-golimumab order (index date). Longitudinal assessments of disease activity using the Clinical Disease Activity Index (CDAI) were calculated in patients continuing IV-golimumab for 6-9- and 9-12-months post-switch. Paired t-tests evaluated significance of mean improvements during the follow-up periods. Most RA patients with disease activity assessments during the 6-month follow-up (N = 100; mean age: 65.3 years; 81% female; 74% white) demonstrated moderate-to-high disease activity (CDAI: 73% [38/52]) at enrollment. On average, patients showed significant improvement in disease activity within 6-9 months of switching; mean CDAI scores improved from 21.3 to 14.1 (p < 0.0001) and were durable through 9-12 months of treatment. Real-world patients with moderate-to-high disease activity who switched from IV-infliximab to IV-golimumab demonstrated significant and sustained improvements post-switch as measured by the CDAI. Key Points • This study used real-world data from the Rheumatology Informatics System for Effectiveness (RISE) registry to evaluate the efficacy of directly switching from intravenous (IV)-infliximab to IV-golimumab to control rheumatoid arthritis (RA) disease activity. • Most IV-infliximab patients had moderate-to-high disease activity at the time of the switch. • On average, IV-golimumab was effective in improving RA disease activity after switching from IV-infliximab as measured by the Clinical Disease Activity Index. • These data suggest that real-world RA patients with persistent symptoms despite treatment with IV-infliximab may realize improved disease control with a switch to IV-golimumab.

Keywords: Disease activity; Intravenous golimumab; Intravenous infliximab; Registry; Rheumatoid arthritis; Tumor necrosis factor.

Fig. 1

Study design for efficacy evaluation of switching from IV-infliximab to IV-golimumab in controlling RA disease. All medication use was reported from patient medication reconciliation, e-prescription, or procedure (medication administration) tables. ^aDate IV-golimumab medication first appeared in the patient medication reconciliation, e-prescription, or procedure (medication administration) tables. ^bContinued IV-golimumab use, with no gaps in treatment, was required for 6–9 months after the index date for the 6-month follow-up. ^cContinued IV-golimumab use, with no gaps in treatment, was required for 9–12 months after the index date for the 9-month follow-up. IV, intravenous; RA, rheumatoid arthritis; RADA, rheumatoid arthritis disease activity; SC, subcutaneous

Fig. 2

Study patient profile. All medication use was reported from patient medication reconciliation, e-prescription, or procedure (medication administration) tables. ^aDate IV-golimumab medication first appeared in the patient medication reconciliation, e-prescription, or procedure (medication administration) tables. ^bContinued IV-golimumab use, with no gaps in treatment, was required for 6–9 months after the index date for the 6-month follow-up. ^cContinued IV-golimumab use, with no gaps in treatment, was required for 9–12 months after the index date for the 9-month follow-up. IV, intravenous; RA, rheumatoid arthritis; RADA, rheumatoid arthritis disease activity; tsDMARD, targeted synthetic disease-modifying antirheumatic drug