Adverse Events and Resource Use Before and After Treat-to-Target in Rheumatoid Arthritis: A Post Hoc Analysis of a Randomized Controlled Trial

Abstract

Objective: Treat-to-target (TTT) is an accepted paradigm for care of patients with rheumatoid arthritis (RA). Because TTT can be associated with more medication switches, concerns arise regarding whether implementing TTT may increase adverse events and/or resource use. The aim of this study was to examine adverse events and resource use during the preintervention and intervention periods of the TTT intervention trial.

Methods: We used data from 6 practices enrolled in an 18-month cluster-randomized controlled trial to compare adverse events and resource use before (months 1-9) and during (months 10-18) a TTT intervention. The outcomes of interest, adverse events and resource use, were based on medical record review of all rheumatology visits for RA patients before and during the intervention.

Results: We examined records for 321 patients before the intervention and 315 during the intervention. An adverse event was recorded in 10.2% of visits before the intervention and 8.8% of visits during the intervention (P = 0.41). Biologic disease-modifying antirheumatic drugs were taken by 53.6% of patients before the intervention and 49.8% of patients during the intervention (P = 0.73). Rheumatology visits were more frequent before the intervention (mean ± SD 4.0 ± 1.4) than during the intervention (mean ± SD 3.6 ± 1.2; P = 0.02). More visits were accompanied by monitoring laboratory tests before the intervention (90.0%) compared with during the intervention (52.7%; P < 0.001). A greater percentage of visits before the intervention included diagnostic imaging (15.4%) versus during the intervention (8.9%; P < 0.001).

Conclusion: We observed similar rates of adverse events before and during the implementation of TTT for RA. Rheumatology visits, use of laboratory monitoring, and diagnostic imaging did not increase during the TTT intervention.

Trial registration: ClinicalTrials.gov NCT02260778.

Conflict of interest statement

Potential Conflicts:

© 2018, American College of Rheumatology.

Figures

Figure:

TRACTION Trial Study Design This figure shows the design of the TRACTION trial. Phase 1 was the cluster randomized controlled clinical trial comparing the Learning Collaborative intervention with a wait-list control group. Phase 2 provided the Learning Collaborative intervention to the Phase 1 control group while the Phase 1 intervention group is observed. The current paper compares the same six Control sites during Phase 1 to Phase 2 (outlined with the black box), with respect to adverse events and resource utilization.