Background/Purpose: Economic considerations and clinical risks of prolonged biologic use in Rheumatoid Arthritis (RA) have emerged as concerns.  In this study, we measured the clinical outcomes and cost savings of biologic de-escalation in patients with well-controlled RA.

Methods: We reviewed the electronic health records of all RA patients treated with a biologic medication from 01/01/13 to 12/31/13 (n= 940) and evaluated biologic de-escalation (decreased dose, frequency, or discontinuation).  Baseline demographics were recorded for all patients. Successful de-escalation was defined as a de-escalation where the dose of biologic on 12/31/13 was lower than the pre-de-escalation dose and the efficacy was maintained until 12/31/13. Flare was defined as addition or increase in dose of steroid or Disease Modifying Anti-Rheumatic Drug or a switch in the biologic medication. We compared the de-escalated and non-de-escalated groups, the outcomes of de-escalation, and financial benefits of de-escalation.  Predictors of successful de-escalation were evaluated using two-sample t or Wilcoxon rank sum tests for continuous variables and Pearson’s chi-square or Fisher’s exact tests for categorical variables.   

Results: Of the 940 RA patients treated with biologics, 87 (9.3%) underwent biologic de-escalation. Successful de-escalation was achieved in 74 RA patients (85.1%) at the end of the study period. Using the CDAI (Clinical Disease Activity Index) to define disease activity, the de-escalated patients had a median duration of 501.5 days in low disease activity or remission prior to a de-escalation attempt. There was no significant difference in the baseline characteristics between the de-escalated and non-de-escalated patients, except the de-escalated patients were more likely to be RF positive (83.1% vs. 67.7%, p=0.015). Results of a univariate analysis showed that the successfully de-escalated patients were more likely to be on their biologic for ≥2 years prior to de-escalation (70.3% vs. 38.5%, p=0.054, marginal significance). The unsuccessful group was more likely to have a RA flare during the observational period (53.8% vs. 6.8%, p<0.001).

Cost Analysis of successful de-escalations revealed savings of $719,702 and projected annualized savings of $1,256,886 if the successfully de-escalated patients remained at their latest biologic dose for 1 year.

Conclusion: This is the largest observational study analyzing clinical outcomes and cost savings of biologic de-escalation in RA. In our cohort of 940 RA patients on a biologic in the year 2013, 85% of the de-escalations were successful. The only predictor of successful de-escalation was biologic use ≥ 2 years prior to de-escalation. Significant cost savings from biologic de-escalation were achieved. Biologic de-escalation in RA is a sound methodology for improving value of care delivery – maintaining clinical disease control while reducing cost.