Background The OuTcomes Associated with taPering biologics among patiEnts with Rheumatoid arthritis (TAPER) study is a multicenter retrospective chart review to assess real-world implication of the Taiwan National Health Insurance Administration policy on tapering and withdrawing biologics in stable rheumatoid arthritis (RA) patients.
Objectives To assess the clinical and health resource utilization (HRU) outcomes associated with dose tapering and withdrawing of biologics among stable RA patients.
Methods Medical chart data were collected from RA patients tapering adalimumab (ADA) or etanercept (ETN) who had been on the treatment for ≥2 years prior to tapering. RA disease flares and HRU were assessed for the 6-month pre-tapering period, and for the 6-month short-term and up to 18-month longer-term post-tapering periods. A flare was defined a priori as any of the following: 1) an increase in DAS28 ≥1.2; 2) an increase in the number of swollen/tender joints; or 3) use of injectable steroids during outpatient or emergency room (ER) visits.
Results Data were collected from medical charts of 261 patients (ADA=106, 40.6%; ETN=155, 59.4%). The majority were female (76.2%), with a mean age of 57.2±13.0 years, and an average RA duration of 10.1±5.6 years. Hypertension (31.4%), osteoporosis (19.2%), other autoimmune diseases (16.9%), and dyslipidemia (14.2%) were the most common comorbidities. More than half of the patients had a longer-term follow-up between one year and18 months (58.6%: ADA=62, 40.5%; ETN=91, 59.5%). The majority of ADA patients were tapered to 40mg every three weeks (63.6%) or 40mg every four weeks (30.8%); most ETN patients were tapered to 25mg every 5 days (49.4%) or once a week (30.5%). Greater proportions of patients had an RA flare post-tapering (pre-tapering: 20.7%; post-tapering short-term: 44.1%; post-tapering longer-term: 73.9%). When compared to the pre-tapering period, the mean RA flare events per patient per year increased substantially post-tapering (pre-tapering: 0.5; post-tapering short-term: 1.2; post-tapering longer-term: 1.6, all p<0.001). Patients had increased office visits during the short-term (pre: 1.2 vs. post: 1.4 per patient per month, p<0.001).
Conclusions Tapering biologic agents among stable RA patients may lead to an increase in RA flare and an increase in outpatient visits.
Disclosure of Interest C. Chang: None declared, K. Chen: None declared, Y. Chen: None declared, T. Cheng: None declared, P. Hsu: None declared, N. Lai: None declared, J. Lan: None declared, C. Lee: None declared, S. Lee: None declared, H. Lin: None declared, G. Tsay: None declared, J. Yen: None declared, C. Tsai Shareholder of: AbbVie, Employee of: AbbVie, Y. Bao Shareholder of: AbbVie, Employee of: AbbVie, M. Skup Shareholder of: AbbVie, Employee of: AbbVie, M. Yang Employee of: Analysis Group, E. Wu Employee of: Analysis Group, V. Garg Shareholder of: AbbVie, Employee of: AbbVie