BackgroundThe OuTcomes Associated with taPering biologics among patiEnts with Rheumatoid arthritis (TAPER) is a retrospective chart review study to assess real-world implication of Taiwan policy on tapering/withdrawing biologics in stable rheumatoid arthritis (RA) patients.1ObjectivesTo assess RA flare rates before and after anti-TNF dose tapering and to identify predictors of flaring upon tapering.MethodsMedical chart data were collected from RA patients tapering adalimumab (ADA) or etanercept (ETN) (methods described elsewhere).1 RA flares were assessed for 6-month pre-tapering, and for short-term (6 months) and longer-term (12 to 18 months) post-tapering. Three alternative flare definitions were used: 1) TAPER: defined a priori the Institutional Review Board submission as a) increase in DAS28≥1.2, b) increase in number of swollen/tender joints, or c) use of injectable steroids during outpatient/ER visits; 2) OMERACT: a) increase in DAS28>1.2, or b) increase in DAS28>0.6 if prior DAS28≥3.2; and 3) Taiwan National Health Insurance Administration: a) increase in DAS28≥1.2 and b) erythrocyte sedimentation rate (ESR) >25mm/h and c) increase in ESR>25%. Logistic regression models were developed to identify factors significantly associated with post-tapering flare.ResultsData came from medical charts of 261 patients (ADA=40.6%; ETN=59.4%). More than half patients had a 12- to 18-month follow-up (58.6%: ADA=40.5%; ETN=59.5%). All three flare criteria showed that a greater proportion of patients had flare post-tapering (see table). During the short-term post-tapering, the risk factors of flaring included a longer disease duration (odds ratio=1.05, p=0.049) and having prior concomitant therapy on Cox-2 inhibitors (OR=2.61, p=0.003); being in remission (DAS28<2.6) prior to tapering was associated with a reduced risk (OR=0.41, p=0.037). Over a longer-term, a longer disease duration (OR=1.13, p=0.028) and having a flare within 6-month post-tapering were associated with an increased risk of flaring (OR=9.99, p<0.001).ConclusionsCareful considerations are needed when tapering a biologic in stable RA patients in order to avoid potentially increased risk of disease flaring. This could include assessing disease duration and remission status prior to tapering, and whether there is a flare within 6-month of tapering when considering for in long-term.ReferencesJ Rheum Dis 2015;18(Suppl1):22Disclosure of InterestC. 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, V. Garg Shareholder of: AbbVie, Employee of: AbbVie, Y. Bao Shareholder of: AbbVie, Employee of: AbbVie, M. Yang Employee of: Analysis Group, E. Wu Employee of: Analysis Group
BackgroundThe 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.ObjectivesTo assess the clinical and health resource utilization (HRU) outcomes associated with dose tapering and withdrawing of biologics among stable RA patients.MethodsMedical 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.ResultsData 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).ConclusionsTapering biologic agents among stable RA patients may lead to an increase in RA flare and an increase in outpatient visits.Disclosure of InterestC. 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
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