Background The 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.1
Objectives To assess RA flare rates before and after anti-TNF dose tapering and to identify predictors of flaring upon tapering.
Methods Medical 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.
Results Data 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).
Conclusions Careful 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.
J Rheum Dis 2015;18(Suppl1):22
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, 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