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THU0161 Prediction of Flaring in Rheumatoid Arthritis Patients upon Biologics Dose Tapering: A Chart Review Study in Taiwan
  1. C. Chang1,
  2. K. Chen2,
  3. Y. Chen3,
  4. T. Cheng4,
  5. P. Hsu5,
  6. N. Lai6,
  7. J. Lan7,
  8. C. Lee8,
  9. S. Lee9,
  10. H. Lin10,
  11. G. Tsay11,
  12. J. Yen12,
  13. C. Tsai13,
  14. V. Garg14,
  15. Y. Bao14,
  16. M. Yang15,
  17. E.Q. Wu15
  1. 1Taipei Medical University Hospital
  2. 2Cathay General Hospital
  3. 3National Yang-Ming University
  4. 4Chang Gung Memorial Hospital
  5. 5National Taiwan University, Taipei
  6. 6Tzu-Chi University, Hualien
  7. 7China Medical University Hospital, Taichung
  8. 8Mackay Memorial Hospital
  9. 9Cheng Hsin General Hospital
  10. 10Taipei Veterans General Hospital & National Yang-Ming University School of Medicine, Taipei
  11. 11Chung Shan Medical University, Taichung
  12. 12Kaohsiung Medical University Hospital, Kaohsiung
  13. 13AbbVie, Taipei, Taiwan, Province of China
  14. 14AbbVie, North Chicago
  15. 15Analysis Group, Boston, United States

Abstract

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.

  1. 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

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