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THU0085 SDAI Remission at week 24 is a Predictor of Good Functional and Structural Outcomes at week 72 in a T2T Implementing Cohort
  1. F. Hirano1,2,
  2. W. Yokoyama1,2,
  3. H. Yamazaki1,2,
  4. K. Amano3,
  5. Y. Kaneko4,
  6. A. Kawakami5,
  7. T. Matsui6,
  8. R. Sakai1,
  9. R. Koike1,2,
  10. N. Miyasaka2,
  11. M. Harigai1,2
  1. 1Department of Pharmacovigilance
  2. 2Department of Rheumatology, Tokyo Medical and Dental University, Tokyo
  3. 3Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe
  4. 4Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo
  5. 5Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki
  6. 6Department of Rheumatology, Sagamihara National Hospital, National Hospital Organization, Sagamihara, Japan

Abstract

Background In the treat-to-target strategy (T2T)1, simplified disease activity index (SDAI) has been proposed as one of measures to define remission2. Predictive ability of SDAI remission for functional and structural outcomes was shown by data from clinical trials, but has not been proven in a T2T implementing cohort.

Objectives To examine if achieving SDAI remission is a predictor of good functional and structural outcomes in a T2T implementing cohort.

Methods The T2T Epidemiological Study is a multi-centre, prospective cohort study, in which RA patients with moderate to high disease activity were enrolled and treated with T2T for 72 weeks. The disease activity was assessed every 12 weeks and the treatment was adjusted accordingly. Primary outcomes were HAQ and ΔmTSS at week 72. Multivariate logistic regression analysis was used to examine association between SDAI remission at week 24 and the two primary outcomes. Missing data were imputed using the multiple imputation method. Statistical significance levels were adjusted for multiple comparison using False Discovery Rate and BH methods.

Results Of total 318 enrolled patients, 244 patients followed up for 72 weeks were analysed. Patient characteristics were as follows: female, 77%; mean age, 61; mean disease duration, 57 months. At week 24, 33% achieved SDAI remission. At week 72, 50% achieved SDAI remission, 61% achieved HAQ remission (≤0.5) and 73% showed ΔmTSS<smallest detectable change (SDC). Factors [odds ratio (95%CI)] significantly associated with HAQ remission at week 72 were Steinbrocker's stage I [2.35 (1.23-4.46), p=0.009], baseline HAQ [0.30 (0.19-0.47), p=2.4x10-7], absence of history of joint replacement related to RA [9.90 (1.57-62.5), p=0.015] and SDAI remission at week 24 [3.24 (1.57-6.71), p=0.0015]. Factors associated with ΔmTSS<SDC were Steinbrocker's stage I [2.82 (1.40-5.65), p=0.0037], serum MMP-3 level at week 24 [0.998 (0.996-1.000), p=0.035] and SDAI remission at week 24 [3.21 (1.46-7.02), p=0.0036].

Table 1.

Factors associated with HAQ ≤0.5 at week 72

Table 2.

Factors associated with ΔmTSS < SDC at week 72

Conclusions SDAI remission at week 24 is a significant predictor of good functional and structural outcomes at week 72 in the T2T implementing cohort.

References

  1. Ann Rheum Dis 2010;68:631-637. 2. Ann Rheum Dis. 2011;70:404-413.

Acknowledgements We all thank all health care professionals and patients who participated in this study.

Disclosure of Interest F. Hirano: None declared, W. Yokoyama: None declared, H. Yamazaki Grant/research support from: Abbvie Japan Co., Ltd., Astellas Pharma Inc., Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Ono Pharmaceuticals, Pfizer Japan Inc., Sanofi-Aventis KK., Santen Pharmaceutical Co., Ltd., Sekisui Medical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., and UCB Japan, K. Amano Grant/research support from: Astellas, Chugai, Pfizer, Tanabe-Mitsubishi, Consultant for: Zenyaku Kogyo, Paid instructor for: Chugai, Pfizer, Santen, Tanabe-Mitsubishi, Speakers bureau: AbbVie, Actellion, Astellas, Bristol-Myers-Squibb, Chugai, Diichi-Sankyo, Eisai, Pfizer, Tanabe-Mitsubishi, Y. Kaneko Consultant for: Abbvie, Paid instructor for: Eisai Pharmaceutical, Chugai Pharmaceutical, Astellas Pharmaceutical, Mitsubishi Tanabe Pharma Corporation, Pfizer, Speakers bureau: Abbvie, Eisai Pharmaceutical, Chugai Pharmaceutical, Bristol Myers Squibb, Astellas Pharmaceutical, Mitsubishi Tanabe Pharma Corporation, Pfizer, Janssen, UCB, A. Kawakami Grant/research support from: Abbvie GK, Eisai Co., Mitsubishi Tanabe Pharma Co., Pfizer Japan, Janssen Pharmaceutical K. K., Takeda Pharmaceutical Company, Astellas Pharma Inc., Santen Pharmaceutical Co., Bristol-Myers Squibb, ONO Pharmaceutical Co., Chugai Pharmaceutical Co., Taisho Toyama Pharmaceutical Co., Speakers bureau: Abbvie GK, Eisai Co., Mitsubishi Tanabe Pharma Co., Pfizer Japan, Janssen Pharmaceutical K. K., Takeda Pharmaceutical Company, Astellas Pharma Inc., Santen Pharmaceutical Co., Bristol-Myers Squibb, ONO Pharmaceutical Co., Chugai Pharmaceutical Co., Taisho Toyama Pharmaceutical Co., T. Matsui: None declared, R. Sakai Grant/research support from: Abbvie Japan Co., Ltd., Astellas Pharma Inc., Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Ono Pharmaceuticals, Pfizer Japan Inc., Sanofi-Aventis KK., Santen Pharmaceutical Co., Ltd., Sekisui Medical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., and UCB Japan, R. Koike: None declared, N. Miyasaka Grant/research support from: Abbott Japan Co., Ltd., Astellas Pharma Inc., Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Dainihon-Sumitomo Pharma Co. Ltd., Daiichi-Sankyo Co. Ltd., Eisai Co. Ltd., Mitsubishi Tanabe Pharma Co., Novartis Pharma K.K., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd, Consultant for: Abbott Japan Co., Ltd., Bristol Myers Squibb, Janssen Pharmaceutical KK, and Otsuka Pharmaceutical Co. Ltd., M. Harigai Grant/research support from: Abbvie Japan Co., Ltd., Astellas Pharma Inc., Bristol Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Ono Pharmaceuticals, Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and UCB Japan, Consultant for: Chugai Pharmaceutical Co., Ltd., Janssen Pharmaceutical KK, Teijin Pharma Ltd.

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