Fumio Hirano1,2, Waka Yokoyama1,2, Hayato Yamazaki1,2, Koichi Amano3, Atsushi Kawakami4, Taichi Hayashi5, Naoto Tamura6, Shinsuke Yasuda7, Hiroaki Dobashi8, Takao Fujii9, Satoshi Ito10, Yuko Kaneko11, Toshihiro Matsui12, Yasuaki Okuda13, Kazuyoshi Saito14, Fumihito Suzuki15, Ryusuke Yoshimi16, Ryoko Sakai1,2, Ryuji Koike1,2, Hitoshi Kohsaka2, Nobuyuki Miyasaka2, Masayoshi Harigai1,2. 1. a Department of Pharmacovigilance. 2. b Department of Rheumatology , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU) , Bunkyō , Japan. 3. c Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Saitama , Japan. 4. d Unit of Translational Medicine, Department of Immunology and Rheumatology , Nagasaki University Graduate School of Biomedical Sciences , Nagasaki , Japan. 5. e Department of Rheumatology, Faculty of Medicine , University of Tsukuba , Tsukuba , Japan. 6. f Department of Internal Medicine and Rheumatology , Juntendo University School of Medicine , Bunkyō , Japan. 7. g Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Sapporo , Japan. 8. h Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine , Kagawa University , Takamatsu , Japan. 9. i Department of the Control for Rheumatic Diseases , Graduate School of Medicine, Kyoto University , Kyoto , Japan. 10. j Department of Rheumatology , Niigata Rheumatic Center , Shibata , Japan. 11. k Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Minato , Japan. 12. l Department of Rheumatology , Sagamihara National Hospital, National Hospital Organization , Sagamihara , Japan. 13. m Department of Internal Medicine , Center for Rheumatic Diseases, Dohgo Spa Hospital , Matsuyama , Japan. 14. n The First Department of Internal Medicine , University of Occupational and Environmental Health, School of Medicine , Kitakyushu , Japan. 15. o Department of Rheumatology , Soka Municipal Hospital , Saitama , Japan. 16. p Department of Hematology and Clinical Immunology , Yokohama City University School of Medicine , Yokohama , Japan.
Abstract
OBJECTIVE: To verify predictive validity of simplified disease activity index (SDAI) remission for subsequent functional and structural outcomes in real-world clinical settings under a treat-to-target strategy (T2T). METHODS: In this multicenter, prospective cohort study, T2T was implemented in rheumatoid arthritis (RA) patients with moderate-to-high disease activity. SDAI or clinical disease activity index (CDAI) was assessed every 12 weeks, and treatment was adjusted to achieve clinical remission or low disease activity (LDA). Multivariate logistic regression models were used to examine the associations of SDAI remission (≤3.3) at week 24 with the health assessment questionnaire-disability index (HAQ-DI) ≤ 0.5 or with the delta van der Heijde-modified total Sharp score (ΔvdH-mTSS) <smallest detectable change (SDC) at week 72. RESULTS: Of 318 patients enrolled, 271 completed the follow-up for 72 weeks and were subjects of the analyses. Factors [odds ratio (95% confidence interval)] significantly associated with the HAQ-DI ≤0.5 were SDAI remission at week 24 [2.99 (1.42-6.28), p = 0.004], baseline HAQ-DI [0.28 (0.18-0.45), p = 1.3 × 10-7], and baseline vdH-mTSS [0.986 (0.976-0.996), p = 0.009]. A factor associated with ΔvdH-mTSS < SDC was SDAI remission at week 24 [3.53 (1.62-7.71), p = 0.002]. CONCLUSION: Predictive validity of SDAI remission for good outcomes was verified in a T2T-implementing cohort in the current clinical settings.
OBJECTIVE: To verify predictive validity of simplified disease activity index (SDAI) remission for subsequent functional and structural outcomes in real-world clinical settings under a treat-to-target strategy (T2T). METHODS: In this multicenter, prospective cohort study, T2T was implemented in rheumatoid arthritis (RA) patients with moderate-to-high disease activity. SDAI or clinical disease activity index (CDAI) was assessed every 12 weeks, and treatment was adjusted to achieve clinical remission or low disease activity (LDA). Multivariate logistic regression models were used to examine the associations of SDAI remission (≤3.3) at week 24 with the health assessment questionnaire-disability index (HAQ-DI) ≤ 0.5 or with the delta van der Heijde-modified total Sharp score (ΔvdH-mTSS) <smallest detectable change (SDC) at week 72. RESULTS: Of 318 patients enrolled, 271 completed the follow-up for 72 weeks and were subjects of the analyses. Factors [odds ratio (95% confidence interval)] significantly associated with the HAQ-DI ≤0.5 were SDAI remission at week 24 [2.99 (1.42-6.28), p = 0.004], baseline HAQ-DI [0.28 (0.18-0.45), p = 1.3 × 10-7], and baseline vdH-mTSS [0.986 (0.976-0.996), p = 0.009]. A factor associated with ΔvdH-mTSS < SDC was SDAI remission at week 24 [3.53 (1.62-7.71), p = 0.002]. CONCLUSION: Predictive validity of SDAI remission for good outcomes was verified in a T2T-implementing cohort in the current clinical settings.
Authors: Sytske Anne Bergstra; Maura C Couto; Nimmisha Govind; Arvind Chopra; Karen Salomon Escoto; Elizabeth Murphy; Tom Wj Huizinga; Cornelia F Allaart Journal: RMD Open Date: 2019-07-30