title: Biologic-free remission of established rheumatoid arthritis after discontinuation of abatacept: a prospective, multicentre, observational study in Japan.
abstract: OBJECTIVE
  The aim of this study was to determine whether biologic-free remission of RA is possible with discontinuation of abatacept.
  
  
  METHODS
  Japanese RA patients in 28-joint DAS with CRP (DAS28-CRP) remission (<2.3) after >2 years of abatacept treatment in a phase II study and its long-term extension entered this 52 week, multicentre, non-blinded, prospective, observational study. At enrolment, the patients were offered the option to continue abatacept or not. The primary endpoint was the proportion of patients who remained biologic-free at 52 weeks after discontinuation. Clinical, functional and structural outcomes were compared between those who continued and those who discontinued abatacept.
  
  
  RESULTS
  Of 51 patients enrolled, 34 discontinued and 17 continued abatacept treatment. After 52 weeks, 22 of the 34 patients (64.7%) remained biologic-free. Compared with the continuation group, the discontinuation group had a similar remission rate (41.2% vs 64.7%, P = 0.144) although they had a significantly higher mean DAS28-CRP score at week 52 (2.9 vs 2.0, P = 0.012). The two groups were also similar with regard to mean HAQ Disability Index (HAQ-DI) score (0.6 for both, P = 0.920), mean change in total Sharp score (ΔTSS; 0.80 vs 0.32, P = 0.374) and proportion of patients in radiographic remission (ΔTSS ≤ 0.5) at the endpoint (64.3% vs 70.6%, P = 0.752). Those attaining DAS28-CRP < 2.3 or < 2.7 without abatacept at the endpoint had significantly lower HAQ-DI score and/or CRP at enrolment. Non-serious adverse events occurred in three patients who continued or resumed abatacept.
  
  
  CONCLUSIONS
  Biologic-free remission of RA is possible in some patients after attaining clinical remission with abatacept. Lower baseline HAQ-DI or CRP may predict maintenance of remission or low disease activity after discontinuation of abatacept.
  
  
  BACKGROUND
  UMIN Clinical Trials Registry, http://www.umin.ac.jp/ctr/ (UMIN000004137).
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan. tsutake@z5.keio.jp.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Matsubara
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Shuji
authors.initials: S
authors.lastname: Ohta
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Masaya
authors.initials: M
authors.lastname: Mukai
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Amano
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Shigeto
authors.initials: S
authors.lastname: Tohma
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Department of Rheumatology, Matsubara Mayflower Hospital, Kato, Department of Rheumatology, Taga General Hospital, Hitachi, Division of Rheumatology and Clinical Immunology, Department of Medicine, Sapporo City General Hospital, Sapporo, Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Hospital, Kitakyushu, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo and Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Miyasaka
mesh_terms: D000069594:Abatacept; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome; D028761:Withholding Treatment
chemical_list: D018501:Antirheumatic Agents; D005938:Glucocorticoids; D018796:Immunoconjugates; D000069594:Abatacept; D008727:Methotrexate
keywords: abatacept; biologic-free remission; observational study; rheumatoid arthritis