title: Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis: Results from registered data analyses.
abstract: OBJECTIVE
  Upper limit of methotrexate (MTX) for patients with rheumatoid arthritis (RA) was recently increased from 8 to 16 mg/week in Japan. We therefore examined the effect of concomitant MTX dose on the efficacy of adalimumab (ADA) in clinical practice.
  
  
  METHODS
  Sixty-one consecutive RA patients treated with ADA were followed for minimum 52 weeks and retrospectively compared by MTX dose; patients receiving concomitant MTX of 10 mg/week or more (MTX ≥10 mg group) and <10 mg/week (MTX <10 mg group). Disease activity and remission were evaluated by the disease activity score 28 (DAS28) criteria.
  
  
  RESULTS
  The MTX ≥10 mg group consistently showed better improvement in DAS28 and resulted in more patients (52.8%) with DAS28-remission compared with the MTX <10 mg group (26.1%). Multivariate analysis showed that MTX ≥10 mg had a significant effect on DAS28 remission with odds ratio of 5.12. ADA retention rate was 72.2% in MTX ≥10 mg group compared with 52.0% in MTX <10 mg group. Discontinuation of ADA due to adverse events were comparable in the MTX ≥10 mg and MTX <10 mg groups (11.1% vs. 12.0%).
  
  
  CONCLUSIONS
  These findings support the critical role of concomitant MTX in the efficacy of ADA, and recommend use of MTX ≥10 mg in Japanese RA patients.
authors.affiliation: a Department of Orthopaedic Surgery , Kyushu University , Fukuoka , Japan.
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Nakashima
authors.affiliation: b Department of Orthopedics , National Hospital Organization Kyushu Medical Center , Fukuoka , Japan.
authors.forename: Hisaaki
authors.initials: H
authors.lastname: Miyahara
authors.affiliation: c Kondo Clinic of Rheumatology and Orthopaedic Surgery , Fukuoka , Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Kondo
authors.affiliation: d Center for Rheumatic Diseases, Kurume University Medical Center , Kurume , Japan.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Fukuda
authors.affiliation: e Morooka Orthopedic Clinic , Fukuoka , Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Harada
authors.affiliation: a Department of Orthopaedic Surgery , Kyushu University , Fukuoka , Japan.
authors.forename: Akihisa
authors.initials: A
authors.lastname: Haraguchi
authors.affiliation: f Department of rheumatology , Fukuoka Red Cross Hospital , Fukuoka , Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Inoue
authors.affiliation: g Ishinishi Orthopaedic Clinic , Fukuoka , Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ishinishi
authors.affiliation: h Maekawa Orthopedics , Yahata , Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Maekawa
authors.affiliation: i Department of Orthopedic Surgery , Fukuoka University , Fukuoka , Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Maeyama
authors.affiliation: d Center for Rheumatic Diseases, Kurume University Medical Center , Kurume , Japan.
authors.forename: Munetoshi
authors.initials: M
authors.lastname: Nakashima
authors.affiliation: j Shono Rheumatology Clinic , Fukuoka , Japan.
authors.forename: Eisuke
authors.initials: E
authors.lastname: Shono
authors.affiliation: k Department of Internal Medicine and Rheumatology , National Hospital Organization Kyushu Medical Center , Fukuoka , Japan.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Suematsu
authors.affiliation: l Fukuoka Hoeikai Hospital , Fukuoka , Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Shimauchi
authors.affiliation: m PS Clinic , Fukuoka , Japan.
authors.forename: Tomomi
authors.initials: T
authors.lastname: Tsuru
authors.affiliation: n Department of Medicine and Biosystemic Science , Kyushu University , Fukuoka , Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsukamoto
authors.affiliation: o National Fukuoka Hospital , Fukuoka , Japan , and.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Yoshizawa
authors.affiliation: p Hamanomachi Hospital , Fukuoka , Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Yoshizawa
authors.affiliation: a Department of Orthopaedic Surgery , Kyushu University , Fukuoka , Japan.
authors.forename: Yukihide
authors.initials: Y
authors.lastname: Iwamoto
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab; D008727:Methotrexate
keywords: Adalimumab; Clinical practice; Methotrexate; Remission; Rheumatoid arthritis