title: Safety and effectiveness of 6 months' etanercept monotherapy and combination therapy in Japanese patients with rheumatoid arthritis: effect of concomitant disease-modifying antirheumatic drugs.
abstract: OBJECTIVE
  To assess real-world safety, tolerability, and effectiveness of etanercept monotherapy, etanercept plus methotrexate (MTX), or etanercept plus other disease-modifying antirheumatic drugs (DMARD) in Japanese patients with active rheumatoid arthritis (RA) despite previous treatment with DMARD.
  
  
  METHODS
  In this 24-week, all-cases postmarketing surveillance study, adverse events (AE) were coded using the Medical Dictionary for Regulatory Activities. Effectiveness was assessed every 4 weeks using the 28-joint Disease Activity Score and the European League Against Rheumatism response criteria.
  
  
  RESULTS
  Of 13,861 patients (81% women) in the analysis, 3616, 2506, and 7739, respectively, were classified into etanercept monotherapy (ETN-mono), etanercept plus DMARD other than MTX (ETN + DMARD), and etanercept plus MTX (ETN + MTX) groups. Rates of AE and serious AE (SAE) in the ETN + MTX group were lower than in other groups. Risk of SAE or serious infections was not significantly increased with higher versus lower MTX doses at baseline or with concomitant use of salazosulfapyridine or bucillamine in ETN + DMARD versus ETN-mono groups. A greater likelihood of achieving clinical remission was seen with ETN + MTX versus ETN-mono (OR 1.36; 95% CI, 1.16-1.60; p < 0.001). Higher MTX dose at baseline was associated with a higher remission rate (> 8 mg vs 0 to ≤ 4 mg, OR 1.47, 95% CI 1.07-2.00, p = 0.016; 6 to ≤ 8 mg vs 0 to ≤ 4 mg, OR 1.27, 95% CI 1.01-1.60, p = 0.038).
  
  
  CONCLUSIONS
  Combination therapies with etanercept plus MTX or other DMARD were reasonably well tolerated, and ETN + MTX at higher doses was more effective than ETN-mono in Japanese patients with RA.
authors.affiliation: From the NTT Sapporo Medical Center, Sapporo; Tokyo Medical Dental University Graduate School, Tokyo; Japanese Red Cross Medical Center, Tokyo; Nagoya University Graduate School of Medicine, Nagoya; Nihon University School of Medicine, Tokyo; Keio University, Tokyo; University of Occupational and Environmental Health, Kitakyushu; Tokyo Women's Medical University, Tokyo; Pfizer Japan Inc., Medical Affairs, and Postmarketing Surveillance, Tokyo, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.forename: Shigeko
authors.initials: S
authors.lastname: Inokuma
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.forename: Junnosuke
authors.initials: J
authors.lastname: Ryu
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Hirose
authors.forename: Takunari
authors.initials: T
authors.lastname: Yoshinaga
authors.forename: Michio
authors.initials: M
authors.lastname: Suzukawa
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D044466:Asian People; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept; D008727:Methotrexate
keywords: ETANERCEPT; METHOTREXATE; POSTMARKETING; PRODUCT SURVEILLANCE; RHEUMATOID ARTHRITIS