title: Adalimumab with Methotrexate in Treatment-Naïve Japanese Patients with Rheumatoid Arthritis at Risk of Progressive Structural Joint Damage: A Postmarketing Observational Study.
abstract: BACKGROUND
  The objective of this study was to evaluate the real-world safety and effectiveness of adalimumab with methotrexate (MTX) in disease-modifying antirheumatic drug (DMARD)- and biologic-naïve Japanese patients with rheumatoid arthritis (RA) at risk of progressive structural joint damage.
  
  
  METHODS
  This multicenter, prospective, observational, postmarketing surveillance study was conducted between February 2013 and April 2015 at 84 centers in Japan. Patients with RA at risk of progressive structural joint damage were enrolled and initiated treatment with adalimumab and MTX. Adverse events were recorded up to week 28. Effectiveness/disease activity was assessed using the Disease Activity Score based on a 28-joint count with erythrocyte sedimentation rate and C-reactive protein (DAS28-4ESR and DAS28-4CRP), Clinical Disease Activity Index, and Simplified Disease Activity Index at 0, 4, 12, and 24 weeks. DAS28-4CRP response was evaluated in the low-dose (<8 mg/week) and high-dose (≥8 mg to ≤16 mg/week) MTX groups at week 24.
  
  
  RESULTS
  One hundred fifty-seven of 163 patients comprised the safety cohort: mean (SD) age, 56.5 (13.9) years; females, 65.6%; rheumatoid factor positive, 73.2%; anti-cyclic citrullinated peptide antibody positive, 66.9%; bone erosions, 51.6%; mean disease duration, 9.5 months. The majority of patients (≥80%) had moderate or high disease activity at baseline, and ≥50% with available data achieved remission or low disease activity at week 24 (DAS28-4CRP <3.2). Five serious adverse drug reactions occurred in four patients, including pyelonephritis, Pneumocystis jiroveci pneumonia, interstitial lung disease, pleurisy, and pericarditis; the outcomes were either recovered or recovering. Significant improvements/reductions in disease activity over 24 weeks were noted in all effectiveness measures (P < 0.0001). Most of the population achieved DAS28-4CRP remission (<2.6) at week 24 regardless of the MTX dose.
  
  
  CONCLUSIONS
  Adalimumab in combination with MTX could be a beneficial treatment option for DMARD- and biologic-naïve Japanese patients with RA at risk of progressive structural joint damage.
  
  
  BACKGROUND
  AbbVie GK and Eisai.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT01783730.
authors.affiliation: AbbVie GK, Tokyo, Japan. yukiko.ito@abbvie.com.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Ito
authors.affiliation: AbbVie GK, Tokyo, Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Hozumi
authors.affiliation: AbbVie GK, Tokyo, Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Okada
authors.affiliation: AbbVie GK, Tokyo, Japan.
authors.forename: Sarina
authors.initials: S
authors.lastname: Kurimoto
keywords: Adalimumab; Effectiveness; Methotrexate; Postmarketing surveillance; Rheumatoid arthritis; Safety