title: Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort.
abstract: OBJECTIVE
  To describe a population with moderate rheumatoid arthritis (RA) before biologic initiation and assess change in disease status, health-related quality of life (HRQOL), and adverse events in etanercept (ETN)-treated patients.
  
  
  METHODS
  Data on adult patients with moderate RA (3.2 < Disease Activity Score in 28 Joints [DAS28] ≤ 5.1) were retrospectively analyzed from the British Society for Rheumatology Biologics Register comparing a nonbiologic-treated group (nBG) using at least one traditional disease-modifying antirheumatic drug to a biologic group (BG) treated with ETN. The HRQOL was assessed by using the Health Assessment Questionnaire disability index score. To mitigate confounding, we controlled for drivers of progression. Appropriate univariate, multivariate, and regression analyses were used.
  
  
  RESULTS
  A total of 1754 patients with RA were assessed (211 BG and 1543 nBG). Compared with the nBG, the BG tended toward higher disease activity, such as significantly higher tender joints and DAS28. The BG compared with the nBG had 1) a greater reduction in DAS28 and Health Assessment Questionnaire scores; 2) disease remission occurring more often (odds ratio = 2.7; P = 0.006); and 3) progression occurring in fewer patients (odds ratio = 0.3; P = 0.002). BG patients had a higher incidence of "other serious infection" and "other central nervous system-related events," with no significant differences in associated hospitalization rates or deaths.
  
  
  CONCLUSIONS
  Among patients with moderate RA from a clinical practice registry, ETN-treated patients had significantly higher disease activity at the time of biologic initiation but significantly reduced disease activity and better HRQOL after 6 months compared with nBG patients, although the possibility of unmeasured confounding remains. The ETN group reported significantly higher incidences of "other serious infections" and "other central nervous system-related events" without higher hospitalization rates.
authors.affiliation: Pfizer, Collegeville, PA.
authors.forename: Sameer
authors.initials: S
authors.lastname: Kotak
authors.affiliation: Pfizer, Collegeville, PA.
authors.forename: Jack
authors.initials: J
authors.lastname: Mardekian
authors.affiliation: Quintiles, Hawthorne, NY. Electronic address: Nathalie.Horowicz-Mehler@quintiles.com.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Horowicz-Mehler
authors.affiliation: Quintiles-Outcome, Rockville, MD.
authors.forename: Ankit
authors.initials: A
authors.lastname: Shah
authors.affiliation: Quintiles-Outcome, Reading, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Burgess
authors.affiliation: Quintiles-Outcome, Reading, UK.
authors.forename: Joseph
authors.initials: J
authors.lastname: Kim
authors.affiliation: Quintiles-Outcome, Rockville, MD.
authors.forename: Eric
authors.initials: E
authors.lastname: Gemmen
authors.affiliation: Pfizer, Walton Oaks, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Boyd
authors.affiliation: Pfizer, Collegeville, PA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Koenig
mesh_terms: D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D016009:Chi-Square Distribution; D057186:Comparative Effectiveness Research; D004185:Disability Evaluation; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012042:Registries; D012074:Remission Induction; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D018501:Antirheumatic Agents; D000068800:Etanercept
keywords: etanercept; health-related quality of life; rheumatoid arthritis; treatment comparison