title: Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study).
abstract: OBJECTIVE
  To describe the long-term adherence, efficacy, and safety in patients with psoriatic arthritis (PsA) treated with etanercept (ETN) in a daily clinical setting in Belgium.
  
  
  METHODS
  The PROVE study was a prospective, multi-centre, open-label, observational study in patients with active PsA who had previously failed disease-modifying anti-rheumatic drugs. Patients were treated with ETN prescribed by their physician and adherence was monitored over 66 months.
  
  
  RESULTS
  A total of 303 patients were enrolled (polyarticular-type n=264; oligoarticular-type n=39). 156 (51.5%) patients adhered to the treatment until the end of the study. The mean study duration was 4.0 (SD, 1.9) years. The most common reasons for discontinuing were non-response (35.9%), patient lost to follow-up (20.7%), and reasons unrelated to ETN (20.0%). Males adhered to treatment significantly longer than females (5.0 vs. 3.9 years; p<0.0001). After 6 months, 49.0% of patients with active synovitis at the start of the study had zero joints with synovitis, and this proportion increased to 77.6% by month 66 (p<0.001 for all time points vs. baseline). In polyarticular-type patients, the mean total Health Assessment Questionnaire (HAQ) score (0-60) decreased from 27.0 (95% CI 25.9-28.1) to 9.7 (8.5-10.9; 64.8% improvement; p<0.001) after 6 months and to 7.7 (6.2-9.3; 66.6% improvement; p<0.001) after 66 months. Treatment-related adverse events were reported in 177 (58.8%) of patients, and 53 (17.6%) patients reported serious adverse events related to treatment.
  
  
  CONCLUSIONS
  In these patients with active PsA from daily clinical practice, adherence to ETN was high observed over 5.5 years and it was well tolerated.
authors.affiliation: Rheumatology, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Kurt
authors.initials: K
authors.lastname: de Vlam
authors.affiliation: Medical Department, Pfizer SA/NV, Brussels, Belgium.
authors.forename: Caroline
authors.initials: C
authors.lastname: Boone
authors.forename: A
authors.initials: A
authors.lastname: The Prove Study Group
mesh_terms: D000328:Adult; D015535:Arthritis, Psoriatic / Q000175:diagnosis / Q000188:drug therapy*; D001530:Belgium; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006304:Health Status; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068800:Etanercept