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Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study)

1, 2

 

  1. Rheumatology, University Hospitals Leuven, Leuven, Belgium.
  2. Medical Department, Pfizer SA/NV, Brussels, Belgium.

and the PROVE Study Group

CER7875
2015 Vol.33, N°5
PI 0624, PF 0631
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PMID: 26212872 [PubMed]

Received: 29/08/2014
Accepted : 19/01/2015
In Press: 23/07/2015
Published: 02/10/2015

Abstract

OBJECTIVES:
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.

Rheumatology Article