Background RA progression is difficult to predict and rheumatologists need to rely on a combination of subjective and objective measurements to assess RA disease activity and severity, as reliance on one measurement is not recommended due to variability. The majority of findings from treatment trials have been derived from patients with predominately severe RA; less is known about patients with moderately active disease, who represent a larger group that may benefit from early effective treatment.
Objectives To help understand and characterize the moderate RA patient, demographic and baseline disease characteristics of subjects participating in the PRESERVE trial are presented.
Methods Enrolled subjects with DAS28 >3.2 and ≤5.1 despite stable doses of oral methotrexate (MTX) received open-label etanercept (ETN) 50 mg QW plus MTX for 36 weeks. Descriptive summary statistics for demographics and clinical disease characteristics are provided for subjects who received ≥1 dose of treatment (N=834); radiographic characteristics are provided for subjects who received ≥1 dose of treatment and had both a baseline and a post-baseline radiographic assessment (N=709).
Results At baseline, most subjects were female (83%), Caucasian (74%), RF+ (73%), and aCCP+ (78%); mean age was 48.4 y (SD 11.9; median 50.0; min/max 18.0/70.0), with a mean MTX dose of 16.5 mg (SD 2.7; median 15.0; min/max 2.5/25.0) and disease duration, 6.9 y (SD 7.0; median 4.5; min/max 0.1/45.1). Overall 18% of subjects had a normal HAQ score (≤0.5) and 45% had paid employment. A majority used NSAIDs (74%) or corticosteroids (59%) within 1 month of screening; a minority used DMARDs (27% after excluding MTX use) within 6 months of screening.
Conclusions The baseline characteristics of subjects who participated in the PRESERVE trial displayed wide variability in disease measures, highlighting the heterogeneity in clinical presentation, structural damage and burden of disease that can be found in moderate RA patients who are not well controlled on MTX alone and may benefit from effective intervention. These results from PRESERVE suggest the moderate RA population is distinct from other more extensively studied RA populations (eg, early severe and established severe disease) and warrants further investigation.
Wolfe F, et al. Arthritis Rheum 2005;52:3873–9.
Disclosure of Interest A. Koenig Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., A. Szumski Shareholder of: Pfizer Inc., Employee of: Pfizer Inc., S. Kotak Employee of: Pfizer Inc., M. Stewart Shareholder of: Pfizer Inc., Employee of: Pfizer Inc.