Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT

Arthritis Res Ther. 2010;12(3):R113. doi: 10.1186/ar3049. Epub 2010 Jun 10.

Abstract

Introduction: To identify independent predictors of radiographic progression in psoriatic arthritis (PsA) for patients treated with adalimumab or placebo in the Adalimumab Effectiveness in PsA Trial (ADEPT).

Methods: Univariate analyses and multivariate linear regression analyses assessed risk for radiographic progression (change in modified total Sharp score, DeltamTSS>0.5) from baseline to week 24 for C-reactive protein (CRP) and other baseline variables, and for 24-week time-averaged CRP (univariate analysis only). Subanalyses determined mean DeltamTSS for CRP subgroups. Analyses were post hoc, with observed data.

Results: One hundred and forty-four adalimumab-treated patients and 152 placebo-treated patients were assessed. Mean CRP was 64% lower by week 2 with adalimumab and essentially unchanged with placebo. Univariate analyses indicated that elevated CRP at baseline and time-averaged CRP were strongly associated with radiographic progression for placebo-treated patients but not for adalimumab-treated patients. Multivariate analysis confirmed that elevated baseline CRP was the only strong independent risk factor for radiographic progression (for CRP>or=1.0 mg/dl: odds ratio=3.28, 95% confidence interval=1.66 to 6.51, P<0.001). Adalimumab treatment reduced risk of progression approximately fivefold. The difference between mean DeltamTSS for adalimumab versus placebo was greatest for patients with baseline CRP>or=2.0 mg/dl (-0.5 vs. 2.6).

Conclusions: Systemic inflammation in PsA, as indicated by elevated baseline CRP, was the only strong independent predictor of radiographic progression. This association was observed predominantly for placebo-treated patients. Adalimumab treatment substantially reduced the overall risk of radiographic progression, and provided greatest radiographic benefit for patients with the greatest CRP concentrations at baseline.

Trial registration: Trial registration: NCT00195689.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab
  • Adult
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Psoriatic / diagnostic imaging*
  • Arthritis, Psoriatic / drug therapy*
  • Arthritis, Psoriatic / metabolism
  • C-Reactive Protein / metabolism
  • Disease Progression*
  • Double-Blind Method
  • Female
  • Humans
  • Linear Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Radiography
  • Risk Factors
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • C-Reactive Protein
  • Adalimumab

Associated data

  • ClinicalTrials.gov/NCT00195689