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Performance of matrix-based risk models for rapid radiographic progression in a cohort of patients with established rheumatoid arthritis.

ABSTRACT: Matrix-based risk models have been proposed as a tool to predict rapid radiographic progression (RRP) in rheumatoid arthritis (RA), but the experience with such models is limited. We tested the performance of 3 risk models for RRP in an observational cohort.Subjects from an observational RA cohort with hand radiographs and necessary predictor variables to be classified by the risk models were identified (n = 478). RRP was defined as a yearly change in the Sharp/van der Heijde score of ?5 units. Patients were placed in the appropriate matrix categories, with a corresponding predicted risk of RRP. The mean predicted probability for cases and noncases, integrated discrimination improvement, Hosmer-Lemeshow statistics, and C statistics were calculated.The median age was 59 years (interquartile range [IQR] 50-66 years), the median disease duration was 12 years (IQR 4-23 years), the median swollen joint count was 6 (IQR 2-13), 84% were women, and 86% had erosions at baseline. Twelve percent of patients (32 of 271) treated with synthetic disease-modifying antirheumatic drugs (DMARDs) at baseline and 10% of patients (21 of 207) treated with biologic DMARDs experienced RRP. Most of the predictor variables had a skewed distribution in the population. All models had a suboptimal performance when applied to this cohort, with C statistics of 0.59 (model A), 0.65 (model B), and 0.57 (model C), and Hosmer-Lemeshow chi-square P values of 0.06 (model A), 0.005 (model B), and 0.05 (model C).Matrix risk models developed in clinical trials of patients with early RA had limited ability to predict RRP in this observational cohort of RA patients.

SUBMITTER: Lillegraven S

PROVIDER: S-EPMC3594116 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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Performance of matrix-based risk models for rapid radiographic progression in a cohort of patients with established rheumatoid arthritis.

Lillegraven Siri S Paynter Nina N Prince Femke H M FH Shadick Nancy A NA Haavardsholm Espen A EA Frits Michelle L ML Iannaccone Christine K CK Kvien Tore K TK Weinblatt Michael E ME Solomon Daniel H DH

Arthritis care & research 20130401 4

<h4>Objective</h4>Matrix-based risk models have been proposed as a tool to predict rapid radiographic progression (RRP) in rheumatoid arthritis (RA), but the experience with such models is limited. We tested the performance of 3 risk models for RRP in an observational cohort.<h4>Methods</h4>Subjects from an observational RA cohort with hand radiographs and necessary predictor variables to be classified by the risk models were identified (n = 478). RRP was defined as a yearly change in the Sharp/ ...[more]

PMID: 23044765

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Project description:INTRODUCTION: Adipokines such as adiponectin, leptin, and visfatin/nicotinamide phosphoribosyltransferase (NAMPT) have recently emerged as pro-inflammatory mediators involved in the pathophysiology of rheumatoid arthritis (RA). We aimed to determine whether serum adipokine levels independently predicted early radiographic disease progression in early RA. METHODS: In total, 791 patients were included from the prospective Etude et Suivi des POlyarthrites Indifférenciées Récentes (ESPOIR) cohort who met the American College of Rheumatology-European League Against Rheumatism criteria for RA (n?=?632) or had undifferentiated arthritis (UA) (n?=?159). Enzyme-linked immunosorbent assay (ELISA) was used to assess baseline serum levels of adiponectin, leptin, and visfatin/NAMPT. In the RA group, we tested the association of serum adipokine levels and (a) baseline radiographic damage and (b) radiographic disease progression, defined as a change >0 or ? 5 in total Sharp-van der Heijde Score (?SHS) between inclusion and 1 year (?SHS ?1 or rapid radiographic progression: ?SHS ?5), adjusting for confounders (age, sex, body-mass index, insulin resistance, C-reactive protein level, Disease Activity Score in 28 joints, Health Assessment Questionnaire score, autoantibody status, steroid use, and radiographic evidence of RA damage at inclusion). RESULTS: Adiponectin level was independently associated with baseline total SHS (adjusted ??=?0.12; P?=?0.006). It was also associated with ?SHS ?1 (adjusted odds ratio (aOR)?=?1.84 (1.25 to 2.72)) involving erosive as well as narrowing disease progression (aOR?=?1.73 (1.17 to 2.55) and 1.93 (1.04 to 3.57), respectively). Serum adiponectin level predicted ?SHS ?5 (aOR?=?2.0 (1.14 to 3.52)). Serum leptin level was independently associated only with ?SHS >0 (aOR?=?1.59 (1.05 to 2.42)). Conversely, serum visfatin/NAMPT level and radiographic disease progression were unrelated. Considering the receiver-operated characteristic curves, the best adiponectin cut-offs were 4.14 ?g/ml for ?SHS ?1 and 6.04 ?g/ml for ?SHS ?5, with a good specificity (58% and 75% for ?SHS ?1 and ?SHS ?5, respectively) and high negative predictive values (75% and 92% for ?SHS ?1 or ?SHS ?5, respectively). CONCLUSION: Serum adiponectin level is a simple useful biomarker associated with early radiographic disease progression in early RA, independent of RA-confounding factors and metabolic status.

Project description:OBJECTIVE:Phase III clinical trials of the tumour necrosis factor inhibitors SB4, SB2, and SB5 (biosimilars to etanercept, infliximab, and adalimumab, respectively) have demonstrated efficacy in moderate-to-severe rheumatoid arthritis (RA). Data from these trials were used to identify baseline characteristics associated with radiographic progression and to build a matrix risk model for its prediction. METHODS:Patients with radiographic progression and baseline demographic and disease characteristic data were pooled across the 3 phase III studies of each biosimilar and its reference product. Baseline demographics and disease characteristics were evaluated for their relationship with radiographic progression (1-year mean change in mTSS >?0); 3 factors were selected based on strongest Pearson's correlation coefficient with the change in modified Total Sharp Score. Univariate logistic regression was performed to assess the association between each baseline factor and the rate of radiographic progression, with subsequent matrix model development performed using multivariate logistic regression. RESULTS:A total of 1371 patients were included in the analysis, with a radiographic progression rate of 27.4%. The 3 baseline predictors of radiographic progression, based on Pearson's correlation coefficient, were 28 swollen joint count (SJC28), C-reactive protein (CRP), and physician global assessment (PhGA). A matrix model showed that the predicted risk of radiographic progression was higher with the increased level of SJC28, CRP, and PhGA (P?<?0.001). CONCLUSIONS:In this pooled analysis of phase III clinical trial data of biosimilars for RA, identifiable baseline factors (SJC28, CRP, and PhGA) associated with radiographic progression were similar to those described in prior studies. Even though radiographic progression was minimal, a small number of patients who have increased SJC28, CRP, and PhGA at baseline should be closely monitored and follow treat-to-target approach. CLINICAL TRIAL REGISTRATION NUMBERS:EudraCT 2012-005026-30. Registered 30 April 2013, https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005026-30/results EudraCT 2012-005733-37. Registered 10 July 2013, https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005733-37/results EudraCT 2013-005013-13. Registered 01 April 2014, https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-005013-13/results.

Dataset Information

Performance of matrix-based risk models for rapid radiographic progression in a cohort of patients with established rheumatoid arthritis.

Publications

Performance of matrix-based risk models for rapid radiographic progression in a cohort of patients with established rheumatoid arthritis.

Similar Datasets

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