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

ABSTRACT: 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).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.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).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: NCT00195689.

SUBMITTER: Gladman DD

PROVIDER: S-EPMC2911906 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature

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

Gladman Dafna D DD Mease Philip J PJ Choy Ernest H S EH Ritchlin Christopher T CT Perdok Renee J RJ Sasso Eric H EH

Arthritis research & therapy 20100610 3

<h4>Introduction</h4>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).<h4>Methods</h4>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-aver ...[more]

PMID: 20537151

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Project description:BACKGROUND:Few clinical trials have investigated the prevention of radiographic progression in children with juvenile idiopathic arthritis treated with antirheumatic drugs. This study aimed to investigate radiographic progression in patients with systemic juvenile idiopathic arthritis (sJIA) and patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with the anti-interleukin-6 receptor antibody tocilizumab for 2?years in the TENDER and CHERISH randomized controlled trials, respectively. METHODS:Standard radiographs of both wrists and both hands in the posteroanterior view were obtained within 4?weeks of baseline and were repeated at weeks 52?±?4 and 104?±?4 in both trials. All films were scored by two independent readers using the adapted Sharp-van der Heijde (aSH) and Poznanski scoring methods. Although the Poznanski score indicates bone growth limitation or cartilage growth decrease, which are not the same as joint space narrowing in rheumatoid arthritis, its change reflects damage to cartilage. Therefore, impairment in the Poznanski score as well as the aSH score was considered as a measure of structural joint damage. Radiographic progression was defined as worsening of radiographic scores beyond the smallest detectable difference. RESULTS:Poznanski and aSH scores were available at baseline and at one or more postbaseline time points for 33 and 47 of 112 sJIA patients and 61 and 87 of 188 pcJIA patients, respectively, providing a representative subset of the study populations. The inter-reader and intra-reader agreement intra-class correlation coefficient was >?0.8. Median baseline Poznanski and aSH scores, respectively, were -?2.4 and 24.6 for sJIA patients and -?1.5 and 8.0 for pcJIA patients. Compared with baseline, aSH scores remained stable for all sJIA patients at week 52, whereas 9.4% of sJIA patients had radiographic progression according to Poznanski scores at week 52; at 104?weeks, radiographic progression according to aSH and Poznanski scores was observed in 5.4% and 11.5%, respectively. In pcJIA patients, radiographic progression from baseline at 52?weeks and at 104?weeks was 12.5% and 2.9%, respectively, using aSH scoring and 6.5% and 4%, respectively, using Poznanski scoring. CONCLUSION:Tocilizumab may delay radiographic progression in children with sJIA and children with pcJIA. TRIAL REGISTRATION:Trial registration numbers and dates: TENDER, NCT00642460 (March 19, 2008); CHERISH, NCT00988221 (October 1, 2009).

Project description:INTRODUCTION:Etanercept, a tumor necrosis factor inhibitor, is used to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA), and is administered via subcutaneous injection. Injection site pain (ISP) associated with subcutaneous administration may affect compliance or hinder initiation of prescribed medications. To improve the patient experience, a new phosphate-free formulation of etanercept was evaluated for reduced ISP associated with administration. METHODS:This phase 3b, multicenter, randomized, double-blind, cross-over study compared the prior formulation of etanercept to a phosphate-free formulation. Etanercept-naïve adults with RA or PsA indicated for treatment with etanercept were eligible. Patients were randomized (1:1) to receive both etanercept formulations (50 mg) in one of two crossover sequences: prior formulation followed by phosphate-free formulation (sequence AB) or phosphate-free formulation followed by prior formulation (sequence BA) at visits 1 week apart. Patients self-reported ISP using a fit-for-purpose 100-mm visual analog scale within 30 s after injection. Safety outcomes included incidence of treatment-emergent adverse events. Mixed-effects analysis of variance model was used to assess ISP, with treatment, study period, sequence, and disease indication as fixed-effect covariates and patient-within-sequence as random effect. RESULTS:A total of 111 patients enrolled (56 sequence AB; 55 sequence BA). Mean ISP score for prior formulation was 23.1 mm and for phosphate-free formulation was 19.1 mm (mean difference - 4 mm; 95% confidence interval: - 8.0, 0.0; P = 0.048). Patients with the highest ISP scores from the prior formulation (by quartile cut points) had the largest reduction in pain with phosphate-free formulation. Injection site reactions were few in number and similar between formulations; no new safety signals were observed. CONCLUSIONS:The new phosphate-free formulation of etanercept had statistically significantly lower mean pain scores than the prior formulation, with largest pain reductions observed among patients who reported highest pain with the prior formulation. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02986139. FUNDING:Amgen Inc, Thousand Oaks, CA USA.

Dataset Information

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

Publications

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

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