The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project)

Objective. A state of minimal disease activity (MDA) was defined and validated as target for treatment in psoriatic arthritis (PsA). We aimed to identify disease characteristics, outcome, and predictors of MDA in patients treated with tumor necrosis factor a (TNFa) blockers. Methods. Patients fulfilling the Classification of Psoriatic Arthritis criteria treated with TNFa blockers were followed every 3-6 months. Patients were considered in MDA when they meet at least 5 of the 7 criteria. Sustained MDA was defined as an MDA state lasting ‡12 months. Patients achieving MDA were compared to non-MDA patients. A proportional odds discrete time survival analysis model was applied, adjusting for sex, age, PsA duration, abnormal erythrocyte sedimentation rate (ESR) and clinically damaged joint count at each visit to identify predictors for MDA. Results. Of the 306 patients treated with TNFa blockers identified from our database, 23 patients were in an MDA state when treatment was commenced; 57 were taking TNFa blockers prior to enrollment. Therefore, 226 subjects were in a non-MDA state and constituted the study population. One hundred forty-five patients of 226 patients (64%) achieved MDA within a mean 6 SD duration of 1.30 6 1.68 years. The mean 6 SD duration of MDA was 3.46 6 2.25 years. At total of 17 patients withdrew from therapy and remained in an MDA state. Male sex (odds ratio [OR] 1.65, 95% confidence interval [95% CI] 1.08-2.53; P 5 0.02) and normal ESR (OR 2.27, 95% CI 1.22-4.17; P 5 0.009) increased the odds for achieving MDA. Conclusion. MDA is achieved in 64% of patients treated with TNFa blockers in a clinical setting. Male sex and normal ESR are predictors for MDA. On withdrawal or reduction in treatment, 11.6% of patients maintained MDA state.

Section: Discussionmentioning

confidence: 99%

Minimal Disease Activity and Anti–Tumor Necrosis Factor Therapy in Psoriatic Arthritis

Haddad

Thavaneswaran

Ruiz-Arruza

et al. 2015

“…The PASDAS was calculated as previously described (8). The following variables were used: patient global VAS (rescaled from 0 -10 to 0 -100), physician global VAS (rescaled from 0 -10 to 0 -100), 66 swollen joint count, 68 tender joint count, CRP level (rescaled from mg/dl to mg/liter), enthesitis (measured in GO-REVEAL as modified Maastricht Ankylosing Spondylitis Enthesitis Score and rescaled to a 0 -6 range by multiplying by a factor of 6/15 for this analysis), tender dactylitis count (the GO-REVEAL study scored each digit from 0 -3 and these were recoded to 0 -1, where any score Ͼ0 equaled 1), and, finally, the physical component summary (PCS) scale of the Short Form 36 (SF-36) health survey.…”

Section: Pasdasmentioning

confidence: 99%

“…The GRACE (GRAPPA Composite Index Exercise) project has enabled the development of 2 new composite indices: the Psoriatic Arthritis Disease Activity Score (PASDAS) and the Arithmetic Mean of the Desirability Function (AMDF) (8). The PASDAS is a weighted index incorporating patient and physician global VAS scores, tender and swollen joint counts, dactylitis and enthesitis, health-related QOL, and CRP level.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Composite Measures of Disease Activity in Psoriatic Arthritis Using Data From an Interventional Study With Golimumab

Helliwell

Kavanaugh

2014

Objective. To compare the performance of the Psoriatic Arthritis Disease Activity Score (PASDAS), the Arithmetic Mean of the Desirability Function (AMDF), the Composite Psoriatic Disease Activity Index (CPDAI), and the Disease Activity Index for Psoriatic Arthritis (DAPSA) in the GO-REVEAL data set. The Disease Activity Score using 28 joints (DAS28) was used as a comparator. Methods. The GO-REVEAL study did not allow full computation of all the composite scores (a modified version of CPDAI was used). The performance of the scores at baseline and followup (weeks 14 and 24) was compared using effect sizes. Results. All indices could distinguish response to treatment at 14 and 24 weeks. Effect sizes at 24 weeks for the 50 mg (100 mg) golimumab doses were 2.18 (2.36), 2.08 (2.36), 1.09 (1.41), 1.80 (1.78), and 1.13 (1.18) for PASDAS, AMDF, modified CPDAI, DAS28, and DAPSA, respectively. Comparison of 24-week values across the 3 treatment groups (placebo, golimumab 50 mg, and golimumab 100 mg) by an analysis of covariance using the baseline values as covariates gave the following F statistics: PASDAS 18.3, AMDF 19.6, modified CPDAI 9.4, DAS28 13.6, and DAPSA 7.9; all of these are highly significant. When the analysis was confined to the 2 golimumab treatment groups, there were no significant between-treatment group differences with any of the composite measures. Conclusion. PASDAS and AMDF were better able to distinguish treatment effect, having larger effect sizes at 24 weeks. PASDAS, AMDF, and modified CPDAI better reflected domains such as skin, enthesitis, and dactylitis.

“…We derived the gout activity score following a data‐driven methodology consistent with that used for other composite measures in rheumatic diseases and in accordance with relevant recommendations 18, 19, 20, 21.…”

Section: Discussionmentioning

confidence: 99%

“…A 3‐step method followed the methodology applied to other composite disease scores in rheumatic disease 19, 20, 21. Variables selected from the Delphi exercise were standardized.…”

Section: Methodsmentioning

confidence: 99%

Development and First Validation of a Disease Activity Score for Gout

Scirè

Carrara

Viroli

et al. 2016

ObjectiveTo develop a new composite disease activity score for gout and provide its first validation.MethodsDisease activity has been defined as the ongoing presence of urate deposits that lead to acute arthritis and joint damage. Every measure for each Outcome Measures in Rheumatology core domain was considered. A 3‐step approach (factor analysis, linear discriminant analysis, and linear regression) was applied to derive the Gout Activity Score (GAS). Decision to change treatment or 6‐month flare count were used as the surrogate criteria of high disease activity. Baseline and 12‐month followup data of 446 patients included in the Kick‐Off of the Italian Network for Gout cohort were used. Construct‐ and criterion‐related validity were tested. External validation on an independent sample is reported.ResultsFactor analysis identified 5 factors: patient‐reported outcomes, joint examination, flares, tophi, and serum uric acid (sUA). Discriminant function analysis resulted in a correct classification of 79%. Linear regression analysis identified a first candidate GAS including 12‐month flare count, sUA, visual analog scale (VAS) of pain, VAS global activity assessment, swollen and tender joint counts, and a cumulative measure of tophi. Alternative scores were also developed. The developed GAS demonstrated a good correlation with functional disability (criterion validity) and discrimination between patient‐ and physician‐reported measures of active disease (construct validity). The results were reproduced in the external sample.ConclusionThis study developed and validated a composite measure of disease activity in gout. Further testing is required to confirm its generalizability, responsiveness, and usefulness in assisting with clinical decisions.