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

2014 ◽  
Vol 66 (5) ◽  
pp. 749-756 ◽  
Author(s):  
Philip S. Helliwell ◽  
Arthur Kavanaugh
2021 ◽  
pp. jrheum.201675
Author(s):  
William Tillett ◽  
Oliver FitzGerald ◽  
Laura C. Coates ◽  
Jon Packham ◽  
Deepak R. Jadon ◽  
...  

Objective To test shortened versions of the psoriatic arthritis (PsA) composite measures for use in routine clinical practice. Methods Clinical and patient-reported outcome measures (PROMs) were assessed in patients with PsA at 3 consecutive follow-up visits in a UK multicenter observational study. Shortened versions of the Composite Psoriatic Arthritis Disease Activity Index (CPDAI) and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Exercise (GRACE) measures were developed using PROMs and tested against the Disease Activity Score in 28 joints (DAS28), composite Disease Activity in Psoriatic Arthritis, and Routine Assessment of Patient Index Data (RAPID3). Discrimination between disease states and responsiveness were tested with the t-score, standardized response mean (SRM), and effect size (ES). Data were presented to members at the GRAPPA 2020 annual meeting and members voted on the recommended composite routine practice. Results The SRM for the GRACE, 3 visual analog scale (VAS), and 4VAS were 0.67, 0.77, and 0.63, respectively, and for CPDAI and shortened CPDAI (sCPDAI) were 0.54 and 0.55, respectively. Shortened versions of the GRACE increased the t-score from 7.8 to 8.7 (3VAS) and 9.0 (4VAS), but reduced the t-score in the CPDAI/sCPDAI from 6.8 and 6.1. The 3VAS and 4VAS had superior performance characteristics to the sCPDAI, DAS28, Disease Activity in Psoriatic Arthritis, and RAPID3 in all tests. Of the members, 60% agreed that the VAS scales contained enough information to assess disease and response to treatment, 53% recommended the 4VAS for use in routine care, and 26% the 3VAS, while leaving 21% undecided. Conclusion Shortening the GRACE to VAS scores alone enhances the ability to detect status and responsiveness and has the best performance characteristics of the tested composite measures. GRAPPA members recommend further testing of the 3VAS and 4VAS in observational and trial datasets.


Rheumatology ◽  
2020 ◽  
Author(s):  
Laura C Coates ◽  
Joseph F Merola ◽  
Philip J Mease ◽  
Alexis Ogdie ◽  
Dafna D Gladman ◽  
...  

Abstract Objectives To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA. Methods The trial randomised 851 patients to receive weekly: MTX (20 mg/week), etanercept (50 mg/week) or MTX plus etanercept. Dichotomous composite measures examined included ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA). Continuous composite measures examined included Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS). Results At week 24, etanercept-treated groups were significantly more effective than MTX monotherapy to achieve ACR 20 (primary end point) and MDA (key secondary end point). When examining score changes from baseline at week 24 across the five continuous composite measures, PASDAS demonstrated relatively greater changes in the etanercept-treated groups compared with MTX monotherapy and had the largest effect size and standardized response. Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments. Conclusion PASDAS was the most sensitive continuous composite measure examined with results that mirrored the protocol-defined primary and key secondary outcomes. Composite measures with multiple domains, such as PASDAS, may better quantify change in PsA disease burden. Trail registration https://ClinicalTrials.gov, number NCT02376790.


2015 ◽  
Vol 43 (3) ◽  
pp. 632-639 ◽  
Author(s):  
Frank Behrens ◽  
Michaela Koehm ◽  
Uta Arndt ◽  
Bianca M. Wittig ◽  
Gerd Greger ◽  
...  

Objective.To examine the influence of concomitant methotrexate (MTX) with adalimumab (ADA) on outcomes in patients with psoriatic arthritis (PsA) using data from an observational study of ADA.Methods.Data from a German noninterventional study of patients with PsA starting treatment with ADA were analyzed retrospectively for effects of concomitant MTX on key outcomes, including Disease Activity Score-28 joints, tender and swollen joint counts, skin assessments, and safety. Patients were categorized into those with symptoms of axial involvement and those with no symptoms of axial involvement as judged by the examining clinician.Results.A total of 1455 patients met the study criteria, 296 with axial involvement (ADA monotherapy = 165; plus MTX = 131) and 1159 with no axial involvement (ADA monotherapy = 658; plus MTX = 501). ADA, alone or combined with MTX, resulted in strong and comparable reductions in disease activity measures in patients with and those without axial disease over 24 months of therapy. In multiple regression analyses, concomitant MTX did not affect joint or skin outcomes in either the group with axial manifestations or the group without axial disease. Neither adverse event rates nor withdrawal rates were significantly influenced by concomitant MTX.Conclusion.ADA is an effective treatment option for patients with PsA with or without axial involvement. Compared with ADA monotherapy, the use of concomitant MTX with ADA does not improve articular or skin outcomes in patients with PsA regardless of axial symptoms. Trial registration: Clinicaltrials.govNCT01111240


2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Priscilla C. H. Wong ◽  
Ying-Ying Leung ◽  
Edmund K. Li ◽  
Lai-Shan Tam

Over the past decade, the assessment of the disease activity in psoriatic arthritis (PsA) has rapidly evolved in view of the need for valid, feasible, and reliable outcome measures that can be ideally employed in longitudinal cohorts, clinical trials, and clinical practice as well as the growing paradigm of tight disease control and treating to target in the management of PsA. This paper reviews the currently available measures used in the assessment of the disease activity in PsA. The composite measures for PsA that are under development are also discussed.


2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Eva Klingberg ◽  
Annelie Bilberg ◽  
Sofia Björkman ◽  
Martin Hedberg ◽  
Lennart Jacobsson ◽  
...  

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Laura Tucker ◽  
Philip Helliwell ◽  
Laura Coates ◽  

Abstract Background/Aims  Multiple composite measures of disease activity are available and used in psoriatic arthritis (PsA) research; however, poor agreement remains amongst clinicians on the optimal measure of disease activity. Research to date has focused on polyarticular PsA, despite oligoarticular disease accounting for around half of cases in clinical practice. We aim to compare the ability of Composite Psoriatic Disease Activity Index (CPDAI), Psoriatic ArthritiS Disease Activity Score (PASDAS), Disease Activity score for PSoriatic Arthritis (DAPSA), GRAppa Composite scorE (GRACE) and Disease Activity Score 28 CRP (DAS28-CRP) to assess disease activity and predict treatment change, amongst usual care patients with oligoarticular and polyarticular psoriatic disease. Methods  The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis Composite Exercise (GRACE) dataset was utilised. Oligoarthritis was defined as < 5 active joints. Reference measures were clinician and patient opinions on disease control and whether treatment was escalated. Patients with baseline data for all composite measures were included. The ability of each composite measure to predict treatment change and capture disease activity was compared using the Mann-Whitney U test. Results  Data were available for 271 patients (152 oligoarthritis, 119 polyarthritis). The mean age, duration of PsA and psoriasis were similar for both groups. A higher proportion of oligoarticular patients were male. Patients with polyarticular disease had higher disease activity in skin, enthesitis and dactylitis. Using both patient and physician definitions of disease control, all composite measures were able to differentiate between patients with active and quiescent disease, regardless of disease subtype (p < 0.05). PASDAS demonstrated the largest differentiation in score. Differences between active and inactive disease scores were more pronounced in oligoarticular disease. PASDAS demonstrated the greatest ability to predict treatment change in both oligoarticular and polyarticular disease. Interestingly, DAPSA could not predict treatment change in polyarticular patients, p = 0.074 (Table 1). Conclusion  This is the first study to compare composite measures, in oligoarticular and polyarticular PsA in a multinational cohort. All composite measures of disease activity were able to differentiate between active and inactive disease in both subtypes. PASDAS demonstrated the largest discrimination in both polyarticular and oligoarticular disease, suggesting greatest clinical and research utility. Disclosure  L. Tucker: None. P. Helliwell: None. L. Coates: None.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1725-1725
Author(s):  
W. Tillett ◽  
P. Helliwell ◽  
O. Fitzgerald ◽  
R. Waxman ◽  
A. Antony ◽  
...  

Background:Composite measures of disease activity have been developed for use in Psoriatic Arthritis (PsA) to capture the wide spectrum of disease but there is a lack of consensus regarding which to adopt for routine practice. It is recognised that more data is required to understand the measurement properties of existing instruments and consider the impact of modifications that may improve face validity, responsiveness or feasibility. It is important to have an estimate of a measurement instrument’s reliability in the setting of stable disease in order to understand measurement error and responsiveness. To our knowledge no data exists on the stability of composite measures in PsA.Objectives:To measure test re-test reliability of composite measures of disease activity in PsA.Methods:Clinical and patient reported outcomes to enable the calculation of composite measures were administered to 141 patients with PsA at five time points in a UK multicentre observational study. All patients fulfilled the CASPAR criteria. Twenty-nine patients with clinically stable disease and receiving no treatment intervention underwent repeat assessment by the same examiner within 2 weeks. Patients in high and low disease were included. Reliability was evaluated by intra-class correlation coefficient (ICC) and Bland Altman plots.Results:Of the 29 patients included 15 were male, the mean age was 52.4 years (SD 13.39), mean disease duration at T0was 9.2yrs (SD 8.11). The mean swollen joint count was 3.4 (SD 5.1), tender joint count 11.3 (SD 15.03) and PASI 1.0 (SD1.04). The ICC (95% CI) for tender and swollen joint counts were 0.94 (0.87-0.97) and 0.91 (0.80-0.96) respectively. The ICC for PASI was 0.95 (0.90-0.98). All composite measures demonstrated high levels of test-retest reliability with ICC >0.85, table. The most reliable measure was the PADAS ICC 0.98 (95% CI 0.954-0.991). The individual ICC for each composite measures are reported in the table and Bland Altman plots, figure.Conclusion:All composite measures show high levels of test-retest reliability in this cohort. The PASDAS was the most stable measure. Modifications to these instruments can now be tested and the impact compared to the original versions.Table.Test Re-Test reliability of each composite measureIntraclass Correlation Coefficient (95% Confidence Interval)GRACE0.929 (0.842-0.968)*CPDAI0.852 (0.635-0.940)*PASDAS0.978 (0.954-0.991)*DAPSA0.922 (0.831-0.964)*3VAS0.915 (0.815-0.960)*RAPID30.899 (0.782-0.953)*Disease Activity Index for PsA (DAPSA), PsA Disease Activity Score (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), GRAppa Composite Exercise (GRACE), 3 Visual Analogue Scale (3VAS), Routine Assessment of Patient Index (RAPID3),*P<0.001Figure.Bland Altman plots for each composite measureFunding:This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.Disclosure of Interests:William Tillett Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, MSD, Pfizer Inc, UCB, Speakers bureau: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, Pfizer Inc, UCB, Philip Helliwell: None declared, Oliver FitzGerald: None declared, Robin Waxman: None declared, Anna Antony: None declared, Laura C Coates: None declared, Deepak Jadon: None declared, Paul Creamer: None declared, Suzanne Lane: None declared, Marco Massarotti: None declared, Charlotte Cavill: None declared, Mel Brooke: None declared, Jonathan Packham: None declared, Eleanor Korendowych: None declared, Anya Lissina: None declared, Neil McHugh: None declared


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