Development of Composite Measures for Psoriatic Arthritis: A Report from the GRAPPA 2010 Annual Meeting

2012 ◽  
Vol 39 (2) ◽  
pp. 398-403 ◽  
Author(s):  
PHILIP S. HELLIWELL ◽  
OLIVER FITZGERALD ◽  
PHILIP J. MEASE

Composite disease outcome measures have been used in rheumatology for some time, but a disease-specific composite measure for psoriatic arthritis (PsA) has not yet been validated. Currently, instruments developed for use in rheumatoid arthritis are employed in PsA and include the American College of Rheumatology response criteria (ACR20, 50, and 70) and the Disease Activity Score for 28 and 44 joints (DAS28 and DAS44); however, these instruments do not cover the full spectrum of psoriatic disease. A composite measure is one way of incorporating an assessment of all relevant clinical outcomes into one single measure. By definition, it incorporates several dimensions of disease status, often by combining these different domains into a single score, which in the case of PsA includes joints, skin, entheses, dactylitis, and axial disease. New indices that combine these diverse clinical manifestations of PsA are under development and, in some cases, in the validation phase. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) established the GRAPPA Composite Exercise (GRACE) project to compare existing and emerging composite measures and to develop a new index. At the GRAPPA 2010 meeting, initial results from this project were presented, and existing and new candidate measures were compared.

2011 ◽  
Vol 38 (3) ◽  
pp. 540-545 ◽  
Author(s):  
PHILIP S. HELLIWELL ◽  
OLIVER FITZGERALD ◽  
C. VIBEKE STRAND ◽  
PHILIP J. MEASE

A composite measure is one way of incorporating an assessment of all relevant clinical outcomes into one single measure. By definition it incorporates several dimensions of disease status often by combining these different domains into a single score. Such instruments are well established in rheumatoid arthritis (RA), and these RA-specific measures have successfully been adopted for use in clinical trials involving patients with psoriatic arthritis (PsA). However, the need for a more PsA-specific composite measure has led to a number of proposals, which, for the large part, incorporate only peripheral articular disease activity. New indices that combine the diverse clinical manifestations of PsA are now under development. These issues were discussed at the 2009 annual meeting of GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) in Stockholm, Sweden, and are summarized here.


2010 ◽  
Vol 37 (2) ◽  
pp. 453-461 ◽  
Author(s):  
DAFNA D. GLADMAN ◽  
ROBERT LANDEWÉ ◽  
NEIL J. McHUGH ◽  
OLIVER FITZGERALD ◽  
DIAMANT THACI ◽  
...  

At the 2008 annual meeting of GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) in Leeds, UK, members discussed the value and current status of composite measures for the assessment of psoriatic arthritis (PsA). In plenary presentations, examples of composite measures developed for rheumatoid arthritis (RA) and ankylosing spondylitis (AS) were reviewed, followed by a presentation of the assessment of disease activity in systemic lupus erythematosus. Three recently devised composite methods of assessing activity or response in PsA also were presented. Considerable discussion followed in breakout groups, and members agreed that a new composite measure specifically for PsA is necessary. The composite measure should include components that encompass the spectrum of psoriatic disease, i.e., in addition to assessment of peripheral joints, it should include assessment of sacroiliitis, spondylitis, enthesitis, and dactylitis, as well as skin and nail disease.


2008 ◽  
Vol 68 (9) ◽  
pp. 1387-1394 ◽  
Author(s):  
C T Ritchlin ◽  
A Kavanaugh ◽  
D D Gladman ◽  
P J Mease ◽  
P Helliwell ◽  
...  

Objective:To develop comprehensive recommendations for the treatment of the various clinical manifestations of psoriatic arthritis (PsA) based on evidence obtained from a systematic review of the literature and from consensus opinion.Methods:Formal literature reviews of treatment for the most significant discrete clinical manifestations of PsA (skin and nails, peripheral arthritis, axial disease, dactylitis and enthesitis) were performed and published by members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Treatment recommendations were drafted for each of the clinical manifestations by rheumatologists, dermatologists and PsA patients based on the literature reviews and consensus opinion. The level of agreement for the individual treatment recommendations among GRAPPA members was assessed with an online questionnaire.Results:Treatment recommendations were developed for peripheral arthritis, axial disease, psoriasis, nail disease, dactylitis and enthesitis in the setting of PsA. In rotal, 19 recommendations were drafted, and over 80% agreement was obtained on 16 of them. In addition, a grid that factors disease severity into each of the different disease manifestations was developed to help the clinician with treatment decisions for the individual patient from an evidenced-based perspective.Conclusions:Treatment recommendations for the cardinal physical manifestations of PsA were developed based on a literature review and consensus between rheumatologists and dermatologists. In addition, a grid was established to assist in therapeutic reasoning and decision making for individual patients. It is anticipated that periodic updates will take place using this framework as new data become available.


2017 ◽  
Vol 44 (10) ◽  
pp. 1445-1452 ◽  
Author(s):  
William Tillett ◽  
Emma Dures ◽  
Sarah Hewlett ◽  
Philip S. Helliwell ◽  
Oliver FitzGerald ◽  
...  

Objective.To rank outcomes identified as important to patients with psoriatic arthritis (PsA) and examine their representation in existing composite measures.Methods.Seven nominal group technique (NGT) meetings took place at 4 hospital sites. Two sorting rounds were conducted to generate a shortlist of outcomes followed by a group discussion and final ranking. In the final ranking round, patients were given 15 points each and asked to rank their top 5 outcomes from the shortlist. The totals were summed across the 7 NGT groups and were presented as a percentage of the maximum possible priority score.Results.Thirty-one patients took part: 16 men and 15 women; the mean age was 54 years (range 24–77; SD 12.2), the mean disease duration was 10.3 years (range 1–40; SD 9.2), and mean Health Assessment Questionnaire was 1.15 (range 0–2.63; SD 0.7). The highest-ranked outcomes that patients wished to see from treatment were pain with 93 points (20.0%), fatigue 62 (13.3%), physical fitness 33 (7.1%), halting/slowing damage 32 (6.9%), and quality of life/well-being 29 (6.2%). Reviewing existing composite measures for PsA demonstrated that no single measure adequately identifies all these outcomes.Conclusion.Pain and fatigue were ranked as the outcomes most important to patients receiving treatment for PsA and are not well represented within existing composite measures. Future work will focus on validating composite measures modified to identify outcomes important to patients.


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


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1298.2-1299
Author(s):  
T. Korotaeva ◽  
I. Gaydukova ◽  
V. Mazurov ◽  
A. Samtsov ◽  
V. Khayrutdinov ◽  
...  

Background:Inflammatory back pain (IBP) is a common symptom of axial disease in patients with psoriatic arthritis (PsA). The reported prevalence of axial disease in patients with PsA is quite variable and must be taken into account while choosing treatment strategy. Netakimab (NTK) is an anti-interleukin-17A monoclonal antibody approved for psoriasis, ankylosing spondylitis, PsA in Russia and Belarus.Objectives:A subanalysis was aimed to investigate the ACR (American College of Rheumatology) 20/50/70 response rate in PsA patients with/without the axial disease, defined by the presence of IBP according to self-reported ASAS IBP criteria, 2009 at baseline.Methods:PATERA is an ongoing phase 3 international double-blind, placebo-controlled clinical study (NCT03598751). 194 adult patients with PsA (CASPAR criteria, 2006) with inadequate response to csDMARD or one TNFi, were randomly assigned to receive NTK 120mg or placebo at weeks 0,1,2,4,6,8,10,14,18,22. The ACR response was calculated in NTK-treated patients with IBP (IBP(+)) and NTK-treated patients without IBP (IBP(-)) according to self-reported ASAS IBP criteria, 2009. Patients with missing values for categorical variables were considered as non-responders in the analysis.Results:97 PsA patients (N=54 IBP(+), N=43 IBP(-)) received NTK. Both subpopulations were comparable in gender, age, and PsA activity at baseline. There were no significant differences in ACR20 achievement between the groups (Figure 1). The percentage of patients with ACR50 was significantly (p<0.05) higher in the IBP(-) subpopulation at weeks 4-20 (data not shown), but not at week 24 with 63% IBP(+) and 79% IBP(-) responders (p≥0.05). Similarly, IBP(+) patients had a lower frequency of ACR70 response (Figure 1).Conclusion:NTK is effective in PsA treatment irrespectively of the presence of axial disease. Both IBP(-) and IBP(+) subpopulations achieved ACR20/50/70 as well, however, the benefit in IBP(-) patients was more pronounced.Figure 1ACR response ratesAcknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Speakers bureau: Abbvie, Biocad, Eli Lilly, Johnson & Johnson, Janssen, Novartis, Pfizer, UCB, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, V Mazurov: None declared., Aleksey Samtsov: None declared., Vladislav Khayrutdinov: None declared., Andrey Bakulev: None declared., Alena Kundzer: None declared., Nikolaj Soroka: None declared., Anna Eremeeva Employee of: Biocad.


2021 ◽  
pp. jrheum.201674
Author(s):  
William Tillett ◽  
Oliver FitzGerald ◽  
Laura C. Coates ◽  
Jon Packham ◽  
Deepak R. Jadon ◽  
...  

Objective To test the addition of pain and fatigue to the Composite Psoriatic Arthritis Disease Activity (CPDAI) and the Group for Research and Assessment of Psoriasis and PsA (GRAPPA) Composite Exercise (GRACE) composite measures of psoriatic arthritis (PsA). Methods Clinical and patient-reported outcome measures were assessed in patients with PsA at 3 consecutive follow-up visits over 6 months in a UK multicenter observational study. A pain visual analog scale and Functional Assessment of Chronic Illness Therapy Fatigue scale were added as modifications to the CPDAI and GRACE composite measures. Original and modified versions were tested against the PsA Disease Activity Score (PASDAS) and the Disease Activity Index for PsA (DAPSA). Discrimination between disease states and responsiveness were tested with t-scores, standardized response means (SRMs), and effect sizes. Data were presented to members at the 2020 annual meeting who then voted on the GRAPPArecommended composite and treatment targets for clinical trials. Results One hundred forty-one patients were recruited with a mean PsA disease duration of 6.1 years (range 0–41 yrs). The SRMs for the GRACE and modified GRACE (mGRACE) were 0.67 and 0.64, respectively, and 0.54 and 0.46, respectively, for the CPDAI and modified CPDAI (mCPDAI). The t-scores for the GRACE and mGRACE were unchanged at 7.8 for both, and 6.8 and 7.0 for the CPDAI and mCPDAI, respectively. The PASDAS demonstrated the best responsiveness (SRM 0.84) and discrimination (t-scores 8.3). Most members (82%) agreed the composites should not be modified and 77% voted for the PASDAS as the GRAPPA-recommended composite for clinical trials, with 90% minimal disease activity (MDA) as the target. Conclusion Modifying the CPDAI and GRACE with the addition of pain and fatigue does not enhance responsiveness nor the measures’ ability to detect disease status in terms of requiring treatment escalation. GRAPPA members voted for the PASDAS as the composite measure in clinical trials and MDA as the target.


2011 ◽  
Vol 38 (7) ◽  
pp. 1496-1501 ◽  
Author(s):  
LAURA C. COATES ◽  
AIZAD MUMTAZ ◽  
PHILIP S. HELLIWELL ◽  
PHILIP J. MEASE ◽  
KRISTINA CALLIS-DUFFIN ◽  
...  

Work within the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) to develop and validate composite disease activity measures in PsA has progressed. At the Outcome Measures in Rheumatology Clinical Trials (OMERACT) 8 meeting, a core set of domains to be assessed in randomized controlled trials (RCT) and longitudinal observational studies (LOS) of PsA was agreed upon. At OMERACT 10, work to date regarding proposed composite responder indices was presented. Five proposed composite responder definitions for PsA were reviewed and discussed including new data from the GRACE (GRAppa Composite Exercise) study. There was agreement that the work to date was promising, and that developing composite outcome measures for use in RCT and LOS was important. Further work was required, including data on followup timepoints and less common phenotypes of PsA, to ensure that all subgroups were represented within GRACE. During discussion on the concept of composite measures for PsA, based on predominant/little/no involvement in several domains (such as skin versus joints, enthesitis, dactylitis, spondyloarthritis) it was acknowledged that a simple summative score encompassing all domains of PsA would be difficult to construct psychometrically and may not be appropriate. Ideally, any composite measure should retain the ability to differentiate between activity in individual domains, such as enthesitis or skin psoriasis, so that the influence of each can be assessed independently. Further work is required within the GRACE dataset to develop an optimal composite measure for PsA. Several proposals to date have shown preliminary validity according to the OMERACT filter.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 340.1-341
Author(s):  
N. Ziade ◽  
J. El-Hajj ◽  
J. Rassi ◽  
S. Hlais ◽  
C. López-Medina ◽  
...  

Background:In patients with spondyloarthritis (SpA), root joint diseases (RJD), i.e. hip or shoulder involvement, may be associated with a distinct disease phenotype compared to those with other affected joints. The ASAS-PerSpA study (PERipheral involvement in SPondyloArthritis) [1], offers a unique opportunity to study the phenotypes of patients with RJD in a global cohort.Objectives:Primary objective was to compare the clinical characteristics of SpA patients with and without RJD. Secondary objectives were to compare the prevalence of RJD across the different SpA subtypes and the different regions of the world, compare the severity of axial disease as well as the disease burden in SpA patients with and without RJD.Methods:This is a post-hoc analysis of the ASAS-PerSpA study, which included 4,465 patients with any subtype of SpA (axial SpA (axSpA), peripheral SpA (pSpA), psoriatic arthritis (PsA), inflammatory bowel disease associated SpA (IBD-SpA), reactive arthritis (ReA) and Juvenile SpA (Juv-SpA)) according to the rheumatologist’s diagnosis. RJD was defined as a positive answer by the investigator to the following question: “Do you consider that the patient has ever suffered from RJD (e.g. hip, shoulder) related to SpA?” In case of a positive answer, a potential specific treatment (e.g. Total Articular Replacement) was investigated. The patient’s characteristics were compared between those with and without RJD involvement, using Chi-2 or Fisher exact test for the categorical variables and t-test for the continuous variables. Two separate multivariable stepwise binary logistic regression analyses were conducted to identify factors associated with the dependent variables “hip involvement” and “shoulder involvement”.Results:RJD occurred in 1,503 patients (33.7%), with more prevalent hip (24.2%) than shoulder (13.2%) involvement. The prevalence of RJD as a group was the highest in Juv-SpA (52.7%), followed by pSpA (44.3%) and axSpA (33.9%). The highest prevalence of RJD was found in Asia and the lowest in Europe and North America. Among patients with hip involvement, 6.0% had a history of hip replacement (highest in the Middle East and North Africa and Latin America); among patients with shoulder involvement, 0.8% had a history of shoulder replacement. Hip had a distinct pattern of associations compared to shoulder involvement (Figure 1). Hip involvement was significantly associated with the SpA main diagnosis (highest in pSpA, lowest in PsA), younger age at first SpA symptom, lower prevalence of family history of psoriasis, positive HLA-B27, occiput-to-wall distance>0, and treatment with cs-DMARDs and b-DMARDs. Shoulder involvement was associated with the SpA main diagnosis (highest in Juv-SpA and pSpA, lowest in axSpA), older age at first SpA symptom, higher prevalence of enthesitis, dactylitis, tender joints count, IBD, occiput-to-wall distance>0, EQ5D score and treatment with cs-DMARDs.Conclusion:Hip involvement was more prevalent than shoulder involvement in patients with SpA, and had a distinct phenotype resembling axial disease whereas shoulder involvement was mostly associated with features of peripheral disease. Hip and shoulder involvement should be analyzed separately in future studies rather than under the RJD entity.References:[1]Lopez-medina, C. et al. Prevalence and Distribution of Peripheral Musculoskeletal Manifestations in Axial Spondyloarthritis, Peripheral Spondyloarthritis and Psoriatic Arthritis: Results of the International, Cross-sectional ASAS-PerSpA Study. RMD Open; 2021;7:e001450.Disclosure of Interests:None declared


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