Musaab Elmamoun

Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016

Objective. To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS). Methods. At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants. Results. We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient’s global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda. Conclusion. The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.

Report of the GRAPPA-OMERACT Psoriatic Arthritis Working Group from the GRAPPA 2015 Annual Meeting

The GRAPPA-OMERACT psoriatic arthritis (PsA) working group is in the process of updating the PsA core domain set to improve and standardize the measurement of PsA outcomes. Work streams comprise literature reviews of domains and outcome measurement instruments, an international qualitative research project with PsA patients to generate domains important to patients, outcome measurement instrument assessment, conduct of domain consensus panels with patients and physicians, and evidence-based selection of instruments. Patient research partners are involved in each of the projects. The working group will present findings and seek endorsement for the new PsA core domain set, outcome measurement set, and research agenda at the OMERACT meeting in May 2016.

Defining outcome measures for psoriatic arthritis: A report from the GRAPPA-OMERACT working group

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group recently published the updated 2016 psoriatic arthritis (PsA) core domain set, a set of disease features that should be measured in all clinical trials. At the GRAPPA annual meeting in July 2016, the PsA working group presented the updated PsA core domain set endorsed by 90% of participants at OMERACT in May 2016 and drafted a roadmap for the development of the PsA core outcome measurement set. In this manuscript, we review the development process of the PsA core domain set and the ongoing and proposed work streams for development of a PsA core measurement set.

Content and Face Validity and Feasibility of 5 Candidate Instruments for Psoriatic Arthritis Randomized Controlled Trials: The PsA OMERACT Core Set Workshop at the GRAPPA 2017 Annual Meeting.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)–Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group is in the process of selecting core instruments for PsA clinical trials. During a 2-h workshop and breakout group discussions at the GRAPPA 2017 annual meeting in Amsterdam, the Netherlands, participants discussed the first set of candidate instruments to be taken through the OMERACT Filter 2.1 instrument selection process: 66/68 swollen/tender joint count (66/68JC), Spondyloarthritis Consortium of Canada (SPARCC) enthesitis index, patient’s global assessment (GRAPPA and OMERACT formulations), Health Assessment Questionnaire–Disability Index (HAQ-DI), Psoriatic Arthritis Impact of Disease (PsAID) questionnaires 9 and 12, and Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue. Based on the assessment of domain match (content and face validity) and feasibility according to the OMERACT instrument selection criteria, the working group recommends continuing with appraisal of construct validity and discrimination for 66/68JC, SPARCC, PsAID 9 and 12, HAQ-DI, and FACIT-Fatigue. In addition, it recommends repeating the OMERACT Filter 2.1 process for patient global instruments because of insufficient votes. Additional sets of candidate instruments for the PsA core instrument set will be evaluated in a similar process.

Treatment of psoriatic arthritis

The primary goal of treating patients with psoriatic arthritis (PsA) is to maximise health-related quality of life (HRQoL), through control of symptoms, prevention of structural damage, and normalization of function and social participation [1]. Treatment goals in PsA should aim at reaching an acceptable disease state as agreed by both patient and physician [2]. In 2009, minimal disease activity (MDA) criteria, the first potential target for treatment in PsA were published.

FRI0469 Measuring Outcome in Psoriatic Arthritis (MOPSA), A New Web-Based Tool for Assessment of Psoriatic Arthritis Showing Initiation of Treatment Change in Patients Achieving Minimal Disease Activity

Background Psoriatic arthritis (PsA) is a heterogeneous disease that includes features of peripheral arthritis, spondylitis, dactylitis, enthesitis, and skin and nail disease. PsA affects about 30% of patients with psoriasis.1 Minimal Disease Activity (MDA) is defined as a patient acceptable disease state which is validated and increasingly recognised as a treatment target. MDA is defined when a patient has 5 of the following 7 criteria: tender joint count ≤1, swollen joint count ≤1, tender entheseal point ≤1, PASI ≤1 or body surface area ≤3%, Pain Visual analogue score (VAS) ≤15, patient global ≤20, Health Assessment Questionnaire ≤0.5.2 Composite Psoriatic Disease Activity Index (CPDAI) assesses the five domains in PsA. Within each domain a score (range 0–3) is assigned according to predefined cut-offs. The scores for each domain are then added together to give a final score range of 0–15, 0 for no disease and 15 for severe disease.3 Recently, Measuring Outcome in Psoriatic Arthritis (MOPsA), a new web-based tool for assessment of PsA was developed and is freely available to use (see https://mopsa.ie). MOPSA will calculate all the scores and determine both MDA and CPDAI. MOPSA provides a graphic representation of CPDAI in the form of a spidergram that can be compared with subsequent visits. Objectives Our aim was to assess, (1) disease activity using CPDAI and the percentage of patients reaching MDA, in consecutive cohort of established PsA patients attending our unit; and (2) whether treatment change was initiated based on MDA state. Methods 137 patients with PsA, fulfilling CASPAR criteria, were included in this study. 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) were recorded. Skin scores included Dermatology Quality of Life Index (DLQI), Body Surface Area (BSA) and Psoriasis Area Severity Index (PASI). Patient reported outcome measures (PROMs) included: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Health Assessment Questionnaire (HAQ), Ankylosing Spondylitis Quality of Life (ASQoL). CPDAI was calculated and MDA status was assessed. Results The mean age was 46.1 (± 11.6) and 72 (52.6%) were females. Clinical outcome measures and PROMs are shown in table 1. The mean CPDAI score was 3.75 (± 2.94); 52 (37%) patients reached MDA. Of the 85 patients not in MDA, CPDAI was 5.94 ± 3 in the 37 who had a treatment change and 4.54 ± 2.49 in the 48 who did not. Of those undergoing treatment changes, 7 patients started on biologics, 4 switched to another biologic and 3 had their dose increased. 6 were started on synthetic DMARD, 2 had a second DMARD added to their regimen, and 8 had their dose increased. 6 patients had a short course of systemic steroids while 12 patients had intra-articular steroids injections. Conclusions MOPsA gives a comprehensive assessment of psoriatic disease that can be followed longitudinally. One third of patients in our cohort achieved MDA. CPDAI was higher in those patients not achieving MDA status where treatment was changed. References Mease PJ, et al. J Am Acad Dermatol. 2013, 69(5):729–35 Coates LC, et al. Ann Rheum Dis. 2010, 69:48–53 Mumtaz A, et al. Ann Rheum Dis. 2011, 70(2):272–7 Disclosure of Interest M. Elmamoun: None declared, A. Szentpetery: None declared, P. Gallagher: None declared, O. FitzGerald Grant/research support from: Pfizer, AbbVie, BMS, UCB, Consultant for: Pfizer, AbbVie, Janssen, MSD, Cellgene, Novartis, Speakers bureau: Pfizer, AbbVie, Janssen, Cellgene

THU0447 Measuring Outcome in Psoriatic Arthritis: Correlation between Different Skin Scores

Background Psoriatic arthritis (PsA) is a heterogeneous disease that includes features of peripheral arthritis, spondylitis, dactylitis, enthesitis, and skin and nail disease. PsA affects about 30% of patients with psoriasis (PsO).1 Measuring outcome in psoriatic arthritis (MOPsA) is a web-based tool, freely available to use (see https://mopsa.ie), that collects clinical information about all domains affected in PsA including skin disease and patient reported outcome measures (PROMs). MOPsA also calculates the composite psoriatic disease activity index (CPDAI) and minimal disease activity (MDA).2,3 Assessment of skin disease in rheumatology clinics can be challenging. Availability of patient self-assessment questionnaires that correlate with, and possibly can replace, physical examination would address this challenge. Objectives Our aim was to correlate skin-related patient self-assessment questionnaires and skin sores assessed by physicians using MOPsA. Methods 189 patients with PsA, fulfilling CASPAR criteria, were recruited in this study. 137 patients from rheumatology clinic and 52 patients from dermatology clinic. We calculated the following skin scores: Dermatology Quality of Life Index (DLQI), Psoriasis Symptom Inventory (PSI), Body Surface Area (BSA) and Psoriasis Area Severity Index (PASI). GraphPad Prism version 6 was used for statistical analysis. Results Data from 189 patients with skin scores were included in this analysis. Mean ± SD age of 44.61 (± 12.54), 99 (52%) patients were males. 96 (51%) patients had nail involvement. Mean ± SD DLQI was 5.57 (± 6.93), PSI 7.36 (±8.68), BSA 7.27 (± 12.17), and PASI 4.57 (± 5.56). There was strong correlation between PASI and BSA (r=0.8502, P<0.0001) and between PASI and DLQI (r=0.7256, P<0.0001), but moderate correlation between PASI and PSI (r=0.5812, P<0.0001). There was strong correlation between BSA and DLQI (r=0.7048, P<0.0001) but moderate correlation between BSA and PSI (r=0.6246, P<0.0001 respectively). Finally, there was strong correlation between DLQI and PSI (r=0.7873, P<0.0001). Conclusions Our analysis confirms the correlation between PASI and DLQI. The strongest correlation was between PASI and BSA. DLQI correlates very well with all three parameters (PASI, BSA and PSI). These preliminary results suggest that the combination of BSA and DLQI might work equally well to PASI and DLQI when accurately accessing skin involvement in rheumatology clinics. References Mease PJ, et al: Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics, J Am Acad Dermatol. 69(5):729–35, 2013 Mumtaz A, et al: Development of a preliminary composite disease activity index in psoriatic arthritis, Ann Rheum Dis. 70(2):272–7, 2011 Coates LC, et al. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis. 69(1):48–53, 2010 Disclosure of Interest M. Elmamoun: None declared, C. Loftus: None declared, A. Szentpetery: None declared, P. Gallagher: None declared, L. Barnes: None declared, O. FitzGerald Grant/research support from: Pfizer, AbbVie, BMS, UCB, Consultant for: Pfizer, AbbVie, Janssen, MSD, Cellgene, Novartis, Speakers bureau: Pfizer, AbbVie, Janssen, Cellgene