ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2662

The EULAR Systemic Sclerosis Impact of Disease (ScleroID) Score – a New Patient-Reported Outcome Measure for Patients with Systemic Sclerosis – Preliminary Results from the Ongoing Validation Study

Rucsandra Dobrota1, Mike Oliver Becker1, Kim Fligelstone2, Jaap Fransen3, Ann Kennedy4, Yannick Allanore5, Patricia Carreira6, László Czirják7, Christopher Denton8, Roger Hesselstrand9, Gunnel Sandqvist10, Otylia Kowal-Bielecka11, Marco Matucci-Cerinic12, Carina Mihai13, Ana Maria Gheorghiu14, Ulf Müller-Ladner15, MC Vonk16, Turid Heiberg17 and Oliver Distler18, 1Department of Rheumatology, Center of Experimental Rheumatology, University Hospital Zurich, Zurich, Switzerland, 2Royal Free Hospital, Scleroderma Unit and Scleroderma Society, London, United Kingdom, 3Department of Rheumatolgy, Radboud University Medical Center, Nijmegen, Netherlands, 4Federation of European Scleroderma Associations (FESCA), Tournai, Belgium, 5Department of Rheumatology, Cochin Hospital, Paris Descartes University, Paris, France, 6Department of Rheumatology, Hospital Universitario 12 de Octubre, Madrid, Spain, 7Department of Rheumatology and Immunology, University of Pécs, Faculty of Medicine, Pécs, Hungary, 8Department of Rheumatology, University College London, Royal Free Hospital, London, United Kingdom, 9Lund University, Lund, Sweden, 10Department of Rheumatology, Lund University Hospital, Lund, Sweden, 11Department of Rheumatology and Internal Medicine, Medical University of Białystok, Białystok, Poland, 12Dept of Medicine/Div of Rheum, University of Florence, Florence, Italy, 13Internal Medicine and Rheumatology Dept., Cantacuzino Clinical Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, 14Carol Davila University of Medicine and Pharmacy,Internal Medicine and Rheumatology Department ,,Dr.I.Cantacuzino'' Clinical Hospital, Bucharest, Romania, 15Justus-Liebig-University Giessen, Department of Internal Medicine and Rheumatology, Kerckhoff-Klinik, Bad Nauheim, Germany, Bad-Nauheim, Germany, 16Rheumatology, Radboud University Medical Centre, Nijmegen, Netherlands, 17Department of Health and Social Sciences, Oestfold University College, Oslo, Norway, 18Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords:

Session Information

Date: Tuesday, November 7, 2017

Title: Systemic Sclerosis, Fibrosing Syndromes and Raynaud's – Clinical Aspects and Therapeutics Poster III

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:

Patient reported outcome measures (PROM) are acknowledged a key role in clinical trials in systemic sclerosis (SSc). Given the unmet need of a validated, comprehensive PROM in SSc, the ScleroID questionnaire was developed by a team of patients with SSc and medical experts in the field. This is intended as a brief, disease-specific, patient-derived, disease impact score for research and clinical use in SSc. Here, we present the preliminary analysis from the ongoing ScleroID validation study.

Methods:

This EULAR-endorsed project involves 11 European expert SSc centers. Patients fullfilling the ACR/EULAR 2013 criteria were prospectively included since 05/16 in the ongoing observational cohort study. Patients filled in the ScleroID questionnaire (Figure 1), as well as selected comparators SHAQ, EQ5D, SF36. Additionally, they weighted the 10 dimensions of the ScleroID by distributing 100 points according to the perceived impact on their health. The final score calculation will be based on the ranking of the weights. The study includes a reliability arm (follow-up questionnaire 7-10 days from baseline), as well as a longitudinal arm, looking at sensitivity to change at follow-up visits after 6 and 12 months from baseline.

Results:

As of 01/2017 the study cohort included 224 patients with valid baseline data, 44 also had a reliability visit and 6 a 6-months follow-up visit. 84.4% of patients were female, 54.4% had limited SSc, median age 58, and median disease duration 8 years. The highest preliminary median weights for ScleroID domains were for Raynaud, impaired hand function, fatigue and pain (Table 1). Except for pain, these dimensions were also scored most highly in the ScleroID questionnaire at baseline. As of 06/2017, 362 patients (72.4% of target) were enrolled into the study.

Conclusion:

The EULAR ScleroID score is a novel tool designed for use in clinical practice and clinical trials to display the disease impact of SSc. In this preliminary analysis, Raynaud syndrome, impaired hand function, and fatigue were the main patient reported drivers of disease impact. However, further recruitment and validation of this new instrument is ongoing.

Disclosure: R. Dobrota, None; M. O. Becker, None; K. Fligelstone, None; J. Fransen, None; A. Kennedy, None; Y. Allanore, Actelion Pharmaceuticals US, 2,Bayer AG, 2,Bristol-Myers Squibb, 2,Inventiva, 2,Medac, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 2,Genentech and Biogen IDEC Inc., 2,Sanofi-Aventis Pharmaceutical, 2,Servier, 2,Actelion Pharmaceuticals US, 5,Bayer AG, 5,Bristol-Myers Squibb, 5,Inventiva, 5,Medac, 5,Pfizer Inc, 5,Roche Pharmaceuticals, 5,Genentech and Biogen IDEC Inc., 5,Sanofi-Aventis Pharmaceutical, 5; P. Carreira, None; L. Czirják, None; C. Denton, None; R. Hesselstrand, None; G. Sandqvist, None; O. Kowal-Bielecka, None; M. Matucci-Cerinic, None; C. Mihai, Actelion Pharmaceuticals Ltd., Geneva Romfarm, Abbvie, Roche, 5; A. M. Gheorghiu, None; U. Müller-Ladner, None; M. Vonk, Actelion Pharmaceuticals Ltd, Therabel and United Therapeutics., 5; T. Heiberg, None; O. Distler, 4 D Science, Actelion, Active Biotec, Bayer, Biogen Idec, Boehringer Ingelheim Pharma, BMS, ChemomAb, EpiPharm, Ergonex, espeRare foundation, GSK,Roche-Genentech, Inventiva, Lilly, medac, MedImmune, Mitsubishi Tanabe, Pharmacyclics, Pfizer, Sanofi, Seroda, 2.

To cite this abstract in AMA style:

Dobrota R, Becker MO, Fligelstone K, Fransen J, Kennedy A, Allanore Y, Carreira P, Czirják L, Denton C, Hesselstrand R, Sandqvist G, Kowal-Bielecka O, Matucci-Cerinic M, Mihai C, Gheorghiu AM, Müller-Ladner U, Vonk M, Heiberg T, Distler O. The EULAR Systemic Sclerosis Impact of Disease (ScleroID) Score – a New Patient-Reported Outcome Measure for Patients with Systemic Sclerosis – Preliminary Results from the Ongoing Validation Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/the-eular-systemic-sclerosis-impact-of-disease-scleroid-score-a-new-patient-reported-outcome-measure-for-patients-with-systemic-sclerosis-preliminary-results-from-the-o/. Accessed .

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