ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 832

Defining Skin Ulcers in Systemic Sclerosis: A Systematic Literature Review of Skin Ulcer Definitions and a Preliminary Consensus-Based New SSc Skin Ulcer Definition

Yossra A Suliman1, Cosimo Bruni2, Sindhu R. Johnson3, Emanuela Praino4, Mohamed Alemam5, Nabeel Borazan6, Laura Cometi7, Bethany Myers8, Dinesh Khanna9, Yannick Allanore10, Murray Baron11, Thomas Krieg12, Ariane L. Herrick13, Suzanne Kafaja14, Christopher Denton15, Marco Matucci Cerinic16 and Daniel E. Furst17, 1Rheumatology and Rehabilitation dept., Rheumatology and Rehabilitation dept. Assiut university hospital, Assiut Egypt, Assiut, Egypt, 2Department of Biomedicine, Division of Rheumatology AOUC, Excellence Centre for Research, Florence, Italy, 3Rheumatology, Mount Sinai Hospital and University Health Network, Toronto, ON, Canada, 4DIM, Rheumatology Unit, Bari, Italy, 5Clinical Pathology and Laboratory Medicine Department, Assistant Lecturer, Qena, Egypt, 6Medicine, David Geffen School of Medicine, Los Angeles, CA, 7Division of Rheumatology, Department of Experimental and Clinical Medicine,, Florencei, Italy, 8UCLA Louise M. Darling Biomedical Library, Research Informationist, Los Angeles, CA, 9University of Michigan, Ann Arbor, MI, 10Immunogenetics, Cochin Institute, Paris, France, 11Rheumatology, McGill University, Jewish General Hospital, Montreal, QC, Canada, 12Universität zu Köln, Köln, Germany, 13Centre for Musculoskeletal Research, University of Manchester, MAHSC, Salford Royal Hospital, Manchester, United Kingdom, 14Medicine/Rheumatology, University of California Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 15Division of Medicine, Centre for Rheumatology and Connective Tissue Disease, University College London, London, United Kingdom, 16Department of BioMedicine, Division of Rheumatology, Transition Unit, University of Florence, Firenze, Italy, 17University of California, Los Angeles, Los Angeles, CA

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords:

Session Information

Date: Sunday, November 13, 2016

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

Session Type: ACR Poster Session A

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

Background/Purpose: Skin ulcers in SSc are a major clinical challenge and there are various un-validated definitions of skin ulcers utilized in SSc-related clinical trials. We wanted to better delineate a precise definition for skin ulcers in SSc to be used in clinical trials. Objective:  To conduct a systematic literature review (SLR) regarding definitions of  skin ulcers. The results were used to develop a consensus definition for SSc-skin ulcers.

Methods: A systematic literature search for SSc-skin ulcer definitions was conducted in PubMed, Web of Science, and Cochrane for articles published from inception to January 1st, 2016. For better generalizability we included related autoimmune diseases where skin ulcers are seen:  SLE, RA and vasculitis. Diabetic ulcers were also included as more data is available when defining diabetic ulcers. Inclusion criteria were: studies reporting a definition of skin ulcer, adults, English language, skin ulcer as a study outcome, diseases as outlined above. Exclusions included: not in humans, pressure ulcers, reviews and case reports <10 pts. PRISMA recommendations were followed where applicable. The extracted definitions were categorized into relevant descriptive terms (Table 1) and formed the basis for a consensus definition. SSc experts discussed the definitions using a nominal process and voted for the pertinent definition terms, during the Scleroderma World Congress (SWC).  A consensus was attained when agreement was > 70%. Photographs of 11 SSc skin lesions were evaluated before and after definition development to examine the face validity and general feasibility of the definition and to allow further refinement of the definition.

Results:   A total of 3464 publications were screened in abstract and title and 446 articles were fully evaluated. Of these, 66 met eligibility criteria and skin ulcer definitions were extracted. Twelve SSc experts (11 rheumatologists, 1 dermatologist) from North America (n=6) and Europe (n=6) discussed, refined and voted on the consensus definition. Descriptive terms and mitigating factors (site, size etc.) were used to develop our new definition and exclusions were decided for its utilization in clinical trials. The preliminary SWC consensus-derived definition of SSc- skin ulcer for clinical trials is: “ Loss of epidermal covering with a break in the basement membrane (which separates dermis from epidermis). It appears clinically as visible blood vessels, fibrin, granulation tissue and/or underlying deeper structures (e.g. muscle, ligament, fat) or as it would appear on debridement"

Conclusion: Using an SLR and a modified nominal technique, a preliminary consensus-based definition of SSc-skin ulcers was developed. Further validation steps are  warranted.

        Table 1: showing the relevant descriptive terms used in various extracted definitions.  

Disclosure: Y. A. Suliman, None; C. Bruni, None; S. R. Johnson, None; E. Praino, None; M. Alemam, None; N. Borazan, None; L. Cometi, None; B. Myers, None; D. Khanna, None; Y. Allanore, Actelion , pfizer, 9; M. Baron, None; T. Krieg, None; A. L. Herrick, None; S. Kafaja, None; C. Denton, GSK, Celgene, Actelion, Bayer, Sanofi, Roche-Genentech, Inventiva, 5,CSL Behring, GSK, Actelion, Roche-Genentech, Inventiva, 2; M. Matucci Cerinic, None; D. E. Furst, Abbott, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, 2,Abbott, Actelion, Amgen, Bristol-Myers Squibb, Biogen, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, 5,Abbott, Actelion, Amgen, Bristol-Myers Squibb, Biogen, Janssen, Gilead, NIH, Roche/Genentech, 9,Abbott, Actelion, UCB Pharma, 8.

To cite this abstract in AMA style:

Suliman YA, Bruni C, Johnson SR, Praino E, Alemam M, Borazan N, Cometi L, Myers B, Khanna D, Allanore Y, Baron M, Krieg T, Herrick AL, Kafaja S, Denton C, Matucci Cerinic M, Furst DE. Defining Skin Ulcers in Systemic Sclerosis: A Systematic Literature Review of Skin Ulcer Definitions and a Preliminary Consensus-Based New SSc Skin Ulcer Definition [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/defining-skin-ulcers-in-systemic-sclerosis-a-systematic-literature-review-of-skin-ulcer-definitions-and-a-preliminary-consensus-based-new-ssc-skin-ulcer-definition/. Accessed .

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