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Eligibility Criteria for Active Ulcerative Pyoderma Gangrenosum in Clinical Trials: A Delphi Consensus on Behalf of the Upgrade (Understanding Pyoderma Gangrenosum: Review and Assessment of Disease Effects) Group Publisher Pubmed



Kamal K1, 2 ; Xia E1, 3 ; Li SJ1, 4 ; Alavi A5 ; Cogen AL6 ; Firooz A7 ; Marzano AV8, 9 ; Kaffenberger BH10 ; Sibbald C11 ; Fernandez AP12, 13 ; Callen JP14 ; Dissemond J15 ; Gontijo JRV16 ; Shams K17 Show All Authors
Authors
  1. Kamal K1, 2
  2. Xia E1, 3
  3. Li SJ1, 4
  4. Alavi A5
  5. Cogen AL6
  6. Firooz A7
  7. Marzano AV8, 9
  8. Kaffenberger BH10
  9. Sibbald C11
  10. Fernandez AP12, 13
  11. Callen JP14
  12. Dissemond J15
  13. Gontijo JRV16
  14. Shams K17
  15. Gerbens LA18
  16. French LE19, 20
  17. Gould LJ21
  18. Bissonnette R22
  19. Shaigany S23
  20. Tolkachjov S24, 25, 26, 27
  21. Yamamoto T28
  22. Weiting Huang W29
  23. Ortegaloayza AG30
  24. Mostaghimi A1
Show Affiliations
Authors Affiliations
  1. 1. Department of Dermatology, Brigham and Women's Hospital, Boston, MA, United States
  2. 2. Harvard Medical School, Boston, MA, United States
  3. 3. Boston University School of Medicine, Boston, MA, United States
  4. 4. Tufts Univeresity School of Medicine, Boston, MA, United States
  5. 5. Department of Dermatology, Mayo Clinic, Rochester, MN, United States
  6. 6. Divison of Dermatology, University of Washington, Seattle, WA, United States
  7. 7. Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran
  8. 8. Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
  9. 9. Department of Pathophysiology and Transplantation, Universita degli Studi di Milano, Milan, Italy
  10. 10. Department of Dermatology, Wexner Medical Center, The Ohio State University, Columbus, OH, United States
  11. 11. Division of Pediatric Dermatology, The Hospital for Sick Children, University of Toronto, Toronto, Canada
  12. 12. Department of Dermatology, Cleveland Clinic, Cleveland, OH, United States
  13. 13. Department of Pathology, Cleveland Clinic, Cleveland, OH, United States
  14. 14. Division of Dermatology, University of Louisville School of Medicine, Louisville, KY, United States
  15. 15. Department of Dermatology, Venereology and Allergology, University Medical Center Essen, Essen, Germany
  16. 16. Dermatology Unit, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
  17. 17. Inflammatory Skin Disease Group, Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom
  18. 18. Department of Dermatology, Amsterdam UMC, location Academic Medical Center, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, Netherlands
  19. 19. Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University (LMU) Munich, Munich, Germany
  20. 20. Dr. Philip Frost Department of Dermatology and Cutaneous Surgery, Miller School of Medicine, University of Miami, Miami, FL, United States
  21. 21. Department of Surgery, South Shore Hospital, South Weymouth, MA, United States
  22. 22. Innovaderm Research, Montreal, Canada
  23. 23. Department of Dermatology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States
  24. 24. Epiphany Dermatology, Dallas, TX, United States
  25. 25. Department of Dermatology, University of Texas at Southwestern, Dallas, TX, United States
  26. 26. Texas A&M College of Medicine, Dallas, TX, United States
  27. 27. Baylor University Medical Center, Dallas, TX, United States
  28. 28. Department of Dermatology, Fukushima Medical University, Fukushima, Japan
  29. 29. Department of Dermatology, Wake Forest University School of Medicine, Winston Salem, NC, United States
  30. 30. Department of Dermatology, Oregon Health & Science University, Portland, OR, United States

Source: Journal of Investigative Dermatology Published:2024


Abstract

At present, there are no standardized guidelines for determining patient eligibility for pyoderma gangrenosum (PG) clinical trials. Thus, we aim to determine which clinical features, histopathological features, or laboratory features should be included in active ulcerative PG clinical trial eligibility criteria for treatment-naive patients and patients already treated with immunomodulating medications (treatment-exposed patients). This study employed 4 rounds of the Delphi technique. Electronic surveys were administered to 21 international board-certified dermatologists and plastic surgeon PG experts (June 2022–December 2022). Our results demonstrated that for a patient to be eligible for a PG trial, they must meet the following criteria: (i) presence of ulcer(s) with erythematous/violaceous undermining wound borders, (ii) presence of a painful or tender ulcer, (iii) history/presence of rapidly progressing disease, (iv) exclusion of infection and other causes of cutaneous ulceration, (v) biopsy for H&E staining, and (vi) a presence/history of pathergy. These criteria vary in importance for treatment-naive versus treatment-exposed patients. Given the international cohort, we were unable to facilitate live discussions between rounds. This Delphi consensus study provides a set of specific, standardized eligibility criteria for PG clinical trials, thus addressing one of the main issues hampering progress toward Food and Drug Administration approval of medications for PG. © 2023 The Authors
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