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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

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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