Defining D-irAEs: Consensus-based disease definitions for the diagnosis of dermatologic adverse events from immune checkpoint inhibitor therapy Journal Article
| Authors: | Chen, S. T.; Semenov, Y. R.; Alloo, A.; Bach, D. Q.; Betof Warner, A.; Bougrine, A.; Burton, L.; Cappelli, L. C.; Castells, M.; Cohen, J.; Dewan, A. K.; Fadden, R.; Guggina, L.; Hegde, A.; Huang, V.; Johnson, D. B.; Kaffenberger, B.; Kroshinsky, D.; Kwatra, S.; Kwong, B.; Lacouture, M. E.; Larocca, C.; Leventhal, J.; Markova, A.; McDunn, J.; Mooradian, M. J.; Naidoo, J.; Choi, J.; Nambudiri, V.; Nelson, C. A.; Patel, A. B.; Pimkina, J.; Rine, J.; Rubin, K. M.; Sauder, M.; Shaigany, S.; Shariff, A.; Sullivan, R. J.; Zubiri, L.; Reynolds, K. L.; Leboeuf, N. R. |
| Article Title: | Defining D-irAEs: Consensus-based disease definitions for the diagnosis of dermatologic adverse events from immune checkpoint inhibitor therapy |
| Abstract: | With an increasing number of patients eligible for immune checkpoint inhibitors, the incidence of immune-related adverse events (irAEs) is on the rise. Dermatologic immune-related adverse events (D-irAEs) are the most common and earliest to manifest, often with important downstream consequences for the patient. Current guidelines lack clarity in terms of diagnostic criteria for D-irAEs. The goal of this project is to better define D-irAE for the purposes of identification, diagnosis, and future study of this important group of diseases. The objectives of this project were to develop consensus guidance for an approach to D-irAEs including disease definitions and severity grading. Knowing that consensus among oncologists, dermatologists, and irAE subspecialists would be critical for usability, we formed a Dermatologic irAE Disease Definition Panel. The panel was composed of 34 experts, including oncologists, dermatologists, a rheumatologist, and an allergist/immunologist from 22 institutions across the USA and internationally. A modified Delphi consensus process was used, with two rounds of anonymous ratings by panelists and two virtual meetings to discuss areas of controversy. Panelists rated content for usability, appropriateness, and accuracy on 9-point scales in electronic surveys and provided free text comments. A working group aggregated survey responses and incorporated them into revised definitions. Consensus was based on numeric ratings using the RAND/UCLA Appropriateness Method with prespecified definitions. Following revisions based on panelist feedback, all items received consensus in the second round of ratings. Consensus definitions were achieved for 10 core D-irAE diagnoses: ICI-vitiligo, ICI-lichen planus, ICI-psoriasis, ICI-exanthem, ICI-bullous pemphigoid, ICI-Grover's, ICI-eczematous, ICI-eruptive atypical squamous proliferation, ICI-pruritus without rash, and ICI-erosive mucocutaneous. A standard evaluation for D-irAE was also found to reach consensus, with disease-specific exceptions detailed when necessary. Each disorder's description includes further details on disease subtypes, symptoms, supportive exam findings, and three levels of diagnostic certainty (definite, probable, and possible). These consensus-driven disease definitions standardize D-irAE classification in a useable framework for multiple disciplines and will be the foundation for future work. Given consensus on their accuracy and usability from a representative panel group, we anticipate that they can be used broadly across clinical and research settings. © 2024 BMJ Publishing Group. All rights reserved. |
| Keywords: | diagnostic accuracy; consensus; skin biopsy; skin defect; sun exposure; incidence; inflammation; practice guideline; immunofluorescence; enzyme linked immunosorbent assay; psoriasis; pruritus; rash; maculopapular rash; immunotherapy; immunoglobulin g; skin examination; erythema; lichen planus; delphi study; daily life activity; liver function test; corticosteroid; autoantibody; immunosuppressive treatment; paraneoplastic syndrome; radioimmunotherapy; genetic counseling; exanthema; guidelines as topic; delayed hypersensitivity; depigmentation; adverse event; thyroxine; vitiligo; eosinophil count; tendon reflex; oncologist; oncologists; atopic dermatitis; atopy; immune checkpoint inhibitor; eczema; humans; human; article; psoriatic arthritis; immune checkpoint inhibitors; bullous pemphigoid; checkpoint inhibitor therapy; joint examination; transient acantholytic dermatosis |
| Journal Title: | Journal for ImmunoTherapy of Cancer |
| Volume: | 12 |
| Issue: | 4 |
| ISSN: | 2051-1426 |
| Publisher: | Biomed Central Ltd |
| Date Published: | 2024-04-01 |
| Start Page: | e007675 |
| Language: | English |
| DOI: | 10.1136/jitc-2023-007675 |
| PUBMED: | 38599660 |
| PROVIDER: | scopus |
| PMCID: | PMC11015215 |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PubMed and PDF -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
MSK Authors
-
86Markova -
76Betof Warner
Related MSK Work