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Ipilimumab Therapy in Patients With Advanced Melanoma and Preexisting Autoimmune Disorders
Abstract
IMPORTANCE: Ipilimumab and other immune therapies are effective treatment options for patients with advanced melanoma but cause frequent immune-related toxic effects. Autoimmune diseases are common, and the safety and efficacy of ipilimumab therapy in patients with preexisting autoimmune disorders is not known. OBJECTIVE: To determine the safety and efficacy of ipilimumab therapy in patients with advanced melanoma with preexisting autoimmune disorders. DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of patients with advanced melanoma and preexisting autoimmune disorders who received ipilimumab at 9 academic tertiary referral centers from January 1, 2012, through August 1, 2015. The data analysis was performed on August 24, 2015. EXPOSURE: Ipilimumab therapy. MAIN OUTCOMES AND MEASURES: Safety, in terms of frequency of autoimmune flares and conventional immune-related adverse events (irAEs), and efficacy, in terms of response rates and overall survival, were evaluated descriptively. RESULTS: Of the 30 patients who received ipilimumab (17 [57%] male; median [range] age, 59.5 [30-80] y), 6 had rheumatoid arthritis, 5 had psoriasis, 6 had inflammatory bowel disease, 2 had systemic lupus erythematosus, 2 had multiple sclerosis, 2 had autoimmune thyroiditis, and 7 had other conditions. Thirteen patients (43%) were receiving immunosuppressive therapy at the time of initiation of ipilimumab therapy, most commonly low-dose prednisone or hydroxychloroquine. With ipilimumab treatment, 8 patients (27%) experienced exacerbations of their autoimmune condition necessitating systemic treatment; all were managed with corticosteroids. Conventional grade 3 to 5 irAEs occurred in 10 patients (33%) and were reversible with corticosteroids or with infliximab therapy in 2 cases. One patient with baseline psoriasis died of presumed immune-related colitis after a 1-week delay prior to reporting symptoms. Fifteen patients (50%) had neither autoimmune disease flares nor irAEs. Six patients experienced an objective response (20%), including 1 with a durable complete response. CONCLUSIONS AND RELEVANCE: To our knowledge, this is the largest series of patients with preexisting autoimmune disease treated with immune checkpoint inhibitors. Ipilimumab was clinically active and was associated with exacerbations of autoimmune disease and conventional ipilimumab-induced irAEs that were readily manageable with standard therapies when started in a timely fashion. Ipilimumab therapy may be considered in this setting with vigilant clinical monitoring.
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“Possible risk factors for ICI-related hepatotoxicity include organ transplantation, comorbidity with autoimmune disease, history of ICI-induced irAEs, high doses of ICIs (particularly cytotoxic T-lymphocyte antigen 4 inhibitors), combination therapy with multiple ICIs, or a combination of an ICI with targeted therapy [165][166][167].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [165]
In the citing paper
“Incidence of endocrine events varies based on type of ICI used (see Figure 2).38”
From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [38]
In the citing paper
“Thyroid events occur in approximately 10% of patients treated with anti-PD-1/PD-L1 monotherapy, and up to 15-20% of those treated with combination PD-1/CTLA-4 blockade (as opposed to only 5% of those treated with ipilimumab monotherapy).9,38”
From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [38]
In the citing paper
“hypophysitis or hypopituitarism occurs in up to 10% of patients who receive anti-CTLA-4 based therapy (either with ipilimumab monotherapy, and slightly more commonly with combination CTLA-4/PD-1 blockade).38”
From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [38]
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Metadata
- Authors
- Johnson, D. B., Sullivan, R. J., Ott, P. A., Carlino, M. S., Khushalani, N. I., Ye, F., Guminski, A., Puzanov, I., Lawrence, D. P., Buchbinder, E. I., Mudigonda, T., Spencer, K., Bender, C., Lee, J., Kaufman, H. L., Menzies, A. M., Hassel, J. C., Mehnert, J. M., Sosman, J. A., Long, G. V., & Clark, J. I.
- Affiliations
- Vanderbilt University Medical Center (US)
- Massachusetts General Hospital (US)
- Dana-Farber Cancer Institute (US)
- The University of Sydney (AU)
- Roswell Park Comprehensive Cancer Center (US)
- Rutgers Cancer Institute (US)
- University Hospital Heidelberg (DE)
- Westmead Hospital (AU)
- Loyola University Medical Center (US)
- Corresponding author
- Johnson, Douglas B.
- ORCID
- Johnson, Douglas B.
- Sullivan, Ryan J.
- Ott, Patrick A.
- Carlino, Matteo S.
- Khushalani, Nikhil I.
- Ye, Fei
- Guminski, Alexander
- Puzanov, Igor
- Lawrence, Donald P.
- Buchbinder, Elizabeth I.
- Spencer, Kristen
- Bender, Carolin
- Lee, Jenny
- Kaufman, Howard L.
- Menzies, Alexander M.
- Hassel, Jessica C.
- Mehnert, Janice M.
- Sosman, Jeffrey A.
- Long, Georgina V.
- Clark, Joseph I.
- Venue
- JAMA Oncology
- Publisher
- American Medical Association (AMA)
- Published
- 2016-02-01
- Volume
- 2
- Issue
- 2
- Pages
- 234
- ISSN
- 2374-2437 (ISSN-L)
- OpenAlex
- W2193769500
- Cited by
- 642
- References
- 30
- Citations by year
- 2026: 13 · 2025: 29 · 2024: 49 · 2023: 44 · 2022: 64 · 2021: 73 · 2020: 94 · 2019: 93 · 2018: 65 · 2017: 68 · 2016: 47
- FWCI
- 26.20
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Cancer Institute (K12 CA 0906525, K12CA090625)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- ipilimumab, advanced melanoma, immune-related adverse events, immune-related colitis, immune-related pneumonitis, immune-related hepatitis, immune-related endocrinopathy, immune-related dermatitis, immune checkpoint inhibitors, immunosuppressive therapy, rheumatoid arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus
- MeSH terms
- Ipilimumab, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Autoimmune Diseases, Female, Humans, Male, Melanoma, Middle Aged, Retrospective Studies, Risk Factors, Skin Neoplasms, Time Factors, Autoimmunity, Treatment Outcome, Risk Assessment, Patient Selection, Tertiary Care Centers
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