Ipilimumab Therapy in Patients With Advanced Melanoma and Preexisting Autoimmune Disorders.
Abstract | IMPORTANCE: 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: 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:
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Authors | Douglas B Johnson, Ryan J Sullivan, Patrick A Ott, Matteo S Carlino, Nikhil I Khushalani, Fei Ye, Alexander Guminski, Igor Puzanov, Donald P Lawrence, Elizabeth I Buchbinder, Tejaswi Mudigonda, Kristen Spencer, Carolin Bender, Jenny Lee, Howard L Kaufman, Alexander M Menzies, Jessica C Hassel, Janice M Mehnert, Jeffrey A Sosman, Georgina V Long, Joseph I Clark |
Journal | JAMA oncology
(JAMA Oncol)
Vol. 2
Issue 2
Pg. 234-40
(Feb 2016)
ISSN: 2374-2445 [Electronic] United States |
PMID | 26633184
(Publication Type: Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
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Chemical References |
- Antibodies, Monoclonal
- Antineoplastic Agents
- Ipilimumab
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Autoimmune Diseases
(complications, diagnosis, immunology)
- Autoimmunity
- Female
- Humans
- Ipilimumab
- Male
- Melanoma
(drug therapy, immunology, pathology)
- Middle Aged
- Patient Selection
- Retrospective Studies
- Risk Assessment
- Risk Factors
- Skin Neoplasms
(drug therapy, immunology, pathology)
- Tertiary Care Centers
- Time Factors
- Treatment Outcome
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