Katharina C Kähler1, Thomas K Eigentler2, Anja Gesierich3, Lucie Heinzerling4, Carmen Loquai5, Friedegund Meier6, Frank Meiss7, Claudia Pföhler8, Max Schlaak9, Patrick Terheyden10, Kai M Thoms11, Mirjana Ziemer12, Lisa Zimmer13, Ralf Gutzmer14. 1. Department of Dermatology, Campus Kiel, University Hospital Schleswig-Holstein (UKSH), Rosalind-Franklind-Str. 7, 24105, Kiel, Germany. kkaehler@dermatology.uni-kiel.de. 2. Department of Dermatology, Eberhard-Karls University of Tübingen, Tübingen, Germany. 3. Department of Dermatology, University Hospital Würzburg, Würzburg, Germany. 4. Department of Dermatology, University Hospital Erlangen, Erlangen, Germany. 5. Department of Dermatology, University Medical Center of Mainz, Mainz, Germany. 6. Department of Dermatology, University of Dresden, Dresden, Germany. 7. Department of Dermatology, Medical Center - Faculty of Medicine, University of Freiburg, Freiburg, Germany. 8. Department of Dermatology, Saarland University Medical School, Homburg/saar, Germany. 9. Department of Dermatology, Skin Cancer Center at Center of Integrated Oncology (CIO), University Hospital Cologne, Cologne-Bonn, Germany. 10. Department of Dermatology, Campus LübeckUniversity, Hospital (UKSH), Lübeck, Germany. 11. Department of Dermatology, University Medical Center Göttingen, Göttingen, Germany. 12. Department of Dermatology, University Hospital Leipzig, Leipzig, Germany. 13. Department of Dermatology, Essen, Germany and German Cancer Consortium (DKTK), University Duisburg-Essen, University Hospital Essen, Heidelberg, Germany. 14. Department of Dermatology and Allergy, Skin Cancer Center Hannover, Hannover Medical School, Hanover, Germany.
Abstract
BACKGROUND: Ipilimumab and programmed death (PD) 1-antibodies are effective treatment options in metastatic melanoma. The safety and efficacy of ipilimumab in patients with pre-existing autoimmune disorders (AD) has only been evaluated in a selected number of patients. METHODS: We performed a retrospective analysis in 14 German skin cancer centers for patients with metastatic melanoma and pre-existing AD treated with ipilimumab. RESULTS: 41 patients with 44 pre-existing AD were treated with ipilimumab (thyroiditis n = 15, rheumatoid n = 11, dermatologic n = 10, Crohn's disease/ulcerative colitis n = 3, neurological n = 2, sarcoidosis n = 2, pancreatitis n = 1). 3 out of 41 patients had two AD, 11 patients required immunosuppressants at the time of induction of ipilimumab. 12 patients (29.2%) experienced a flare of their pre-existing AD, mainly patients with rheumatoid or dermatologic diseases. Additional immune-related adverse events (irAEs) occurred in 12 patients (29.2%). In 23 patients (56%) neither a change of their AD nor additional irAEs were observed. Objective responses were seen in five patients (one complete remission, four partial remissions, 12.1%). CONCLUSION: This is the largest series of patients with pre-existing AD and treatment with ipilimumab reported. Flares of pre-existing AD were observed but manageable. Response rates and occurrence of new irAEs were comparable to previous trials. Thus, in this patient subgroup, ipilimumab can be a treatment option after a thorough discussion of pros and cons and taking severity and activity of the preexisting AD into account.
BACKGROUND:Ipilimumab and programmed death (PD) 1-antibodies are effective treatment options in metastatic melanoma. The safety and efficacy of ipilimumab in patients with pre-existing autoimmune disorders (AD) has only been evaluated in a selected number of patients. METHODS: We performed a retrospective analysis in 14 German skin cancer centers for patients with metastatic melanoma and pre-existing AD treated with ipilimumab. RESULTS: 41 patients with 44 pre-existing AD were treated with ipilimumab (thyroiditis n = 15, rheumatoid n = 11, dermatologic n = 10, Crohn's disease/ulcerative colitis n = 3, neurological n = 2, sarcoidosis n = 2, pancreatitis n = 1). 3 out of 41 patients had two AD, 11 patients required immunosuppressants at the time of induction of ipilimumab. 12 patients (29.2%) experienced a flare of their pre-existing AD, mainly patients with rheumatoid or dermatologic diseases. Additional immune-related adverse events (irAEs) occurred in 12 patients (29.2%). In 23 patients (56%) neither a change of their AD nor additional irAEs were observed. Objective responses were seen in five patients (one complete remission, four partial remissions, 12.1%). CONCLUSION: This is the largest series of patients with pre-existing AD and treatment with ipilimumab reported. Flares of pre-existing AD were observed but manageable. Response rates and occurrence of new irAEs were comparable to previous trials. Thus, in this patient subgroup, ipilimumab can be a treatment option after a thorough discussion of pros and cons and taking severity and activity of the preexisting AD into account.
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