Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab

Combination CTLA-4 (ipilimumab) and PD-1 (nivolumab) checkpoint inhibition (dual-ICI) improves survival in patients with advanced melanoma. However, many patients also experience immune-related adverse events (irAE) that require systemic treatment with corticosteroids. Corticosteroids dampen the ant...

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Main Authors: Hifaa Al Remawi, Maria Lindén, Zhiyuan Zhao, Ankur Pandita, Anna Rudin, Lars Ny, Sara Bjursten, Max Levin
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:OncoImmunology
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Online Access:https://www.tandfonline.com/doi/10.1080/2162402X.2025.2543510
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author Hifaa Al Remawi
Maria Lindén
Zhiyuan Zhao
Ankur Pandita
Anna Rudin
Lars Ny
Sara Bjursten
Max Levin
author_facet Hifaa Al Remawi
Maria Lindén
Zhiyuan Zhao
Ankur Pandita
Anna Rudin
Lars Ny
Sara Bjursten
Max Levin
author_sort Hifaa Al Remawi
collection DOAJ
description Combination CTLA-4 (ipilimumab) and PD-1 (nivolumab) checkpoint inhibition (dual-ICI) improves survival in patients with advanced melanoma. However, many patients also experience immune-related adverse events (irAE) that require systemic treatment with corticosteroids. Corticosteroids dampen the anti-tumoral response and may impair survival. Here, we investigated the association between irAE and overall survival as well as exposure to corticosteroids and second line immunosuppressants in dual ICI-treated patients with advanced melanoma (n = 205). Patients with irAE (n = 113) had superior OS compared to patients with no irAE (n = 92). The survival benefit persisted after adjusting for immortal time bias. Regarding specific irAE, patients with colitis, hepatitis, rheumatic irAE, hypophysitis, and skin-related irAE had improved OS after adjusting for negative baseline factors. A survival benefit persisted for hypophysitis (p = 0.03) and hepatitis (p = 0.04) after adjusting for immortal time bias, whereas rheumatic (p = 0.05) and skin-related irAE (p = 0.06) where borderline significant. Hepatitis and colitis required higher doses of corticosteroids for longer times and more often second-line immunosuppression compared to other irAE. In conclusion, irAE are associated with superior OS in patients with advanced melanoma treated with dual ICI. Hepatitis and hypophysitis were most strongly associated with better survival outcomes. Studies investigating the mechanisms underlying hepatitis and hypophysitis may identify important response mechanisms.
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spelling doaj-art-a5b056b06d0947428fd753ff915d867a2025-08-20T03:39:19ZengTaylor & Francis GroupOncoImmunology2162-402X2025-12-0114110.1080/2162402X.2025.2543510Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumabHifaa Al Remawi0Maria Lindén1Zhiyuan Zhao2Ankur Pandita3Anna Rudin4Lars Ny5Sara Bjursten6Max Levin7Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenCombination CTLA-4 (ipilimumab) and PD-1 (nivolumab) checkpoint inhibition (dual-ICI) improves survival in patients with advanced melanoma. However, many patients also experience immune-related adverse events (irAE) that require systemic treatment with corticosteroids. Corticosteroids dampen the anti-tumoral response and may impair survival. Here, we investigated the association between irAE and overall survival as well as exposure to corticosteroids and second line immunosuppressants in dual ICI-treated patients with advanced melanoma (n = 205). Patients with irAE (n = 113) had superior OS compared to patients with no irAE (n = 92). The survival benefit persisted after adjusting for immortal time bias. Regarding specific irAE, patients with colitis, hepatitis, rheumatic irAE, hypophysitis, and skin-related irAE had improved OS after adjusting for negative baseline factors. A survival benefit persisted for hypophysitis (p = 0.03) and hepatitis (p = 0.04) after adjusting for immortal time bias, whereas rheumatic (p = 0.05) and skin-related irAE (p = 0.06) where borderline significant. Hepatitis and colitis required higher doses of corticosteroids for longer times and more often second-line immunosuppression compared to other irAE. In conclusion, irAE are associated with superior OS in patients with advanced melanoma treated with dual ICI. Hepatitis and hypophysitis were most strongly associated with better survival outcomes. Studies investigating the mechanisms underlying hepatitis and hypophysitis may identify important response mechanisms.https://www.tandfonline.com/doi/10.1080/2162402X.2025.2543510CTLA-4 inhibitorimmune-related adverse eventsmelanomaPD-1 inhibitorsurvival
spellingShingle Hifaa Al Remawi
Maria Lindén
Zhiyuan Zhao
Ankur Pandita
Anna Rudin
Lars Ny
Sara Bjursten
Max Levin
Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab
OncoImmunology
CTLA-4 inhibitor
immune-related adverse events
melanoma
PD-1 inhibitor
survival
title Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab
title_full Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab
title_fullStr Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab
title_full_unstemmed Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab
title_short Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab
title_sort immune related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab
topic CTLA-4 inhibitor
immune-related adverse events
melanoma
PD-1 inhibitor
survival
url https://www.tandfonline.com/doi/10.1080/2162402X.2025.2543510
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