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Introduction <p>Dermatologic toxicities represent a broad and heterogeneous group of immune-related adverse events (irAEs) in patients with melanoma treated with immunotherapy, ranging from mild, transient, and self-limiting reactions to severe and potentially life-threatening conditions. Certain dermatologic toxicities have been shown to reflect immune system activation and may influence decisions on treatment continuation. The objective of this study was to comprehensively analyse real-world evidence in order to characterise the frequency, time to onset, and spectrum of dermatologic toxicities in patients with melanoma treated with immunotherapy.</p> Materials and Methods <p>A systematic literature search was conducted in the PubMed and EBSCO (MEDLINE Complete) databases to identify relevant reports published between January 2014 and December 2024. Case reports and letters describing skin toxicities in adult patients with melanoma undergoing immunotherapy were included.</p> Results <p>A total of 18 patients with melanoma who had experienced dermatologic immune-related adverse events (d-irAEs) were identified. Breslow thickness ranged from 0.85 to 5.1&#xa0;mm. The most frequently administered treatment was anti-PD-1 monotherapy. All reported cases involved metastatic disease (18/18, 100%; 95%&#xa0;CI 81.47–100%). Autoimmune bullous disorders were the most common toxicities (27.8%; 95%&#xa0;CI 9.69–53.48%). The&#xa0;median time to onset was 14&#xa0;weeks (IQR 23.5&#xa0;weeks; Q1 3.75&#xa0;weeks; Q3 27.3&#xa0;weeks). Disease progression or patient death occurred in 12 of 18 cases (66.7%; 95%&#xa0;CI 40.99–86.66%).</p> Conclusion <p>The increasing prevalence of immunotherapy is accompanied by a paucity of real-world data, particularly with regard to mild-to-moderate skin toxicities. This underreporting emphasises the necessity for systematic documentation to more accurately define the true clinical burden of these events and to provide more personalised management strategies for patients with melanoma.</p>

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Real-World Cutaneous Immune-Related Adverse Events of Immunotherapy in Melanoma: A Systematic Review and Meta-Analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月6日

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  • Karolina Zarańska,
  • Grażyna Kamińska-Winciorek,
  • Alexander Jorge Cortez,
  • Grażyna Wąsik,
  • Maksymilian Gajda

摘要

Introduction

Dermatologic toxicities represent a broad and heterogeneous group of immune-related adverse events (irAEs) in patients with melanoma treated with immunotherapy, ranging from mild, transient, and self-limiting reactions to severe and potentially life-threatening conditions. Certain dermatologic toxicities have been shown to reflect immune system activation and may influence decisions on treatment continuation. The objective of this study was to comprehensively analyse real-world evidence in order to characterise the frequency, time to onset, and spectrum of dermatologic toxicities in patients with melanoma treated with immunotherapy.

Materials and Methods

A systematic literature search was conducted in the PubMed and EBSCO (MEDLINE Complete) databases to identify relevant reports published between January 2014 and December 2024. Case reports and letters describing skin toxicities in adult patients with melanoma undergoing immunotherapy were included.

Results

A total of 18 patients with melanoma who had experienced dermatologic immune-related adverse events (d-irAEs) were identified. Breslow thickness ranged from 0.85 to 5.1 mm. The most frequently administered treatment was anti-PD-1 monotherapy. All reported cases involved metastatic disease (18/18, 100%; 95% CI 81.47–100%). Autoimmune bullous disorders were the most common toxicities (27.8%; 95% CI 9.69–53.48%). The median time to onset was 14 weeks (IQR 23.5 weeks; Q1 3.75 weeks; Q3 27.3 weeks). Disease progression or patient death occurred in 12 of 18 cases (66.7%; 95% CI 40.99–86.66%).

Conclusion

The increasing prevalence of immunotherapy is accompanied by a paucity of real-world data, particularly with regard to mild-to-moderate skin toxicities. This underreporting emphasises the necessity for systematic documentation to more accurately define the true clinical burden of these events and to provide more personalised management strategies for patients with melanoma.