Immune Checkpoint Inhibitor Data in Metastatic Melanoma with Pre-Existing Autoimmune Disease: A Real World Experience
- 1Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori-IRCCS-Fondazione “G. Pascale”, 80131 Naples, Italy
- 2Dermatology Unit, Department of Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy
- 3Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II, 80131 Naples, Italy
Abstract
Patients with pre-existing autoimmune disease (AID) are underrepresented in trials of immune checkpoint inhibitors (ICIs). We retrospectively compared 41 patients with stage IV melanoma and pre-existing AID with 162 contemporaneous controls without AID who received ICI treatment between November 2016 and April 2023. In the AID and control cohorts, respectively, the objective response rates were 46.3% and 32.7%, and the disease control rates were 80.5% and 51.2%. Treatment interruption attributed to worsening of the baseline AID was recorded in 11/41 patients, while 13/41 interrupted treatment because of toxicity distinct from the baseline AID. The full cohort contributed 114 progression-free survival (PFS) events and 92 deaths. In models adjusted for age, sex, ICI regimen and M category, AID was associated with PFS (adjusted hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.24–0.99; p = 0.046), whereas the association with overall survival (OS) was not statistically significant (adjusted HR 0.63, 95% CI 0.29–1.34; p = 0.232). These findings support the feasibility of ICI therapy in carefully selected patients with clinically stable AID, while the observational design and residual confounding require cautious interpretation of comparative outcomes.
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BibTeX
@article{vitale2026immune,
title = {{Immune Checkpoint Inhibitor Data in Metastatic Melanoma with Pre-Existing Autoimmune Disease: A Real World Experience}},
author = {Maria Grazia Vitale and Domenico Mallardo and Francesca Sparano and Lucia Festino and Vito Vanella and Claudia Trojaniello and Margaret Ottaviano and Eleonora Cioli and Mario Mallardo and Bianca Arianna Facchini and Ester Simeone and Paolo Antonio Ascierto},
journal = {International Journal of Molecular Sciences},
year = {2026},
month = oct,
doi = {10.3390/ijms27198832},
url = {https://www.mdpi.com/1422-0067/27/19/8832},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Immune Checkpoint Inhibitor Data in Metastatic Melanoma with Pre-Existing Autoimmune Disease: A Real World Experience
AU - Maria Grazia Vitale
AU - Domenico Mallardo
AU - Francesca Sparano
AU - Lucia Festino
AU - Vito Vanella
AU - Claudia Trojaniello
AU - Margaret Ottaviano
AU - Eleonora Cioli
AU - Mario Mallardo
AU - Bianca Arianna Facchini
AU - Ester Simeone
AU - Paolo Antonio Ascierto
PY - 2026
DA - 2026/10/03
JO - International Journal of Molecular Sciences
DO - 10.3390/ijms27198832
UR - https://www.mdpi.com/1422-0067/27/19/8832
AB - Patients with pre-existing autoimmune disease (AID) are underrepresented in trials of immune checkpoint inhibitors (ICIs). We retrospectively compared 41 patients with stage IV melanoma and pre-existing AID with 162 contemporaneous controls without AID who received ICI treatment between November 2016 and April 2023. In the AID and control cohorts, respectively, the objective response rates were 46.3% and 32.7%, and the disease control rates were 80.5% and 51.2%. Treatment interruption attributed to worsening of the baseline AID was recorded in 11/41 patients, while 13/41 interrupted treatment because of toxicity distinct from the baseline AID. The full cohort contributed 114 progression-free survival (PFS) events and 92 deaths. In models adjusted for age, sex, ICI regimen and M category, AID was associated with PFS (adjusted hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.24–0.99; p = 0.046), whereas the association with overall survival (OS) was not statistically significant (adjusted HR 0.63, 95% CI 0.29–1.34; p = 0.232). These findings support the feasibility of ICI therapy in carefully selected patients with clinically stable AID, while the observational design and residual confounding require cautious interpretation of comparative outcomes.
SN - 1422-0067
ER -