Cited by 300Cancer Immunotherapy and BiomarkersPharmacovigilance and Adverse Drug ReactionsT-cell and B-cell Immunology

Safety and efficacy of anti-programmed death 1 antibodies in patients with cancer and pre-existing autoimmune or inflammatory disease

Danlos, François-Xavier, Voisin, Anne-Laure, Dyevre, Valérie, Michot, Jean-Marie, Routier, Emilie, Taillade, Laurent, Champiat, Stéphane, Aspeslagh, Sandrine +13 more·2018·European Journal of Cancer

Abstract

Objective Patients with autoimmune or inflammatory disease (AID) are susceptible to immune-related adverse events (irAEs) when treated with immune check-point inhibitors (ICIs). We decided to analyse the safety and effectiveness of anti-PD-1 antibodies in AID patients and look for an association between the presence of pre-existing AID and the clinical outcome.Methods In a prospective study of the REISAMIC registry of grade ≥2 irAEs occurring in ICI-treated patients, we studied the associations between pre-existing AID on one hand and irAE-free survival, overall survival and best objective response rate on the other.Results We identified 45 patients with 53 AIDs in REISAMIC. The cancer diagnoses included melanoma (n = 36), non-small-cell lung cancer (n = 6) and others (n = 3). The most frequent pre-existing AIDs were vitiligo (n = 17), psoriasis (n = 12), thyroiditis (n = 7), Sjögren syndrome (n = 4) and rheumatoid arthritis (n = 2). Twenty patients (44.4%) presented with at least one irAE: eleven of these were associated with a pre-existing AID ('AID flare'). Treatment with anti-PD-1 antibodies was maintained in 15 of the 20 patients with an irAE. The IrAE-free survival time was significantly shorter in AID patients (median: 5.4 months) than in AID-free patients (median: 13 months, p = 2.1 × 10-4). The AID and AID-free groups did not differ significantly with regard to the overall survival time and objective response rate (p = 0.38 and 0.098, respectively).Conclusion In patients treated with anti-PD-1 antibody, pre-existing AID was associated with a significantly increased risk of irAEs. Our results indicate that cancer treatments with anti-PD-1 antibodies are just as effective in AID patients as they are in AID-free patients.

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Crossref · 10.1016/j.ejca.2017.12.008

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  • A pre-existing AID was associated with a significantly increased risk of irAEs in that prospective study.

    “Nonetheless, a pre-existing AID was associated with a significantly increased risk of irAEs [53].”
  • A prospective study of 45 patients showed that overall survival time and objective response rates did not differ between patients with a pre-existing AID and patients without when treated with anti-PD-1 antibodies.

    “A prospective study of 45 patients has shown that overall survival time and objective response rates did not differ between patients with a pre-existing AID and patients without a pre-existing AID when treated with anti-PD-1 antibodies.”

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Authors
Danlos, F.-X., Voisin, A.-L., Dyevre, V., Michot, J.-M., Routier, E., Taillade, L., Champiat, S., Aspeslagh, S., Haroche, J., Albiges, L., Massard, C., Girard, N., Dalle, S., Besse, B., Laghouati, S., Soria, J.-C., Mateus, C., Robert, C., Lanoy, E., Marabelle, A., & Lambotte, O.
Affiliations
  • Université Paris-Saclay (FR)
  • Institut Gustave Roussy (FR)
  • Assistance Publique – Hôpitaux de Paris (FR)
  • Lyon 1 Université (FR)
  • Université de Lyon (FR)
  • Inserm (FR)
  • Université Paris-Sud (FR)
Corresponding author
Lambotte, Olivier
Venue
European Journal of Cancer
Publisher
Elsevier BV
Published
2018-03
Volume
91
Pages
21-29
ISSN
0959-8049 (ISSN-L)
OpenAlex
W2784120148
Cited by
300
References
35
Citations by year
2026: 14 · 2025: 19 · 2024: 38 · 2023: 26 · 2022: 40 · 2021: 53 · 2020: 55 · 2019: 35 · 2018: 19
FWCI
15.19
Type
journal article
Language
en
Open access
closed
Locations
  • European Journal of Cancer (publishedVersion)
  • PubMed (publishedVersion)
  • VUBIR (Vrije Universiteit Brussel) (submittedVersion)
Topics
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
Keywords
anti-PD-1, immune checkpoint inhibitors, immune-related adverse events, inflammatory diseases, melanoma, non-small cell lung cancer, vitiligo, psoriasis, thyroiditis, Sjögren's syndrome, rheumatoid arthritis, treatment safety, treatment efficacy
MeSH terms
Antineoplastic Agents, Immunological, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Autoimmune Diseases, Female, France, Humans, Inflammation, Male, Middle Aged, Neoplasms, Prospective Studies, Registries, Risk Factors, Time Factors, Treatment Outcome, Disease-Free Survival, Young Adult, Programmed Cell Death 1 Receptor

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