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Inflammatory gastrointestinal diseases associated with PD-1 blockade antibodies
M Collins1, J M Michot2, F X Danlos2
1Department of Gastroenterology, Kremlin Bicêtre Hospital, Assistance Publique-Hopitaux de Paris, Le Kremlin Bicêtre;; Paris Sud University, Le Kremlin Bicêtre.
Background:
Immune check-point blockade agents have shown clinical activity in cancer patients but are associated with immune-related adverse events that could limit their development. The aim of this study was to describe the gastrointestinal immune-related adverse events (GI-irAE) in patients with cancer treated with anti-PD-1.
Methods:
this is a retrospective study of consecutive adult patients who had a suspected GI-irAE due to anti-PD-1 antibodies between 2013 and 2016. Patients were recruited through a pharmacovigilance registry. Patients' data were reviewed by a multidisciplinary committee that included gastroenterologists, oncologists and a pathologist. Quantitative variables are described by median (range), qualitative variable by frequency (percentage).
Results:
Forty-four patients were addressed to a Gastroenterology unit for a suspected GI-IrAE. Twenty patients had a confirmed GI-irAE related to anti-PD-1, which occurred 4.2 months (0.2; 22.1) after the initiation of anti-PD-1. GI-IrAE incidence rate under anti-PD-1 treatment was estimated to be 1.5%. Among patients with GI-IrAE, main symptoms were diarrhoea (n = 16, 80%), abdominal pain (n = 13, 65%), nausea and vomiting (n = 11, 55%), intestinal obstruction (n = 1, 5%), and haematochezia (n = 2, 10%). No patient had colectomy. Four distinct categories of GI-irAE were observed: acute colitis (n = 8, 40%), microscopic colitis (n = 7, 35%), upper gastrointestinal tract inflammation (n = 4, 20%) and pseudo-obstruction (n = 1, 5%). Response rates to corticosteroids were 87.5% (7/8) in acute colitis, 57% (4/7) in microscopic colitis and 75% (3/4) in upper gastrointestinal tract inflammation. Median time to resolution was 36 days (6-172) in acute colitis, and 98 days (42-226) in microscopic colitis.
Conclusion:
This study suggests that GI-irAE are different and less frequent with anti PD-1 than with anti CTLA-4.
Insights
Immune checkpoint inhibitors like anti-PD-1 can cause gastrointestinal immune-related adverse events (GI-irAE). This study found GI-irAE occurred in 1.5% of patients, with acute colitis being most common and responding well to steroids.
Area of Science:
- Oncology
- Immunology
- Gastroenterology
Background:
- Immune checkpoint blockade agents, such as anti-PD-1, demonstrate clinical efficacy in cancer treatment.
- However, these agents are associated with immune-related adverse events (irAEs) that can impede their development.
- Gastrointestinal irAEs (GI-irAEs) are a significant concern in patients receiving anti-PD-1 therapy.
Purpose of the Study:
- To characterize the incidence, clinical presentation, and outcomes of gastrointestinal immune-related adverse events (GI-irAEs).
- To investigate GI-irAEs specifically in cancer patients treated with anti-PD-1 antibodies.
- To compare the frequency and nature of GI-irAEs with those observed with anti-CTLA-4 therapy.
Main Methods:
- A retrospective study of adult patients with suspected GI-irAEs from anti-PD-1 therapy between 2013 and 2016.
- Patient data were collected via a pharmacovigilance registry and reviewed by a multidisciplinary team.
- Descriptive statistics were used, with quantitative variables presented as median (range) and qualitative variables as frequency (percentage).
Main Results:
- Twenty out of 44 investigated patients (1.5% incidence) had confirmed GI-irAEs related to anti-PD-1 treatment, occurring a median of 4.2 months after initiation.
- The primary symptoms included diarrhea (80%), abdominal pain (65%), and nausea/vomiting (55%).
- The main diagnoses were acute colitis (40%), microscopic colitis (35%), and upper GI inflammation (20%), with corticosteroid response rates ranging from 57% to 87.5%.
Conclusions:
- GI-irAEs associated with anti-PD-1 therapy appear to be less frequent and distinct in presentation compared to those seen with anti-CTLA-4 agents.
- Acute colitis and microscopic colitis are significant GI-irAEs under anti-PD-1 treatment, with varying responses to corticosteroids.
- Further research is warranted to fully understand and manage these events.
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