Characteristics | ICI-duodenitis (n=9) | ICI-celiac disease (n=8) | P value |
Median age at presentation, years (range) | 60 (29–71) | 55 (44–73) | 0.804 |
Sex (F:M) | 5:4 | 2:6 | 0.334 |
Malignancy type, N (%) | |||
Melanoma | 8/9 (89) | 4/8 (50) | 0.131 |
Lung | 0/9 (0) | 2/8 (25) | 0.205 |
Other | 1/9 (11) | 2/8 (25) | 0.576 |
Stage at initiation of ICI | |||
III | 3/9 (33) | 3/8 (37.5) | >0.999 |
IV | 6/9 (67) | 5/8 (62.5) | |
Metastatic sites at ICI initiation | |||
Lung | 3/9 (33) | 3/8 (37.5) | >0.999 |
Liver | 2/9 (22) | 2/8 (25) | |
Brain | 2/9 (22) | 1/8 (12.5) | |
Other | 4/9 (44) | 0/8 (0) | |
None | 3/9 (33) | 3/8 (37.5) | |
History of prior immunotherapy use | 5/9 (56) | 1/8 (12.5) | 0.132 |
Immunotherapy at time of symptom onset, N (%) | |||
α-CTLA-4 | 4/9 (44) | 1/8 (12.5) | 0.294 |
α-PD-(L)1 | 3/9 (33) | 5/8 (62.5) | 0.346 |
Combined therapy | 2/9 (22) | 2/8 (25) | 0.999 |
Autoimmune disease history, N (%) | 0/9 (0) | 0/8 (0) | >0.999 |
Luminal GI disease history | |||
GERD | 4/9 (44) | 3/8 (37.5) | >0.999 |
H.pylori PUD | 0/9 (0) | 0/8 (0) | >0.999 |
IBD | 0/9 (0) | 0/8 (0) | >0.999 |
Celiac disease | 0/9 (0) | 1/8 (12.5) | 0.47 |
Family history of CeD | 0/9 (0) | 2/8 (25) | 0.205 |
The p value was calculated by Student’s t-test and analysis of variance method for numerical covariates and Fisher’s exact for categorical covariates where appropriate. Other malignancy types for immune checkpoint inhibitor-associated duodenitis (ICI-Duo): Hodgkin lymphoma (n=1). Other malignancy types for ICI-CeD: extraskeletal myxoid chondrosarcoma (n=1) and tonsillar squamous cell carcinoma (n=1). Patients with (none) listed for metastatic sites at therapy initiation had stage III disease. Other metastatic sites for ICI-Duo: adrenal gland (n=1), bone (n=2), and peritoneum (n=1). History of prior immunotherapy use was identified as any ICI used prior to the current regimen. Combined therapy denotes that patients recieved ipilimumab and a programmed cell death receptor (ligand)-1 (PD-(L)1) inhibitor as standard of care or on an investigational protocol. Family history of celiac disease denotes CeD in first or second degree relative.
CTLA-4, cytotoxic T cell associated antigen 4; GERD, gastroesophageal reflux disease; GI, gastrointestinal; H.pylori, Helicobacter pylori; IBD, inflammatory bowel disease; PUD, peptic ulcer disease.