Table 1

Demographics and baseline characteristics

CharacteristicsICI-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)5:42:60.334
Malignancy type, N (%)
 Melanoma8/9 (89)4/8 (50)0.131
 Lung0/9 (0)2/8 (25)0.205
 Other1/9 (11)2/8 (25)0.576
Stage at initiation of ICI
 III3/9 (33)3/8 (37.5)>0.999
 IV6/9 (67)5/8 (62.5)
Metastatic sites at ICI initiation
 Lung3/9 (33)3/8 (37.5)>0.999
 Liver2/9 (22)2/8 (25)
 Brain2/9 (22)1/8 (12.5)
 Other4/9 (44)0/8 (0)
 None3/9 (33)3/8 (37.5)
History of prior immunotherapy use5/9 (56)1/8 (12.5)0.132
Immunotherapy at time of symptom onset, N (%)
 α-CTLA-44/9 (44)1/8 (12.5)0.294
 α-PD-(L)13/9 (33)5/8 (62.5)0.346
 Combined therapy2/9 (22)2/8 (25)0.999
Autoimmune disease history, N (%)0/9 (0)0/8 (0)>0.999
Luminal GI disease history
 GERD4/9 (44)3/8 (37.5)>0.999
 H.pylori PUD0/9 (0)0/8 (0)>0.999
 IBD0/9 (0)0/8 (0)>0.999
 Celiac disease0/9 (0)1/8 (12.5)0.47
Family history of CeD0/9 (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.