Table 3.
Immune checkpoint inhibitor-associated duodenitis (ICI-Duo) and ICI-celiac disease (CeD) treatment and survival
| Characteristics | ICI-Duo (n=9) | ICI-CeD (n=8) | P value |
| Remission-inducing therapy | |||
| GFD | 0/9 (0%) | 5/8 (62.5%) | 0.009 |
| Immunosuppression | 9/9 (100%) | 1/8 (12.5%) | 0.0004 |
| GFD + immunosuppression | 0/9 (0%) | 2/8 (25%) | 0.205 |
| Total duration on steroids if used (weeks) | |||
| Mean±SD | 9.50±3.26 (n=8) | 32.19±25.36 (n=3) | 0.261 |
| Number of steroid tapering attempts | |||
| 0 | 1/9 (11%) | 5/8 (62.5%) | 0.049 |
| 1 | 5/9 (56%) | 1/8 (12.5%) | 0.131 |
| 2 | 2/9 (22%) | 0/8 (0%) | 0.47 |
| >2 | 1/9 (11%) | 2/8 (25%) | 0.576 |
| Doses of infliximab to remission (mean) | 3 (n=4) | 1 (n=1) | N/A |
| Remission TTG IgA | |||
| Mean±SD | N/A | 37.9±57.87 (n=5) | N/A |
| Median | 5.5 | ||
| Remission IgA | |||
| Mean±SD | N/A | 155.0±57.17 (n=3) | N/A |
| Median | 173 | ||
| Need to discontinue immunotherapy, N (%) | 6/9 (67) | 2/8 (25) | 0.153 |
| Number of additional ICI doses received after onset of symptoms | |||
| Mean±SD | 0.44±0.73 | 1.38±1.69 | 0.151 |
| Median (range) | 0 (0–2) | 1 (0–5) | |
| Malignancy restaging (best response) | |||
| Complete response/relapse-free | 4/9 (44%) | 3/8 (37.5%) | >0.999 |
| Objective response/partial response | 1/9 (11%) | 2/8 (25%) | 0.576 |
| Stable disease | 0/9 (0%) | 0/8 (0%) | >0.999 |
| Progressive disease/relapsed | 4/9 (44%) | 3/8 (37.5%) | >0.999 |
| Progression-free survival (months) |
Mean: 11±11.29; | Mean: 13.75±16.39; | 0.689 |
| Median: 7; range: 1–29 | Median: 7; range: 1–47 | ||
| Overall survival (months) |
Mean: 22.44±9.70; | Mean: 29.13±15.92 | 0.306 |
| Median: 20; range: 13–41 | Median: 28; range: 8–52 | ||
The p-value was calculated by Student’s t-test and analysis of variance method for numerical covariates and χ2 test or Fisher’s exact for categorical covariates where appropriate. Immunosuppression denotes the use of either corticosteroids or antitumor necrosis factor medications. Remission tissue transglutaminase (tTG) IgA was defined as tTG IgA measured at the time of clinical symptomatic remission or endoscopic remission. Need to discontinue immunotherapy: restricted to complications of ICI-CeD or ICI-Duo and not due to loss of therapeutic effect or disease progression. Malignancy restaging after ICI was determined by the best response per Response Evaluation Criteria In Solid Tumors.
GFD, gluten-free diet; N/A, not applicable.