Table 5.
Correlation between response and immune-related adverse events
| Parameter | ntotal (% of n = 170) | BOR, n (% of ntotal) |
P value | ||
|---|---|---|---|---|---|
| CR/PR/SD | PD | ||||
| irAEs(–) | 21 (12) | 3 (14) | 18 (86) | <0.001a | |
| irAEs(+) | 149 (88) | 100 (67) | 49 (33) | ||
| irAE CTCAE grade 0 | 21 (12) | 3 (14) | 18 (86) | 0.005b | |
| irAE CTCAE grades 1-2 | 77 (45) | 51 (66) | 26 (34) | ||
| irAE CTCAE grades 3-5 | 72 (42) | 49 (68) | 23 (32) | ||
| ANA-associated irAEs | |||||
| Pruritus | Yes | 50 (29) | 40 (80) | 10 (20) | 0.001a |
| No | 120 (71) | 63 (53) | 57 (47.5) | ||
| Cutaneous adverse eventsc | Yes | 56 (33) | 43 (77) | 13 (23) | 0.002a |
| No | 114 (67) | 60 (53) | 54 (47) | ||
| Arthralgia, myalgia, musculoskeletal pain | Yes | 36 (21) | 29 (81) | 7 (19) | 0.006a |
| No | 134 (79) | 74 (55) | 60 (45) | ||
| Peripheral facial paresis, paraparesis | Yes | 3 (2) | 2 (67) | 1 (33) | 0.828a |
| No | 167 (98) | 101 (60.5) | 66 (39.5) | ||
| Polyarthritis | Yes | 4 (2) | 3 (75) | 1 (25) | 0.551a |
| No | 166 (98) | 100 (60) | 66 (40) | ||
| PCA-associated irAEs | |||||
| Gastritis, stomatitis mucosal inflammation, gastroenteritis | Yes | 10 (6) | 6 (60) | 4 (40) | 0.969a |
| No | 160 (94) | 97 (61) | 63 (39) | ||
| SMA-associated irAEs | |||||
| Hepatotoxicity, immune-mediated hepatitis | Yes | 5 (3) | 4 (80) | 1 (20) | 0.367a |
| No | 165 (97) | 99 (60) | 66 (40) | ||
| Liver value increased (alanine/aspartate aminotransferases) | Yes | 22 (13) | 16 (73) | 6 (27) | 0.212a |
| No | 148 (87) | 87 (59) | 61 (41) | ||
| xANCA-associated irAEs | |||||
| Colitis, diverticulitis, immune-mediated enterocolitis | Yes | 16 (9) | 10 (62.5) | 6 (37.5) | 0.869a |
| No | 154 (91) | 93 (60) | 61 (40) | ||
| Diarrhea, constipation | Yes | 43 (25) | 31 (72) | 12 (28) | 0.074a |
| No | 127 (75) | 72 (57) | 55 (43) | ||
| Pancreatitis and/or autoimmune pancreatitis | Yes | 3 (2) | 2 (67) | 1 (33) | 0.828a |
| No | 167 (98) | 101 (60.5) | 66 (39.5) | ||
| Anti-TG/anti-TPO-associated irAEs | |||||
| Hypothyroidism, hyperthyroidism, thyroid-stimulating hormone increased/decreased | Yes | 27 (16) | 21 (78) | 6 (22) | 0.046a |
| No | 143 (84) | 82 (57) | 61 (43) | ||
ANA, anti-nuclear antibodies; BOR, best overall response; CR, complete response; CTCAE, Common Terminology Criteria for Adverse Events (version 4.0); irAE, immune-related adverse event; PCA, parietal cell antibodies; PD, progressive disease; PR, partial response; SD, stable disease; SMA, smooth muscle antibodies; TG, thyroglobulin; TPO, thyroid peroxidase; xANCA, atypical anti-neutrophil cytoplasmatic antibodies.
a
Chi-square test.
b
Cochran–Mantel–Haenszel test.
c
Cutaneous adverse events: rash, erythema, skin exfoliation, blister, dermatitis.