Table 3.
Correlation between autoantibodies and the occurrence of immune-related adverse events
| Parameter | ntotal (% of n = 170) | irAE(−), n (% of ntotal) |
irAE(+) n (% of ntotal) |
P value | |
|---|---|---|---|---|---|
| CTCAE grade 0 | CTCAE grades 1-2 | CTCAE grades 3-5 | |||
| Autoantibody positivity at IP1 | 63 (37) | 13 (21) | 50 (79) | 0.012a | |
| Autoantibody negativity at IP1 | 107 (63) | 8 (7) | 99 (93) | ||
| Autoantibody positivity at IP1 | 63 (37) | 13 (21) | 29 (46) | 21 (33) | 0.021b |
| Autoantibody negativity at IP1 | 107 (63) | 8 (7) | 48 (45) | 51 (48) | |
| Strong autoantibody titer at IP1 | 35 (21) | 8 (23) | 27 (77) | 0.001b | |
| Intermediate autoantibody titer at IP1 | 28 (16) | 5 (18) | 23 (82) | ||
| Borderline autoantibody titer at IP1 | 31 (18) | 6 (19) | 25 (81) | ||
| Undetectable autoantibodies at IP1 | 76 (45) | 2 (3) | 74 (97) | ||
| Strong autoantibody titer at IP1 | 35 (21) | 8 (23) | 17 (49) | 10 (29) | 0.004b |
| Intermediate autoantibody titer at IP1 | 28 (16) | 5 (18) | 12 (43) | 11 (39) | |
| Borderline autoantibody titer at IP1 | 31 (18) | 6 (19) | 13 (42) | 12 (39) | |
| Undetectable autoantibodies at IP1 | 76 (45) | 2 (3) | 35 (46) | 39 (51) | |
| New occurrence of autoantibodies during therapyc | |||||
| Yes | 97 (57) | 8 (8) | 89 (92) | 0.061a | |
| No | 73 (43) | 13 (18) | 60 (82) | ||
| Yes | 97 (57) | 8 (8) | 45 (46) | 44 (45) | 0.182b |
| No | 73 (43) | 13 (18) | 32 (44) | 28 (38) | |
Course of autoantibody titers during therapy.
CTCAE, Common Terminology Criteria for Adverse Events (version 4.0); IP1, baseline time during induction phase; irAE, immune-related adverse event; irAE(+), patients with at least one irAE; irAE(−), patients without irAE.
a
Chi-square test.
b
Cochran–Mantel–Haenszel test.
c
Patients could experience a new occurrence of autoantibodies during multiple study phases.