Table 2. Stratification of 137 Patients by Presence or Absence of Antibodies.
| Response | No. (%) of Patients | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any Preexisting Antibody | Preexisting RF | Preexisting ANA | Preexisting Antithyroid | |||||||||
| With (n = 80)a | Without (n = 57) | P Valueb | With (n = 38)c | Without (n = 99) | P Valueb | With (n = 48)d | Without (n = 89) | P Valueb | With (n = 25)e | Without (n = 112) | P Valueb | |
| Objective response ratef | 33 (41) | 10 (18) | .006 | 17 (45) | 26 (26) | .06 | 18 (38) | 25 (28) | .35 | 12 (48) | 31 (28) | .08 |
| Disease control rateg | 65 (81) | 31 (54) | .001 | 31 (82) | 65 (66) | .11 | 37 (77) | 59 (66) | .26 | 22 (88) | 74 (66) | .05 |
| Development of irAE | 48 (60) | 18 (32) | .002 | 26 (68) | 40 (40) | .006 | 29 (60) | 37 (42) | .05 | 15 (60) | 51 (46) | .28 |
| Development of irAE >grade 3 | 6 (8) | 3 (5) | .86 | 3 (8) | 6 (6) | >.99 | 4 (8) | 5 (6) | .80 | 1 (4) | 8 (7) | .90 |
| Skin reaction | 32 (40) | 10 (18) | .009 | 18 (47) | 24 (24) | .02 | 18 (38) | 24 (27) | .28 | 10 (40) | 32 (29) | .38 |
| Pneumonitis | 8 (10) | 6 (11) | >.99 | 4 (11) | 10 (10) | >.99 | 4 (8) | 10 (11) | .81 | 3 (12) | 11 (10) | >.99 |
| Hypothyroidism | 6 (8) | 0 | .07 | 2 (5) | 4 (4) | >.99 | 3 (6) | 3 (3) | .51 | 5 (20) | 1 (1) | <.001 |
| Hyperthyroidism | 1 (1) | 0 | >.99 | 0 | 1 (1) | >.99 | 1 (2) | 0 | .66 | 1 (4) | 0 | .48 |
| Hepatitis | 3 (4) | 3 (5) | >.99 | 2 (5) | 4 (4) | >.99 | 1 (2) | 5 (6) | .60 | 0 | 6 (5) | .52 |
| Myositis or peripheral neuropathy | 4 (5) | 1 (2) | .62 | 0 | 5 (5) | .38 | 3 (6) | 2 (2) | .45 | 2 (8) | 3 (3) | .58 |
| Treatment discontinued due to irAE | 9 (11) | 6 (11) | >.99 | 3 (8) | 12 (12) | .69 | 8 (17) | 7 (8) | .20 | 4 (16) | 11 (10) | .59 |
Abbreviations: ANA, antinuclear antibody; irAE, immune-related adverse event; RF, rheumatoid factor.
A patient was considered positive if any RF, ANA, antithyroglobulin, or antithyroid peroxidase was present at pretreatment.
By χ2 test.
A patient was considered positive if RF was greater than 15 IU/mL at pretreatment.
A patient was considered positive if ANA was 1:40 or greater at pretreatment.
A patient was considered positive if either antithyroglobulin or antithyroid peroxidase was present at pretreatment.
Proportion of patients achieving complete or partial response based on modified Response Evaluation Criteria in Solid Tumors, version 1.1.
Proportion of patients achieving complete response, partial response, or stable disease based on modified Response Evaluation Criteria in Solid Tumors, version 1.1.