Table 2.
Mortality and irAE presence and type after immune checkpoint inhibitor initiation for pre-existing RA cases (n=87) and comparators (n=203).
| Pre-existing RA cases (n=87) |
Matched non-RA comparators (n=203) |
p-value | |
|---|---|---|---|
| All-cause mortality | 60 (69%) | 127 (63%) | 0.30 |
| All RA flares and irAE | |||
| Any all-grade irAE | 53 (61%) | 99 (49%) | 0.058 |
| Any grade 3+ irAE | 12 (14%) | 30 (15%) | 0.83 |
| Any grade 4+ irAE | 4 (5%) | 6 (3%) | 0.20 |
| Any grade 5 irAE | 0 (0%) | 2 (1%) | 0.49 |
| Median and IQR number of all-grade irAE | 1 (0, 1) minimum 0 maximum 4 |
0 (0, 1) minimum 0 maximum 5 |
0.45 |
| Median and IQR number of grade 3+ irAE | 0 (0, 0) minimum 0 maximum 3 |
0 (0, 0) minimum 0 maximum 4 |
0.73 |
| Exactly one all-grade irAE | 36 (41%) | 57 (28%) | 0.026 |
| Two or more all-grade irAE | 17 (20%) | 42 (21%) | 0.82 |
| Excluding RA flares for cases and inflammatory arthritis events for comparators | |||
| Any all-grade irAE | 26 (30%) | 99 (49%) | 0.0029 |
| Any grade 3+ irAE | 11 (13%) | 30 (15%) | 0.63 |
| Median and IQR number of all-grade irAE* | 0 (0, 1) minimum 0 maximum 3 |
0 (0, 1) minimum 0 maximum 5 |
0.0018 |
| Median and IQR number of grade 3+ irAE | 0 (0, 0) minimum 0 maximum 2 |
0 (0, 0) minimum 0 maximum 4 |
0.4586 |
| Exactly one all-grade irAE | 17 (20%) | 57 (28%) | 0.13 |
| Two or more all-grade irAE | 9 (10%) | 42 (21%) | 0.034 |
| Specific irAE types | |||
| RA flare (for cases) or inflammatory arthritis (for comparators) | |||
| All-grade | 42 (48%) | 14 (7%) | <0.0001 |
| Grade 3+ | 2 (2%) | 0 (0%) | 0.089 |
| Rash/dermatitis | |||
| All-grade | 5 (6%) | 28 (14%) | 0.048 |
| Grade 3+ | 1 (1%) | 1 (1%) | 0.42 |
| Colitis/enteritis | |||
| All-grade | 6 (7%) | 28 (14%) | 0.094 |
| Grade 3+ | 1 (1%) | 10 (5%) | 0.090 |
| Endocrinopathy (hypo/hyperthyroidism, adrenal, pituitary, type 1 diabetes) | |||
| All-grade | 2 (2%) | 22 (11%) | 0.0078 |
| Grade 3+ | 0 (0%) | 3 (2%) | 0.34 |
| Hepatitis | |||
| All-grade | 3 (4%) | 19 (9%) | 0.043 |
| Grade 3+ | 1 (1%) | 6 (3%) | 0.25 |
| Pneumonitis | |||
| All-grade | 9 (10%) | 19 (9%) | 0.79 |
| Grade 3+ | 4 (5%) | 6 (3%) | 0.20 |
| Hematologic (cytopenias, autoimmune hemolytic anemia, immune thrombocytopenic purpura, hemolytic uremic syndrome, aplastic anemia) | |||
| All-grade | 2 (2%) | 4 (2%) | 0.33 |
| Grade 3+ | 1 (1%) | 1 (1%) | 0.42 |
| Other rheumatologic (PMR-like syndrome, lupus, vasculitis, sicca syndrome) | |||
| All-grade | 1 (1%) | 6 (3%) | 0.24 |
| Grade 3+ | 0 (0%) | 1 (1%) | 0.70 |
| Myocarditis/pericarditis | |||
| All-grade | 1 (1%) | 4 (2%) | 0.36 |
| Grade 3+ | 1 (1%) | 4 (2%) | 0.36 |
| Myositis | |||
| All-grade | 0 (0%) | 2 (1%) | 0.49 |
| Grade 3+ | 0 (0%) | 1 (1%) | 0.70 |
| Other neurologic (autonomic, neuropathy, meningitis, cerebritis, transverse myelitis, Gullain-Barré syndrome) | |||
| All-grade | 2 (2%) | 5 (3%) | 0.32 |
| Grade 3+ | 1 (1%) | 2 (1%) | 0.44 |
| Myasthenia gravis | |||
| All-grade | 0 (0%) | 1 (1%) | 0.70 |
| Grade 3+ | 0 (0%) | 1 (1%) | 0.70 |
| Nephritis | |||
| All-grade | 1 (1%) | 3 (2%) | 0.41 |
| Grade 3+ | 1 (1%) | 1 (1%) | 0.42 |
| Ocular (uveitis/iritis/episcleritis/blepharitis) | |||
| All-grade | 1 (1.2%) | 1 (0.5%) | 0.42 |
| Grade 3+ | 0 (0.0%) | 0 (0.0%) | - |
| Pancreatitis | |||
| All-grade | 1 (1.2%) | 2 (1.0%) | 0.44 |
| Grade 3+ | 1 (1.2%) | 0 (0.0%) | 0.30 |
| Vitiligo | |||
| All-grade | 2 (2%) | 3 (2%) | 0.31 |
| Grade 3+ | 0 (0%) | 0 (0%) | - |
| Other | |||
| All-grade | 0 (0%) | 1 (1%) | 0.70 |
| Grade 3+ | 0 (0%) | 0 (0%) | N/A |
*
See Appendix p.12 for a histogram comparing number of irAE for pre-existing RA cases and non-RA comparators after excluding RA flares for cases and IA events for comparators.
IA, inflammatory arthritis; IQR, interquartile range; irAE, immune-related adverse event; PMR, polymyalgia rheumatica; RA, rheumatoid arthritis.