Table 3.
Characteristics and management of autoimmune disorder (AD) exacerbations and new immune-related adverse events (irAEs) on checkpoint inhibitors (CPI)
| RCC | UC | Overall | ||||
| AD flare | New irAE |
AD flare | New irAE |
AD flare | New irAE |
|
| In all patients | (n=58) | (n=48) | (n=106) | |||
| Total events, N (%) | 18 (31%) | 22 (38%) | 20 (42%) | 18 (38%) | 38 (36%) | 40 (38%) |
| Cumulative incidence, % (95% CI) | ||||||
| At 3 months | 21 (11 to 33) | 22 (12 to 34) | 31 (19 to 45) | 17 (8 to 29) | 29 (20 to 38) | 22 (15 to 30) |
| At 6 months | 21 (11 to 33) | 34 (21 to 47) | 38 (24 to 52) | 26 (14 to 39) | 32 (23 to 41) | 32 (23 to 41) |
| In patients with irAE | (n=18) | (n=22) | (n=20) | (n=18) | (n=38) | (n=40) |
| Median time from CPI start to event, days (range) | 76 (25–315) | 56 (2–305) | 33 (1–368) | 120 (12–443) | 61 (1–368) | 68 (2–443) |
| Severity of symptoms*, N (%) | ||||||
| Grade 1 | 6 (33%) | 7 (32%) | 2 (10%) | 3 (17%) | 8 (21%) | 10 (25%) |
| Grade 2 | 7 (39%) | 8 (36%) | 12 (60%) | 7 (39%) | 19 (50%) | 15 (38%) |
| Grade 3–4 | 2 (11%) | 7 (32%) | 4 (20%) | 6 (33%) | 6 (16%) | 13 (33%) |
| Unknown | 3 (17%) | 0 (0%) | 2 (10%) | 2 (11%) | 5 (13%) | 2 (5%) |
| Received topical corticosteroids, N (%) | ||||||
| Yes | 9 (50%) | 0 (0%) | 3 (15%) | 2 (6%) | 12 (32%) | 2 (5%) |
| No | 9 (50%) | 22 (100%) | 17 (85%) | 16 (94%) | 26 (68%) | 38 (95%) |
| Received systemic corticosteroids, N (%) | ||||||
| Yes | 5 (28%) | 11 (50%) | 12 (60%) | 11 (61%) | 17 (45%) | 22 (55%) |
| No | 13 (72%) | 11 (50%) | 8 (40%) | 7 (39%) | 21 (55%) | 18 (45%) |
| Received immunomodulatory agents†, N (%) | ||||||
| Yes | 1 (6%) | 0 (0%) | 1 (5%) | 0 (0%) | 2 (5%) | 0 (0%) |
| No | 17 (94%) | 22 (100%) | 19 (95%) | 18 (100%) | 36 (95%) | 40 (100%) |
| CPI management, N (%) | ||||||
| Continued | 13 (72%) | 11 (50%) | 11 (55%) | 7 (39%) | 24 (63%) | 18 (45%) |
| Temporarily discontinued | 3 (17%) | 8 (36%) | 5 (25%) | 6 (33%) | 8 (21%) | 14 (35%) |
| Permanently discontinued | 2 (11%) | 3 (14%) | 4 (20%) | 5 (28%) | 6 (16%) | 8 (20%) |
| irAE outcome‡, N (%) | ||||||
| Ongoing but controlled | 7 (39%) | 6 (27%) | 12 (60%) | 5 (28%) | 19 (50%) | 11 (28%) |
| Ongoing but uncontrolled | 3 (17%) | 0 (0%) | 3 (15%) | 0 (0%) | 6 (16%) | 0 (0%) |
| Resolved | 8 (44%) | 16 (73%) | 5 (25%) | 11 (61%) | 13 (34%) | 27 (68%) |
| Unknown | 0 (0%) | 0 (0%) | 0 (0%) | 2 (11%) | 0 (0%) | 2 (5%) |
*Only the worst grade for the same symptom is captured. No grade 5 events occurred.
†Two patients received one of the following treatments: methotrexate (polymyalgia rheumatica), rituximab (granulomatosis with polyangiitis).
‡Controlled was defined as a now asymptomatic adverse event still requiring immunosuppression agents. Uncontrolled was defined as an irAE that was still symptomatic at the time of the analysis.
RCC, renal cell carcinoma; UC, urothelial carcinoma.