Clinical feature | Ipilimumab | Nivolumab | Pembrolizumab | Checkmate 238 | Ipi+Niv (Simultaneous) | Total |
Instances of hepatitis | 4 | 1 | 4 | 1 | 11 | 21 |
Onset of hepatitis after treatment (days) (Median, range) | 36 (30–62) | 85 | 31.5 (14–103) | 29 | 39 (6–90) | 38.5 (6–103) Average: 44 |
Age at time of hepatitis (years) (Median, range) | 68.5 (42–76) | 71 | 71 (61–76) | 71 | 46 (21–70) | 62 (21–76) Average: 56 |
Number of males (%) | 2 (50%) | 1 (100%) | 2 (50%) | 0 | 6 (54%) | 11 (52%) |
Clinical properties broken down by treatment group | ||||||
Grade 1 (n, %) | 1 (100%) | 2 (18%) | 3 | |||
Grade 2 (n, %) | 1 (25%) | 1 (25%) | 2 (18%) | 4 | ||
Grade 3 (n, %) | 1 (25%) | 2 (50%) | 1 (100%) | 5 (45%) | 9 | |
Grade 4 (n, %) | 2 (50%) | 1 (25%) | 2 (18%) | 5 | ||
Number of patients needing hospital admissions for hepatitis | 3 (75%) | 3 (75%) | 7 (60%) | 13 (62%) | ||
Number of patients having liver biopsy | 0 | 0 | 0 | 0 | 0 | |
Treatment | ||||||
Steroids only (n) | 4 | 0 | 2 | 5 | 11 (52%) | |
Infliximab (n) | 0 | 0 | 0 | 2 (1 for colitis) | 2 | |
Mycophenolate mofetil (n) | 1 | 0 | 1 | 1 | 5 | 8 |
Tacrolimus (n) | 0 | 0 | 1 | 1 |
Breakdown by type of regimen patients were receiving at the time of development of hepatitis as well as clinical outcomes.
ICPI, immune checkpoint inhibitor.