Table 3.
Cohort 2: ircAEs in patients with biopsy-proven irColitis.
| Variable | Developed only irColitis | Developed irColitis + ircAEs | p-Value | |||
|---|---|---|---|---|---|---|
| n | % | n | % | |||
| All Patients with Biopsy-Proven Colitis | 211 | 85.8 | 35 | 14.2 | p = 0.010 | |
| ICB Target | Anti-PD-1/PD-L1 | 114 | 87.7 | 16 | 12.3 | |
| Anti-CTLA4 | 36 | 97.3 | 1 | 2.7 | ||
| Anti-PD-1/PD-L1 + Anti-CTLA4 | 61 | 77.2 | 18 | 22.8 | ||
| ICB Antibody | Atezolizumab | 9 | 100.0 | 0 | 0.0 | p = 0.125 |
| Avelumab | 1 | 50.0 | 1 | 50.0 | ||
| Cemiplimab | 1 | 100.0 | 0 | 0.0 | ||
| Durvalumab | 6 | 87.7 | 1 | 14.3 | ||
| Nivolumab | 32 | 91.4 | 3 | 8.6 | ||
| Pembrolizumab | 65 | 85.5 | 11 | 14.5 | ||
| Ipilimumab | 34 | 97.1 | 1 | 2.9 | ||
| Tremelimumab | 2 | 100.0 | 0 | 0.0 | ||
| Ipilimumab/ Nivolumab | 55 | 76.4 | 17 | 23.6 | ||
| Tremelimumab/ Durvalumab | 6 | 85.7 | 1 | 14.3 | ||
| Patients with Biopsy-Proven irColitis AND ircAE | n | % | p-Value | |||
| ircAE Phenotype | Lichenoid | 4 | 11.4 | - | ||
| Maculopapular | 13 | 37.1 | - | |||
| Pruritus | 5 | 14.3 | - | |||
| Psoriasis | 1 | 2.9 | - | |||
| Urticaria | 4 | 11.4 | - | |||
| Vitiligo | 2 | 5.7 | - | |||
| Other | 6 | 17.1 | - | |||
| ircAE and GI irAE Relationship | ircAE Before irColitis | 26 | 74.3 | p = 0.0001 | ||
| irColitis Before ircAE | 9 | 25.7 | ||||
p-values represent chi-squared tests between patients who developed only ircAEs and those who developed both ircAEs + GI irAEs. Binomial probability was assessed for ircAE preceding GI irAE using the Bernoulli model.