Table 1

Characteristics of patients with colitis treated with tocilizumab

Baseline patient characteristics (colitis)Characteristics of the patients' colitis treated with tocilizumab
Patient IDSex, AgeCancer, stage
Treatment (doses)
BORICI-statusOther IrAEs than colitis
Duration≥1 CTCAE grade before inclusionShifted from GCsCTCAE grade, week 0CTCAE grade, week 8CTCAE grade, week 24Supportive, “as needed”Systemic GCs within 24 weeksResponse to TCZ
ColitisDiarrheaAbdominal painColitisDiarrheaAbdominal painColitisDiarrheaAbdominal pain
C1M 70yCCA, IV
Ipi 1mg/kg+Nivo 3 mg/kg (3+1)
SDOngoingNoneNew-onset, 4 daysNo232↓1↓1↑3ANENENELoperamideYes, in Week 20, due to transition to palliative careYes
C2M 67yNSCLC, IV Pembro 2 mg/kg (15)PRInterruptedRash (1)New-onset, 3 daysNo210NENENENENENELoperamideYes, shifted to prednisolone on Day 12 due to worseningNo
C9M 66yMelanoma, III Nivo 480 mg, adj. (2)NEInterruptedNoneNew-onset, 33 daysNo231↓↓0↓1↓↓0↓↓0↓↓0↓↓0LoperamideNoYes
C14F 55yMelanoma, IV Nivo 6 mg/kgB (1)NEPermanently discontinuedHypothyroidism (2)Chronic, 101 daysYes, steroid-refractory221↓1↓1↓↓0↓↓0↓↓0↓↓0LoperamideNoYes
C15M 63yRCC, IV
nivo 3 mg/kg (2)
NERestartedArthralgia (1)New-onset, 16 daysNo221↓1↓1↓↓0NENENENoneYes, relapse of colitis during ICI reintroductionYes
C17F 56yCCA, IV
Ipi 1mg/kg
+nivo 3mg/kg (4)
SDInterruptedHyperthyroidism (1), rash (1)New-onset, 17 daysNo130↔1↓20NENENEPsylliumYes, switch to budesonide with responseNo
C18M 55yMelanoma, IV Ipi 3 mg/kg+nivo 1 mg/kg (2)NEInterruptedNoneNew-onset, 26 daysNo120↓↓0↓10NENENELoperamideYes, single dose methylprednisolone due to a treatment-related reactionYes
C19F 71yBladder cancer, IV Pembro 2 mg/kg (23)NEInterruptedNoneChronic, 97 daysNo211↓1↓↓0↓↓0↓↓000Loperamide, PsylliumNoYes
AC12M 72yNSCLC, IV Pembro 2 mg/kg (33)PRPermanently discontinuedRash (1)Chronic, 333 daysYes, steroid-dependent110↓↓0↓↓00↓↓0↓↓00LoperamideNoYes
AC20F 60yOcular melanoma, IV Pembro 2 mg/kgB (10)SDRestartedHypophysitis (2), pneumonitis (2)Chronic, 787 daysYes, steroid-dependent211↓1↓0↔1↓↓0↓↓0↓↓0LoperamideNoYes
  • The arrows indicate the following: ↔, stable/no change; ↑ or ↓, increase or decrease of CTCAE grade ≥1; and ↓↓complete remission of symptoms. Some patients were not evaluable owing to initiation of non-ICI therapy or treatment with systemic glucocorticoids for colitis or arthritis. Definition of new-onset irAEs, debut of irAEs within <90 days; chronic irAEs, debut for more than ≥90 days ago. Colitis was classified as grade 1, asymptomatic; grade 2, abdominal pain, mucus or blood in stool; grade 3, severe abdominal pain, peritoneal signs; grade 4, life-threatening, urgent intervention is indicated. Diarrhea as grade 1, increase <4 stools/day over baseline; grade 2, increase 4–6 stools/day over baseline; increase ≥7 stools/day over baseline, hospitalization indicated; grade 4, life-threatening. Abdominal pain as grade 1 mild pain; grade 2, moderate pain, limiting instrumental activities of daily living; grade 3, severe pain-limiting self-care activities of daily living.

  • *Cancer-related pain, requiring increased doses of morphine.

  • †Previous treatment with ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg).

  • ‡Management of irAE prior to screening: C14 received prednisolone 5-100 mg (192 days for colitis) and infliximab (5 mg/kg, 2 doses for colitis, last dose 45 days prior to inclusion). AC12 received prednisolone 10-23 (922 days for colitis). AC20 received prednisolone 2.5-250 mg (680 days for colitis), hydrocortisone 30 mg (62 days for hypophysitis), betamethasone IA (for artritis), infliximab (2 doses for colitis, given 2 years prior to inclusion). All others received no treatment for irAE.

  • AC, arthritis and colitis; BOR, best overall response; C, colitis; CCA, cholangiocarcinoma; CTCAE, Common Terminology Criteria for Adverse Events; F, female; GCs, glucocorticoids; IA, intra-articular; ICIs, immune checkpoint inhibitors; Ipi, ipilimumab; irAE, immune-related adverse events; M, male; NE, not evaluable; Nivo, nivolumab; NSCLC, non-small cell lung cancer; Pembro, pembrolizumab; PR, partial response; RCC, renal cell carcinoma; SD, stable disease; TCZ, tocilizumab.