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Table 2 IrEC management and outcomes

From: Concurrent therapy with immune checkpoint inhibitors and TNFα blockade in patients with gastrointestinal immune-related adverse events

Patient ICI type/dose Initial management Number of steroid tapering attempts Infliximab
Dose-frequency
Doses of infliximab to clinical remission Doses of ICI concurrently administered with infliximab Follow up endoscopy on concurrent treatment (months) Recurrence # of months of follow-up on ICI/on concurrent therapy Disease progression/Follow up
1 Pembrolizumb
Dose: 3 mg/kg
Frequency: every 3 weeks
Prednisone 40 mg > 60 mg PO daily> taper failure
+azithromycin + metronidazole
2 5 mg/kg
- every 2 weeks for first 2 doses then every 6 weeks
1 12 Flexible Sigmoidoscopy (4 months):
Endoscopic: erythematous mucosa in sigmoid, normal colon for 40 cm
Histologic: Mild active chronic colitis
Patient developed Clostridium difficile colitis then flare of irEC.
Treatment:
- Infliximab 10 mg/kg
- Methylprednisolone 1 mg/kg BID then prednisone 75 mg PO BID followed by a taper
- PO vancomycin
- Immunotherapy was discontinued
14.5/10.5 - Staging scans after concurrent therapy (12 doses) showed stable disease
- Developed retroperitoneal bleed and was transitioned to hospice care
2 Ipilimumab/Nivolumab
Dose:
Ipilimumab-1 mg/kg, Nivolumab- 240 mg (3 mg/kg)
Frequency: combined every 6 weeks (4 doses total) followed by nivolumab alone every 2 weeks
Prednisone 60 mg PO daily>taper 1 5 mg/kg
- every 2 weeks for first 2 doses then every 4 weeks
1 3 doses of (ipilimuab+Nivolumab) and 12 doses of nivolumab alone Upper endoscopy (3 months):
Endoscopic:
- Gastric body: localized mild inflammation characterized by erythema and friability
- Duodenum: an acquired benign-appearing, intrinsic moderate stenosis was found in the second portion of the duodenum associated with a small erosion
Histologic:
- Gastric body: lymphocytic involvement of gastric pits
- Duodenum: no diagnostic abnormality
- Duodenal stricture: ulceration and expansion of lamina propria by mononuclear cells
No 12/7.5 - Staging scans after concurrent therapy (15 doses) showed stable disease and patient continues concurrent therapy
- Developed mucositis/stomatitis that is being managed conservatively
3 Ipilimumab
Dose: 3 mg/kg
Frequency: every 3 weeks
Methylprednisolone 1 mg/kg IV twice daily >taper failure 1 5 mg/kg
- every 4 weeks
1 2 Not done No 6.5/3.5 - Staging scans showed stable bulk of disease after concurrent therapy (2 doses) with ongoing slight progression in one metastatic lesion in the lung
- Developed skin rash (ipilimumab cutaneous toxicity) that was managed successfully with topical steroids
4 Ipilimumab/Nivolumab
Dose:
Ipilimumab-3 mg/kg, Nivolumab-1 mg/kg
Frequency: combined every 3 weeks
Prednisone 60 mg daily>taper failure 1 5 mg/kg
- every 4 weeks
1 3 Upper endoscopy (1 month):
Endoscopic/histologic
- Stomach: normal/chronic inactive gastritis
- Duodenum Normal/normal
Colonoscopy (1 month):
- Sigmoid/transverse colon ulcers: fragments of colonic mucosa with crypt architectural disarray and mildly increased cellularity of the lamina propria.
Colonoscopy
(3 months)
- Colonic mucosa with scattered crypt epithelial apoptosis and minimal crypt architectural distortion
No 5/3 - Staging scans showed interval progression of his disease in the chest, abdomen and pelvis.
5 Cemiplimab
Dose: 350 mg
Frequency: every 3 weeks
Prednisone 60 mg daily>taper failure 1 5 mg/kg
- once
1 2 Not done No 4/2.5 - Staging scans demonstrated interval decrease in the disease burden in the chest and lymph nodes
- Patient developed radiation/checkpoint pneumonitis and was treated with high dose oral steroids