APC Recommendations:

JPC Recommendation:

• The committee ratified the EoEPAC* bulletin including its list of recommendations below:. Full EoEPAC* bulletin is attached for information.
East of England Priorities Advisory Committee recommendations

o Infliximab is recommended for the treatment of severe Immune Checkpoint Inhibitor (ICPI) related diarrhoea or colitis grade 3 or 4, in line with the treatment pathway outlined in appendix 1.

o Treatment must be initiated and monitored under the guidance of a gastroenterologist and oncologist.

o Ipilimumab monotherapy and in combination with nivolumab must be permanently discontinued in patients with grade 3 or 4 diarrhoea or colitis.

o Other Immune Checkpoint Inhibitors (nivolumab monotherapy, pembrolizumab, atezolizumab) must be permanently discontinued in patients with grade four diarrhoea or colitis.

o All other causes, including cytomegalovirus (CMV) infection/reactivation and other viral, bacterial and parasitic aetiology, must be excluded along with any other clinical contraindications (e.g. gastrointestinal perforation or sepsis) before starting infliximab.

o A single dose of biosimilar infliximab 5mg/kg should be considered as a second line option for corticosteroid-refractory grade 3 or 4 diarrhoea or colitis related to the ICPI therapy, following treatment with systemic high-dose intravenous corticosteroids for three to five days.

o A second dose of infliximab at two weeks may be necessary for some patients. Very rarely a third dose may be required.

o Outcome data must be provided to the Clinical Commissioning Group (CCG) to inform future policy.

o These recommendations will be reviewed on publication of guidelines from the British Society of Gastroenterology or other national guidelines.

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