Costs to patients and health service associated with immune checkpoint inhibitor-mediated colitis – a single site experience.


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Binu Chandrasekharapillai Janardanan Nair1,Dana Shor1,Tim Raine1,Pippa Corrie1,Sarah J Welsh1
1Cambridge University Hospitals NHS Foundation Trust

Abstract

Background

Colitis is a common immune-related adverse event (AE) associated with immune checkpoint inhibitors (ICPI). ‘Real-world’ (off-trial) data regarding incidence, management, outcome and costs associated with treating ICPI-mediated colitis is still lacking.

Method

We conducted a retrospective analysis of patients who received ≥1 dose of ICPI at Addenbrooke’s hospital (01/12/2014 to 01/12/2018) and who developed ICPI-mediated colitis. A cost analysis of treating colitis was performed using standard NHS tariffs.

Results

26(7.4 %) of 349 advanced cancer patients (21 melanoma, 3 renal, 1 colon, 1 bladder cancer) who received ≥1 dose of ICPI developed colitis of any CTCAE (v5) grade. ICPI received was Ipilimumab in 9(35%), Ipilimumab+Nivolumab in 7(27%) and Pembrolizumab or Nivolumab in 5 (19%) cases. Median (range) number of cycles prior to colitis were: Ipilimumab 3(1-4), Nivolumab 6.5(2-17), Ipilimumab+Nivolumab 2(1-3) and pembrolizumab 3(2-22). Incidence of any grade/grade 3 colitis was: Ipilimumab 11.5%/5%, Nivolumab 6.5%/2.6%, Ipilimumab+Nivolumab 18.9%/13.5% and Pembrolizumab 2.5%/1%. No grade 4 or 5 colitis events were identified.

15(58 %) patients were hospitalised for treatment. Median (range) length of stay was 6 days (1-126). 24(92 %) patients received steroids (oral or intravenous) with median duration 65 days (0-417). 10 (38%) patients received IV steroids, 5(19%) had Infliximab and 1(4%) received vedolizumab. Colitis resolved in 19(73%) patients, median (range) time to resolution to grade 1 was 17 days (1-55) and to complete resolution was 65 days (22-238). A preliminary cost analysis of 9 colitis related admissions showed the mean (range) cost of hospital stay to be £4936 (£1203-£13475). With median follow-up 507 days, 18(69%) patients were alive, 12(46%) had on-going treatment response.

Conclusion

Our local experience shows that over half of patients experiencing ICPI-related colitis were hospitalised, generating significant additional healthcare costs, but none died from this toxicity.