The increasing use of immunotherapies in cancer will lead to more cases of steroid-refractory colitis that can only be treated with infliximab, gastroenterologists predict.
But the anti-TNF drug is not available on the PBS or hospital formularies for the treatment immunotherapy-related colitis, and so patients may be denied access to effective treatment for the serious, life threatening complications of colitis, according to clinicians at the University of Newcastle, NSW.
Writing in the Internal Medicine Journal, gastroenterologist Dr Tim Walker and oncologist colleagues at Calvary Healthcare in Newcastle describe a recent case of a cancer patient who developed steroid-refractory colitis after immunotherapy, which they say is likely to be typical of further cases in the future.
The 65-year-old man with metastatic melanoma developed severe colitis after two cycles of ipilimumab and nivolumab, which did not respond to 10 days of intravenous hydrocortisone, but resolved within 24 hours of receiving infliximab. The drug was only obtained on special approval at a cost of $1450 to the hospital. The patient had a recurrence of colitis almost a year later which again responded rapidly to infliximab after no response to three days of IV hydrocortisone
The doctors said in previous case series 29%-56% of patients with immunotherapy colitis were steroid refractory and only responded to infliximab.
But although its efficacy is recognised in oncology guidelines for this indication, infliximab is not approved for it by the TGA nor available through the PBS or hospital formularies.
This means there is likely to be an infliximab “access crisis” they warn.
“Without ready access to infliximab, administration delays may occur with consequence of distressing symptom prolongation, extended hospital admissions and increased risk of complications including perforation, colectomy and death,” they write.
“With increasing immunotherapy use, including recent PBS approval of combination immunotherapy for melanoma and renal cell carcinoma, where colitis occurs more frequently, immunotherapy induced colitis frequency and need for infliximab access is likely to increase.”
“Urgent advocacy is required to ensure infliximab access is secured for these patients,” they conclude.