Acute graft-versus-host disease following orthotopic liver transplantation is a rare but feared complication arising in 1% to 2% of cases with a dismal prognosis. It most often presents as fever, rash, and diarrhea with or without pancytopenia. Patients die from complications of marrow failure such as sepsis or bleeding. Because of its low incidence, there is no clear treatment protocol for this complication. Both increasing and withdrawing immunosuppression have been attempted with variable success. Although anti-tumor necrosis factor ␣ therapy has been widely used for the treatment of steroid-resistant acute graft-versus-host disease in the hematopoietic stem cell transplant setting, there previously have been no reported cases of its use in liver transplantation. The aim of this report is to review a case of acute graft-versus-host disease and the use of etanercept to manage this complication. Etanercept has never previously been used in liver transplantation complicated by acute graft-versus-host disease. In the hematology literature, the success of its use is offset by significant rates of serious infectious (especially fungal) complications. However, preliminary results are encouraging and offer insight into its use as a potentially viable therapeutic option. We report the first successful use of etanercept in liver transplantation-associated graft-versus-host disease, albeit complicated by invasive aspergillosis, and recommend concurrent antifungal prophylaxis when the drug is used in this setting. Liver Transpl 15: 421-426, 2009.
Using TE, the prevalence of clinically significant liver disease in IBD patients is low. The association of increased BMI and age with increased LS in IBD suggests fatty liver disease being the prevailing aetiology in these patients.
Tacrolimus is able to induce a clinical response in a third and remission in a fifth of medically refractory patients with inflammatory bowel disease at 1 year. A 90-day therapeutic trial is worthwhile in difficult to treat patients.
Objective
To examine whether non‐medical switching of patients with inflammatory bowel disease (IBD) from originator infliximab to a biosimilar (CT‐P13, Inflectra) is safe and clinically non‐inferior to continued treatment with originator infliximab.
Design
Prospective, open label, multicentre, parallel cohort, non‐inferiority study in seven Australian hospitals over 48 weeks, May 2017 – October 2019.
Participants
Adults (18 years or older) with IBD receiving maintenance originator infliximab (Remicade) who had been in steroid‐free clinical remission for at least 12 weeks.
Intervention
Managed program for switching patients in four hospitals from originator to biosimilar infliximab (CT‐P13); patients in three other hospitals continued to receive originator infliximab (control).
Main outcome measures
Clinical disease worsening requiring infliximab dose escalation or change in therapy.
Results
The switch group included 204 patients, the control group 141 patients with IBD. Ten patients in the control group (7%) and 16 patients switched to CT‐P13 (8%) experienced clinical deterioration; the adjusted risk difference (control v switch group) was –1.1 percentage points (95% CI, –6.1 to 8.2 percentage points), within our pre‐specified non‐inferiority margin of 15 percentage points. Serious adverse events leading to infliximab discontinuation were infrequent in both the switch (six, 3%) and control (six, 4%) groups.
Conclusion
Switching patients with IBD from originator to biosimilar infliximab is safe and non‐inferior to continuing treatment with originator infliximab. Moreover, the introduction of biosimilar infliximab, by increasing market competition, has resulted in substantial cost savings for the Pharmaceutical Benefits Scheme.
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