The benefit to risk ratio of concomitant immunosuppressives with scheduled infliximab maintenance therapy for Crohn's disease is an issue of debate.
Dr Gert Van Assche and colleagues studied the influence of immunosuppressives discontinuation in patients in remission with combination therapy in an open-label, randomized, controlled trial.
The research team investigated patients with controlled disease 6 months or more after the start of infliximab (5 mg/kg intravenously) combined with immunosuppressives.
The patients were randomized to continue or to interrupt immunosuppressives, while all patients received scheduled infliximab maintenance therapy for 104 weeks.
Primary end point was the proportion of patients who required a decrease in infliximab dosing interval or stopped infliximab therapy.
|Mucosal ulcers were absent in 61% with interrupted immunosuppressives|
Secondary end points included infliximab trough levels, safety, and mucosal healing.
A similar proportion of patients in both groups needed a change in infliximab dosing interval or stopped infliximab therapy.
The team observed that C-reactive protein was higher, and infliximab trough levels were lower in the group with interrupt immunosuppressives.
The researchers found low infliximab trough levels correlated with increased C-reactive protein and clinical score.
Mucosal ulcers were absent at week 104 in 64% with continued immunosuppressives, and in 61% with interrupted immunosuppressives and ongoing response to infliximab.
Dr van Van Assche's team commented, "Continuation of immunosuppressives beyond 6 months offers no clear benefit over scheduled infliximab monotherapy but is associated with higher median infliximab trough and decreased C-reactive protein levels."
"The impact of these observations on long-term outcomes needs to be explored further."