A clinical trial is being conducted to evaluate the safety and efficacy of a novel therapy to treat refractory Crohn disease. The medication is a monoclonal antibody against the a4B7 integrin, which inhibits migration of T-lymphocytes into the intestinal parenchyma and produces a gut-selective anti-inflammatory effect. Patients who have active, moderate to severe Crohn disease and have failed conventional therapy are enrolled in the study. Many of these patients have renal or hepatic dysfunction, and some take other medications that affect cytochrome P450 enzymes. Which of the following is the most appropriate dose adjustment in this patient population to decrease drug toxicity?

Question

A clinical trial is being conducted to evaluate the safety and efficacy of a novel therapy to treat refractory Crohn disease.  The medication is a monoclonal antibody against the a4B7 integrin, which inhibits migration of T-lymphocytes into the intestinal parenchyma and produces a gut-selective anti-inflammatory effect.  Patients who have active, moderate to severe Crohn disease and have failed conventional therapy are enrolled in the study.  Many of these patients have renal or hepatic dysfunction, and some take other medications that affect cytochrome P450 enzymes.  Which of the following is the most appropriate dose adjustment in this patient population to decrease drug toxicity?

Quizplus · Accepted Answer

Eductional Objective: Monoclonal antibodies (mAbs) are not eliminated by hepatic or renal clearance. Therefore, no dose adjustment is necessary with impaired hepatic/renal function or use of cytochrome P450 inducers or inhibitors.

A Clinical Trial Is Being Conducted to Evaluate the Safety