Patients with Crohn’s disease responded well to treatment with natalizumab while experiencing manageable side effects in a recent study.
Participants included 30 patients prescribed natalizumab to treat moderate-to-severe Crohn’s disease between April 2008 and September 2010 at Mayo Clinic Rochester in Rochester, Minn. All patients had previously undergone anti-tumor necrosis factor therapy before enrollment. A median of nine infusions (range 1-30) of the drug were administered approximately one month apart, with patients’ responses evaluated at each infusion, along with the occurrence of adverse effects such as infection, hospitalization, neoplasm and other incidences.
All participants experienced at least one side effect from the treatment, with gastrointestinal (n=25), ENT (n=18) and neurological (n=18) symptoms the most common. Infection was experienced by 11 patients (37%), including nine considered serious adverse events likely related to treatment. Investigators held but subsequently continued treatment for five patients (17%) because of infection. In addition to the nine infections, 10 additional serious adverse events were recorded, one of which (acute urticaria) was considered probably related to treatment.
Complete clinical response occurred in 14 participants, partial response in 12 and no response occurred in four patients. A response occurred after the first infusion in 10% of patients, and 50% of the complete response cases took place within the first four months. Investigators determined a cumulative probability of complete response within 1 year of 56% (95% CI, 28%-73%). A longer duration of illness was associated with a lower probability of response to the treatment (HR=0.3; 95% CI, 0.1-0.8).
“Our clinical experience with natalizumab shows that overall patients tolerate [the drug],” the researchers wrote, adding that treatment should be held in the event of infection until the reaction can be treated. “Adverse effects were common in our patient population; however, therapy was rarely held or stopped secondary to these events. Natalizumab appears to result in clinical benefit in patients who have failed other medical therapies, with a careful discussion of the risks and benefits.”