W1097 Steroid-Free Remission and Fistula Closure in Adalimumab-Treated Patients with Moderate to Severe Crohn's Disease: the Access Trial

BACKGROUND: Natalizumab (NAT), a monoclonal antibody to α4-integrin, was recently approved by the FDA for use in the treatment of moderate to severe Crohn's disease (CD). AIM: To prospectively report the clinical outcomes and safety in patients (pts) treated with NAT at a tertiary care IBD center. METHODS: Eighteen pts with moderate to severe CD treated in clinical practice with intravenous NAT every 4 weeks were enrolled in a registry. Patients were assessed for clinical response to NAT (categorized as complete response [CR], partial response [PR], or no response [NR]), steroid reduction, and adverse events (AE). RESULTS: The median age of this group was 43.5 years (range 20-63) with median disease duration of 13 years (range 3-43). All patients had failed prior anti-TNF therapy (median of 2 agents). Twelve pts (67%) had ileocolonic CD at diagnosis and 5 (28%) had undergone colectomy prior to NAT. The median follow-up was 88 days (range 3-219). Two pts had screening brain MRI or CT prior to NAT. Pts received one to eight infusions of NAT for a total of 77 infusions. In total, 2 pts (11%) had CR, 13 (72%) had PR and 3 (17%) had NR. Two pts achieved complete mucosal healing as documented by radiography. There were 6 pts on corticosteroids; 4 prior to NAT and 2 initiated during treatment. One pt successfully completed prednisone taper and 2 pts are currently tapering (mean dose change 7.5 mg). Sixteen pts (89%) had a total of 55 AE. Clinically significant AE included 1 ileocolonic resection due to active CD with high-grade dysplasia found in surgical specimen, 1 abdominal wall abscess, 1 Epstein Barr virus febrile infection, 3 infusion reactions characterized by rash, pruritus or throat irritation and 4 hospitalizations secondary to volume depletion (2), abscess drainage (1) and fever work-up (1). Eight pts (44%) complained of headache following infusions and 1 of loss of balance and tinnitus. Two patients with neurologic symptoms underwent brain CT or MRI evaluations, which were negative. Minor infectious AE included 4 upper respiratory tract infections and 1 each of conjunctivitis, sinus infection, cystitis and otitis. Only 1 pt discontinued NAT due to an infusion reaction and acute infectious colitis. CONCLUSIONS: In this initial clinical practice experience, NAT was a clinically beneficial and well-tolerated option for patients with CD who had lost their response to, or who could not tolerate, anti-TNF agents.