Abstract

with TPN dependence in 33%, at least one surgical resection in 72%, and fistula in 50% of patients. Failure of at least two anti-TNFs was observed in 89% of patients, methotrexate in 83%, and thiopurines in 89%. Natalizumab had been used in 16.7% of patients prior to ustekinumab. The induction dose ranged from 45mg to 270mg SC at week zero. The most common maintenance dose was 90mg SC every eight weeks. The median duration of followup after initiation of ustekinumab was 9.1 months (5.7-27.8). The cumulative probability of any response was 11.1% at one month, 38.9% at three months, and 44.4% at six months. The cumulative probability of loss of response among patients with partial or complete response was 25% at 1, 3, and 6 months. Of the 15 patients on steroids at the beginning of therapy, 4 (26.7%) were able to taper off successfully. Mucosal healing was observed in 3 of the 8 patients (37.5%) who had a repeat endoscopy. Adverse events (AE) occurred in 10 patients; six month survival free of AE was 50%. Worsening arthralgias was the most common AE in 50% of patients. Serious infections included line-sepsis in one patient receiving TPN, and herpes zoster in another patient. Conclusion: In our clinical experience, patients with moderate to severe Crohn's disease who are refractory to currently approved therapies may benefit from treatment with ustekinumab.

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