Abstract

have shown that ustekinumab induces and maintains clinical response in Crohn’s disease (CD). Data of the effectiveness of ustekinumab in CD in clinical practice are lacked. The aim of this study was to assess the effectiveness and safety of ustekinumab in CD after multi-drug failure, in a compassionate program. Methods: Consecutive patients with CD in whom ustekinumab was administrated under compassionate use until October 2011, in 15 Spanish centers were retrospectively included. Demographic characteristics, medical and surgical history, dosage and schedule of ustekinumab administration were registered. The clinical response and remission to induction and maintenance treatment were evaluated based on the Harvey Bradshaw index (HBI), and by medical judgment. Side effects were also recorded. Results: Thirty CD patients (18 female, median age 35 years, range 17 80) followed up for 189±148 days were included. Most of them had ileocolonic involvement (60%), non-stenosant non-penetrating behavior (60%), and longstanding disease (median 10 years, range 3 34). Sixteen patients had at least one previous intestinal resection (range 1 7). Twentyfour (67%) patients had previously failed to at least two immunosuppressants and 80% to at least two anti-TNFs agents. Twenty-eight (93.3%) patients had received at least 4 doses of ustekinumab. Twenty-four patients received ustekinumab induction and the most frequent (71%) schedule was 90mg weekly during 4 weeks subcutaneously. Nineteen (82.6%) patients received 90mg of ustekinumab every eight weeks subcutaneously as maintenance schedule therapy. Clinical remission, response and failure rates after induction and at the end of follow-up are shown in the table.

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