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P425. One-year outcomes of ustekinumab therapy in a multi-drug refractory Crohn's disease cohort

D. Ginard1, S. Khorrami1, I. Marín2, M. Chaparro3, M. Aguas4, J. Martínez-González5, J.L. Cabriada6, V. García-Sánchez7, A. Villoria8, J. Gelabert9, F. Casellas10, A. Sansó11, J. Riera12, D. Hervías13, S. García14, E. García-Planella15, J.P. Gisbert3, 1Hospital Son Espases, Gastroenterology, Palma de Mallorca, Spain, 2Hospital Gregorio Marañón, Gastroenterology, Spain, 3Hospital de La Princesa, IP and CIBEREHD, Gastroenterology, Spain, 4Hospital La Fe, Gastroenterology, Valencia, Spain, 5Hospital Ramón y Cajal, Gastroenterology, Spain, 6Hospital Galdakao, Gastroenterology, Spain, 7Hospital Reina Sofía, Gastroenterology, Spain, 8Hospital Parc Taulí, Gastroenterology, Spain, 9Hospital Mateo Orfila, Gastroenterology, Mahón, Spain, 10Hospital Vall D'Hebrón, Gastroenterology, Spain, 11Hospital de Manacor, Gastroenterology, Spain, 12Hospital Son Llàtzer, Gastroenterology, Spain, 13Hospital Virgen de Altagracia, Gastroenterology, Spain, 14Hospital Miguel Servet, Gastroenterology, Spain, 15Hospital de la Santa Creu y de San Pau, Gastroenterology, Spain

Background

Ustekinumab is a monoclonal antibody against IL-12/23, which induces and maintains clinical response in refractory Crohn's disease (CD). The aim of this study was to assess the effectiveness and safety of ustekinumab at one year in refractory CD.

Methods

Consecutive patients with CD in whom ustekinumab was administrated under compassionate use until October 2012, in 15 Spanish centers were retrospectively included. Demographic characteristics, medical and surgical history, dosage and schedule of ustekinumab administration were registered. The clinical remission and response at one year were evaluated based on the Harvey–Bradshaw index and by medical judgment. Side effects were also recorded.

Results

Thirty-three CD patients (20 female, 37±15 year-old) were included. Most of them had ileocolonic involvement (57.6%), non-stenosant non-penetrating behavior (63.6%) and longstanding disease (mean 10 years, IQI 6.7–14.8). Sixteen patients had at least one previous intestinal resection. Twenty-three (69.7%) patients had previously failed to at least two immunosuppressants and 81.8% to at least two anti-TNF agents. Twenty-seven patients received an induction regime with ustekinumab and twenty-nine received maintenance therapy. The most frequent maintenance scheme (66.7%) was 90 mg of ustekinumab every 8 weeks subcutaneously. The proportions of patients who achieved clinical remission and response at one year were 42.4 and 15.2 respectively. Of 27 primary responders to ustekinumab, 66.7% maintained the beneficial effect (remission 51.9% and response 14.8%) after one year of maintenance therapy. Surgery was needed in 8 of 14 patients in whom ustekinumab failed. Only 4 non-severe adverse events were reported.

Conclusion

Ustekinumab seems to be effective and safe at one year in multi-drug refractory CD. Half of patients with initial response to ustekinumab achieved clinical remission after one year with ustekinumab as maintenance therapy.