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P252. Effectiveness and safety of ustekinumab as rescue therapy in multi-drug resistant Crohn's disease

D. Ginard1, S. Khorrami1, I. Marín2, M. Chaparro3, M. Aguas4, J. Martínez-González5, J.L. Cabriada6, V. García-Sánchez7, A. Villoria8, F. Casellas9, A. Sansó10, J. Riera11, D. Hervías12, S. García13, E. García-Planella14, F. Muñoz15, J.P. Gisbert3

1Hospital Son Espases, Gastroenterology, Spain; 2Hospital Gregorio Marañón, Gastroenterology, Spain; 3Hospital de La Princesa, IP and CIBEREHD, Gastroenterology, Spain; 4Hospital La Fe, Gastroenterology, Spain; 5Hospital Ramón y Cajal, Gastroenterology, Spain; 6Hospital Galdakao, Gastroenterology, Spain; 7Hospital Reina Sofía, Gastroenterology, Spain; 8Hospital Parc Taulí, Gastroenterology, Spain; 9Hospital Vall D'Hebrón, Gastroenterology, Spain; 10Hospital de Manacor, Gastroenterology, Spain; 11Hospital Son Llàtzer, Gastroenterology, Spain; 12Hospital Virgen de Altagracia, Gastroenterology, Spain; 13Hospital Miguel Servet, Gastroenterology, Spain; 14Hospital de la Santa Creu y de San Pau, Gastroenterology, Spain; 15Complejo Asistencial de León, Gastroenterology, Spain

Background: Ustekinumab is a monoclonal antibody against IL‑12/23, effective in psoriasis. Recently two phase 2b studies 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). Twenty-four (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 90 mg weekly during 4 weeks subcutaneously. Nineteen (82.6%) patients received 90 mg 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.

 Remission n/N (%)Response n/N (%)Failure n/N (%)
After induction7/24 (29.2)13/24 (54.2)4/24 (16.7)
At the end of follow-up14/30 (46.7)9/30 (30.0)7/30 (23.3)

From 7 failures, 2 patients needed surgery. Only 4 non-severe adverse events were reported.

Conclusions: Ustekinumab seems to be effective and safe in multi-drug refractory CD. More studies are needed in order to evaluate the effectiveness of ustekinumab and determine the best therapeutic scheme.