P263 Influence of Crohn´s Disease phenotype in the retention rate of ustekinumab treatment: SUSTAIN Study
Chaparro, M.(1);Bastón Rey, I.(2);Fernández-Salgado, E.(3);González García, J.(4);Ramos, L.(5);Diz-Lois Palomares, M.T.(6);Argüelles, F.(7);Iglesias Flores, E.(8);Cabelo, M.(9);Rubio Iturria, S.(10);Núñez Ortiz, A.(11);Charro, M.(12);Ginard, D.(13);Dueñas Sadornil, C.(14);Merino Ochoa, O.(15);David, B.(16);Iyo, E.(17);Gutiérrez Casbas, A.(18);Ramírez de la Piscina, P.(19);Boscá-Watts, M.M.(20);Arroyo, M.(21);García, M.J.(22);Hinojosa, E.(23);Gordillo, J.(24);Martínez Montiel, P.(25);Velayos Jiménez, B.(26);Quílez Ivorra, C.(27);Vázque morón, J.M.(28);Huguet, J.M.(29);González Lama, Y.(30);Muñagorri Santos, A.I.(31);Amo, V.M.(32);Martín Arranz, M.D.(33);Bermejo, F.(34);Martínez Cadilla, J.(35);Fradejas Salazar, P.(36);Novella, C.(37);Vispo, E.(37);Barreiro-de Acosta, M.(2);P. Gisbert, J.(1);
(1)Hospital Universitario de La Princesa- Instituto de Investigación Sanitaria Princesa IIS-IP- Universidad Autónoma de Madrid and Centro de Investigación Biomédica en Red de Enfermedades Hepaticas y Digestivas CIBERehd, Gastroenterology, Madrid, Spain;(2)Complejo Hospitalario Universitario de Santiago, Gastroenterology, Santiago de Compostela, Spain;(3)Complejo Hospitalario de Pontevedra, Gastroenterology, Pontevedra, Spain;(4)Hospital Público Comarcal la Inmaculada, Gastroenterology, Almería, Spain;(5)Hospital Universitario de Canarias, Gastroenterology, Tenerife, Spain;(6)Hospital Universitario A Coruña, Gastroenterology, A Coruña, Spain;(7)Hospital Universitario Virgen Macarena- Facultad de Medicina- Universidad de Sevilla, Gastroenterology, Sevilla, Spain;(8)Hospital Universitario Reina Sofía- Universidad de Córdoba- Instituto Maimónides de Investigación Biomédica de Córdoba, Gastroenterology, Córdoba, Spain;(9)Hospital Universitario Virgen de Valme, Gastroenterology, Sevilla, Spain;(10)Complejo Hospitalario de Navarra, Gastroenterology, Pamplona, Spain;(11)Hospital Universitario Virgen del Rocío, Gastroenterology, Sevilla, Spain;(12)Hospital de Barbastro, Gastroenterolgy, Barbastro, Spain;(13)Hospital Universitario Son Espases, Gastroenterology, Palma de Mallorca, Spain;(14)Hospital San Pedro de Álcantara, Gastroenteroloy, Cáceres, Spain;(15)Hospital Universitario Cruces, Gastroenterology, Barakaldo, Spain;(16)Hospital Universitari de Girona Doctor Josep Trueta, Gastroenterology, Girona, Spain;(17)Hospital Comarcal de Inca, Gastroenterology, Inca, Spain;(18)Hospital General Universitario de Alicante- Instituto de Investigación Sanitaria y Biomédica de Alicante ISABIAL and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd- Madrid, Gastroenterology, Alicante, Spain;(19)Hospital Universitario de Araba-Txagorritxu, Gastroenterology, Araba-Txagorritxu, Spain;(20)Hospital Clínico Universitario de Valencia, Gastroenterology, Valencia, Spain;(21)Hospital Clínico Universitario Lozano Blesa, Gastroenterology, Zaragoza, Spain;(22)Hospital Universitario Marqués de Valdecilla- IDIVAL, Gastroenterolory, Santander, Spain;(23)Hospital de Manises, Gastroenterology, Manises, Spain;(24)Hospital de la Santa Creu i Sant Pau, Gastroenterology, Barcelona, Spain;(25)Hospital Universitario 12 de Octubre, Gastroenterology, Madrid, Spain;(26)Hospital Clínico Universitario de Valladolid, Gastroenterology, Valladolid, Spain;(27)Hospital Marina Baixa, Gastroenterology, Villajoyosa, Spain;(28)Hospital Universitario Juan Ramón Jiménez, Gastroenterology, Huelva, Spain;(29)Hospital General Universitario de Valencia, Gastroenterology, Valencia, Spain;(30)Hospital Universitario Puerta de Hierro, Gastroenterology, Majadahonda, Spain;(31)Hospital Universitario de Donostia, Gastroenterology, San Sebastián, Spain;(32)Hospital Regional de Málaga, Gastroenterology, Málaga, Spain;(33)Hospital Universitario de La Paz- Instituto de Investigación Sanitaria del Hospital La Paz IdiPaz- Facultad de Medicina- Universidad Autónoma de Madrid, Gastroenterology, Madrid, Spain;(34)Hospital Universitario de Fuenlabrada- Instiuto de Investigación Sanitaria del Hospital La Paz IdiPaz, Gastroenterology, Madrid, Spain;(35)Hospital Álvaro Cunqueiro, Gastroenterology, Vigo, Spain;(36)Hospital Virgen de la Concha, Gastroenterology, Zamora, Spain;(37)Janssen Medical Department, Gastroenterology, Madrid, Spain
Background
Crohn´s disease (CD) is a progressive inflammatory bowel disease that can lead to complications such as strictures or penetrating disease, and ultimately surgery, representing a complex clinical challenge in the care of patients. We aimed to evaluate the influence of CD phenotype in the retention rate of ustekinumab in the Sustain study.
Methods
Retrospective, multicentre study (>60 sites) including patients with active CD [(Harvey-Bradshaw (HBI)>4)] who received ≥1 dose of ustekinumab intravenously before July 2018. Clinical remission was defined as HBI≤4 and response as ≥3 points decrease from baseline. Loss of response (LoR) was defined as reappearance of symptoms that led to intensifying the treatment dose, adding another medication to control CD, switching or surgery in patients with short-term remission.
Disease characteristics were collected (date of diagnosis; location; behaviour: inflammatory, stenosing or penetrating; presence of perianal disease or extraintestinal manifestations; previous surgeries, etc.).
The retention rates in patients on ustekinumab depending of their disease phenotype were evaluated by descriptive analysis and Kaplan-Meier survival curves. Survival curves were compared using the log-rank test. Predictive factors were assessed by Cox-regression. Data quality was assured by remote monitoring.
Results
463 CD patients were included (Table 1)..png)
87 patients (18.6%) had penetrating CD in our cohort.
The probability of maintaining UST treatment was 91% at 6, 83% at 12, 76% at 18 and 73% at 24 months.
Similar retention rates were observed in patients with inflammatory (77.6%), stricturing (76.4%) and penetrating (79%) disease behaviour (p>0.05). Figure 1.
Conclusion
Ustekinumab has shown to be equally effective in the treatment of inflammatory, stricturing and penetrating CD phenotype in Sustain, the largest study evaluating its use in CD in clinical practice, having the longest follow-up period reported to date.