Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study
Por:
Chaparro, M, Baston-Rey, I, Fernandez-Salgado, E, Garcia, JG, Ramos, L, Palomares, MTDL, Arguelles-Arias, F, Flores, EI, Cabello, M, Iturria, SR, Ortiz, AN, Charro, M, Ginard, D, Sadornil, CD, Ochoa, OM, Busquets, D, Iyo, E, Casbas, AG, de la Piscina, PR, Bosca-Watts, MM, Arroyo, M, Garcia, MJ, Hinojosa, E, Gordillo, J, Montiel, PM, Jimenez, BV, Ivorra, CQ, Moron, JMV, Huguet, JM, Gonzalez-Lama, Y, Santos, AIM, Amo, VM, Martin-Arranz, MD, Bermejo, F, Cadilla, JM, de Celix, CR, Salazar, PF, San Roman, AL, Jimenez, N, Lopez, SG, Figuerola, A, Jimenez, I, Cerezo, FJM, Taxonera, C, Varela, P, de Francisco, R, Monfort, D, Arriero, GM, Camba, AH, Garcia-Alonso, FJ, Van Domselaar, M, Villarroya, RP, Nunez, A, Moranta, FR, Marin-Jimenez, I, Alonso, VR, Rodriguez, MDM, Camo-Monterde, P, Tercero, IG, Llavat, MN, Garcia, LA, Cruz, DH, Sulleiro, S, Novella, C, Vispo, E, Barreiro-de Acosta, M, Gisbert, JP
Publicada:
2 nov 2022
Ahead of Print:
1 feb 2022
Resumen:
Background Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn's disease (CD) patients in real-world clinical practice. Methods A retrospective, multicentre study was conducted in Spain in patients with active CD who had received >= 1 intravenous dose of ustekinumab for >= 6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety. Results A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received >= 3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had >= 1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever). Conclusions Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.
Lay Summary This large retrospective study demonstrated the short- and long-term effectiveness and safety of ustekinumab in patients with Crohn's disease in real-world clinical practice, including those with refractory disease.
Filiaciones:
Chaparro, M:
Univ Autonoma Madrid, Hosp Univ La Princesa, Gastroenterol Dept, Inst Invest Sanitaria Princesa, Madrid, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Baston-Rey, I:
Complejo Hosp Univ Santiago, Gastroenterol Dept, Santiago De Compostela, Spain
Fernandez-Salgado, E:
Complejo Hosp Pontevedra, Gastroenterol Dept, Pontevedra, Spain
Garcia, JG:
Hosp Publ Comarcal Inmaculada, Gastroenterol Dept, Almeria, Spain
Ramos, L:
Hosp Univ Canarias, Gastroenterol Dept, Tenerife, Spain
Palomares, MTDL:
Hosp Univ A Coruna, Gastroenterol Dept, La Coruna, Spain
Arguelles-Arias, F:
Univ Seville, Hosp Univ Virgen Macarena, Fac Med, Gastroenterol Dept, Seville, Spain
Flores, EI:
Univ Cordoba, Hosp Univ Reina Sofia, Inst Maimonides Invest Biomed Cordoba, Gastroenterol Dept, Cordoba, Spain
Cabello, M:
Hosp Univ Virgen de Valme, Gastroenterol Dept, Seville, Spain
Iturria, SR:
Complejo Hosp Navarra, Gastroenterol Dept, Pamplona, Spain
Ortiz, AN:
Hosp Univ Virgen del Rocio, Gastroenterol Dept, Seville, Spain
Charro, M:
Hosp Barbastro, Gastroenterol Dept, Barbastro, Spain
Ginard, D:
Hosp Univ Son Espases, Gastroenterol Dept, Palma De Mallorca, Spain
Sadornil, CD:
Hosp San Pedro de Alcantara, Gastroenterol Dept, Caceres, Spain
Ochoa, OM:
Hosp Univ Cruces, Gastroenterol Dept, Baracaldo, Spain
Busquets, D:
Hosp Univ Girona Doctor Josep Trueta, Gastroenterol Dept, Girona, Spain
Iyo, E:
Hosp Comarcal Inca, Gastroenterol Dept, Inca, Spain
Casbas, AG:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Hosp Gen Univ Alicante, Inst Invest Sanitaria & Biomed Alicante, Gastroenterol Dept, Alicante, Spain
de la Piscina, PR:
Hosp Univ Araba Txagorritxu, Gastroenterol Dept, Araba Txagorritxu, Spain
Bosca-Watts, MM:
Hosp Clin Univ Valencia, Gastroenterol Dept, Valencia, Spain
Arroyo, M:
Hosp Clin Univ Lozano Blesa, Gastroenterol Dept, Zaragoza, Spain
Garcia, MJ:
Hosp Univ Marques de Valdecilla, Inst Invest Sanitario Valdecilla IDIVAL, Gastroenterol Dept, Santander, Spain
Hinojosa, E:
Hosp Manises, Gastroenterol Dept, Manises, Spain
Gordillo, J:
Hosp Santa Creu & Sant Pau, Gastroenterol Dept, Barcelona, Spain
Montiel, PM:
Hosp Univ 12 Octubre, Gastroenterol Dept, Madrid, Spain
Jimenez, BV:
Hosp Clin Univ Valladolid, Gastroenterol Dept, Valladolid, Spain
Ivorra, CQ:
Hosp Marina Baixa, Gastroenterol Dept, Villajoyosa, Spain
Moron, JMV:
Hosp Univ Juan Ramon Jimenez, Gastroenterol Dept, Huelva, Spain
Huguet, JM:
Hosp Gen Univ Valencia, Gastroenterol Dept, Valencia, Spain
Gonzalez-Lama, Y:
Hosp Univ Puerta de Hierro, Gastroenterol Dept, Majadahonda, Spain
Santos, AIM:
Hosp Univ Donostia, Gastroenterol Dept, Donostia San Sebastian, Spain
Amo, VM:
Hosp Reg Malaga, Gastroenterol Dept, Malaga, Spain
Martin-Arranz, MD:
Univ Autonoma Madrid, Hosp Univ La Paz, Inst Hlth Res La Paz, Gastroenterol Dept, Madrid, Spain
Bermejo, F:
Hosp Univ Fuenlabrada, Inst Invest Sanitaria Hosp La Paz, Gastroenterol Dept, Madrid, Spain
Cadilla, JM:
Hosp Alvaro Cunqueiro, Gastroenterol Dept, Vigo, Spain
de Celix, CR:
Univ Autonoma Madrid, Hosp Univ La Princesa, Gastroenterol Dept, Inst Invest Sanitaria Princesa, Madrid, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Salazar, PF:
Hosp Virgen de la Concha, Gastroenterol Dept, Zamora, Spain
San Roman, AL:
Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid, Spain
Jimenez, N:
Hosp Gen Univ Elche, Gastroenterol Dept, Elche, Spain
Lopez, SG:
Hosp Univ Miguel Servet, Gastroenterol Dept, Zaragoza, Spain
Figuerola, A:
Hosp Gen Univ Castellon, Gastroenterol Dept, Castellon De La Plana, Spain
Jimenez, I:
Hosp Univ Galdakao Usansolo, Gastroenterol Dept, Galdakao, Spain
Hosp Gen Univ Gregorio Maranon, Serv Aparato Digest, IiSGM, Madrid, Spain
Univ Complutense Madrid, Fac Med, Madrid, Spain
Cerezo, FJM:
Hosp Univ St Joan Reus, Gastroenterol Dept, Reus, Spain
Taxonera, C:
Hosp Clin Univ San Carlos, Hosp Clin San Carlos, Gastroenterol Dept, Inst Invest, Madrid, Spain
Varela, P:
Hosp Univ Cabuenes, Gastroenterol Dept, Gijon, Spain
de Francisco, R:
Hosp Univ Cent Asturias, Inst Invest Biosanitaria Principado Asturias, Gastroenterol Dept, Oviedo, Spain
Monfort, D:
Consorci Sanitari Terrassa, Gastroenterol Dept, Terrassa, Spain
Arriero, GM:
Complejo Hosp Univ Ferrol, Gastroenterol Dept, Ferrol, Spain
Camba, AH:
Hosp Univ Nuestra Senora Candelaria, Gastroenterol Dept, Santa Cruz De Tenerife, Spain
Garcia-Alonso, FJ:
Hosp Univ Rio Hortega, Gastroenterol Dept, Valladolid, Spain
Van Domselaar, M:
Hosp Univ Torrejon, Gastroenterol Dept, Madrid, Spain
Villarroya, RP:
Hosp Univ Infanta Sofia, Gastroenterol Dept, Madrid, Spain
Nunez, A:
Hosp Clin Univ Salamanca, Gastroenterol Dept, Salamanca, Spain
Moranta, FR:
Hosp Univ Bellvitge, Gastroenterol Dept, Barcelona, Spain
Marin-Jimenez, I:
Hosp Gen Univ Gregorio Maranon, Serv Aparato Digest, IiSGM, Madrid, Spain
Univ Complutense Madrid, Fac Med, Madrid, Spain
Alonso, VR:
Hosp Univ Vall dHebron, Gastroenterol Dept, Barcelona, Spain
Rodriguez, MDM:
Hosp Univ Virgen de las Nieves, Gastroenterol Dept, Granada, Spain
Camo-Monterde, P:
Hosp Univ San Jorge, Gastroenterol Dept, Huesca, Spain
Tercero, IG:
Hosp Gen Univ Santa Lucia, Gastroenterol Dept, Cartagena, Spain
Llavat, MN:
Gastroenterol Dept, Hosp St Joan Despi Moises Broggi, St Joan Despi, Spain
Garcia, LA:
Hosp Univ Burgos, Gastroenterol Dept, Burgos, Spain
Cruz, DH:
Hosp Gen Univ Ciudad Real, Gastroenterol Dept, Ciudad Real, Spain
Sulleiro, S:
Janssen Med Dept, Madrid, Spain
Novella, C:
Janssen Med Dept, Madrid, Spain
Vispo, E:
Janssen Med Dept, Madrid, Spain
Barreiro-de Acosta, M:
Complejo Hosp Univ Santiago, Gastroenterol Dept, Santiago De Compostela, Spain
Gisbert, JP:
Univ Autonoma Madrid, Hosp Univ La Princesa, Gastroenterol Dept, Inst Invest Sanitaria Princesa, Madrid, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
hybrid, All Open Access, Hybrid Gold
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