000121175 001__ 121175
000121175 005__ 20240319081015.0
000121175 0247_ $$2doi$$a10.1093/ibd/izab357
000121175 0248_ $$2sideral$$a131827
000121175 037__ $$aART-2022-131827
000121175 041__ $$aeng
000121175 100__ $$aChaparro, María
000121175 245__ $$aLong-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn’s Disease Patients: The SUSTAIN Study
000121175 260__ $$c2022
000121175 5060_ $$aAccess copy available to the general public$$fUnrestricted
000121175 5203_ $$aBackground
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.
000121175 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/
000121175 590__ $$a4.9$$b2022
000121175 592__ $$a1.834$$b2022
000121175 591__ $$aGASTROENTEROLOGY & HEPATOLOGY$$b28 / 93 = 0.301$$c2022$$dQ2$$eT1
000121175 593__ $$aImmunology and Allergy$$c2022$$dQ1
000121175 593__ $$aGastroenterology$$c2022$$dQ1
000121175 594__ $$a10.1$$b2022
000121175 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000121175 700__ $$aBaston-Rey, Iria
000121175 700__ $$aFernández-Salgado, Estela
000121175 700__ $$aGonzález García, Javier
000121175 700__ $$aRamos, Laura
000121175 700__ $$aDiz-Lois Palomares, María Teresa
000121175 700__ $$aArgüelles-Arias, Federico
000121175 700__ $$aIglesias Flores, Eva
000121175 700__ $$aCabello, Mercedes
000121175 700__ $$aRubio Iturria, Saioa
000121175 700__ $$aNúñez Ortiz, Andrea
000121175 700__ $$aCharro, Mara
000121175 700__ $$aGinard, Daniel
000121175 700__ $$aDueñas Sadornil, Carmen
000121175 700__ $$aMerino Ochoa, Olga
000121175 700__ $$aBusquets, David
000121175 700__ $$aIyo, Eduardo
000121175 700__ $$aGutiérrez Casbas, Ana
000121175 700__ $$aRamírez de la Piscina, Patricia
000121175 700__ $$aBoscá-Watts, Marta Maia
000121175 700__ $$aArroyo, Maite
000121175 700__ $$aGarcía, María José
000121175 700__ $$aHinojosa, Esther
000121175 700__ $$aGordillo, Jordi
000121175 700__ $$aMartínez Montiel, Pilar
000121175 700__ $$aVelayos Jiménez, Benito
000121175 700__ $$aQuílez Ivorra, Cristina
000121175 700__ $$aVázquez Morón, Juan María
000121175 700__ $$aMaría Huguet, José
000121175 700__ $$aGonzález-Lama, Yago
000121175 700__ $$aMuñagorri Santos, Ana Isabel
000121175 700__ $$aAmo, Víctor Manuel
000121175 700__ $$aMartín-Arranz, María Dolores
000121175 700__ $$aBermejo, Fernando
000121175 700__ $$aMartínez Cadilla, Jesús
000121175 700__ $$aRubín de Célix, Cristina
000121175 700__ $$aFradejas Salazar, Paola
000121175 700__ $$aSan Román, Antonio López
000121175 700__ $$aJiménez, Nuria
000121175 700__ $$0(orcid)0000-0003-3970-5457$$aGarcía López, Santiago$$uUniversidad de Zaragoza
000121175 700__ $$aFiguerola, Anna
000121175 700__ $$aJiménez, Itxaso
000121175 700__ $$aMartínez Cerezo, Francisco José
000121175 700__ $$aTaxonera, Carlos
000121175 700__ $$aVarela, Pilar
000121175 700__ $$ade Francisco, Ruth
000121175 700__ $$aMonfort, David
000121175 700__ $$aMolina Arriero, Gema
000121175 700__ $$aHernández Camba, Alejandro
000121175 700__ $$aGarcía-Alonso, Francisco Javier
000121175 700__ $$aVan Domselaar, Manuel
000121175 700__ $$aPajares Villarroya, Ramón
000121175 700__ $$aNúñez, Alejandro
000121175 700__ $$aRodríguez Moranta, Francisco
000121175 700__ $$aMarín-Jiménez, Ignacio
000121175 700__ $$aRobles Alonso, Virginia
000121175 700__ $$aMartín Rodríguez, María del Mar
000121175 700__ $$aCamo-Monterde, Patricia
000121175 700__ $$aGarcía Tercero, Iván
000121175 700__ $$aNavarro Llavat, Mercedes
000121175 700__ $$aArias García, Lara
000121175 700__ $$aHervías Cruz, Daniel
000121175 700__ $$aSulleiro, Sara
000121175 700__ $$aNovella, Cynthia
000121175 700__ $$aVispo, Eugenia
000121175 700__ $$aBarreiro-de Acosta, Manuel
000121175 700__ $$aGisbert, Javier P
000121175 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000121175 773__ $$g28, 11 (2022), 1725-1736$$pInflamm. bowel dis.$$tINFLAMMATORY BOWEL DISEASES$$x1078-0998
000121175 8564_ $$s2526655$$uhttps://zaguan.unizar.es/record/121175/files/texto_completo.pdf$$yVersión publicada
000121175 8564_ $$s3072053$$uhttps://zaguan.unizar.es/record/121175/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000121175 909CO $$ooai:zaguan.unizar.es:121175$$particulos$$pdriver
000121175 951__ $$a2024-03-18-15:35:00
000121175 980__ $$aARTICLE