دورية أكاديمية
Effectiveness and safety of ustekinumab in bio-naïve Crohn’s disease patients: a multicentre observational retrospective study
| العنوان: | Effectiveness and safety of ustekinumab in bio-naïve Crohn’s disease patients: a multicentre observational retrospective study |
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| المؤلفون: | Valdés Delgado, Teresa, Olmedo-Martín, Raúl Vicente, Herrera de Guise, Claudia Maria, Fuentes-Valenzuela, Esteban, Melcarne, Luigi, Iborra, Marisa |
| المساهمون: | Institut Català de la Salut, Valdés Delgado T Gastroenterology Department, Virgen Macarena University Hospital, Seville, Spain. Olmedo Martín R Regional University Hospital of Malaga, Malaga, Spain. Iborra M La Fe University and Politechnic Hospital, Valencia, Spain. Herrera de Guisé C Vall d’Hebron Hospital Universitari, Barcelona, Spain. Fuentes-Valenzuela E Río Hortega University Hospital, Valladolid, Spain. Melcarne L Park Taulí University Hospital, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| المصدر: | Scientia |
| بيانات النشر: | SAGE Publications |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Crohn, Malaltia de - Tractament, Anticossos monoclonals - Ús terapèutic, Avaluació de resultats (Assistència sanitària), ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome, CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal, Other subheadings::Other subheadings::/therapeutic use, DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases::Crohn Disease, Other subheadings::Other subheadings::Other subheadings::/drug therapy, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento, COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales, Otros calificadores::Otros calificadores::/uso terapéutico, ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal::enfermedad de Crohn, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia |
| الوصف: | Crohn’s disease; Biological therapy; Effectiveness ; Malaltia de Crohn; Teràpia biològica; Eficàcia ; Enfermedad de Crohn; Terapia biológica; Eficacia ; Background: Clinical trials have demonstrated the efficacy and safety of ustekinumab in Crohn’s disease (CD). However, more data are necessary on the effectiveness of ustekinumab in bio-naïve patients in real-life studies. Objectives: The aim of our study was to evaluate the effectiveness and safety of ustekinumab in patients with CD refractory or intolerant to conventional therapy and without previous exposure to biological drugs. Design: We performed a nationwide, observational, retrospective, multicentre study including patients with CD, in which ustekinumab was used as the first biological drug. Methods: The corticosteroid-free clinical and biological response and remission were analysed at weeks 16, 24, 52 and 72. Clinical remission was defined as Harvey–Bradshaw index ⩽ 4 and biological remission as a faecal calprotectin (FC) <250 mg/g and C-reactive protein (CRP) <5 mg/L. Moreover, the persistence of the treatment and any adverse events were assessed. Results: In all, 84 patients were included in the study, males and females were equally distributed, with a median age of 63 years [interquartile range (IQR): 51–75] and a median disease duration of 6.8 years [IQR: 3.6–17.0]. The majority (86.9%) of patients were treated with ustekinumab as monotherapy, without concomitant immunosuppressive medication. The proportion of patients in corticosteroid-free clinical remission or response at weeks 16, 24, 52 and 72 was 93.3% (56/60), 86.8% (46/53), 82.2% (37/45) and 71.4% (30/42), respectively. CRP returned to normal values in 47.6%, 43.2%, 50% and 52.4% of patients at weeks 16, 24, 52 and 72, respectively. Similarly, FC was normalized in 45.5%, 45.5%, 48.6% and 50% of patients at weeks 16, 24, 52 and 72, respectively. The cumulative probability of remaining on ustekinumab treatment was 84.8% (95% confidence interval: 73.3–91.6) after 72 weeks. Ustekinumab ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1756-2848 |
| العلاقة: | Therapeutic Advances in Gastroenterology;16; https://doi.org/10.1177/17562848231153560Test; Valdés Delgado T, Olmedo Martín R, Iborra M, Herrera de Guisé C, Fuentes-Valenzuela E, Melcarne L, et al. Effectiveness and safety of ustekinumab in bio-naïve Crohn’s disease patients: a multicentre observational retrospective study. Therap Adv Gastroenterol. 2023;16:1–13.; https://hdl.handle.net/11351/9913Test; 000928764100001 |
| DOI: | 10.1177/17562848231153560 |
| الإتاحة: | https://doi.org/10.1177/17562848231153560Test https://hdl.handle.net/11351/9913Test |
| حقوق: | Attribution-NonCommercial 4.0 International ; http://creativecommons.org/licenses/by-nc/4.0Test/ ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.9DC7AF92 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 17562848 |
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| DOI: | 10.1177/17562848231153560 |