• Inflamm. Bowel Dis. · Aug 2017

    Multicenter Study

    Clinical Outcomes of Golimumab as First, Second or Third Anti-TNF Agent in Patients with Moderate-to-Severe Ulcerative Colitis.

    • Carlos Taxonera, Cristina Rodríguez, Federico Bertoletti, Luís Menchén, Julia Arribas, Mónica Sierra, Lara Arias, Pilar Martínez-Montiel, Alba Juan, Eva Iglesias, Alicia Algaba, Noemí Manceñido, Montserrat Rivero, Manuel Barreiro-de Acosta, Pilar López-Serrano, Federico Argüelles-Arias, Ana Gutierrez, David Busquets, Javier P Gisbert, David Olivares, Marta Calvo, Cristina Alba, and Collaborators.
    • 1Inflammatory Bowel Disease Unit, Department of Gastroenterology, Hospital Clínico San Carlos and Instituto de Investigación del Hospital Clínico San Carlos (IdISSC), Madrid, Spain; 2Department of Gastroenterology, Complejo Hospitalario de Navarra, Pamplona, Spain; 3Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 4Department of Gastroenterology, Hospital Gregorio Marañón and Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain; 5Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; 6Department of Gastroenterology, Hospital Ramón y Cajal, Madrid, Spain; 7Department of Gastroenterology, Complejo Asistencial Universitario de León, León, Spain; 8Department of Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain; 9Department of Gastroenterology, Hospital 12 de Octubre, Madrid, Spain; 10Department of Gastroenterology, Hospital Germans Trias i Pujol, Badalona, Spain; 11Department of Gastroenterology, Hospital Reina Sofía, Córdoba, Spain; 12Department of Gastroenterology, Hospital de Fuenlabrada, Madrid, Spain; 13Department of Gastroenterology, Hospital Infanta Sofía, Madrid, Spain; 14Department of Gastroenterology, Hospital Marqués de Valdecilla, Santander, Spain; 15Department of Gastroenterology, Hospital Clínico de Santiago, Santiago de Compostela, Spain; 16Department of Gastroenterology, Hospital Universitario Fundación Alcorcón, Madrid, Spain; 17Department of Gastroenterology, Hospital Universitario Virgen Macarena, Sevilla, Spain; 18Department of Gastroenterology, Hospital General Universitario de Alicante, Alicante, Spain; 19Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; 20Department of Gastroenterology, Hospital Universitari Doctor Josep Trueta, Girona, Spain; 21Department of Gastroenterology, Hospital de la Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain; and 22Department of Gastroenterology, Hospital Puerta de Hierro, Madrid, Spain.
    • Inflamm. Bowel Dis. 2017 Aug 1; 23 (8): 1394-1402.

    BackgroundGolimumab efficacy data in ulcerative colitis (UC) are limited to anti-tumor necrosis factor α (TNF)-naive patients. The aim of this study was to assess the short-term and long-term efficacy of golimumab used as first, second, or third anti-TNF in UC in a real-life clinical setting.MethodsThis retrospective multicenter cohort study included patients with moderate-to-severe UC treated with golimumab. The primary efficacy endpoints were short-term partial Mayo score response, long-term golimumab failure-free survival, and colectomy-free survival.ResultsIn 142 patients with UC, golimumab was administered as first (40%), second (23%), or third anti-TNF (37%). Ninety-two patients (65%, 95% confidence interval 56.6-73) achieved short-term clinical response. Forty-five patients (32%, 95% confidence interval 23.7-39.7) achieved clinical remission. Response rates for golimumab were 75% as first anti-TNF, 70% as second anti-TNF (ns versus first anti-TNF), and 50% as third anti-TNF (P = 0.007 versus first anti-TNF). After 12 months median follow-up (interquartile range 6-18), 60 patients (42%, 95% confidence interval 34-51) had golimumab failure, and 15 patients (11%) needed colectomy. Thirty-one patients (22%) needed golimumab dose escalation, and 71% of these regained response after escalation. Starting maintenance with 100 mg golimumab doses and short-term nonresponse were independent predictors of golimumab failure.ConclusionsIn this real-life cohort of patients with UC, golimumab therapy was effective for inducing and maintaining clinical response. Although anti-TNF-naive patients had better outcomes, golimumab was also effective in anti-TNF-experienced patients. Only the patients given golimumab after previous failure of 2 anti-TNF agents had significantly worse outcomes. Golimumab dose escalation was beneficial and safe.

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