Clinical Outcomes of Golimumab as First, Second or Third Anti-TNF Agent in Patients with Moderate-to-Severe Ulcerative Colitis
Por:
Taxonera, C, Rodriguez, C, Bertoletti, F, Menchen, L, Arribas, J, Sierra, M, Arias, L, Martinez-Montiel, P, Juan, A, Iglesias, E, Algaba, A, Mancenido, N, Rivero, M, Barreiro-de Acosta, M, Lopez-Serrano, P, Arguelles-Arias, F, Gutierrez, A, Busquets, D, Gisbert, JP, Olivares, D, Calvo, M, Alba, C
Publicada:
1 ago 2017
Resumen:
Background: Golimumab efficacy data in ulcerative colitis (UC) are limited to anti-tumor necrosis factor a (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.
Methods: This 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.
Results: In 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.
Conclusions: In 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.
Filiaciones:
Taxonera, C:
Hosp Clin San Carlos, Dept Gastroenterol, Inflammatory Bowel Dis Unit, Madrid, Spain
Hosp Clin San Carlos IdISSC, Inst Invest, Madrid, Spain
Rodriguez, C:
Complejo Hosp Navarra, Dept Gastroenterol, Pamplona, Spain
Bertoletti, F:
Hosp Santa Creu & Sant Pau, Dept Gastroenterol, Barcelona, Spain
Menchen, L:
Hosp Gregorio Maranon, Dept Gastroenterol, Madrid, Spain
IISGM, Madrid, Spain
CIBEREHD, Madrid, Spain
Arribas, J:
Hosp Ramon & Cajal, Dept Gastroenterol, Madrid, Spain
Sierra, M:
Complejo Asistencial Univ Leon, Dept Gastroenterol, Leon, Spain
Arias, L:
Hosp Univ Burgos, Dept Gastroenterol, Burgos, Spain
Martinez-Montiel, P:
Hosp 12 Octubre, Dept Gastroenterol, Madrid, Spain
Juan, A:
Hosp Badalona Germans Trias & Pujol, Dept Gastroenterol, Badalona, Spain
Iglesias, E:
Hosp Reina Sofia, Dept Gastroenterol, Cordoba, Spain
Algaba, A:
Hosp Fuenlabrada, Dept Gastroenterol, Madrid, Spain
Mancenido, N:
Hosp Infanta Sofia, Dept Gastroenterol, Madrid, Spain
Rivero, M:
Hosp Marques Valdecilla, Dept Gastroenterol, Santander, Spain
Barreiro-de Acosta, M:
Hosp Clin Santiago, Dept Gastroenterol, Santiago De Compostela, Spain
Lopez-Serrano, P:
Hosp Univ Fundac Alcorcon, Dept Gastroenterol, Madrid, Spain
Arguelles-Arias, F:
Hosp Univ Virgen Macarena, Dept Gastroenterol, Seville, Spain
Gutierrez, A:
CIBEREHD, Madrid, Spain
Hosp Gen Univ Alicante, Dept Gastroenterol, Alicante, Spain
Busquets, D:
Hosp Univ Doctor Josep Trueta, Dept Gastroenterol, Girona, Spain
Gisbert, JP:
CIBEREHD, Madrid, Spain
Hosp Princesa, Inst Invest Sanitaria Princesa IIS IP, Dept Gastroenterol, Madrid, Spain
Olivares, D:
Hosp Clin San Carlos, Dept Gastroenterol, Inflammatory Bowel Dis Unit, Madrid, Spain
Hosp Clin San Carlos IdISSC, Inst Invest, Madrid, Spain
Calvo, M:
Hosp Puerta Hierro, Dept Gastroenterol, Madrid, Spain
Alba, C:
Hosp Clin San Carlos, Dept Gastroenterol, Inflammatory Bowel Dis Unit, Madrid, Spain
Hosp Clin San Carlos IdISSC, Inst Invest, Madrid, Spain
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