{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,2]],"date-time":"2025-08-02T04:17:11Z","timestamp":1754108231679},"reference-count":11,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2019,4,16]],"date-time":"2019-04-16T00:00:00Z","timestamp":1555372800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"MSD Portugal","award":["MK8259-22"],"award-info":[{"award-number":["MK8259-22"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,10,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background and Aims<\/jats:title>\n                  <jats:p>Golimumab has an established exposure-response relationship in patients with ulcerative colitis [UC]. However, the association of serum golimumab trough levels [TL] with objective markers of disease activity, such as endoscopic and histological activity scores and concentrations of biomarkers, remains less understood. This report describes the relationship of serum golimumab TL at the end of the induction period [Week 6] with clinical, endoscopic, histological, and biomarker parameters.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This was an open-label, uncontrolled, prospective and interventional study. Moderate to severely active UC patients na\u00efve to biologic therapy were treated with golimumab. Serum golimumab TL and faecal calprotectin levels were measured at baseline [Week 0 of induction] and Week 6.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 34 patients completed the induction phase [Week 6] and were included in this analysis. Overall, 47.1% and 14.7% of patients achieved clinical response and remission with significantly higher serum golimumab TL in patients with early response or remission [3.7 \u03bcg\/mL vs 1.3 \u03bcg\/mL, p = 0.0013; and 3.1 \u03bcg\/mL vs 1.7 \u03bcg\/mL, p = 0.0164, respectively]. In addition, golimumab TL were significantly higher in patients achieving histological remission [4.2 \u03bcg\/mL vs 1.7 \u03bcg\/mL, p = 0.0049]. Week 6 golimumab TL were inversely correlated with the total Mayo score [rs = -0.546; p = 0.0008], the Mayo endoscopic subscore [rs = -0.381; p = 0.0262], the Geboes histological activity score [rs = -0.464; p = 0.0057], and faecal calprotectin levels [rs = -0.497; p = 0.0044].<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>A higher early exposure to golimumab is associated with a better objective response in active UC patients and appears to drive the outcome at Week 6.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjz071","type":"journal-article","created":{"date-parts":[[2019,4,12]],"date-time":"2019-04-12T15:19:30Z","timestamp":1555082370000},"page":"1387-1393","source":"Crossref","is-referenced-by-count":14,"title":["Low Golimumab Trough Levels at Week 6 Are Associated With Poor Clinical, Endoscopic and Histological Outcomes in Ulcerative Colitis Patients: Pharmacokinetic and Pharmacodynamic Sub-analysis of the Evolution Study"],"prefix":"10.1093","volume":"13","author":[{"given":"F","family":"Magro","sequence":"first","affiliation":[{"name":"Centro Hospitalar S\u00e3o Jo\u00e3o, Departamento de Gastrenterologia, Porto, Portugal"},{"name":"Faculdade de Medicina, Universidade do Porto, Porto, Portugal"}]},{"given":"S","family":"Lopes","sequence":"additional","affiliation":[{"name":"Centro Hospitalar S\u00e3o Jo\u00e3o, Departamento de Gastrenterologia, Porto, Portugal"}]},{"given":"M","family":"Silva","sequence":"additional","affiliation":[{"name":"Centro Hospitalar S\u00e3o Jo\u00e3o, Departamento de Gastrenterologia, Porto, Portugal"}]},{"given":"R","family":"Coelho","sequence":"additional","affiliation":[{"name":"Centro Hospitalar S\u00e3o Jo\u00e3o, Departamento de Gastrenterologia, Porto, Portugal"}]},{"given":"F","family":"Portela","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Universit\u00e1rio de Coimbra, Departamento de Gastrenterologia, Coimbra, Portugal"}]},{"given":"D","family":"Branquinho","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Universit\u00e1rio de Coimbra, Departamento de Gastrenterologia, Coimbra, Portugal"}]},{"given":"L","family":"Correia","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Lisboa Norte, Departamento de Gastrenterologia, Lisboa, Portugal"}]},{"given":"S","family":"Fernandes","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Lisboa Norte, Departamento de Gastrenterologia, Lisboa, Portugal"}]},{"given":"M","family":"Cravo","sequence":"additional","affiliation":[{"name":"Hospital Beatriz \u00c2ngelo, Departamento de Gastrenterologia, Loures, Portugal"}]},{"given":"P","family":"Caldeira","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Universit\u00e1rio do Algarve, Departamento de Ci\u00eancias Biom\u00e9dicas e Medicina, Universidade do Algarve, Algarve Biomedical Centre, Universidade do Algarve, Faro, Portugal"}]},{"given":"H T","family":"Sousa","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Universit\u00e1rio do Algarve, Departamento de Ci\u00eancias Biom\u00e9dicas e Medicina, Universidade do Algarve, Algarve Biomedical Centre, Universidade do Algarve, Faro, Portugal"}]},{"given":"M","family":"Patita","sequence":"additional","affiliation":[{"name":"Hospital Garcia de Orta, Departamento de Gastrenterologia, Almada, Portugal"}]},{"given":"P","family":"Lago","sequence":"additional","affiliation":[{"name":"Centro Hospitalar do Porto, Departamento de Gastrenterologia, Porto, Portugal"}]},{"given":"J","family":"Ramos","sequence":"additional","affiliation":[{"name":"Centro Hospitalar Lisboa Central, Departamento de Gastrenterologia, Lisboa, Portugal"}]},{"given":"J","family":"Afonso","sequence":"additional","affiliation":[{"name":"Faculdade de Medicina, Universidade do Porto, Porto, Portugal"}]},{"given":"I","family":"Redondo","sequence":"additional","affiliation":[{"name":"MSD Portugal, Medical Affairs, Pa\u00e7o de Arcos, Portugal"}]},{"given":"P","family":"Machado","sequence":"additional","affiliation":[{"name":"MSD Portugal, Medical Affairs, Pa\u00e7o de Arcos, Portugal"}]},{"given":"F","family":"Cornillie","sequence":"additional","affiliation":[{"name":"Merck Sharp & Dohme, Kriens, Switzerland"}]},{"given":"J","family":"Lopes","sequence":"additional","affiliation":[{"name":"Faculdade de Medicina, Universidade do Porto, Porto, Portugal"}]},{"given":"F","family":"Carneiro","sequence":"additional","affiliation":[{"name":"Faculdade de Medicina, Universidade do Porto, Porto, Portugal"},{"name":"Instituto de Patologia e Imunologia Molecular da Universidade do Porto [Ipatimup], i3S\u2010Instituto de Investiga\u00e7\u00e3o e Inova\u00e7\u00e3o em Sa\u00fade, Universidade do Porto, Porto, Portugal"}]},{"name":"Portuguese IBD Group 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