Portal de investigação
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
Data de publicação:
Autores da FMUP
Participantes de fora da FMUP
- Lopes, S
- Silva, M
- Coelho, R
- Portela, F
- Branquinho, D
- Correia, L
- Fernandes, S
- Cravo, M
- Caldeira, P
- Sousa, HT
- Patita, M
- Lago, P
- Ramos, J
- Afonso, J.
- Redondo, I
- Machado, P
- Cornillie, F
- Portuguese IBD Group GEDII
Unidades de investigação
Abstract
Background and Aims: 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. Methods: This was an open-label, uncontrolled, prospective and interventional study. Moderate to severely active UC patients naive 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. Results: 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 mu g/mL vs 1.3 mu g/mL, p = 0.0013; and 3.1 mu g/mL vs 1.7 mu g/mL, p = 0.0164, respectively]. In addition, golimumab TL were significantly higher in patients achieving histological remission [4.2 mu g/mL vs 1.7 mu g/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]. Conclusions: 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.
Dados da publicação
- ISSN/ISSNe:
- 1873-9946, 1876-4479
- Tipo:
- Article
- Páginas:
- 1387-1393
- Link para outro recurso:
- www.scopus.com
JOURNAL OF CROHNS & COLITIS Oxford University Press
Citações Recebidas na Web of Science: 14
Citações Recebidas na Scopus: 15
Documentos
- Não há documentos
Filiações
Keywords
- Golimumab; trough levels; ulcerative colitis
Financiamento
Proyectos asociados
Contributo da endoscopia, biomarcadores e imagiologia na evolução clinica dos doentes com doença inflamatória intestinal
Investigador Principal: Fernando José Magro Dias
Estudo Clínico Académico . 2019
Citar a publicação
Magro F,Lopes S,Silva M,Coelho R,Portela F,Branquinho D,Correia L,Fernandes S,Cravo M,Caldeira P,Sousa HT,Patita M,Lago P,Ramos J,Afonso J,Redondo I,Machado P,Cornillie F,Lopes J,Carneiro F,Portuguese IBD Group G. 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. J. Crohn's Colitis. 2019. 13. (11):p. 1387-1393. IF:8,658. (1).
