Portal de investigación
Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study
Fecha de publicación:
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Bosca-Watts, MM
- Cortes, X
- Huguet, JM
- Sempere, L
- Garcia, G
- Gil, R
- Garcia, M
- Munoz, M
- Almela, P
- Maroto, N
- Paredes, JM
Grupos
Abstract
AIM To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response. METHODS We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at wk 0 and 14 with the physician' s global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database. RESULTS Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naive, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at wk 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 mu g/g, and 170.5 mu g/g at wk 14. Being anti-TNF treatment naive was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of followup. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted. CONCLUSION This real-life practice study endorses golimumab's promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.
Datos de la publicación
- ISSN/ISSNe:
- 1007-9327, 2219-2840
- Tipo:
- Article
- Páginas:
- 10432-10439
- PubMed:
- 28058024
- Factor de Impacto:
- 1,273 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
WORLD JOURNAL OF GASTROENTEROLOGY BAISHIDENG PUBLISHING GROUP INC
Citas Recibidas en Web of Science: 30
Documentos
- No hay documentos
Filiaciones
Keywords
- Golimumab; Ulcerative colitis; Real-life results
Campos de Estudio
Cita
Bosca MM,Cortes X,IBORRA M,Huguet JM,Sempere L,Garcia G,Gil R,Garcia M,Munoz M,Almela P,Maroto N,Paredes JM. Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study. World J. Gastroenterol. 2016. 22. (47):p. 10432-10439. IF:3,365. (2).