Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study

Fecha de publicación: 21/12/2016

Autores de IIS La Fe

Marisa Iborra Colomino

Autor

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

Enfermedad Inflamatoria Intestinal

Leader

Pilar Nos Mateu

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
DOI:: 10.3748/wjg.v22.i47.10432
Factor de Impacto:: 1,273 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Métricas

Filiaciones

Bosca-Watts, MM:: Univ Valencia, Univ Clin Hosp Valencia, Digest Dis Dept, Inflammatory Bowel Dis Unit, Avda Blasco Ibanez 17, Valencia 46010, Spain
Cortes, X:: Hosp Sagunto, Digest Dis Dept, Valencia 46010, Spain
Iborra, M:: Hosp Univ & Politecn La Fe, Dept Gastroenterol, Valencia 46026, Spain

Hosp Univ & Politecn La Fe, CIBEREHD, Valencia 46026, Spain
Huguet, JM:: Gen Hosp Valencia, Digest Dis Dept, Valencia 46014, Spain
Sempere, L:: Gen Hosp Alicante, Digest Dis Dept, Alacant 03010, Spain
Garcia, G:: San Juan Univ Hosp Alicante, Digest Dis Dept, Valencia 46010, Spain
Gil, R:: Arnau Hosp Valencia, Digest Dis Dept, Valencia 46015, Spain
Garcia, M:: Gen Univ Hosp Elche, Digest Dis Dept, Alicante 03203, Spain
Munoz, M:: Gen Hosp Castellon, Digest Dis Dept, Castellon De La Plana 12004, Spain
Almela, P:: Gen Hosp Castellon, Digest Dis Dept, Castellon De La Plana 12004, Spain
Maroto, N:: Hosp Manises, Digest Dis Dept, Inflammatory Bowel Dis Unit, Manises 46940, Spain
Paredes, JM:: Peset Univ Hosp Valencia, Digest Dis Dept, Valencia 46017, Spain