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

被引：38

作者：

Maia Bosca-Watts, Marta ^{[1
]}

Cortes, Xavier ^{[2
]}

Iborra, Marisa ^{[3
,4
]}

Maria Huguet, Jose ^{[5
]}

Sempere, Laura ^{[6
]}

Garcia, Gloria ^{[7
]}

Gil, Rafa ^{[8
]}

Garcia, MariFe ^{[9
]}

Munoz, Marga ^{[10
]}

Almela, Pedro ^{[10
]}

Maroto, Nuria ^{[11
]}

Maria Paredes, Jose ^{[12
]}

机构：

[1] Univ Valencia, Univ Clin Hosp Valencia, Digest Dis Dept, Inflammatory Bowel Dis Unit, Avda Blasco Ibanez 17, Valencia 46010, Spain

[2] Hosp Sagunto, Digest Dis Dept, Valencia 46010, Spain

[3] Hosp Univ & Politecn La Fe, Dept Gastroenterol, Valencia 46026, Spain

[4] Hosp Univ & Politecn La Fe, CIBEREHD, Valencia 46026, Spain

[5] Gen Hosp Valencia, Digest Dis Dept, Valencia 46014, Spain

[6] Gen Hosp Alicante, Digest Dis Dept, Alacant 03010, Spain

[7] San Juan Univ Hosp Alicante, Digest Dis Dept, Valencia 46010, Spain

[8] Arnau Hosp Valencia, Digest Dis Dept, Valencia 46015, Spain

[9] Gen Univ Hosp Elche, Digest Dis Dept, Alicante 03203, Spain

[10] Gen Hosp Castellon, Digest Dis Dept, Castellon De La Plana 12004, Spain

[11] Hosp Manises, Digest Dis Dept, Inflammatory Bowel Dis Unit, Manises 46940, Spain

[12] Peset Univ Hosp Valencia, Digest Dis Dept, Valencia 46017, Spain

来源：

WORLD JOURNAL OF GASTROENTEROLOGY | 2016年 / 22卷 / 47期

关键词：

Golimumab; Ulcerative colitis; Real-life results; INFLAMMATORY-BOWEL-DISEASE; CLINICAL-RESPONSE; INFLIXIMAB; MANAGEMENT; PREDICTORS; THERAPY;

D O I：

10.3748/wjg.v22.i47.10432

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

100201 [内科学];

摘要：

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.

引用

页码：10432 / 10439

页数：8

共 20 条

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Real-life outcome of anti-tumor necrosis factor α in the ambulatory treatment of ulcerative colitis [J].