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Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study 被引量:6
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作者 Marta Maia Bosca-Watts Xavier Cortes +9 位作者 Marisa Iborra Jose Maria Huguet Laura Sempere Gloria Garcia Rafa Gil Mari Fe Garcia Marga Munoz Pedro Almela nuria maroto Jose Maria Paredes 《World Journal of Gastroenterology》 SCIE CAS 2016年第47期10432-10439,共8页
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 treat... 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 na?ve, 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 μg/g, and 170.5 μg/g at wk 14. Being anti-TNF treatment na?ve 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. 展开更多
关键词 GOLIMUMAB Ulcerative colitis Real-life results
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Real-world data on the infliximab biosimilar CT-P13 (Remsima®) in inflammatory bowel disease
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作者 Jose María Huguet Xavier Cortés +5 位作者 Marta Maia Bosca-Watts Marian Aguas nuria maroto Lidia Martí Cirilo Amorós Jose María Paredes 《World Journal of Clinical Cases》 SCIE 2021年第36期11285-11299,共15页
BACKGROUND In recent years,biological therapies have revolutionized the management of inflammatory bowel disease(IBD);however,they are expensive.The development of biosimilar products has allowed us to reduce healthca... BACKGROUND In recent years,biological therapies have revolutionized the management of inflammatory bowel disease(IBD);however,they are expensive.The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’access to these treatments.Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety,there are unmet needs regarding research on these agents in the context of IBD.AIM To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice.METHODS An observational,prospective,multicenter study of IBD patients treated with CTP13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out.No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice.The primary endpoints were clinical response rates and number of adverse events.The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3,6,9,and 12 mo.RESULTS A total of 220 IBD patients treated with CT-P13(Remsima®)were included in the study:87(40%)with ulcerative colitis and 133(60%)with Crohn’s disease.Mean age of the patients was 41.47(SD 15.74)years,and 58%were female.Nineteen(9%)patients started treatment with CT-P13 after switching from infliximab.Of the remaining 201 patients,142(65%)were naïve to biologic agents.At baseline,68.6%(n=138/201)of patients presented with active disease.After 12 mo of treatment,14.8%(n=12/81)presented with active disease,and 64.2%(n=52/81)were in clinical remission without corticosteroids.After 3 mo,75.5%(n=115/152)had a clinical response or achieved clinical remission,which was sustained for 12 mo(85.2%;n=69/81).There was a decrease in specific IBD indices at 3,6,9,and 12 mo(P<0.001).A total of 34 adverse events were reported by 27(12.3%)patients,9(26.5%)of which were serious.CONCLUSION CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD. 展开更多
关键词 Crohn’s disease Ulcerative colitis Inflammatory bowel disease INFLIXIMAB BIOSIMILAR CT-P13
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