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Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar(CT-P13)in patients with inflammatory bowel disease

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World Journal of Gastroenterology 2018年第46期24卷 5288-5296页

作者： María Fernanda Guerra Veloz Federico Argüelles-Arias Luisa Castro Laria Belén Maldonado Pérez Antonio Benítez Roldan Raúl Perea Amarillo Vicente Merino Bohórquez miguel angel calleja angel Caunedo Alvarez angel Vilches Arenas Department of Gastroenterology University Hospital Virgen MacarenaSeville 41007Spain Pharmacy Unit University Hospital Virgen MacarenaSeville 41007Spain Preventive Medicine and Public Health University Hospital Virgen MacarenaSeville 41007Spain

BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with *** An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar(CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the ***98 patients(CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar(P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar(P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar(CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

关键词： Crohn’s disease Ulcerative colitis CT-P13 Inflammatory bowel disease Biosimilar agent Infliximab original Efficacy

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Tenofovir vs lamivudine plus adefovir in chronic hepatitis B:TENOSIMP-B study

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World Journal of Gastroenterology 2017年第41期23卷 7459-7469页

作者： Manuel Rodríguez Juan Manuel Pascasio Enrique Fraga Javier Fuentes Martín Prieto Gloria Sánchez-Antolín Jose Luis calleja Esther Molina María Luisa García-Buey María angeles Blanco Javier Salmerón María Lucía Bonet Jose Antonio Pons Jose Manuel González miguel angel Casado Francisco Jorquera 无 Division of Gastroenterology and Hepatology.Hospital Universitario Central de Asturias Unit for the Clinical Management of Digestive Diseases IBISHospital Universitario Virgen del Rocío Liver Transplantation and Hepatology Unit Gastroenterology ServiceHospital Universitario Reina Sofía Digestive Medicine Service Hospital Universitario Miguel Servet Hepatology Unit Digestive Medicine ServiceHospital Universitari i Politècnic La Fe Hepatology Unit Hospital Universitario Rio Hortega Liver Unit Hospital Universitario Puerta de Hierro de MajadahondaUniversidad Autónoma de Madrid Digestive Medicine Service Hospital Clínico de Santiago de Compostela Liver Unit Hospital Universitario de La Princesa Digestive Medicine Service Hospital General Universitario Gregorio Maranon Digestive Medicine Unit Complejo Hospitalario de Granada Digestive Medicine Service Hospital Universitario Son Espases Hepatology Unit IMIB Hospital Universitario Virgen de la Arrixaca Digestive Medicine Service Hospital Clínico Universitario de Valladolid Pharmacoeconomics and Outcomes Research Iberia Division of Gastroenterology and Hepatology Complejo Asistencial Universitario de León the TENOSIMP-B Research Group

AIM To demonstrate the non-inferiority(15% non-inferiority limit) of monotherapy with tenofovir disoproxil fumarate(TDF) vs the combination of lamivudine(LAM) plus adefovir dipivoxil(ADV) in the maintenance of virologic response in patients with chronic hepatitis B(CHB) and prior failure with *** This study was a Phase IV prospective, randomized, open, controlled study with 2 parallel groups(TDF and LAM+ADV) of adult patients with hepatitis B e antigen(HBe Ag)-negative CHB, prior failure with LAM, on treatment with LAM+ADV for at least 6 mo, without prior resistance to ADV and with an undetectable viral load at the start of the study, in 14 Spanish hospitals. The follow-up time for each patient was 48 wk after randomization, with quarterly visits in which the viral load, biochemical and serological parameters, adverse effects, adherence to treatment and consumption of hospital resources were *** Forty-six patients were evaluated [median age: 55.4 years(30.2-75.2); 84.8% male], including 22 patients with TDF and 24 with LAM+ADV. During study development, hepatitis B virus DNA(HBV-DNA) remained undetectable, all patients remained HBe Ag negative, and hepatitis B surface antigen(HBs Ag) positive. Alanine aminotransferase(ALT) values at the end of the study were similar in the 2 groups(25.1± 7.65, TDF vs 24.22 ± 8.38, LAM+ADV, P = 0.646). No significant changes were observed in creatinine or serum phosphorus values in either group. No significant differences between the 2 groups were noted in the identification of adverse effects(AEs)(53.8%, TDF vs 37.5%, LAM+ADV, P = 0.170), and none of the AEs which occurred were serious. Treatment adherence was 95.5% and 83.3% in the TDF and the LAM+ADV groups, respectively(P = 0.488). The costs associated with hospital resource consumption were significantly lower with the TDF treatment than the LAM+ADV treatment(€4943 ± 1059 vs €5811 ± 1538, respectively, P < 0.001).CONCLUSION TDF monotherapy proved to be safe

关键词： Tenofovir Lamivudine+Adefovir Efficacy Safety Adherence Costs Hepatitis B

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天津滨海图书馆

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建筑实践 2019年第11期 158-163页

作者： Maria López calleja Kyo Suk Lee Sen Yang Marta Pozo Chi Li Ray Zhu angel Sanchez Navarro Daehee Suk Guang Ruey Tan Xichen Sun Michael Zhang Mariya Gyaurova Antonio Luca Coco Constanza Cuccato Matteo Artico Tomaso Maschietti 董天杰侯勇军韩宁安志红田轶凡黄轩孙科章夏磊刘磊高艳任艳琴陈旭陆伟伟吴书驰张明宇张明韩薇李薇薇韩海磊郭鹏张萌战长恒 MVRDV建筑规划事务所天津市城市规划设计研究院 MVRDV

天津滨海图书馆是MVRDV建筑规划事务所与天津市城市规划设计研究院共同设计建造的城市新型图书馆,是滨海文化中心的一部分,一期由五个文化场馆与一条文化走廊构成,分别由国内外知名建筑团队合作设计,包括MVRDV建筑师事务所、伯纳德·屈... 详细信息

天津滨海图书馆是MVRDV建筑规划事务所与天津市城市规划设计研究院共同设计建造的城市新型图书馆,是滨海文化中心的一部分,一期由五个文化场馆与一条文化走廊构成,分别由国内外知名建筑团队合作设计,包括MVRDV建筑师事务所、伯纳德·屈米建筑师事务所、GMP建筑师事务所、Bing Thom建筑师事务所、天津华汇工程建筑设计有限公司、天津市城市规划设计研究院及

关键词： MVRDV 研究院天津滨海图书馆天津市建筑设计院城市规划设计

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