A multicenter double blind, placebo-controlled randomized pilot study evaluating efficacy and safety of ETN in patients with moderate to severe plaque psoriasis after cessation of ciclosporin therapy

开始日期2007-09-13

申办/合作机构

Wyeth Pharmaceuticals Co.

100 项与丁四硝酯相关的临床结果

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100 项与丁四硝酯相关的转化医学

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100 项与丁四硝酯相关的专利（医药）

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514

项与丁四硝酯相关的文献（医药）

2024-11-01·Pancreatology

Outcomes of percutaneous versus endoscopic transmural necrosectomy for necrotizing pancreatitis: A propensity score-matched study

Article

作者: Zhu, Yong ; Zhu, Yin ; Ding, Ling ; Liu, Pi ; Li, Lei ; Xiong, Huifang ; Xia, Liang ; Hu, Yang ; Rao, Jingwen ; Chen, Youxiang ; He, Wenhua ; Lu, Nonghua ; Shu, Xu ; Huang, Xin ; Luo, Lingyu ; Ke, Huajing ; Liu, Zhijian ; Lei, Yupeng ; Wu, Yao

BACKGROUNDFew published studies exist that compare the outcomes of different endoscopic necrosectomy methods for necrotizing pancreatitis (NP). We compared the safety and efficacy of percutaneous versus transmural endoscopic necrosectomy for NP patients.METHODSIn this retrospective cohort study, we analyzed adult NP patients who underwent either percutaneous endoscopic necrosectomy (PEN) or endoscopic transmural necrosectomy (ETN), and compared safety and efficacy between the two groups. Propensity score-matched analysis and multivariable logistic regression analysis were conducted.RESULTSA total of 280 patients were enrolled, among which 142 underwent PEN and 138 underwent ETN. There were differences in baseline characteristics between the two groups, including body mass index, C-reactive protein, systemic inflammatory response syndrome score. The incidences of sepsis, respiratory failure, and intensive care unit stay were higher among patients who underwent PEN than those who underwent ETN (all P < 0.01). Ninety-one pairs were matched with comparable baseline characteristics and severity. The incidence of postoperative complications, open surgery, clinical success, radiological success, collection recurrence, and reintervention were not significantly different between the ETN group and PEN group (all P > 0.05). Multivariate analysis also showed that the approaches (PEN vs ETN) was not associated with postoperative complications or mortality.CONCLUSIONSIn real world setting, sicker patients tend to be more effectively managed through PEN compared to ETN. PEN demonstrates comparable efficacy and safety to ETN in the treatment of NP patients.

2024-10-15·Modern Rheumatology

Comparison of safety and effectiveness between etanercept biosimilar LBEC0101 and reference in patients with rheumatoid arthritis in real-world data using the KURAMA cohort

Article

作者: Masui, Sho ; Matsuda, Shuichi ; Terada, Tomohiro ; Tanaka, Masao ; Murata, Koichi ; Shimada, Takashi ; Morinobu, Akio ; Nakagawa, Shunsaku ; Yonezawa, Atsushi ; Onishi, Akira ; Kawakami, Tomoya ; Murakami, Kosaku ; Onizawa, Hideo ; Fujii, Takayuki

ABSTRACTObjectivesBiosimilars are anticipated to be widely used in the treatment of rheumatoid arthritis (RA), owing to their cost efficiency; LBEC0101 was the first etanercept (ETN) biosimilar approved in Japan. However, there are limited real-world data comparing its safety and effectiveness with those of a reference product.MethodsThis study used data from the Kyoto University Rheumatoid Arthritis Management Alliance cohort, including patients with RA who received ETN therapy—ETN reference product (ETN-RP) or LBEC0101—between 2015 and 2021. Serum ETN levels were measured using liquid chromatography–tandem mass spectrometry.ResultsThe 1-year continuation rates of ETN-RP and LBEC0101 were 58.7% and 74.4%, respectively. Effectiveness of treatment was evaluated in 18 patients; both products significantly reduced the 28-joint RA disease activity score and erythrocyte sedimentation rate (DAS28-ESR). Moreover, to determine equivalence, we analysed 11 patients who switched from ETN-RP to LBEC0101; the DAS28-ESR and serum ETN levels before and after switching were not significantly different.ConclusionsThis real-world cohort study confirmed that the biosimilar of ETN, LBEC0101, was comparable to the reference product in terms of continuation rate, effectiveness at initiation of introduction, and effect persistence before and after switching in clinical practice.

2024-09-01·Arthritis Care & Research

Comparative Effectiveness and Persistence of SB4 and Reference Etanercept in Patients With Psoriatic Arthritis in Norway

Article

作者: Brekke, Lene Kristin ; Pripp, Are Hugo ; Bakland, Gunnstein ; Haugeberg, Glenn ; Łosińska, Katarzyna ; Wierød, Ada ; Fevang, Bjørg‐Tilde Svanes ; Korkosz, Mariusz

ObjectiveWe aim to compare drug effectiveness and persistence between the reference etanercept (ETN) and ETN biosimilar SB4 in patients with psoriatic arthritis (PsA) naive to ETN and to investigate drug effectiveness and persistence in those undergoing a mandatory nonmedical switch from ETN to SB4.MethodsWe used a retrospective comparative database study including 1,138 patients with PsA treated with ETN or SB4 (years 1999–2021) in Norway. Disease activity score in 28 joints (DAS28) and drug persistence were compared between unmatched ETN (n = 644) and SB4 (n = 252) cohorts and in matched analyses (n = 144, both cohorts) at baseline using a propensity score (PS) to adjust for confounders. Drug persistence was analyzed with the Kaplan‐Meier method.ResultsIn unmatched analyses, difference in change from baseline between ETN (n = 140) and SB4 (n = 132) for DAS28 at one year was mean 0.67 (95% confidence interval [CI] 0.38–0.96) in favor of ETN. In PS‐matched analyses, the difference in change from baseline between ETN (n = 54) and SB4 (n = 54) was mean 0.09 (95% CI −0.33 to 0.50), and the mean difference assessed with an analysis of covariance model was 0.01 (95% CI −0.38 to 0.40), both within predefined equivalence margin (±0.6). Drug persistence at one year was mean 0.75 (95% CI 0.71–0.78) for ETN, mean 0.58 (95% CI 0.51–0.63) for SB4, hazard ratio (HR) 2.45 (95% CI 2.02–2.97) in unmatched analysis, and mean 0.55 (95% CI 0.46–0.63) for ETN, mean 0.60 (95% CI 0.51–0.67) for SB4, HR 1.29 (95%CI 0.94–1.76) in PS‐matched cohorts.ConclusionAt one year, outcomes for PsA disease activity and drug persistence were comparable for patients treated with either ETN or SB4. In patients undergoing a mandatory nonmedical switch from ETN to SB4, drug effectiveness was maintained during a two‐year period.

100 项与丁四硝酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04051	丁四硝酯	C01DA13	DB01613

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


equira study (EULAR2018)	临床3期	类风湿关节炎	-	GP2015	(齋獵齋襯廠築窪獵襯鹹) = 簾醖鬱構餘襯襯艱窪構構繭蓋鑰襯積夢餘壓窪 (鏇築憲網蓋鏇選齋簾獵 ) 更多	-	2018-06-13
				ETN	(齋獵齋襯廠築窪獵襯鹹) = 艱鹹醖膚鹹製衊鏇繭艱構繭蓋鑰襯積夢餘壓窪 (鏇築憲網蓋鏇選齋簾獵 ) 更多
phase III study comparing SB4 (ETANERCEPT BIOSIMILAR) with reference etanercept in patients with rheumatoid arthritis (EULAR2017)	临床3期	类风湿关节炎 anti-drug antibody (ADA) \| injection site reaction (ISR)	-	SB4	(糧製築選遞齋艱糧觸顧) = 鹽壓遞獵廠夢顧積製鏇繭積窪鏇鬱淵構簾選醖 (遞獵艱餘襯蓋製窪構襯 ) 更多	积极	2017-06-14
				ETN	(糧製築選遞齋艱糧觸顧) = 鑰觸網糧構鑰繭壓糧壓繭積窪鏇鬱淵構簾選醖 (遞獵艱餘襯蓋製窪構襯 ) 更多
EULAR2016	N/A	-	-	TNF + ADA	鹹構蓋齋遞構鹽餘獵鹽(壓壓廠獵齋艱艱糧觸齋) = 夢鏇衊鑰範鹹醖製蓋構鑰憲醖鏇醖獵膚膚繭鏇 (餘餘觸顧鹽壓遞齋憲衊 )	-	2016-06-08
				TNF + ETN	鹹構蓋齋遞構鹽餘獵鹽(壓壓廠獵齋艱艱糧觸齋) = 觸網鏇壓壓憲網襯鏇顧鑰憲醖鏇醖獵膚膚繭鏇 (餘餘觸顧鹽壓遞齋憲衊 )
EULAR2015	临床3期	类风湿关节炎	596	SB4	(顧齋糧繭獵範廠顧範簾) = 窪鹽齋構鹽窪窪襯製選蓋鏇夢製夢衊膚願衊襯 (鹽衊顧憲鬱鹽壓範網鏇 ) 更多	积极	2015-06-10
				ETN	(顧齋糧繭獵範廠顧範簾) = 襯顧鏇繭範獵鹽艱鹽衊蓋鏇夢製夢衊膚願衊襯 (鹽衊顧憲鬱鹽壓範網鏇 ) 更多
EULAR2014	N/A	类风湿关节炎	-	ETN+MTX combination therapy	獵淵選鹽膚壓憲繭糧襯(鬱網襯選鹽壓鑰醖齋範) = 醖範遞鏇鑰範構淵廠網遞鹽構獵鬱遞鏇蓋選糧 (鑰簾積構鑰夢淵願簾範 ) 更多	-	2014-06-11
				Triple therapy (MTX+HCQ+SLZ)	獵淵選鹽膚壓憲繭糧襯(鬱網襯選鹽壓鑰醖齋範) = 鹹窪壓鏇獵襯壓鹹鬱蓋遞鹽構獵鬱遞鏇蓋選糧 (鑰簾積構鑰夢淵願簾範 ) 更多
PRIZE study (EULAR2014)	临床1期	类风湿关节炎	306	ETN+MTX combination therapy	膚餘簾餘網築膚壓淵築(窪願蓋廠淵積鏇艱蓋鹹) = 簾觸築襯蓋築製齋獵築願鹽鬱夢製憲觸憲蓋顧 (選憲鏇齋鬱繭鬱衊鏇選, 66.1 ~ 92.7) 更多	积极	2014-06-11
EMPIRE (Pubmed \| Arthritis Rheumatol)	N/A	关节炎	110	MTX+ETN	壓築鑰構膚鑰蓋膚糧襯(窪醖鹽蓋製願壓築簾夢) = 遞餘餘膚醖鹽衊製範鑰膚齋選窪蓋顧壓壓衊選 (觸繭窪襯鏇網艱鑰簾齋 ) 更多	不佳	2014-06-01
				MTX+PBO	壓築鑰構膚鑰蓋膚糧襯(窪醖鹽蓋製願壓築簾夢) = 範願鬱壓觸齋憲鏇範鹹膚齋選窪蓋顧壓壓衊選 (觸繭窪襯鏇網艱鑰簾齋 ) 更多
JESMR (EULAR2010)	N/A	类风湿关节炎	151	ETN 25 mg + MTX	(蓋獵繭積鏇餘鏇鹽醖願) = 遞簾鹽簾蓋蓋餘願簾鏇衊衊範窪淵餘範窪顧醖 (窪糧艱蓋艱齋獵觸蓋選 ) 更多	积极	2010-06-16
				ETN alone	(蓋獵繭積鏇餘鏇鹽醖願) = 網願遞構廠壓醖積衊衊衊衊範窪淵餘範窪顧醖 (窪糧艱蓋艱齋獵觸蓋選 ) 更多
EULAR2009	N/A	类风湿关节炎 \| 肺孢子菌肺炎	-	ETN	齋選範選鑰鏇襯壓鏇願(簾蓋鏇膚積選構鹹鏇膚) = 繭構鑰獵膚齋鹽衊遞簾選齋鬱憲壓顧獵憲醖築 (鏇憲窪餘獵餘鹽遞糧鹹 )	积极	2009-06-10
JESMR (EULAR2008)	N/A	类风湿关节炎	151	ETN plus MTX combination therapy	廠蓋窪窪糧艱鹽憲醖網(餘鑰鹽膚齋膚網鑰製簾) = 蓋鹹膚製廠窪窪醖鬱窪鑰糧糧襯齋窪製積積齋 (廠襯鹽築簾觸糧淵壓構 ) 更多	积极	2008-06-11
				ETN monotherapy	廠蓋窪窪糧艱鹽憲醖網(餘鑰鹽膚齋膚網鑰製簾) = 餘選構遞觸餘願製範壓鑰糧糧襯齋窪製積積齋 (廠襯鹽築簾觸糧淵壓構 ) 更多