Budesonide 9 mg Is at Least as Effective as Mesalamine 4.5 g in Patients With Mildly to Moderately Active Crohn's Disease

Tromm, Andreas; Bunganič, Ivan; Tomsová, Eva; Tulassay, Zsolt; Lukáš, Milan; Kykal, Jan; Bátovský, M; Fixa, B; Gabalec, Libor; Safadi, Rifaat; Kramm, Heinz-Jochen; Altorjay, István; Löhr, Hanns; Koutroubakis, Ioannis E.; Bar‐Meir, Simon; Štimac, Davor; Schäffeler, Elke; Glasmacher, Elke; Dilger, Karin; Mohrbacher, Ralf; Greinwald, Roland

doi:10.1053/j.gastro.2010.11.004

Cited by 86 publications

(47 citation statements)

References 27 publications

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“…Budesonide is a safe locally acting steroid drug, due to extensive hepatic metabolism by CYP3A enzymes. 6 Our main concern was to evaluate the toxicity of our carrier system (Azo-pu ES NPs), which has not been reported before. Therefore, we further evaluated blank particles in high concentrations in healthy rats and in cell biocompatibility studies.…”

Section: Discussionmentioning

confidence: 99%

“…4,5 Budesonide is a glucocorticoid with anti-inflammatory properties and few side effects; however, it has limited systemic bioavailability due to extensive first-pass hepatic metabolism by CYP3A enzymes. 6 Therefore, many groups have sought to develop efficient colon-targeted delivery systems for budesonide to overcome this limitation. 7 Various approaches have been used to develop colon-targeted delivery, including prodrugs, pH-dependent release systems, time-dependent release systems, and enzyme-dependent release systems.…”

Section: Introductionmentioning

confidence: 99%

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Enhanced therapeutic efficacy of budesonide in experimental colitis with enzyme/pH dual-sensitive polymeric nanoparticles

Naeem

Cao

Choi

et al. 2015

IJN

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Current colon-targeted drug-delivery approaches for colitis therapy often utilize single pH-triggered systems, which are less reliable due to the variation of gut pH in individuals and in disease conditions. Herein, we prepared budesonide-loaded dual-sensitive nanoparticles using enzyme-sensitive azo-polyurethane and pH-sensitive methacrylate copolymer for the treatment of colitis. The therapeutic potential of the enzyme/pH dual-sensitive nanoparticles was evaluated using a rat colitis model and compared to single pH-triggered nanoparticles. Clinical activity scores, colon/body weight ratios, myeloperoxidase activity, and proinflammatory cytokine levels were markedly decreased by dual-sensitive nanoparticles compared to single pH-triggered nanoparticles and budesonide solution. Moreover, dual-sensitive nanoparticles accumulated selectively in inflamed segments of the colon. In addition, dual-sensitive nanoparticle plasma concentrations were lower than single pH-triggered nanoparticles, and no noticeable in vitro or in vivo toxicity was observed. Our results demonstrate that enzyme/pH dual-sensitive nanoparticles are an effective and safe colon-targeted delivery system for colitis therapy.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Enhanced therapeutic efficacy of budesonide in experimental colitis with enzyme/pH dual-sensitive polymeric nanoparticles

Naeem

Cao

Choi

et al. 2015

IJN

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“…Tromm found no difference in the efficacy to induce remission in moderate CD of 5ASA compared to budesonide. Remission rate for budesonide was 69% vs 62% for 5ASA [61] . These data have to compare with a previous metaanalysis which showed 5ASA no more effective than placebo [62] .…”

Section: CDmentioning

confidence: 87%

Pharmacological- and non-pharmacological therapeutic approaches in inflammatory bowel disease in adults

Leitner

Vogelsang

2016

WJGPT

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Inflammatory bowel diseases (IBDs) are a group of chronic inflammatory conditions mainly of the colon and small intestine. Crohn's disease (CD) and ulcerative colitis (UC) are the most frequent types of IBD. IBD is a complex disease which arises as a result of the interaction of environmental, genetic and immunological factors. It is increasingly thought that alterations of immunological reactions of the patients to their own enterable bacteria (microfilm) may contribute to inflammation. It is characterized by mucosal and sub mucosal inflammation, perpetuated by infiltration of activated leukocytes. CD may affect the whole gastrointestinal tract while UC only attacks the large intestine. The therapeutic goal is to achieve a steroidfree long lasting remission in both entities. UC has the possibility to be cured by a total colectomy, while CD never can be cured by any operation. A lifelong intake of drugs is mostly necessary and essential. Medical treatment of IBD has to be individualized to each patient and usually starts with anti-inflammatory drugs. The choice what kind of drugs and what route administered (oral, rectal, intravenous) depends on factors including the type, the localization, and severity of the patient's disease. IBD may require immune-suppression to control symptoms such as prednisolone, thiopurines, calcineurin or sometimes folic acid inhibitors or biologics like TNF-α inhibitors or anti-integrin antibodies. For both types of disease (CD, UC) the same drugs are available but they differ in their preference in efficacy between CD and UC as 5-aminosalicylic acid for UC or budesonide for ileocecal CD. As therapeutic alternative the main mediators of the disease, namely the activated pro-inflammatory cytokine producing leukocytes can be selectively removed via two apheresis systems (Adacolumn and Cellsorba) in steroid-refractory or dependent cases. Extracorporeal photopheresis results in an increase of regulatory B cells, regulatory CD8 + T cells and T-regs Type 1. Both types of apheresis were able to induce clinical remission and mucosal healing accompanied by tapering of steroids.

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“…A relapse rate of 56% was found in patients treated with 5-ASA compared with 57% for patients on placebo treatments. In a 2011 study, mesalamine and budesonide were found to be equally efficacious in inducing remission in patients who had mild to moderate activity CD [87] . Remission rates were similar between those who were receiving budesonide and mesalamine (70% vs 62%).…”

Section: Aminosalicylatesmentioning

confidence: 99%

Pregnancy and inflammatory bowel diseases: Current perspectives, risks and patient management

Hosseini‐Carroll¹,

Mutyala²,

Seth³

et al. 2015

WJGPT

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Manas K made critical revisions of the manuscript; Becker F and Alexander JS contributed equally as senior authors. Conflict-of-interest statement:There are no known conflicts of interest. The authors (Pegah Hosseini-Carroll, Monica Mutyala, Abhishek Seth, Shaheen Nageeb, Demiana Soliman, Moheb Boktor, Ankur Sheth, Jonathon Chapman, James Morris, Paul Jordan, Kenneth Manas, Felix Becker, and J Steven Alexander) have no relevant financial considerations related to this proposal, and the study was not supported by any corporate entity. There is no known intellectual property associated with this report. AbstractInflammatory bowel diseases (IBD) are chronic idiopathic inflammatory conditions characterized by relapsing and remitting episodes of inflammation which can affect several different regions of the gastrointestinal tract, but also shows extra-intestinal manifestations. IBD is most frequently diagnosed during peak female reproductive years, with 25% of women with IBD conceiving after their diagnosis. While IBD therapy has improved dramatically with enhanced surveillance and more abundant and powerful treatment options, IBD disease can have important effects on pregnancy and presents several challenges for maintaining optimal outcomes for mothers with IBD and the developing fetus/neonate. Women with IBD, the medical team treating them (both gastroenterologists and obstetricians/gynecologists) must often make highly complicated choices regarding conception, pregnancy, and post-natal care (particularly breastfeeding) related to their choice of treatment options at different phases of pregnancy as well as post-partum. This current review discusses current concerns and recommendations for pregnancy during 157November 6, 2015|Volume 6|Issue 4| WJGPT|www.wjgnet.com Hosseini-Carroll P et al . Pregnancy and inflammatory bowel diseases IBD and is intended for gastroenterologists, general practitioners and IBD patients intending to become, (or already) pregnant, and their families. We have addressed patterns of IBD inheritance, effects of IBD on fertility and conception (in both men and women), the effects of IBD disease activity on maintenance of pregnancy and outcomes, risks of diagnostic procedures during pregnancy and potential risks and complications associated with different classes of IBD therapeutics. We also have evaluated the clinical experience using "top-down" care with biologics, which is currently the standard care at our institution. Post-partum care and breastfeeding recommendations are also addressed. Core tip: Inflammatory bowel diseases (IBD) are chronic inflammatory conditions characterized by relapsing and remitting episodes of intestinal inflammation. IBD is most frequently diagnosed during peak female reproductive years, with 25% of women with IBD conceiving after their diagnosis. While therapies have improved dramatically, IBDs have important effects on pregnancy and present challenges for maintaining optimal outcomes for mothers and their developing fetus/ neonate. Women with IBD and physician...

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Budesonide 9 mg Is at Least as Effective as Mesalamine 4.5 g in Patients With Mildly to Moderately Active Crohn's Disease

Cited by 86 publications

References 27 publications

Enhanced therapeutic efficacy of budesonide in experimental colitis with enzyme/pH dual-sensitive polymeric nanoparticles

Enhanced therapeutic efficacy of budesonide in experimental colitis with enzyme/pH dual-sensitive polymeric nanoparticles

Pharmacological- and non-pharmacological therapeutic approaches in inflammatory bowel disease in adults

Pregnancy and inflammatory bowel diseases: Current perspectives, risks and patient management

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