Efficacy and Safety of Oral Budesonide in Patients with Active Crohn's Disease in Japan: A Multicenter, Double-Blind, Randomized, Parallel-Group Phase 3 Study

Yokoyama, Tadashi; Ohta, Akihiko; Motoya, Satoshi; Takazoe, Masakazu; Yajima, Toshitaka; Date, Masataka; Nii, Masahiro; Nagy, Péter; Suzuki, Yasuo; Hibi, Toshifumi

doi:10.1159/000484047

Cited by 17 publications

(40 citation statements)

References 19 publications

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“…A Cochrane systematic review and meta-analysis from 2015 reviewed two RCTs 39,40 that compared budesonide at a dose of 9 mg/day to mesalazine up to 4.5 g/day. More recently, a Japanese trial 41…”

Section: Accepted Manuscriptmentioning

confidence: 99%

ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment

Torres

Bonovas

Doherty

et al. 2019

Journal of Crohn's and Colitis

910

786

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IntroductionCrohn's disease [CD] is a chronic inflammatory bowel disease [IBD] that can result in progressive bowel damage and disability 1 . CD can affect individuals of any age, from children to the elderly, 2,3 and may cause significant morbidity and impact on quality of life. Up to one-third of patients present with complicated behaviour [strictures, fistula, or abscesses] at diagnosis 4 . Most patients over time will develop a complication, with roughly 50% of patients requiring surgery within 10 years of diagnosis [5][6][7] . As the precise aetiology of CD remains unknown, a curative therapy is not yet available 8 . Several agents are available for the medical treatment of CD. Medical agents include mesalazine [5-ASA], locally active steroids [such as budesonide], systemic steroids, thiopurines such as azathioprine [AZA] and mercaptopurine [MP], methotrexate [MTX], and biological therapies [such as anti-TNF, anti-integrins, and anti-IL12/23].The European Crohn's and Colitis Organisation [ECCO] produces and regularly updates several guidelines aimed at providing evidence-based guidance on critical aspects of IBD care to all healthcare professionals who manage patients with IBD. To provide high-quality evidence-based recommendations on medical and surgical treatment in CD, ECCO decided to develop these guidelines by adopting the GRADE [Grading of Recommendations Assessment, Development, and Evaluation] approach 9 . GRADE is a systematic process for developing guidelines that addresses how to frame the healthcare questions, summarize the evidence, formulate the recommendations, and grade their strength and the quality of the associated evidence. GRADE increases transparency at all levels of this process and makes explicit the three considerations that lead to a particular recommendation: the quality of the evidence, the balance of benefits and harms, and the patients' values and preferences. Therefore, ECCO reviewed the available high-quality evidence on the medical management of CD and developed evidence-based recommendations on the medical treatment of adult patients with CD. These guidelines do not cover specific situations, such as post-operative management of adult patients with CD, which was already covered in the last ECCO Guidelines on Crohn's disease 10 . MethodsBased on the GRADE workflow, the Guidelines Committee of ECCO [GuiCom] selected a panel of 48 experts supported by a team of methodologists and librarians. Selection was based on IBD expertise, scientific background, and knowledge of the GRADE methodology. All panellists received adequate training in GRADE before starting the process.Additionally, four patients with CD representing the European Federation of Crohn's and Colitis Associations [EFCCA] were invited to participate in all face-to-face meetings and to provide their experiences and state their preferences.Three domains for medical treatment of CD were identified: 1) induction therapy 2) maintenance therapy 3) therapy of fistulizing perianal disease.All panellists were assigned to...

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Section: Accepted Manuscriptmentioning

confidence: 99%

ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment

Torres

Bonovas

Doherty

et al. 2019

Journal of Crohn's and Colitis

910

786

View full text Add to dashboard Cite

show abstract

“…Although it has a high first-pass metabolism, prolonged use of budesonide may result in mild suppres- sion of adrenal glucocorticoid generation but no hemodynamically or endocrinologically significant side effect has been described in the usual clinical circumstances (2,(18)(19)(20). In contrast, typical systemic steroid side effects such as iatrogenic Cushing syndrome have been described in circumstances where the metabolism of budesonide was slowed by inhibitors to cytochrome P-450 such as ritonavir, fluvoxamine, and azoles (21,22).…”

Section: Discussionmentioning

confidence: 99%

Budesonide-Induced Hyperosmolar Hyperglycemic State Following Transjugular Intrahepatic Portosystemic Shunt

Jayakrishnan

Babu

Goodnow

et al. 2020

AACE Clinical Case Reports

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Objective: Recognize a rare endocrinological side effect of a drug, budesonide, which surfaced as a result of a major procedure. Methods: We describe a patient who presented with hyperglycemic hyperosmolar state (HHS) likely as a result of the bypass of first-pass metabolism due to budesonide treatment after a transjugular intrahepatic portosystemic shunt (TIPS) procedure. Results: A 62-year-old female with history of combined variable immunodeficiency complicated by colitis (managed by 9 mg budesonide by mouth daily) and refractory ascites secondary to non-cirrhotic portal hypertension (status post-TIPS 3 weeks prior) presented to the hospital with HHS. Her initial insulin requirements were high but improved after discontinuation of budesonide. She was able to be transitioned to a sliding scale and discharged on metformin. When taken orally, budesonide is subject to high first-pass metabolism resulting in minimal systemic effects. Development of HHS and dramatic insulin requirements within 3 weeks of TIPS with drastic improvement following the discontinuation of budesonide leads us to postulate that this was bypassed, leading to steroid-induced diabetes. Conclusion: The case beckons us to be mindful of procedures that alter drug metabolism and make necessary adjustments to prevent complications.

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“…A literature review was conducted to estimate model variables for the treatment response associated with induction therapy[ 8 - 13 ], risk of disease relapse associated with maintenance therapy[ 14 ], surgery risk associated with active CD, perioperative mortality associated with surgery, and the hazard ratio of mortality associated with active CD relative to age and gender-matched general population[ 15 - 30 ]. Meta-analysis was used as the main approach to synthesize the identified evidence from the literature review.…”

Section: Methodsmentioning

confidence: 99%

Real-world cost-effectiveness associated with infliximab maintenance therapy for moderate to severe Crohn’s disease in China

Shi

Luo

Chen

et al. 2020

WJG

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BACKGROUND Infliximab was the first approved biologic treatment for moderate to severe Crohn’s disease (MS-CD) in China. However, the cost-effectiveness of infliximab maintenance therapy (IMT) for MS-CD relative to conventional maintenance therapy remained unclarified. AIM To assess the cost-effectiveness of IMT for MS-CD in Chinese patients from the perspective of Chinese public insurance payer. METHODS A cohort of MS-CD patients managed in a Chinese tertiary care hospital was created to compare IMT with conventional maintenance therapy (CMT) for clinical outcomes and direct medical costs over a 1-year observation time using conventional regression analyses. A decision-analytic model with the generated evidence was constructed to assess the cost-effectiveness of IMT relative to CMT using reimbursed medical costs. RESULTS Based on the included 389 patients, IMT was associated with significantly higher disease remission chance [odds ratio: 4.060, P = 0.003], lower risk of developing new complications (odds ratio: 0.527, P = 0.010), higher utility value for quality of life (coefficient 0.822, P = 0.008), and lower total hospital costs related to disease management (coefficient -0.378, P = 0.008) than CMT. Base-case cost-effectiveness analysis estimated that IMT could cost Chinese health insurance payers ¥55260 to gain one quality-adjusted life year (QALY). The cost-effectiveness of IMT was mainly driven by the estimate of quality of life, treatment efficacy of maintenance therapy, mortality risk associated with active disease, and unit price of infliximab. The probability that IMT was cost-effective at a willingness-to-pay threshold of three times gross domestic product [2018 Chinese gross domestic product per capita (GDPPC)] was 86.4%. CONCLUSION IMT significantly improved real-world health outcomes and cost the Chinese public health insurance payers less than one GDPPC to gain one QALY in Chinese MS-CD patients.

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Efficacy and Safety of Oral Budesonide in Patients with Active Crohn's Disease in Japan: A Multicenter, Double-Blind, Randomized, Parallel-Group Phase 3 Study

Cited by 17 publications

References 19 publications

ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment

ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment

Budesonide-Induced Hyperosmolar Hyperglycemic State Following Transjugular Intrahepatic Portosystemic Shunt

Real-world cost-effectiveness associated with infliximab maintenance therapy for moderate to severe Crohn’s disease in China

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