Oral Prolonged Release Beclomethasone Dipropionate and Prednisone in the Treatment of Active Ulcerative Colitis: Results From a Double-Blind, Randomized, Parallel Group Study

Assche, Gert Van; Manguso, Francesco; Zibellini, Marco; Cabriada, José Luis; Goldiş, Adrian; Ткаченко, Е. И.; Varoli, Guido; Kleczkowski, D; Annese, Vito; D’Heygere, F; Balzano, A.

doi:10.1038/ajg.2015.114

Cited by 50 publications

(52 citation statements)

References 22 publications

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“…Ten studies conducted from 2001 to 2015 included data on efficacy of BDP, orally administered as tablets, in patients with active UC [24–33]. Of them, eight evaluated patients with left sided (i.e., limited to below the splenic flexure) or total colitis [24,26,28–33], one evaluated patients with left sided colitis [25], while another evaluated patients without restriction for colitis extension [28]. The sample size was precalculated only in five studies [24,30–33].…”

Section: Resultsmentioning

confidence: 99%

“…Of them, eight evaluated patients with left sided (i.e., limited to below the splenic flexure) or total colitis [24,26,28–33], one evaluated patients with left sided colitis [25], while another evaluated patients without restriction for colitis extension [28]. The sample size was precalculated only in five studies [24,30–33]. Four studies were conducted in double blind [24,30,32–33], two in single blind [25,31], and four in open fashion [26–29].…”

Section: Resultsmentioning

confidence: 99%

“…The sample size was precalculated only in five studies [24,30–33]. Four studies were conducted in double blind [24,30,32–33], two in single blind [25,31], and four in open fashion [26–29]. Randomization of patients was made in seven studies [24–25,28,30–33].…”

Section: Resultsmentioning

confidence: 99%

“…A first attempt to develop an oral controlled-release formulation of BDP that would enhance delivery of a pharmacologically active drug to the terminal ileum and right colon was made in 1986 for patients with IBD [23]. More recently, oral prolonged release preparation of BDP with an acid-resistant film-coating (Eudragit-L100/55) that dissolves at pH<6, releasing the active drug in the distal small bowel and colon, has been used in more extensive UC [24–33] and other gastrointestinal diseases such as pouchitis [34], Crohn’s disease [35], gastrointestinal graft-versus-host disease [36], lymphocytic colitis [37], and segmental colitis associated with diverticulosis [38]. When used in low doses, BDP has been shown to be free of many of the deleterious side effects associated with systemically absorbed CSs [23].…”

Section: Introductionmentioning

confidence: 99%

“…Oral BDP for UC has been approved in a number of European and non-European countries [1], but only a few randomized controlled trials (RCTs) have been produced to evaluate the efficacy and safety of oral BDP in UC patients [24–25,28,30–33]. Given that few data have been published in the field, we conducted a meta-analysis to estimate the efficacy and safety of oral prolonged release of BDP 5 mg/day vs. all oral active controls in adult patients with extensive or left-sided mild to moderate UC.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

et al. 2016

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Background and AimWe performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA.MethodsLiterature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis.ResultsFive randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23–2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03–1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00–2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76–2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24–1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44–1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD.ConclusionsOral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

et al. 2016

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Conventional Therapy of Ulcerative Colitis: Corticosteroids

Taylor

2017

Crohn's Disease and Ulcerative Colitis

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Role of interleukin-6-mediated inflammation in the pathogenesis of inflammatory bowel disease: focus on the available therapeutic approaches and gut microbiome

Shahini

2022

J. Cell Commun. Signal.

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Inflammatory bowel disease (IBD) is considered a chronic inflammatory and multifactorial disease of the gastrointestinal tract. Crohn’s disease (CD) and ulcerative colitis (UC) are two types of chronic IBD. Although there is no accurate information about IBD pathophysiology, evidence suggests that various factors, including the gut microbiome, environment, genetics, lifestyle, and a dysregulated immune system, may increase susceptibility to IBD. Moreover, inflammatory mediators such as interleukin‐6 (IL‐6) are involved in the immunopathogenesis of IBDs. IL‐6 contributes to T helper 17 (Th17) differentiation, mediating further destructive inflammatory responses in CD and UC. Moreover, Th1‐mediated responses participate in IBD, and the antiapoptotic IL‐6/IL‐6 receptor (IL‐6R)/signal transducer and activator of transcription 3 (STAT3) signals are responsible for preserving Th1 cells in the site of inflammation. It has been revealed that fecal bacteria isolated from UC‐active and UC‐remission patients stimulate the hyperproduction of several cytokines, such as IL‐6, tumor necrosis factor‐α (TNF‐α), IL‐10, and IL‐12. Given the importance of the IL‐6/IL‐6R axis, various therapeutic options exist for controlling or treating IBD. Therefore, alternative therapeutic approaches such as modulating the gut microbiome could be beneficial due to the failure of the target therapies so far. This review article summarizes IBD immunopathogenesis focusing on the IL‐6/IL‐6R axis and discusses available therapeutic approaches based on the gut microbiome alteration and IL‐6/IL‐6R axis targeting and treatment failure.

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Oral Prolonged Release Beclomethasone Dipropionate and Prednisone in the Treatment of Active Ulcerative Colitis: Results From a Double-Blind, Randomized, Parallel Group Study

Abstract: BDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups.

Cited by 50 publications

References 22 publications

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

Conventional Therapy of Ulcerative Colitis: Corticosteroids

Role of interleukin-6-mediated inflammation in the pathogenesis of inflammatory bowel disease: focus on the available therapeutic approaches and gut microbiome

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