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

Abstract

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 Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes.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.

Review article: prevention, diagnosis and management of COVID‐19 in the IBD patient

“…Data for budesonide and beclomethasone, locally acting corticosteroids with low systemic bioavailability, demonstrate that these medications are associated with significantly fewer side effects when compared to systemic corticosteroids with adverse events similar to placebo 65‐69 Corticosteroids Corticosteroids (particularly ≥20 mg prednisolone or its equivalent) are associated with an increased risk of infection; however, it is unclear if treatment with corticosteroids is associated with an increased risk of COVID‐19 infection or complications. Where possible, corticosteroid use should be avoided and rapid tapering should be considered ± switch to budesonide.…”

Glucocorticoid Therapy in Inflammatory Bowel Disease: Mechanisms and Clinical Practice

“…A similar efficacy to that observed with prednisolone was evident, and there was no difference in the prevalence of adverse events. However, as a second-generation GC with low systemic absorption, it is associated with fewer adverse events than that of first-generation GCs ( 44 , 45 ).…”

Reviewing treatments and outcomes in the evolving landscape of ulcerative colitis

“…Oral beclomethasone dipropionate is a second-generation corticosteroid with limited systemic activity that is released throughout the colon [72,73]. A meta-analysis compared the efficacy and safety of at least 4 weeks of treatment with oral beclomethasone dipropionate with oral prednisone or oral 5-ASAs in five randomized, controlled studies of patients with mild-to-moderate leftsided or extensive UC [72].…”

“…Oral beclomethasone dipropionate is a second-generation corticosteroid with limited systemic activity that is released throughout the colon [72,73]. A meta-analysis compared the efficacy and safety of at least 4 weeks of treatment with oral beclomethasone dipropionate with oral prednisone or oral 5-ASAs in five randomized, controlled studies of patients with mild-to-moderate leftsided or extensive UC [72]. The odds of achieving clinical response, as defined by each independent study, were significantly greater with oral beclomethasone dipropionate compared with oral prednisone or oral 5-ASAs (65.6% vs. 60.0%, respectively; odds ratio (OR), 1.41; 95% confidence interval (CI), 1.03-1.93; p = 0.03); no significant differences were observed for clinical remission, as defined in the individual studies (OR, 1.30; 95% CI, 0.76-2.23; p = 0.34) [72].…”