Stefanos Bonovas1,2, Georgios K Nikolopoulos3, Daniele Piovani1,2, Marien González-Lorenzo1,2, Katerina Pantavou3, Theodore Lytras4, Laurent Peyrin-Biroulet5, Silvio Danese1,2. 1. Department of Biomedical Sciences, Humanitas University, Milan, Italy. 2. IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy. 3. Medical School, University of Cyprus, Nicosia, Cyprus. 4. Hellenic Center for Disease Control and Prevention, Athens, Greece. 5. Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.
Abstract
AIMS: The comparative efficacy, safety and tolerability of budesonide-MMX and oral mesalamine in active, mild-to-moderate ulcerative colitis (UC) are unclear. We conducted a network meta-analysis to fill this evidence gap. METHODS: We searched PubMed, Scopus, Embase, the Cochrane Library, clinical trial registries, regulatory agencies' websites and international conference proceedings, up to July 2018, to identify randomized controlled trials of adult patients with active, mild-to-moderate UC, comparing budesonide-MMX or mesalamine against placebo, or against each other, or different dosing strategies, for induction of remission. Two reviewers independently abstracted study data and outcomes, and assessed each trial's risk-of-bias. RESULTS: We identified and synthesized evidence from 15 eligible trials including 4083 participants. Budesonide-MMX 9 mg/day and mesalamine >2.4 g/day had similar efficacy for induction of clinical and endoscopic remission (OR = 0.97; 0.59-1.60), both showing superiority over placebo (OR = 2.68; 1.75-4.10, and OR = 2.75; 1.94-3.90, respectively). Furthermore, mesalamine >2.4 g/day was more efficacious than mesalamine 1.6-2.4 g/day (odds ratio = 1.27; 1.03-1.56). Secondary analyses showed that mesalamine >2.4 g/day ranks at the top among comparator treatments regarding safety (serious adverse events; surface under the cumulative ranking area [SUCRA] 79.2%) and tolerability (treatment discontinuations or withdrawals from the study due to adverse events; SUCRA 96.7%). There was no evidence of inconsistency, while heterogeneity between studies and risk of publication bias were low. CONCLUSION: Budesonide-MMX and mesalamine >2.4 g/day had similar efficacy for induction of clinical and endoscopic remission in active, mild-to-moderate UC; however, mesalamine >2.4 g/day showed better tolerability. Further high-quality research is warranted.
AIMS: The comparative efficacy, safety and tolerability of budesonide-MMX and oral mesalamine in active, mild-to-moderate ulcerative colitis (UC) are unclear. We conducted a network meta-analysis to fill this evidence gap. METHODS: We searched PubMed, Scopus, Embase, the Cochrane Library, clinical trial registries, regulatory agencies' websites and international conference proceedings, up to July 2018, to identify randomized controlled trials of adult patients with active, mild-to-moderate UC, comparing budesonide-MMX or mesalamine against placebo, or against each other, or different dosing strategies, for induction of remission. Two reviewers independently abstracted study data and outcomes, and assessed each trial's risk-of-bias. RESULTS: We identified and synthesized evidence from 15 eligible trials including 4083 participants. Budesonide-MMX 9 mg/day and mesalamine >2.4 g/day had similar efficacy for induction of clinical and endoscopic remission (OR = 0.97; 0.59-1.60), both showing superiority over placebo (OR = 2.68; 1.75-4.10, and OR = 2.75; 1.94-3.90, respectively). Furthermore, mesalamine >2.4 g/day was more efficacious than mesalamine 1.6-2.4 g/day (odds ratio = 1.27; 1.03-1.56). Secondary analyses showed that mesalamine >2.4 g/day ranks at the top among comparator treatments regarding safety (serious adverse events; surface under the cumulative ranking area [SUCRA] 79.2%) and tolerability (treatment discontinuations or withdrawals from the study due to adverse events; SUCRA 96.7%). There was no evidence of inconsistency, while heterogeneity between studies and risk of publication bias were low. CONCLUSION:Budesonide-MMX and mesalamine >2.4 g/day had similar efficacy for induction of clinical and endoscopic remission in active, mild-to-moderate UC; however, mesalamine >2.4 g/day showed better tolerability. Further high-quality research is warranted.
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Authors: William J Sandborn; Jaroslaw Regula; Brian G Feagan; Elena Belousova; Njegica Jojic; Milan Lukas; Bruce Yacyshyn; Piotr Krzeski; Chyon-Hwa Yeh; Christi A Messer; Stephen B Hanauer Journal: Gastroenterology Date: 2009-09-18 Impact factor: 22.682
Authors: Brian Hutton; Georgia Salanti; Deborah M Caldwell; Anna Chaimani; Christopher H Schmid; Chris Cameron; John P A Ioannidis; Sharon Straus; Kristian Thorlund; Jeroen P Jansen; Cynthia Mulrow; Ferrán Catalá-López; Peter C Gøtzsche; Kay Dickersin; Isabelle Boutron; Douglas G Altman; David Moher Journal: Ann Intern Med Date: 2015-06-02 Impact factor: 25.391