Comparative assessment of budesonide‐MMX and mesalamine in active, mild‐to‐moderate ulcerative colitis: A systematic review and network meta‐analysis

• Published in: British journal of clinical pharmacology 2019-10, Vol.85 (10), p.2244-2254
• Main Authors: Bonovas, Stefanos, Nikolopoulos, Georgios K., Piovani, Daniele, González‐Lorenzo, Marien, Pantavou, Katerina, Lytras, Theodore, Peyrin‐Biroulet, Laurent, Danese, Silvio
• Format: Article
• Language: English
• Subjects: Adult; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Budesonide - administration & dosage; Budesonide - adverse effects; budesonide‐MMX, mesalamine, ulcerative colitis; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - physiopathology; Delayed-Action Preparations; Glucocorticoids - administration & dosage; Glucocorticoids - adverse effects; Humans; Mesalamine - administration & dosage; Mesalamine - adverse effects; Randomized Controlled Trials as Topic; Severity of Illness Index; Systematic Review and Meta‐analysis; Treatment Outcome
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/bcp.14051

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 ed 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.