Systematic review and meta-analysis of randomised controlled trials: Medical therapies for the treatment and prevention of pouchitis.
Pouchitis
randomised controlled trials
treatment
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
revised:
15
05
2023
received:
16
03
2023
accepted:
16
05
2023
medline:
17
7
2023
pubmed:
29
5
2023
entrez:
29
5
2023
Statut:
ppublish
Résumé
We conducted a systematic review to assess medical therapy for the treatment and prevention of pouchitis. Randomised controlled trials (RCTs) of medical therapy in adults with or without pouchitis were searched to March 2022. Primary outcomes included clinical remission/response, maintenance of remission and prevention of pouchitis. Twenty RCTs (N = 830) were included. Acute pouchitis: One study compared ciprofloxacin with metronidazole. At 2 weeks, 100% (7/7) of ciprofloxacin participants achieved remission, compared with 67% (6/9) of metronidazole participants (RR: 1.44, 95% CI: 0.88-2.35, very low certainty evidence). One study compared budesonide enemas with oral metronidazole. Fifty percent (6/12) of budesonide participants achieved remission compared with 43% (6/14) of metronidazole participants (RR: 1.17, 95% CI: 0.51-2.67, low certainty evidence). Chronic pouchitis: Two studies (n = 76) assessed De Simone Formulation. Eighty-five percent (34/40) of De Simone Formulation participants maintained remission at 9-12 months compared with 3% (1/36) placebo participants (RR: 18.50, 95% CI: 3.86-88.56, moderate certainty evidence). One study assessed vedolizumab. Thirty-one percent (16/51) of vedolizumab participants achieved clinical remission at 14 weeks compared with 10% (5/51) of placebo participants (RR: 3.20, 95% CI: 1.27-8.08, moderate certainty evidence). Two studies assessed De Simone Formulation. Ninety percent (18/20) of De Simone Formulation participants did not develop pouchitis compared with 60% (12/20) of placebo participants (RR: 1.50, 95% CI: 1.02-2.21, moderate certainty evidence). Apart from vedolizumab and the De Simone formulation, the effects of other medical interventions for pouchitis are uncertain.
Sections du résumé
BACKGROUND AND AIMS
We conducted a systematic review to assess medical therapy for the treatment and prevention of pouchitis.
METHODS
Randomised controlled trials (RCTs) of medical therapy in adults with or without pouchitis were searched to March 2022. Primary outcomes included clinical remission/response, maintenance of remission and prevention of pouchitis.
RESULTS
Twenty RCTs (N = 830) were included. Acute pouchitis: One study compared ciprofloxacin with metronidazole. At 2 weeks, 100% (7/7) of ciprofloxacin participants achieved remission, compared with 67% (6/9) of metronidazole participants (RR: 1.44, 95% CI: 0.88-2.35, very low certainty evidence). One study compared budesonide enemas with oral metronidazole. Fifty percent (6/12) of budesonide participants achieved remission compared with 43% (6/14) of metronidazole participants (RR: 1.17, 95% CI: 0.51-2.67, low certainty evidence). Chronic pouchitis: Two studies (n = 76) assessed De Simone Formulation. Eighty-five percent (34/40) of De Simone Formulation participants maintained remission at 9-12 months compared with 3% (1/36) placebo participants (RR: 18.50, 95% CI: 3.86-88.56, moderate certainty evidence). One study assessed vedolizumab. Thirty-one percent (16/51) of vedolizumab participants achieved clinical remission at 14 weeks compared with 10% (5/51) of placebo participants (RR: 3.20, 95% CI: 1.27-8.08, moderate certainty evidence).
PROPHYLAXIS
Two studies assessed De Simone Formulation. Ninety percent (18/20) of De Simone Formulation participants did not develop pouchitis compared with 60% (12/20) of placebo participants (RR: 1.50, 95% CI: 1.02-2.21, moderate certainty evidence).
CONCLUSIONS
Apart from vedolizumab and the De Simone formulation, the effects of other medical interventions for pouchitis are uncertain.
Substances chimiques
Metronidazole
140QMO216E
Ciprofloxacin
5E8K9I0O4U
Budesonide
51333-22-3
Types de publication
Meta-Analysis
Systematic Review
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
268-282Informations de copyright
© 2023 John Wiley & Sons Ltd.
Références
Sedano R, Nguyen TM, Almradi A, Rieder F, Parker CE, Shackelton LM, et al. Disease activity indices for Pouchitis: a systematic review. Inflamm Bowel Dis. 2022;28(4):622-38.
Sedano R, Ma C, Pai RK, D'Haens G, Guizzetti L, Shackelton LM, et al. An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials. Aliment Pharmacol Ther. 2021;53(10):1108-17.
European Medicines Agency. Entyvio-H-C-2782-II-0061: EPAR - Assessment report - Variation. Amsterdam: European Medicines Agency; 2022https://www.ema.europa.eu/en/medicines/human/EPAR/entyvio#authorisation-details-section. Accessed 10 April 2023.
Pardi DS, D'Haens G, Shen B, Campbell S, Gionchetti P. Clinical guidelines for the management of pouchitis. Inflamm Bowel Dis. 2009;15(9):1424-31.
Ollech JE, Rubin DT, Glick L, Weisshof R, el Jurdi K, Israel A, et al. Ustekinumab is effective for the treatment of chronic antibiotic-refractory pouchitis. Dig Dis Sci. 2019;64(12):3596-601.
Jairath V, Feagan BG, Silverberg MS, Danese S, Gionchetti P, Löwenberg M, et al. Mucosal healing with vedolizumab in inflammatory bowel disease patients with chronic pouchitis: evidence from EARNEST, a randomized, double-blind, placebo-controlled trial. J Crohns Colitis. 2023;17(Supplement 1):i13-4.
Jairath V, Feagan B, Silverberg MS, Danese S, Gionchetti P, Löwenberg M, et al. Mucosal healing with vedolizumab in inflammatory bowel disease: evidence from Earnest, a randomized, double-blind, placebo-controlled trial in chronic Pouchitis. United European Gastroenterol J. 2022;10(Supplement 8):329-30.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JPA, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700.
Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539-58.
Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924-6.
Brown SJMJ, Smith S, Matchet D, Elliott R. Bifidobacterium longum BB-536 and prevention of acute pouchitis. Gastroenterology. 2004;126(4 Suppl 2):A465.
NCT02790138. A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST). https://clinicaltrials.gov/ct2/show/NCT02790138. Accessed 1 Aug, 2022.
Feagan BLJ, Rogler G, Moran G, Varawalla N. Alicaforsen enema in chronic pouchitis: results of a phase 3 randomized, double-blind, placebo-controlled trial. Am J Gastroenterol. 2021;116(Suppl):S365.
Gionchetti P, Rizzello F, Venturi A, Brigidi P, Matteuzzi D, Bazzocchi G, et al. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. Gastroenterology. 2000;119(2):305-9.
Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, et al. Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology. 2003;124(5):1202-9.
Ha CYBJ, Lazarev M, Swaminath A, Sparrow M, Murphy SJ. Early institution of tinidazole may prevent pouchitis following ileal pouch-anal anastomosis (IPAA) surgery in ulcerative colitis (UC) patients. Gastroenterology. 2010;138(5 Suppl 1):S69-9.
Herfarth H, Barnes EL, Long MD, Isaacs KL, Leith T, Silverstein M, et al. Combined endoscopic and oral fecal microbiota transplantation in patients with antibiotic-dependent pouchitis: low clinical efficacy due to low donor microbial engraftment. Inflamm Intest Dis. 2019;4(1):1-6.
Isaacs KL, Sandler RS, Abreu M, Picco MF, Hanauer SB, Bickston SJ, et al. Rifaximin for the treatment of active pouchitis: a randomized, double-blind, placebo-controlled pilot study. Inflamm Bowel Dis. 2007;13(10):1250-5.
Joelsson M, Andersson M, Bark T, Gullberg K, Hallgren T, Jiborn H, et al. Allopurinol as prophylaxis against pouchitis following ileal pouch-anal anastomosis for ulcerative colitis. A randomized placebo-controlled double-blind study. Scand J Gastroenterol. 2001;36(11):1179-84.
Karjalainen EK, Renkonen-Sinisalo L, Satokari R, Mustonen H, Ristimäki A, Arkkila P, et al. Fecal microbiota transplantation in chronic pouchitis: a Randomized, parallel, double-blinded clinical trial. Inflamm Bowel Dis. 2021;27(11):1766-72.
Kjaer MD, Qvist N, Nordgaard-Lassen I, Christensen LA, Kjeldsen J. Adalimumab in the treatment of chronic pouchitis. A randomized double-blind, placebo-controlled trial. Scand J Gastroenterol. 2019;54(2):188-93.
Kuisma J, Mentula S, Jarvinen H, Kahri A, Saxelin M, Farkkila M. Effect of Lactobacillus rhamnosus GG on ileal pouch inflammation and microbial flora. Aliment Pharmacol Ther. 2003;17(4):509-15.
Mimura T, Rizzello F, Helwig U, Poggioli G, Schreiber S, Talbot IC, et al. Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis. Gut. 2004;53(1):108-14.
Pronio A, Montesani C, Butteroni C, Vecchione S, Mumolo G, Vestri AR, et al. Probiotic administration in patients with ileal pouch-anal anastomosis for ulcerative colitis is associated with expansion of mucosal regulatory cells. Inflamm Bowel Dis. 2008;14(5):662-8.
Sambuelli A, Boerr L, Negreira S, Gil A, Camartino G, Huernos S, et al. Budesonide enema in pouchitis--a double-blind, double-dummy, controlled trial. Aliment Pharmacol Ther. 2002;16(1):27-34.
Shen B, Achkar JP, Lashner BA, Ormsby AH, Remzi FH, Brzezinski A, et al. A randomized clinical trial of ciprofloxacin and metronidazole to treat acute pouchitis. Inflamm Bowel Dis. 2001;7(4):301-5.
Tan HT, Morton D, Bain IM, Keighley MR. Ursodeoxycholic acid has no influence on function after restorative proctocolectomy in ulcerative colitis. Aliment Pharmacol Ther. 1999;13(12):1593-6.
Tremaine WJ, Sandborn WJ, Wolff BG, Carpenter HA, Zinsmeister AR, Metzger PP. Bismuth carbomer foam enemas for active chronic pouchitis: a randomized, double-blind, placebo-controlled trial. Aliment Pharmacol Ther. 1997;11(6):1041-6.
Van Assche G, Ferrante M, Vermeire S, et al. Octreotide for the treatment of diarrhoea in patients with ileal pouch anal anastomosis: a placebo-controlled crossover study. Colorectal Dis. 2012;14(4):e181-6.
Yasueda A, Mizushima T, Nezu R, Sumi R, Tanaka M, Nishimura J, et al. The effect of clostridium butyricum MIYAIRI on the prevention of pouchitis and alteration of the microbiota profile in patients with ulcerative colitis. Surg Today. 2016;46(8):939-49.
Hosten TA, Zhao K, Han HQ, Liu G, He XH. Alicaforsen: an emerging therapeutic agent for ulcerative colitis and refractory pouchitis. Gastroenterology Res. 2014;7(2):51-5.