Systematic review with meta-analysis: comparative efficacy of biologics for induction and maintenance of mucosal healing in Crohn's disease and ulcerative colitis controlled trials

Alimentary Pharmacology and Therapeutics

Volumn 45, Issue 10, 2017, Pages 1291-1302

  Cholapranee, A ^a   Hazlewood, G S ^b,c   Kaplan, G G ^b   Peyrin Biroulet, L ^d   Ananthakrishnan, A N ^e  

^a MONTEFIORE MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALGARY   (Canada)

^c UNIVERSITY OF CALGARY   (Canada)

^d UNIVERSITY HOSPITAL OF NANCY   (France)

^e MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; BIOLOGICAL PRODUCT; GOLIMUMAB; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; INTEGRIN MONOCLONAL ANTIBODY; PLACEBO; TUMOR NECROSIS FACTOR ANTIBODY; UNCLASSIFIED DRUG; VEDOLIZUMAB; BIOLOGICAL FACTOR; MONOCLONAL ANTIBODY;

COMPARATIVE EFFECTIVENESS; CROHN DISEASE; DISEASE SEVERITY; FOLLOW UP; HUMAN; REVIEW; SYSTEMATIC REVIEW; ULCERATIVE COLITIS; COLITIS, ULCERATIVE; DRUG EFFECTS; INDUCTION CHEMOTHERAPY; MAINTENANCE CHEMOTHERAPY; META ANALYSIS; MUCOSA; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT OUTCOME; WOUND HEALING;

ANTIBODIES, MONOCLONAL; BIOLOGICAL FACTORS; BIOLOGICAL PRODUCTS; COLITIS, ULCERATIVE; CROHN DISEASE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INDUCTION CHEMOTHERAPY; MAINTENANCE CHEMOTHERAPY; MUCOUS MEMBRANE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; WOUND HEALING;

EID: 85016075263     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.14030     Document Type: Review

References (54)

1. Molodecky NA, Soon IS, Rabi DM, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology 2012; 142: 46–54, e42; quiz e30.
2. Burisch J, Jess T, Martinato M, et al. The burden of inflammatory bowel disease in Europe. J Crohns Colitis 2013; 7: 322–37.
3. Ananthakrishnan AN, Korzenik JR, Hur C. Can mucosal healing be a cost-effective endpoint for biologic therapy in Crohn's disease? A decision analysis Inflamm Bowel Dis 2013; 19: 37–44.
4. Froslie KF, Jahnsen J, Moum BA, et al. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology 2007; 133: 412–22.
5. Rutgeerts P, Vermeire S, Van Assche G. Mucosal healing in inflammatory bowel disease: impossible ideal or therapeutic target? Gut 2007; 56: 453–5.
6. Shah SC, Colombel JF, Sands BE, et al. Mucosal healing is associated with improved long-term outcomes of patients with ulcerative colitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2016; 14: 1245–55.e8.
7. Van Assche G. Does mucosal healing impact patient outcomes long-term? Inflamm Bowel Dis 2008; 14: 577–8.
8. Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Selecting therapeutic targets in inflammatory bowel disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol 2015; 110: 1324–38.
9. Schoepfer AM, Beglinger C, Straumann A, et al. Fecal calprotectin correlates more closely with the Simple Endoscopic Score for Crohn's disease (SES-CD) than CRP, blood leukocytes, and the CDAI. Am J Gastroenterol 2010; 105: 162–9.
10. Jones J, Loftus EV Jr, Panaccione R, et al. Relationships between disease activity and serum and fecal biomarkers in patients with Crohn's disease. Clin Gastroenterol Hepatol 2008; 6: 1218–24.
11. Schnitzler F, Fidder H, Ferrante M, et al. Mucosal healing predicts long-term outcome of maintenance therapy with infliximab in Crohn's disease. Inflamm Bowel Dis 2009; 15: 1295–301.
12. Frolkis AD, Dykeman J, Negron ME, et al. Risk of surgery for inflammatory bowel diseases has decreased over time: a systematic review and meta-analysis of population-based studies. Gastroenterology 2013; 145: 996–1006.
13. Shah SC, Colombel JF, Sands BE, et al. Systematic review with meta-analysis: mucosal healing is associated with improved long-term outcomes in Crohn's disease. Aliment Pharmacol Ther 2016; 43: 317–33.
14. Peyrin-Biroulet L, Ferrante M, Magro F, et al. Results from the 2nd Scientific Workshop of the ECCO. I: Impact of mucosal healing on the course of inflammatory bowel disease. J Crohns Colitis 2011; 5: 477–83.
15. Panaccione R, Ghosh S, Middleton S, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology 2014; 146: 392–400, e3.
16. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010; 362: 1383–95.
17. Danese S, Fiorino G, Peyrin-Biroulet L, et al. Biological agents for moderately to severely active ulcerative colitis: a systematic review and network meta-analysis. Ann Intern Med 2014; 160: 704–11.
18. Hazlewood GS, Rezaie A, Borman M, et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis. Gastroenterology 2015; 148: 344–54, e5; quiz e14-5.
19. Singh S, Garg SK, Pardi DS, et al. Comparative efficacy of biologic therapy in biologic-naive patients with Crohn disease: a systematic review and network meta-analysis. Mayo Clin Proc 2014; 89: 1621–35.
20. Stidham RW, Lee TC, Higgins PD, et al. Systematic review with network meta-analysis: the efficacy of anti-TNF agents for the treatment of Crohn's disease. Aliment Pharmacol Ther 2014; 39: 1349–62.
21. Stidham RW, Lee TC, Higgins PD, et al. Systematic review with network meta-analysis: the efficacy of anti-tumour necrosis factor-alpha agents for the treatment of ulcerative colitis. Aliment Pharmacol Ther 2014; 39: 660–71.
22. Vickers AD, Ainsworth C, Mody R, et al. Systematic review with network meta-analysis: comparative efficacy of biologics in the treatment of moderately to severely active ulcerative colitis. PLoS ONE 2016; 11: e0165435.
23. Thorlund K, Druyts E, Toor K, et al. Comparative efficacy of golimumab, infliximab, and adalimumab for moderately to severely active ulcerative colitis: a network meta-analysis accounting for differences in trial designs. Expert Rev Gastroenterol Hepatol 2015; 1–8.
24. Mei WQ, Hu HZ, Liu Y, et al. Infliximab is superior to other biological agents for treatment of active ulcerative colitis: A meta-analysis. World J Gastroenterol 2015; 21: 6044–51.
25. Neurath MF, Travis SP. Mucosal healing in inflammatory bowel diseases: a systematic review. Gut 2012; 61: 1619–35.
26. Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928.
27. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986; 7: 177–88.
28. Dias S, Sutton AJ, Ades AE, et al. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making 2013; 33: 607–17.
29. Ades AE, Sculpher M, Sutton A, et al. Bayesian methods for evidence synthesis in cost-effectiveness analysis. Pharmacoeconomics 2006; 24: 1–19.
30. Turner RM, Davey J, Clarke MJ, et al. Predicting the extent of heterogeneity in meta-analysis, using empirical data from the Cochrane Database of Systematic Reviews. Int J Epidemiol 2012; 41: 818–27.
31. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013; 369: 699–710.
32. Rutgeerts P, Diamond RH, Bala M, et al. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc 2006; 63: 433–42; quiz 464.
33. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353: 2462–76.
34. Rutgeerts P, Van Assche G, Sandborn WJ, et al. Adalimumab induces and maintains mucosal healing in patients with Crohn's disease: data from the EXTEND trial. Gastroenterology 2012; 142: 1102–11, e2.
35. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2014; 146: 85–95; quiz e14-5.
36. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2014; 146: 96–109; e1.
37. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut 2011; 60: 780–7.
38. Suzuki Y, Motoya S, Hanai H, et al. Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis. J Gastroenterol 2014; 49: 283–94.
39. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med 2013; 369: 711–21.
40. Lemann M, Mary JY, Duclos B, et al. Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial. Gastroenterology 2006; 130: 1054–61.
41. Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2012; 142: 257–65. e1-3.
42. D'Haens GR, Panaccione R, Higgins PD, et al. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organization: when to start, when to stop, which drug to choose, and how to predict response? Am J Gastroenterol 2011; 106: 199–212; quiz 213.
43. Akobeng AK, Zachos M. Tumor necrosis factor-alpha antibody for induction of remission in Crohn's disease. Cochrane Database Syst Rev 2004; CD003574.
44. Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev 2008; CD006893.
45. Lawson MM, Thomas AG, Akobeng AK. Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database Syst Rev 2006; CD005112.
46. Mosli MH, MacDonald JK, Bickston SJ, et al. Vedolizumab for induction and maintenance of remission in ulcerative colitis: a Cochrane systematic review and meta-analysis. Inflamm Bowel Dis 2015; 21: 1151–9.
47. Peyrin-Biroulet L. Anti-TNF therapy in inflammatory bowel diseases: a huge review. Minerva Gastroenterol Dietol 2010; 56: 233–43.
48. Hebuterne X, Lemann M, Bouhnik Y, et al. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol. Gut 2013; 62: 201–8.
49. Filik L, Dagli U, Ulker A. C-reactive protein and monitoring the activity of Crohn's disease. Adv Ther 2006; 23: 655–62.
50. Jorgensen LG, Fredholm L, Hyltoft Petersen P, et al. How accurate are clinical activity indices for scoring of disease activity in inflammatory bowel disease (IBD)? Clin Chem Lab Med 2005; 43: 403–11.
51. Sipponen T, Savilahti E, Kolho KL, et al. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis 2008; 14: 40–6.
52. Brandse JF, van den Brink GR, Wildenberg ME, et al. Loss of infliximab into feces is associated with lack of response to therapy in patients with severe ulcerative colitis.Gastroenterology 2015; 149: 350–5, e2.
53. Barreiro-Acosta M, Vallejo N, de la Iglesia D, et al. Mucosal healing in ulcerative colitis: Do Mayo 0 and 1 scores really have the same prognostic value? A prospective observational cohort study J Crohns Colitis 2014; 8: DOP050.
54. Zenlea T, Yee EU, Rosenberg L, et al. Histology grade is independently associated with relapse risk in patients with ulcerative colitis in clinical remission: a prospective study. Am J Gastroenterol 2016; 111: 685–90.