Systematic review with network meta-analysis: comparative assessment of tofacitinib and biological therapies for moderate-to-severe ulcerative colitis

Alimentary Pharmacology and Therapeutics

Volumn 47, Issue 4, 2018, Pages 454-465

  Bonovas, S ^a,b   Lytras, T ^c   Nikolopoulos, G ^d   Peyrin Biroulet, L ^e   Danese, S ^a,b  

^a HUMANITAS UNIVERSITY   (Italy)

^b HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

^c Hellenic Center for Disease Control and Prevention   (Greece)

^d UNIVERSITY OF CYPRUS   (Cyprus)

^e UNIVERSITY HOSPITAL OF NANCY   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; GOLIMUMAB; INFLIXIMAB; PLACEBO; TOFACITINIB; VEDOLIZUMAB; BIOLOGICAL PRODUCT; PIPERIDINE DERIVATIVE; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

COLON RESECTION; COMPARATIVE STUDY; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; HUMAN; INDUCTION CHEMOTHERAPY; MAINTENANCE THERAPY; META ANALYSIS; MUCOSAL HEALING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK ASSESSMENT; SYSTEMATIC REVIEW; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; WOUND HEALING; ADULT; BIOLOGICAL THERAPY; DOUBLE BLIND PROCEDURE; NETWORK META-ANALYSIS; PATHOLOGY; SEVERITY OF ILLNESS INDEX;

ADULT; BIOLOGICAL PRODUCTS; BIOLOGICAL THERAPY; COLITIS, ULCERATIVE; DOUBLE-BLIND METHOD; HUMANS; NETWORK META-ANALYSIS; PIPERIDINES; PYRIMIDINES; PYRROLES; SEVERITY OF ILLNESS INDEX;

EID: 85037655363     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.14449     Document Type: Review

References (49)

1. Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017;389:1756-1770.
2. Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011;365:1713-1725.
3. 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:e42.
4. 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;110:1324-1338.
5. Harbord M, Eliakim R, Bettenworth D, et al. European Crohn's and Colitis Organisation. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. part 2: current management. J Crohns Colitis. 2017;11:769-784.
6. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American college of gastroenterology, practice parameters committee. Am J Gastroenterol. 2010;105:501-523.
7. 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;160:704-711.
8. Bonovas S, Fiorino G, Allocca M, et al. Biologic therapies and risk of infection and malignancy in patients with inflammatory bowel disease: a systematic review and network meta-analysis. Clin Gastroenterol Hepatol. 2016;14:e10.
9. Fiorino G, Bonovas S, Cicerone C, et al. The safety of biological pharmacotherapy for the treatment of ulcerative colitis. Expert Opin Drug Saf. 2017;16:437-443.
10. Bradley CA. IBD: tofacitinib effective in ulcerative colitis. Nat Rev Gastroenterol Hepatol. 2017;14:388.
11. Cipriani A, Higgins JP, Geddes JR, Salanti G. Conceptual and technical challenges in network meta-analysis. Ann Intern Med. 2013;159:130-137.
12. Mills EJ, Thorlund K, Ioannidis JP. Demystifying trial networks and network meta-analysis. BMJ. 2013;346:f2914.
13. Caldwell DM, Ades AE, Higgins JP. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ. 2005;331:897-900.
14. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions. The Cochrane Collaboration; 2011, version 5.0.1.
15. Jansen JP, Fleurence R, Devine B, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR task force on indirect treatment comparisons good research practices: part 1. Value Health. 2011;14:417-428.
16. Hoaglin DC, Hawkins N, Jansen JP, et al. Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR task force on indirect treatment comparisons good research practices: part 2. Value Health. 2011;14:429-437.
17. Hutton B, Salanti G, Caldwell DM, et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med. 2015;162:777-784.
18. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987;317:1625-1629.
19. Dias SW, Sutton NJ, Sutton AJ, Ades AE. NICE DSU Technical Support Document 1: Introduction to Evidence Synthesis for Decision Making, 2011 (last updated April 2012). http://scharr.dept.shef.ac.uk/nicedsu/wp-content/uploads/sites/7/2016/03/TSD1-Introduction.final_.08.05.12.pdf
20. Wells GA, Sultan SA, Chen L, Khan M, Coyle D. Indirect Evidence: indirect Treatment Comparisons in Meta-Analysis. Ottawa, Ontario, Canada: Canadian Agency for Drugs and Technologies in Health; 2009. www.cadth.ca/media/pdf/H0462_itc_tr_e.pdf
21. Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
22. Bonovas S, Lytras T, Nikolopoulos G. On the criteria used for assessing the risk of bias in randomized trials included in systematic reviews and meta-analyses addressing adverse effects. Eur J Epidemiol. 2015;30:249-250.
23. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22:719-748.
24. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177-188.
25. Cochran WG. The combination of estimates from different experiments. Biometrics. 1954;810:101-129.
26. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539-1558.
27. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557-560.
28. Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol. 1997;50:683-691.
29. R Development Core Team. R: a Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing; 2014.
30. Schwarzer G. meta: an R package for meta-analysis. R News. 2007;7:40-45.
31. Wells GA, Sultan SA, Chen L, Khan M, Coyle D. Indirect Treatment Comparison [Computer Program]. Version 1.0. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2009.
32. Sandborn WJ, Su C, Sands BE, et al. OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723-1736.
33. Hibi T, Imai Y, Senoo A, Ohta K, Ukyo Y. Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: A phase 3, double-blind, randomized, placebo-controlled study (PURSUIT-J study). J Gastroenterol. 2017;52:1101-1111.
34. Kobayashi T, Suzuki Y, Motoya S, et al. First trough level of infliximab at week 2 predicts future outcomes of induction therapy in ulcerative colitis – results from a multicenter prospective randomized controlled trial and its post hoc analysis. J Gastroenterol. 2016;51:241-251.
35. Jiang XL, Cui HF, Gao J, Fan H. Low-dose infliximab for induction and maintenance treatment in Chinese patients with moderate to severe active ulcerative colitis. J Clin Gastroenterol. 2015;49:582-588.
36. 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;49:283-294.
37. Sandborn WJ, Feagan BG, Marano C, et al. PURSUIT-Maintenance Study GroupSubcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:e1.
38. Sandborn WJ, Feagan BG, Marano C, et al. PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:85-95.
39. Feagan BG, Rutgeerts P, Sands BE, et al. GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699-710.
40. Feagan BG, Rubin DT, Danese S, et al. Efficacy of vedolizumab induction and maintenance therapy in patients with ulcerative colitis, regardless of prior exposure to tumor necrosis factor antagonists. Clin Gastroenterol Hepatol. 2017;15:e5.
41. Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S. Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012;367:616-624.
42. 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: 257-265.e1-3.
43. 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;60:780-787.
44. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462-2476.
45. Sands B, D'Haens G, Sandborn WJ, et al. Tofacitinib has induction efficacy in moderately to severely active ulcerative colitis, regardless of prior TNF inhibitor therapy. Am J Gastroenterol. 2016;111:S261.
46. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis. http://clinicaltrials.gov/show/NCT00853099
47. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of CP-690,550 in Subjects With Moderate to Severe Ulcerative Colitis. Study A3921063 - Public Disclosure Synopsis. https://www.clinicaltrialsregister.eu/ctr-search/rest/download/result/attachment/2008-004564-40/1/2700
48. US Food and Drug Administration, Center for Drug Evaluation and Research, BLA 125057Orig1s232: Adalimumab. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125057Orig1s232.pdf
49. Gray JR, Leung E, Scales J. Treatment of ulcerative colitis from the patient's perspective: a survey of preferences and satisfaction with therapy. Aliment Pharmacol Ther. 2009;29:1114-1120.