An indirect comparison of ustekinumab and vedolizumab in the therapy of TNF-failure Crohn's disease patients
Abstract
Aim: An indirect comparison of ustekinumab versus vedolizumab in patients with active moderate-to-severe Crohn's disease who were nonresponsive or intolerant to previous TNF-antagonist therapy. Methods: A systematic review was performed in Medline via PubMed, Embase, Cochrane Library, until 30 April 2017. Inclusion criteria were: randomized controlled trials, patients treated for Crohn's disease, ustekinumab or vedolizumab therapy. Included trials were critically appraised and afterward indirect comparison by Bucher was conducted; the manuscript was prepared in accordance to the PRISMA requirements. Results: Five randomized controlled trials were included and assessed for homogeneity; they occurred eligible for indirect comparison referring to induction or maintenance phase of TNF-antagonist failure population treatment; no statistically significant differences in clinical response (relative benefit [RB]: 1.14; 95% CI: 0.65–1.99; p = 0.64) as well as in clinical remission (RB: 1.16; 95% CI: 0.54–2.48; p = 0.71) in induction phase of therapy were revealed; no significant disparity was presented in a maintenance phase in clinical remission (RB: 0.72; 95% CI: 0.30–1.68; p = 0.44). No significant differences were also revealed in primary and secondary nonresponders subpopulations in clinical response. Indirect comparison of the safety profile presented no statistically significant difference between the biologics (relative risk [RR]: 0.93; 95% CI: 0.81–1.08; p = 0.35). Conclusion: No significant differences between vedolizumab and ustekinumab in clinical response and clinical remission for induction and remission in maintenance phase of TNF refractory patients therapy were revealed. In addition, no significant disparities in the risk of adverse events suggest a similar safety profile.
Supplementary Material
References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
Baumgart DC, Sandborn WJ. Crohn's disease. Lancet 380(9853), 1590–1605 (2012).
2.
Molodecky NA, Soon IS, Rabi DM et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology 142(1), 46–54 (2012).
3.
Gomollon F, Dignass A, Vito A et al. 3rd European evidence based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management. J. Crohns Colitis 11(1), 3–25 (2017).
4.
Roda G, Jharap B, Neeraj N, Colombel JF. Loss of response to anti-TNFs: definition, epidemiology, and management. Clin. Transl. Gastroenterol. 7(1), e135 (2016).
5.
Colombel JF, Sandborn WJ, Rutgeerts P et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 132, 52–65 (2007).
6.
Summaryof Product Characteristics for Entyvio (vedolizumab). (Accessed 2 August 2017). www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000958/WC500058513.pdf.
7.
Tilg H, Kaser A. Vedolizumab, a humanizedmab against the alpha4beta7 integrin for the potential treatment of ulcerativecolitis and Crohn's disease. Curr. Opin. Investig. Drugs 11(11), 1295–1304 (2010).
8.
Wyant T, Leach T, Sankoh S et al. Vedolizumab affectsantibody responses to immunisation selectively in the gastrointestinal tract:randomised controlled trial results. Gut 64(1), 77–83 (2015).
9.
Summaryof Product Characteristics for Entyvio (vedolizumab). (Accessed 7 August 2017). https://ec.europa.eu/health/documents/community-register/2014/20140522128514/anx_128514_en.pdf.
10.
Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct andindirect treatment comparisons in meta-analysis of randomized controlled trials. J. Clin. Epidemiol. 50(6), 683–691 (1997).
11.
Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 6(7), e1000097 (2009).
12.
Higgins JP, Green S. Cochrane handbook forsystematic reviews of interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration (2011).
13.
Sandborn WJ, Gasink C, Long-Long G et al. Ustekinumab induction andmaintenance therapy in refractory Crohn's disease. N. Engl. J. Med. 367, 1519–1528 (2012).
• Pivotal input for indirect comparisons performed.
14.
Feagan BG, Sandborn WJ, Gasink C et al. Ustekinumab as inductionand maintenance therapy for Crohn's disease. N. Engl. J. Med. 375, 1946–1960 (2016).
• Pivotal input for indirect comparisons performed.
15.
Sandborn WJ, Feagan BG, Rutgeerts P et al. Vedolizumab as inductionand maintenance therapy for Crohn's disease. N. Engl. J. Med. 369(8), 711–721 (2013).
• Pivotal input for indirect comparisons performed.
16.
Sands BE, Feagan BG, Rutgeerts P et al. Effects of vedolizumabinduction therapy for patients with Crohn's disease in whom tumor necrosisfactor antagonist treatment failed. Gastroenterology 147(3), 618–627 (2014).
• Pivotal input for indirect comparisons performed.
17.
Sands BE, Sandborn WJ, Van Assche G et al. Vedolizumab as inductionand maintenance therapy for Crohn's disease in patients naïve to or who havefailed tumor necrosis factor antagonist therapy. Inflamm. Bowel Dis. 23(1), 97–106 (2017).
• Pivotal input for indirect comparisons performed.
18.
Feagan BH, Patel H, Colombel JF et al. Effectsof vedolizumab on health-related quality of life in patients withulcerative colitis: results from the randomised GEMINI 1 trial. Aliment Pharmacol. Ther. 45(2), 264–275 (2017).
19.
Moćko P, Kawalec P, Smela-Lipińska B, Pilc A. Effectiveness and safety ofvedolizumab for treatment of Crohn's disease: a systematic review andmeta-analysis. Arch. Med. Sci. 12(5), 1088–1096 (2016).
•• Additional data on pivotal studies included to indirect comparisons.
20.
Sandborn WJ, Feagan BG, Fedorak RN et al. A randomized trial ofustekinumab, a human interleukin-12/23 monoclonal antibody, in patients withmoderate-to-severe Crohn's disease. Gastroenterology 135(4), 1130–1141 (2008).
•• Additional data on pivotal studies included to indirect comparisons.
21.
Sandborn WJ. Clinical perspectives inCrohn's disease. Moving forward with anti-TNF-alpha therapy: current needs andfuture treatments. Rev. Gastroenterol. Disord. 7(Suppl. 2), S23–S35 (2007).
22.
Sandborn WJ, Rutgeerts P, Enns R et al. Adalimumab inductiontherapy for Crohn disease previously treated with infliximab: a randomizedtrial. Ann. Intern. Med. 146, 829–838 (2007).
23.
Kawalec P, Moćko P, Pilc A, Radziwon Zalewska M, Malinowska-Lipień I. Vedolizumab compared withcertolizumab in the therapy of Crohn's disease: a systematic review and indirectcomparison. J. Human Pharmacol. Drug Ther. 36(8), 861–869 (2016).
24.
Brignardello-Petersen R, Rochwerg B, Guyatt GH et al. What is a networkmeta-analysis and how can we use it to inform clinical practice? Pol. Arch. Med. Wewn. 124(12), 659–660 (2014).
25.
European Network for Health Technology Assessment. Guideline: comparators and comparisons. Direct and Indirect Comparisons (2013). (Accessed 2 August 2017). www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Direct%20and%20indirect%20comparisons.pdf.
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Received: 12 June 2017
Accepted: 11 August 2017
Published online: 8 November 2017
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An indirect comparison of ustekinumab and vedolizumab in the therapy of TNF-failure Crohn's disease patients. (2017) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2017-0041
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