Table of Contents Author Guidelines Submit a Manuscript
International Journal of Rheumatology
Volume 2017 (2017), Article ID 8417249, 15 pages
https://doi.org/10.1155/2017/8417249
Review Article

Tofacitinib versus Biologic Treatments in Moderate-to-Severe Rheumatoid Arthritis Patients Who Have Had an Inadequate Response to Nonbiologic DMARDs: Systematic Literature Review and Network Meta-Analysis

1Mapi, Boston, MA, USA
2Pfizer Inc., Groton, CT, USA
3Pfizer Inc., New York City, NY, USA

Correspondence should be addressed to Gene Wallenstein; moc.rezifp@nietsnellaw.eneg

Received 28 July 2016; Accepted 24 November 2016; Published 9 March 2017

Academic Editor: Tim Jansen

Copyright © 2017 Evelien Bergrath et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. A. J. Silman and J. E. Pearson, “Epidemiology and genetics of rheumatoid arthritis,” Arthritis research, vol. 4, no. 3, pp. S265–S272, 2002. View at Publisher · View at Google Scholar · View at Scopus
  2. J. J. Sacks, Y.-H. Luo, and C. G. Helmick, “Prevalence of specific types of arthritis and other rheumatic conditions in the ambulatory health care system in the United States, 2001–2005,” Arthritis Care and Research, vol. 62, no. 4, pp. 460–464, 2010. View at Publisher · View at Google Scholar · View at Scopus
  3. J. A. Singh, D. E. Furst, A. Bharat et al., “2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis,” Arthritis care & research, vol. 64, no. 5, pp. 625–639, 2012. View at Publisher · View at Google Scholar · View at Scopus
  4. J. S. Smolen, D. Aletaha, J. W. J. Bijlsma et al., “Treating rheumatoid arthritis to target: recommendations of an international task force,” Annals of the Rheumatic Diseases, vol. 69, no. 4, pp. 631–637, 2010. View at Publisher · View at Google Scholar · View at Scopus
  5. “Summary of opinion (post authorisation)-Kineret (anakinra),” http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000363/WC500150030.pdf.
  6. Drug treatment for rheumatoid arthritis, http://pathways.nice.org.uk/pathways/rheumatoid-arthritis.
  7. S. D. Mathias, H. H. Colwell, D. P. Miller, L. W. Moreland, M. Buatti, and L. Wanke, “Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo,” Clinical Therapeutics, vol. 22, no. 1, pp. 128–139, 2000. View at Publisher · View at Google Scholar · View at Scopus
  8. L. W. Moreland, M. H. Schiff, S. W. Baumgartner et al., “Etanercept therapy in rheumatoid arthritis: a randomized, controlled trial,” Annals of Internal Medicine, vol. 130, no. 6, pp. 478–486, 1999. View at Publisher · View at Google Scholar · View at Scopus
  9. L. B. A. Van De Putte, C. Atkins, M. Malaise et al., “Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed,” Annals of the Rheumatic Diseases, vol. 63, no. 5, pp. 508–516, 2004. View at Publisher · View at Google Scholar · View at Scopus
  10. J. A. Singh, K. G. Saag, S. L. Bridges et al., “2015 American college of rheumatology guideline for the treatment of rheumatoid arthritis,” Arthritis Care & Research, vol. 68, no. 1, pp. 1–25, 2016. View at Publisher · View at Google Scholar · View at Scopus
  11. K. Ghoreschi, M. I. Jesson, X. Li et al., “Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550),” Journal of Immunology, vol. 186, no. 7, pp. 4234–4243, 2011. View at Publisher · View at Google Scholar · View at Scopus
  12. H.-B. Park, K. Oh, N. Garmaa et al., “CP-690550, a janus kinase inhibitor, suppresses CD4+ T-cell-mediated acute graft-versus-host disease by inhibiting the interferon-γ pathway,” Transplantation, vol. 90, no. 8, pp. 825–835, 2010. View at Publisher · View at Google Scholar · View at Scopus
  13. R. Fleischmann, M. Cutolo, M. C. Genovese et al., “Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs,” Arthritis and Rheumatism, vol. 64, no. 3, pp. 617–629, 2012. View at Publisher · View at Google Scholar · View at Scopus
  14. R. Fleischmann, J. Kremer, J. Cush et al., “Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis,” New England Journal of Medicine, vol. 367, no. 6, pp. 495–507, 2012. View at Publisher · View at Google Scholar · View at Scopus
  15. J. M. Kremer, S. Cohen, B. E. Wilkinson et al., “A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone,” Arthritis and Rheumatism, vol. 64, no. 4, pp. 970–981, 2012. View at Publisher · View at Google Scholar · View at Scopus
  16. G. R. Burmester, R. Blanco, C. Charles-Schoeman et al., “Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial,” The Lancet, vol. 381, no. 9865, pp. 451–460, 2013. View at Publisher · View at Google Scholar · View at Scopus
  17. J. M. Kremer, B. J. Bloom, F. C. Breedveld et al., “The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo,” Arthritis and Rheumatism, vol. 60, no. 7, pp. 1895–1905, 2009. View at Publisher · View at Google Scholar · View at Scopus
  18. J. Kremer, Z.-G. Li, S. Hall et al., “Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial,” Annals of Internal Medicine, vol. 159, no. 4, pp. 253–261, 2013. View at Publisher · View at Google Scholar · View at Scopus
  19. Y. Tanaka, M. Suzuki, H. Nakamura, S. Toyoizumi, and S. H. Zwillich, “Phase II study of tofacitinib (CP-690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate,” Arthritis Care and Research, vol. 63, no. 8, pp. 1150–1158, 2011. View at Publisher · View at Google Scholar · View at Scopus
  20. D. Van Der Heijde, Y. Tanaka, R. Fleischmann et al., “Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study,” Arthritis and Rheumatism, vol. 65, no. 3, pp. 559–570, 2013. View at Publisher · View at Google Scholar · View at Scopus
  21. R. F. Van Vollenhoven, R. Fleischmann, S. Cohen et al., “Tofacitinib or adalimumab versus placebo in rheumatoid arthritis,” New England Journal of Medicine, vol. 367, no. 6, pp. 508–519, 2012. View at Publisher · View at Google Scholar · View at Scopus
  22. E. B. Lee, R. Fleischmann, S. Hall, R. F. van Vollenhoven, J. D. Bradley, and D. Gruben, “Radiographic, clinical and functional comparison of tofacitinib monotherapy versus methotrexate in methotrexate-naive patients with rehumatoid arthritis,” Arthritis and Rheumatism, vol. 64, supplement 10, p. S1049, 2012. View at Google Scholar
  23. D. M. Caldwell, A. E. Ades, and J. P. T. Higgins, “Simultaneous comparison of multiple treatments: combining direct and indirect evidence,” British Medical Journal, vol. 331, no. 7521, pp. 897–900, 2005. View at Publisher · View at Google Scholar · View at Scopus
  24. D. C. Hoaglin, N. Hawkins, J. P. Jansen 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 in Health, vol. 14, no. 4, pp. 429–437, 2011. View at Publisher · View at Google Scholar · View at Scopus
  25. J. P. Jansen, R. Fleurence, B. Devine 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 in Health, vol. 14, no. 4, pp. 417–428, 2011. View at Publisher · View at Google Scholar · View at Scopus
  26. G. Lu and A. E. Ades, “Combination of direct and indirect evidence in mixed treatment comparisons,” Statistics in Medicine, vol. 23, no. 20, pp. 3105–3124, 2004. View at Publisher · View at Google Scholar · View at Scopus
  27. D. T. Felson, J. J. Anderson, M. Boers et al., “The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials,” Arthritis and Rheumatism, vol. 36, no. 6, pp. 729–740, 1993. View at Publisher · View at Google Scholar · View at Scopus
  28. J. F. Fries, P. W. Spitz, and D. Y. Young, “The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales,” Journal of Rheumatology, vol. 9, no. 5, pp. 789–793, 1982. View at Google Scholar · View at Scopus
  29. Center for Reviews and Dissemination, CRD's Guidance for Undertaking Reviews in Health Care, Center for Reviews and Dissemination, York, UK, 2009.
  30. S. Dias, A. J. Sutton, A. E. Ades, and N. J. Welton, “Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials,” Medical Decision Making, vol. 33, no. 5, pp. 607–617, 2013. View at Publisher · View at Google Scholar · View at Scopus
  31. S. Dias, N. J. Welton, A. J. Sutton, D. M. Caldwell, G. Lu, and A. E. Ades, “Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials,” Medical Decision Making, vol. 33, no. 5, pp. 641–656, 2013. View at Publisher · View at Google Scholar · View at Scopus
  32. A. J. Sutton and K. R. Abrams, “Bayesian methods in meta-analysis and evidence synthesis,” Statistical Methods in Medical Research, vol. 10, no. 4, pp. 277–303, 2001. View at Publisher · View at Google Scholar · View at Zentralblatt MATH · View at Scopus
  33. J. P. Jansen, B. Crawford, G. Bergman, and W. Stam, “Bayesian meta-analysis of multiple treatment comparisons: an introduction to mixed treatment comparisons,” Value in Health, vol. 11, no. 5, pp. 956–964, 2008. View at Publisher · View at Google Scholar · View at Scopus
  34. D. J. Spiegelhalter, N. G. Best, B. P. Carlin, and A. van der Linde, “Bayesian measures of model complexity and fit,” Journal of the Royal Statistical Society. Series B. Statistical Methodology, vol. 64, no. 4, pp. 583–639, 2002. View at Publisher · View at Google Scholar · View at MathSciNet · View at Scopus
  35. D. Lunn, D. Spiegelhalter, A. Thomas, and N. Best, “The BUGS project: evolution, critique and future directions,” Statistics in Medicine, vol. 28, no. 25, pp. 3049–3067, 2009. View at Publisher · View at Google Scholar · View at MathSciNet · View at Scopus
  36. D. J. Spiegelhalter, A. Thomas, N. G. Best, and D. Lunn, WinBUGS User Manual: Version 1.4, MRC Biostatistics Unit, Cambridge, UK, 2003.
  37. E. Bergrath, G. Wallenstein, R. Gerbert, D. Gruben, and C. Makin, “SAT0165tofacitinib versus biologic treatments in moderate to severe rheumatoid arthritis patients who have had an inadequate response to nonbiologic dmards: systematic literature review and network meta-analysis,” Annals of the Rheumatic Diseases, vol. 75, supplement 2, article no. 726, 2016. View at Publisher · View at Google Scholar
  38. P. L. C. M. Van Riel, A. J. Taggart, J. Sany et al., “Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: The ADORE Study,” Annals of the Rheumatic Diseases, vol. 65, no. 11, pp. 1478–1483, 2006. View at Publisher · View at Google Scholar · View at Scopus
  39. P. L. C. M. Van Riel, B. Freundlich, D. MacPeek, R. Pedersen, J. R. Foehl, and A. Singh, “Patient-reported health outcomes in a trial of etanercept monotherapy versus combination therapy with etanercept and methotrexate for rheumatoid arthritis: The ADORE trial,” Annals of the Rheumatic Diseases, vol. 67, no. 8, pp. 1104–1110, 2008. View at Publisher · View at Google Scholar · View at Scopus
  40. B. Combe, C. Codreanu, U. Fiocco et al., “Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison,” Annals of the Rheumatic Diseases, vol. 65, no. 10, pp. 1357–1362, 2006. View at Publisher · View at Google Scholar · View at Scopus
  41. B. Combe, C. Codreanu, U. Fiocco et al., “Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: A Double-blind Randomised 2-year Study,” Annals of the Rheumatic Diseases, vol. 68, no. 7, pp. 1146–1152, 2009. View at Publisher · View at Google Scholar · View at Scopus
  42. G. J. D. Bergman, M. C. Hochberg, M. Boers, N. Wintfeld, A. Kielhorn, and J. P. Jansen, “Indirect comparison of tocilizumab and other biologic agents in patients with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs,” Seminars in Arthritis and Rheumatism, vol. 39, no. 6, pp. 425–441, 2010. View at Publisher · View at Google Scholar · View at Scopus
  43. E. B. Devine, R. Alfonso-Cristancho, and S. D. Sullivan, “Effectiveness of biologic therapies for rheumatoid arthritis: an indirect comparisons approach,” Pharmacotherapy, vol. 31, no. 1, pp. 39–51, 2011. View at Publisher · View at Google Scholar · View at Scopus
  44. R. Launois, B. Avouac, F. Berenbaum et al., “Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment bayesian metaanalysis,” Journal of Rheumatology, vol. 38, no. 5, pp. 835–845, 2011. View at Publisher · View at Google Scholar · View at Scopus
  45. R. M. Nixon, N. Bansback, and A. Brennan, “Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis,” Statistics in Medicine, vol. 26, no. 6, pp. 1237–1254, 2007. View at Publisher · View at Google Scholar · View at MathSciNet · View at Scopus
  46. C. Salliot, A. Finckh, W. Katchamart et al., “Indirect comparisons of the efficacy of biological antirheumatic agents in rheumatoid arthritis in patients with an inadequate response to conventional disease-modifying antirheumatic drugs or to an anti-tumour necrosis factor agent: a meta-analysis,” Annals of the Rheumatic Diseases, vol. 70, no. 2, pp. 266–271, 2011. View at Publisher · View at Google Scholar · View at Scopus
  47. S. Schmitz, R. Adams, C. D. Walsh, M. Barry, and O. FitzGerald, “A mixed treatment comparison of the efficacy of anti-TNF agents in rheumatoid arthritis for methotrexate non-responders demonstrates differences between treatments: a Bayesian approach,” Annals of the Rheumatic Diseases, vol. 71, no. 2, pp. 225–230, 2012. View at Publisher · View at Google Scholar · View at Scopus
  48. J. A. Singh, R. Christensen, G. A. Wells et al., “A network meta-analysis of randomized controlled trials of biologics for rheumatoid arthritis: a Cochrane overview,” Canadian Medical Association Journal, vol. 181, no. 11, pp. 787–796, 2009. View at Publisher · View at Google Scholar · View at Scopus
  49. E. Turkstra, S.-K. Ng, and P. A. Scuffham, “A mixed treatment comparison of the short-term efficacy of biologic disease modifying anti-rheumatic drugs in established rheumatoid arthritis,” Current Medical Research and Opinion, vol. 27, no. 10, pp. 1885–1897, 2011. View at Publisher · View at Google Scholar · View at Scopus