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International Journal of Rheumatology
Volume 2015 (2015), Article ID 975028, 7 pages
http://dx.doi.org/10.1155/2015/975028
Research Article

Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East

1Weill Cornell Medical College in Qatar and Hamad General Hospital, Doha, Qatar
2Department of Medicine, Faculty of Medicine, Kuwait University, Kuwait City, Kuwait
3Rheumatic Disease Unit, Alamiri Hospital, Kuwait City, Kuwait
4Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
5Rheumatology Ward, Loghman Hakim University Hospital, Shahid Beheshti University of Medical Sciences, Tehran 14155 6153, Iran

Received 12 January 2015; Revised 21 April 2015; Accepted 30 April 2015

Academic Editor: Tim Jansen

Copyright © 2015 Mohammed Hammoudeh 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. S. E. Gabriel and K. Michaud, “Epidemiological studies in incidence, prevalence, mortality, and comorbidity of the rheumatic diseases,” Arthritis Research & Therapy, vol. 11, no. 3, p. 229, 2009. View at Publisher · View at Google Scholar · View at Scopus
  2. N. Moghimi, F. Davatchi, E. Rahimi et al., “WHO-ILAR COPCORD study (stage 1, urban study) in Sanandaj, Iran,” Clinical Rheumatology, vol. 34, pp. 535–543, 2015. View at Publisher · View at Google Scholar · View at Scopus
  3. H. M. Al Attia, O. B. Gatee, S. George, and M. M. Masri, “Rheumatoid arthritis in a population sample in the Gulf: clinical observations,” Clinical Rheumatology, vol. 12, no. 4, pp. 506–510, 1993. View at Publisher · View at Google Scholar · View at Scopus
  4. F. Davatchi, M. Akbarian, F. Shahram, A. Nadji, F. Gharibdoost, and A.-R. Jamshidi, “DMARD combination therapy in rheumatoid arthritis: 5-year follow-up results in a daily practice setting,” APLAR Journal of Rheumatology, vol. 9, no. 1, pp. 60–63, 2006. View at Publisher · View at Google Scholar · View at Scopus
  5. H. Badsha, K. O. Kong, and P. P. Tak, “Rheumatoid arthritis in the United Arab Emirates,” Clinical Rheumatology, vol. 27, no. 6, pp. 739–742, 2008. View at Publisher · View at Google Scholar · View at Scopus
  6. H. Badsha, K. O. Kong, and P. P. Tak, “Rheumatoid arthritis in Dubai—delayed diagnosis and low usage of disease modifying antirheumatic drugs,” Annals of the Rheumatic Diseases, vol. 66, no. 6, p. 835, 2007. View at Publisher · View at Google Scholar · View at Scopus
  7. T. Sokka, S. Toloza, M. Cutolo et al., “Women, men, and rheumatoid arthritis: analyses of disease activity, disease characteristics, and treatments in the QUEST-RA Study,” Arthritis Research and Therapy, vol. 11, no. 1, p. R7, 2009. View at Publisher · View at Google Scholar · View at Scopus
  8. A. Lutf, A. R. Poil, and M. Hammoudeh, “Characteristics of patients with rheumatoid arthritis in Qatar: a cross-sectional study,” International Journal of Rheumatic Diseases, vol. 17, no. 1, pp. 63–65, 2014. View at Publisher · View at Google Scholar · View at Scopus
  9. M. A. Sattar, M. Al-Saffar, R. T. Guindi, T. N. Sugathan, and K. Behbehani, “Association between HLA-DR antigens and rheumatoid arthritis in Arabs,” Annals of the Rheumatic Diseases, vol. 49, no. 3, pp. 147–149, 1990. View at Publisher · View at Google Scholar · View at Scopus
  10. H. M. Al Attia, A. Santosh, and M. Zalzala, “Is there predilection for nonnodular rheumatoid arthritis in Arabs with HLA-DR 1?” Journal of Clinical Rheumatology, vol. 11, no. 6, pp. 342–344, 2005. View at Publisher · View at Google Scholar · View at Scopus
  11. S. L. Bridges Jr. and R. P. Kimberly, “Genetic influences on treatment response in rheumatoid arthritis,” in Modern Therapeutics in Rheumatic Diseases, G. C. Tsokos, L. W. Moreland, G. M. Kammer, J. P. Pelletier, and J. J. Martel-Pelletier, Eds., pp. 11–22, Humana Press, New York, NY, USA, 2014. View at Google Scholar
  12. J. M. Dayer and E. Choy, “Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor,” Rheumatology, vol. 49, no. 1, pp. 15–24, 2010. View at Publisher · View at Google Scholar · View at Scopus
  13. M. Hashizume and M. Mihara, “The roles of interleukin-6 in the pathogenesis of rheumatoid arthritis,” Arthritis, vol. 2011, Article ID 765624, 8 pages, 2011. View at Publisher · View at Google Scholar
  14. M. Mihara, K. Kasutani, M. Okazaki et al., “Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family,” International Immunopharmacology, vol. 5, no. 12, pp. 1731–1740, 2005. View at Publisher · View at Google Scholar · View at Scopus
  15. N. Nishimoto, K. Terao, T. Mima, H. Nakahara, N. Takagi, and T. Kakehi, “Mechanisms and pathologic significances in increase in serum interleukin-6 (IL-6) and soluble IL-6 receptor after administration of an anti-IL-6 receptor antibody, tocilizumab, in patients with rheumatoid arthritis and Castleman disease,” Blood, vol. 112, no. 10, pp. 3959–3964, 2008. View at Publisher · View at Google Scholar · View at Scopus
  16. Actemra (Tocilizumab) Injection for Intravenous Infusion [Prescribing Information], Genentech, South San Francisco, Calif, USA, 2013.
  17. RoACTEMRA 20 mg/ml Concentrate for Solution for Infusion, Prescribing Information, Roche Registration Limited, Welwyn Garden City, UK, 2012.
  18. R. N. Maini, P. C. Taylor, J. Szechinski et al., “Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate,” Arthritis and Rheumatism, vol. 54, no. 9, pp. 2817–2829, 2006. View at Publisher · View at Google Scholar · View at Scopus
  19. J. S. Smolen, A. Beaulieu, A. Rubbert-Roth et al., “Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial,” The Lancet, vol. 371, no. 9617, pp. 987–997, 2008. View at Publisher · View at Google Scholar · View at Scopus
  20. P. Emery, E. Keystone, H. P. Tony et al., “IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial,” Annals of the Rheumatic Diseases, vol. 67, no. 11, pp. 1516–1523, 2008. View at Publisher · View at Google Scholar · View at Scopus
  21. M. C. Genovese, J. D. McKay, E. L. Nasonov et al., “Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study,” Arthritis and Rheumatism, vol. 58, no. 10, pp. 2968–2980, 2008. View at Publisher · View at Google Scholar · View at Scopus
  22. G. Jones, A. Sebba, J. Gu et al., “Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study,” Annals of the Rheumatic Diseases, vol. 69, no. 1, pp. 88–96, 2010. View at Publisher · View at Google Scholar · View at Scopus
  23. J. M. Kremer, R. Blanco, M. Brzosko et al., “Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: Results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year,” Arthritis and Rheumatism, vol. 63, no. 3, pp. 609–621, 2011. View at Publisher · View at Google Scholar · View at Scopus
  24. M. L. L. Prevoo, M. A. Van 'T Hof, H. H. Kuper, M. A. Van Leeuwen, L. B. A. Van De Putte, and P. L. C. M. Van Riel, “Modified disease activity scores that include twenty-eight-joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis,” Arthritis and Rheumatism, vol. 38, no. 1, pp. 44–48, 1995. View at Publisher · View at Google Scholar · View at Scopus
  25. J. F. Fries, P. Spitz, R. G. Kraines, and H. R. Holman, “Measurement of patient outcome in arthritis,” Arthritis and Rheumatism, vol. 23, no. 2, pp. 137–145, 1980. View at Publisher · View at Google Scholar · View at Scopus
  26. V. P. Bykerk, A. J. Kstr, J. Alvaro-Gracia et al., “Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice,” Annals of the Rheumatic Diseases, vol. 71, no. 12, pp. 1950–1954, 2012. View at Publisher · View at Google Scholar · View at Scopus
  27. G. R. Burmester, E. Feist, H. Kellner, J. Braun, C. Iking-Konert, and A. Rubbert-Roth, “Effectiveness and safety of the interleukin 6-receptor antagonist tocilizumab after 4 and 24 weeks in patients with active rheumatoid arthritis: the first phase IIIb real-life study (TAMARA),” Annals of the Rheumatic Diseases, vol. 70, no. 5, pp. 755–759, 2011. View at Publisher · View at Google Scholar · View at Scopus