Cited by 132

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Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study

Genovese, Mark C, Fleischmann, Roy, Furst, Daniel, Janssen, Namieta, Carter, John, Dasgupta, Bhaskar, Bryson, Judy, Duncan, Benjamin, Zhu, Wei, Pitzalis, Costantino, Durez, Patrick, Kretsos, Kosmas·2014·Annals of the Rheumatic Diseases

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Crossref · 10.1136/annrheumdis-2013-204760

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Figure 1 Patient disposition.
Figure 1 Patient disposition.CC BY-NC · PubMed Central
Figure 2 Analysis of efficacy endpoints. (A) DAS28(CRP) scorea; (B) DAS28(CRP) change from baseline at Week 12; (C) ACR20 response ratea and (D) ACR50 response ratea.
Figure 2 Analysis of efficacy endpoints. (A) DAS28(CRP) scorea; (B) DAS28(CRP) change from baseline at Week 12; (C) ACR20 response ratea and (D) ACR50 response ratea.CC BY-NC · PubMed Central

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Citations

Cites

Research works printed but not linked: 29

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  2. Smolen, 2010, EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs, Ann Rheum Dis, 69, 964, 10.1136/ard.2009.126532 · DOI
  3. Cohen, 2008, Unresolved issues in identifying and overcoming inadequate response in rheumatoid arthritis: weighing the evidence, J Rheumatol Suppl, 81, 4
  4. Marchesoni, 2009, TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice, Ann N Y Acad Sci, 1173, 837, 10.1111/j.1749-6632.2009.04621.x · DOI
  5. Rubbert-Roth, 2009, Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review, Arthritis Res Ther, 11, S1, 10.1186/ar2666 · DOI
  6. McInnes, 2007, Cytokines in the pathogenesis of rheumatoid arthritis, Nat Rev Immunol, 7, 429, 10.1038/nri2094 · DOI
  7. Kokebie, 2011, The role of synovial fluid markers of catabolism and anabolism in osteoarthritis, rheumatoid arthritis and asymptomatic organ donors, Arthritis Res Ther, 13, R50, 10.1186/ar3293 · DOI
  8. Sack, 1993, Interleukin-6 in synovial fluid is closely associated with chronic synovitis in rheumatoid arthritis, Rheumatol Int, 13, 45, 10.1007/BF00307733 · DOI
  9. Srirangan, 2010, The role of interleukin 6 in the pathophysiology of rheumatoid arthritis, Ther Adv Musculoskelet Dis, 2, 247, 10.1177/1759720X10378372 · DOI
  10. Dougados, 2013, Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY), Ann Rheum Dis, 72, 43, 10.1136/annrheumdis-2011-201282 · DOI
  11. Emery, 2008, 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, Ann Rheum Dis, 67, 1516, 10.1136/ard.2008.092932 · DOI · Paper page
  12. Hashimoto, 2011, Mod Rheumatol, 21, 10, 10.3109/s10165-010-0325-3 · DOI
  13. Hushaw, 2010, Critical appraisal of tocilizumab in the treatment of moderate to severe rheumatoid arthritis, Ther Clin Risk Manag, 6, 143
  14. Nakashima, 2010, Clinical evaluation of tocilizumab for patients with active rheumatoid arthritis refractory to anti-TNF biologics: tocilizumab in combination with methotrexate, Mod Rheumatol, 20, 343, 10.3109/s10165-010-0290-x · DOI
  15. Nishimoto, 2007, Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab, Ann Rheum Dis, 66, 1162, 10.1136/ard.2006.068064 · DOI
  16. Nishimoto, 2009, Mod Rheumatol, 19, 12, 10.3109/s10165-008-0125-1 · DOI
  17. Hickling, 2011, Safety and pharmacokinetics of CDP6038, an anti-IL-6 monoclonal antibody, administered by subcutaneous injection and intravenous infusion to healthy male volunteers: a phase 1 study, Ann Rheum Dis, 70, 471
  18. Fleischmann, 2011, A Pilot Study Investigating the Tolerability and Pharmacodynamic Effect of Single Intravenous/Subcutaneous Doses of Olokizumab, an Anti-Interleukin-6 Monoclonal Antibody, in Patients with Rheumatoid Arthritis, Ann Rheum Dis, 70, 471
  19. Arnett, 1988, The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis, Arthritis Rheum, 31, 315, 10.1002/art.1780310302 · DOI
  20. Aletaha, 2010, 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative, Arthritis Rheum, 62, 2569, 10.1002/art.27584 · DOI
  21. Steinbrocker, 1949, Therapeutic criteria in rheumatoid arthritis, JAMA, 140, 659, 10.1001/jama.1949.02900430001001 · DOI
  22. Araujo, 2011, Increased rheumatoid factor interference observed during immunogenicity assessment of an Fc-engineered therapeutic antibody, J Pharm Biomed Analysis, 55, 1041, 10.1016/j.jpba.2011.03.008 · DOI
  23. Tatarewicz, 2010, Rheumatoid factor interference in immunogenicity assays for human monoclonal antibody therapeutics, J Immunol Methods, 357, 10, 10.1016/j.jim.2010.03.012 · DOI
  24. Maini, 2006, 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 Rheum, 54, 2817, 10.1002/art.22033 · DOI · Paper page
  25. Gabay, 2013, Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial, Lancet, 381, 1541, 10.1016/S0140-6736(13)60250-0 · DOI · Paper page
  26. Mease, 2012, A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate, Ann Rheum Dis, 71, 1183, 10.1136/annrheumdis-2011-200704 · DOI
  27. Hsu, 2012, Results from a 2-part, proof-of-concept, dose-ranging, randomized, double-blind, placebo-controlled, phase 2 study of sirukumab, a human anti-il-6 monoclonal antibody, in patients with active rheumatoid arthritis despite methotrexate therapy, Ann Rheum Dis, 71, 61, 10.1136/annrheumdis-2012-eular.1708 · DOI
  28. Finch, 2011, Whole-molecule antibody engineering: generation of a high-affinity anti-IL-6 antibody with extended pharmacokinetics, J Mol Biol, 411, 791, 10.1016/j.jmb.2011.06.031 · DOI
  29. De Bruyn, 2012, Anti-IL-6 Receptor Nanobody (ALX-0061) Seamless “First-in-Human” Phase I/II Proof-of-Concept Study in Patients with Active Rheumatoid Arthritis on Stable Methotrexate Treatment: Single-dose results, Arthritis Rheum, 64, S561

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Metadata

Authors
Genovese, M. C., Fleischmann, R., Furst, D., Janssen, N., Carter, J., Dasgupta, B., Bryson, J., Duncan, B., Zhu, W., Pitzalis, C., Durez, P., & Kretsos, K.
Venue
Annals of the Rheumatic Diseases
Publisher
Elsevier BV
Published
2014-09
Volume
73
Issue
9
Pages
1607-1615
ISSN
0003-4967
Cited by
132
References
1
Language
en

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