Mavrilimumab : an evidence based review of its potential in the treatment of rheumatoid arthritis

References

• McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011;365(23):2205–2219.
   PubMed Web of Science ®Google Scholar
• Singh JA, Furst DE, Bharat A, 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 Res (Hoboken). 2012;64(5):625–639.
   PubMed Web of Science ®Google Scholar
• O’Dell JR, Mikuls TR, Taylor TH, et al; CSP 551 RACAT Investigators. Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med. 2013;369(4):307–318.
   PubMed Web of Science ®Google Scholar
• Papagoras C, Voulgari PV, Drosos AA. Strategies after the failure of the first anti-tumor necrosis factor alpha agent in rheumatoid arthritis. Autoimmun Rev. 2010;9(8):574–582.
   PubMed Web of Science ®Google Scholar
• Hamilton JA. Colony-stimulating factors in inflammation and autoimmunity. Nat Rev Immunol. 2008;8(7):533–544.
   PubMed Web of Science ®Google Scholar
• Shibata Y, Berclaz PY, Chroneos ZC, Yoshida M, Whitsett JA, Trapnell BC. GM-CSF regulates alveolar macrophage differentiation and innate immunity in the lung through PU.1. Immunity. 2001;15(4):557–567.
   PubMed Web of Science ®Google Scholar
• Stanley E, Lieschke GJ, Grail D, et al. Granulocyte/macrophage colony-stimulating factor-deficient mice show no major perturbation of hematopoiesis but develop a characteristic pulmonary pathology. Proc Natl Acad Sci U S A. 1994;91(12):5592–5596.
   PubMed Web of Science ®Google Scholar
• Bagby GC Jr, Dinarello CA, Wallace P, Wagner C, Hefeneider S, McCall E. Interleukin 1 stimulates granulocyte macrophage colony-stimulating activity release by vascular endothelial cells. J Clin Invest. 1986;78(5):1316–1323.
   PubMed Web of Science ®Google Scholar
• Leizer T, Cebon J, Layton JE, Hamilton JA. Cytokine regulation of colony-stimulating factor production in cultured human synovial fibroblasts: I. Induction of GM-CSF and G-CSF production by interleukin-1 and tumor necrosis factor. Blood. 1990;76(10):1989–1996.
   PubMed Web of Science ®Google Scholar
• Campbell IK, Novak U, Cebon J, Layton JE, Hamilton JA. Human articular cartilage and chondrocytes produce hemopoietic colony-stimulating factors in culture in response to IL-1. J Immunol. 1991; 147(4):1238–1246.
   PubMed Web of Science ®Google Scholar
• Filonzi EL, Zoellner H, Stanton H, Hamilton JA. Cytokine regulation of granulocyte-macrophage colony stimulating factor and macrophage colony-stimulating factor production in human arterial smooth muscle cells. Atherosclerosis. 1993;99(2):241–252.
   PubMed Web of Science ®Google Scholar
• Hamilton JA. Coordinate and noncoordinate colony stimulating factor formation by human monocytes. J Leukoc Biol. 1994;55(3):355–361.
   PubMed Web of Science ®Google Scholar
• Shi Y, Liu CH, Roberts AI, et al. Granulocyte-macrophage colony-stimulating factor (GM-CSF) and T-cell responses: what we do and don’t know. Cell Res. 2006;16(2):126–133.
   PubMed Web of Science ®Google Scholar
• Lang RA, Metcalf D, Cuthbertson RA, et al. Transgenic mice expressing a hemopoietic growth factor gene (GM-CSF) develop accumulations of macrophages, blindness, and a fatal syndrome of tissue damage. Cell. 1987;51(4):675–686.
   PubMed Web of Science ®Google Scholar
• Campbell IK, Rich MJ, Bischof RJ, Dunn AR, Grail D, Hamilton JA. Protection from collagen-induced arthritis in granulocyte-macrophage colony-stimulating factor-deficient mice. J Immunol. 1998;161(7):3639–3644.
   PubMed Web of Science ®Google Scholar
• Cook AD, Braine EL, Campbell IK, Rich MJ, Hamilton JA. Blockade of collagen-induced arthritis post-onset by antibody to granulocyte-macrophage colony-stimulating factor (GM-CSF): requirement for GM-CSF in the effector phase of disease. Arthritis Res. 2001;3(5):293–298.
   PubMedGoogle Scholar
• de Vries EG, Willemse PH, Biesma B, Stern AC, Limburg PC, Vellenga E. Flare-up of rheumatoid arthritis during GM-CSF treatment after chemotherapy. Lancet. 1991;338(8765):517–518.
   PubMed Web of Science ®Google Scholar
• Hazenberg BP, Van Leeuwen MA, Van Rijswijk MH, Stern AC, Vellenga E. Correction of granulocytopenia in Felty’s syndrome by granulocyte-macrophage colony-stimulating factor. Simultaneous induction of interleukin-6 release and flare-up of the arthritis. Blood. 1989;74(8):2769–2770.
   PubMed Web of Science ®Google Scholar
• Mulherin D, Fitzgerald O, Bresnihan B. Synovial tissue macrophage populations and articular damage in rheumatoid arthritis. Arthritis Rheum. 1996;39(1):115–124.
   PubMed Web of Science ®Google Scholar
• Xu WD, Firestein GS, Taetle R, Kaushansky K, Zvaifler NJ. Cytokines in chronic inflammatory arthritis. II. Granulocyte-macrophage colony-stimulating factor in rheumatoid synovial effusions. J Clin Invest. 1989;83(3):876–882.
   PubMed Web of Science ®Google Scholar
• Fiehn C, Wermann M, Pezzutto A, Hüfner M, Heilig B. [Plasma GM-CSF concentrations in rheumatoid arthritis, systemic lupus erythematosus and spondyloarthropathy]. Z Rheumatol. 1992;51(3):121–126. German.
   PubMed Web of Science ®Google Scholar
• Singh JA, Pando JA, Tomaszewski J, Schumacher HR. Quantitative analysis of immunohistologic features of very early rheumatoid synovitis in disease modifying antirheumatic drug- and corticosteroid-naïve patients. J Rheumatol. 2004;31(7):1281–1285.
   PubMed Web of Science ®Google Scholar
• Bresnihan B, Gerlag DM, Rooney T, et al. Synovial macrophages as a biomarker of response to therapeutic intervention in rheumatoid arthritis: standardization and consistency across centers. J Rheumatol. 2007;34(3):620–622.
   PubMed Web of Science ®Google Scholar
• Bresnihan B, Pontifex E, Thurlings RM, et al. Synovial tissue sublining CD68 expression is a biomarker of therapeutic response in rheumatoid arthritis clinical trials: consistency across centers. J Rheumatol. 2009;36(8):1800–1802.
   PubMed Web of Science ®Google Scholar
• Nair JR, Edwards SW, Moots RJ. Mavrilimumab, a human monoclonal GM-CSF receptor-α antibody for the management of rheumatoid arthritis: a novel approach to therapy. Expert Opin Biol Ther. 2012;12(12):1661–1668.
   PubMed Web of Science ®Google Scholar
• Burmester GR, Feist E, Sleeman MA, Wang B, White B, Magrini F. Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-α, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study. Ann Rheum Dis. 2011;70(9):1542–1549.
   PubMed Web of Science ®Google Scholar
• Burmester GR, Weinblatt ME, McInnes IB, et al; EARTH Study Group. Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis. Ann Rheum Dis. 2013;72(9):1445–1452.
   PubMed Web of Science ®Google Scholar
• Felson DT, Anderson JJ, Boers JJ et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727–735.
   PubMed Web of Science ®Google Scholar
• A study of mavrilimumab in subjects with moderate-to-severe rheumatoid arthritis [webpage on the Internet]. Bethesda, MD: ClinicalTrials.gov. Available from: http://clinicaltrials.gov/ct2/show/NCT01706926?term=mavrilimumab&rank=2. Accessed October 19, 2013.
   Google Scholar
• A long term safety study of mavrilimumab in adult subjects with rheumatoid arthritis [webpage on the Internet]. Bethesda, MD: ClinicalTrials.gov. Available from: http://clinicaltrials.gov/ct2/show/NCT01712399?term=mavrilimumab&rank=3. Accessed October 19, 2013.
   Google Scholar
• A study of mavrilimumab versus anti tumour necrosis factor in subjects with rheumatoid arthritis [webpage on the Internet]. Bethesda, MD: ClinicalTrials.gov. Available from: http://clinicaltrials.gov/ct2/show/NCT01715896?term=mavrilimumab&rank=1. Accessed October 19, 2013.
   Google Scholar
• A study of the safety and preliminary efficacy of MOR103, a human antibody to granulocyte macrophage colony-stimulating factor (GM-CSF), in patients with active rheumatoid arthritis [webpage on the Internet]. Bethesda, MD: ClinicalTrials.gov. Available from: http://clinicaltrials.gov/ct2/show/study/NCT01023256?term=DMOR103=rank&1. Accessed September 30, 2013.
   Google Scholar
• Study of KB003 in biologics-inadequate rheumatoid arthritis [webpage on the Internet]. Bethesda, MD: ClinicalTrials.gov. Available from: http://clinicaltrials.gov/ct2/show/NCT00995449?term=kb003&rank=2. Accessed September 30, 2013.
   Google Scholar
• Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48(1):35–45.
   PubMed Web of Science ®Google Scholar
• Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340(4):253–259.
   PubMed Web of Science ®Google Scholar
• Keystone E, Heijde DV, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008;58(11):3319–3329.
   PubMed Web of Science ®Google Scholar
• Kremer JM, Genant HK, Moreland LW, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006;144(12):865–876.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Beaulieu A, Rubbert-Roth A, et al; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008;371(9617):987–997.
   PubMed Web of Science ®Google Scholar
• Walsh NC, Gravallese EM. Bone remodeling in rheumatic disease: a question of balance. Immunol Rev. 2010;233(1):301–312.
   PubMedGoogle Scholar
• Ruderman EM. Overview of safety of non-biologic and biologic DMARDs. Rheumatology (Oxford). 2012;51 Suppl 6:vi37–vi43.
   Google Scholar
• Smolen JS, Aletaha D, Bijlsma JW, et al; T2T Expert Committee. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010;69(4):631–637.
   PubMed Web of Science ®Google Scholar