476
Views
23
CrossRef citations to date
0
Altmetric
Drug Evaluation

Mavrilimumab: a unique insight and update on the current status in the treatment of rheumatoid arthritis

, , , & ORCID Icon
Pages 573-581 | Received 24 Jan 2019, Accepted 11 Jun 2019, Published online: 17 Jun 2019

References

  • Myasoedova E, Crowson CS, Kremers HM, et al. Is the incidence of rheumatoid arthritis rising?: results from Olmsted County, Minnesota, 1955–2007. Arthritis Rheum. 2010 Jun;62(6):1576–1582.
  • Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016 Oct;388(10055):2023–2038.
  • Aletaha D, Smolen JS. Diagnosis and management of rheumatoid arthritis: a review. JAMA. 2018 Oct 2;320(13):1360–1372.
  • McInnes IB, Buckley CD, Isaacs JD. Cytokines in rheumatoid arthritis - shaping the immunological landscape. Nat Rev Rheumatol. 2016 Jan;12(1):63–68.
  • McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec;365(23):2205–2219.
  • Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Jun;76(6):960–977.
  • Singh JA, Saag KG, Bridges SL Jr., et al. 2015 American college of rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2016 Jan;68(1):1–25.
  • Favalli EG, Biggioggero M, Meroni PL. Methotrexate for the treatment of rheumatoid arthritis in the biologic era: still an “anchor” drug? Autoimmun Rev. 2014 Nov;13(11):1102–1108.
  • Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492–509.
  • Chighizola CB, Favalli EG, Meroni PL. Novel mechanisms of action of the biologicals in rheumatic diseases. Clin Rev Allergy Immunol. 2014 Aug;47(1):6–16.
  • Favalli EG, Pregnolato F, Biggioggero M, et al. Twelve-year retention rate of first-line tumor necrosis factor inhibitors in rheumatoid arthritis: real-life data from a local registry. Arthritis Care Res (Hoboken). 2016 Apr;68(4):432–439.
  • Iannone F, Sinigaglia L, Favalli EG, et al. Drug survival of adalimumab in patients with rheumatoid arthritis over 10 years in the real-world settings: high rate remission together with normal function ability. Clin Rheumatol. 2016 Nov;35(11):2649–2656.
  • Iannone F, Ferraccioli G, Sinigaglia L, et al. Real-world experience of tocilizumab in rheumatoid arthritis: sub-analysis of data from the Italian biologics’ register GISEA. Clin Rheumatol. 2018 Feb;37(2):315–321.
  • Favalli EG, Biggioggero M, Marchesoni A, et al. Survival on treatment with second-line biologic therapy: a cohort study comparing cycling and swap strategies. Rheumatology (Oxford). 2014 Sep;53(9):1664–1668.
  • Taylor PC, Moore A, Vasilescu R, et al. A structured literature review of the burden of illness and unmet needs in patients with rheumatoid arthritis: a current perspective. Rheumatol Int. 2016 May;36(5):685–695.
  • Favalli EG, Raimondo MG, Becciolini A, et al. The management of first-line biologic therapy failures in rheumatoid arthritis: current practice and future perspectives. Autoimmun Rev. 2017 Dec;16(12):1185–1195.
  • Todoerti M, Favalli EG, Iannone F, et al. Switch or swap strategy in rheumatoid arthritis patients failing TNF inhibitors? Results of a modified Italian Expert Consensus. Rheumatology (Oxford). 2018 10;57(57 Suppl 7):vii42–vii53.
  • Cantini F, Niccoli L, Nannini C, et al. Tailored first-line biologic therapy in patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis. Semin Arthritis Rheum. 2016 Apr;45(5):519–532.
  • Cantini F, Niccoli L, Nannini C, et al. Second-line biologic therapy optimization in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Semin Arthritis Rheum. 2017 10;47(2):183–192.
  • Ingegnoli F, Favalli EG, Meroni PL. Does polymorphysm of genes coding for pro-inflammatory mediators predict the clinical response to tnf alpha blocking agents? A review analysis of the literature. Autoimmun Rev. 2011 Jun;10(8):460–463.
  • Selmi C, Kon E, De Santis M, et al. How advances in personalized medicine will change rheumatology. Per Med. 2018 03;15(2):75–78.
  • Metcalf D. The colony-stimulating factors and cancer. Cancer Immunol Res. 2013 Dec;1(6):351–356.
  • Hamilton JA. Colony-stimulating factors in inflammation and autoimmunity. Nat Rev Immunol. 2008 Jul;8(7):533–544.
  • Leizer T, Cebon J, Layton JE, et al. 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 Nov 15;76(10):1989–1996.
  • Campbell IK, Novak U, Cebon J, et al. Human articular cartilage and chondrocytes produce hemopoietic colony-stimulating factors in culture in response to IL-1. J Immunol. 1991 Aug 15;147(4):1238–1246.
  • Hamilton JA, Cook AD, Tak PP. Anti-colony-stimulating factor therapies for inflammatory and autoimmune diseases. Nat Rev Drug Discov. 2016 12;16(1):53–70.
  • Hansen G, Hercus TR, McClure BJ, et al. The structure of the GM-CSF receptor complex reveals a distinct mode of cytokine receptor activation. Cell. 2008 Aug 8;134(3):496–507.
  • van de Laar L, Coffer PJ, Woltman AM. Regulation of dendritic cell development by GM-CSF: molecular control and implications for immune homeostasis and therapy. Blood. 2012 Apr 12;119(15):3383–3393.
  • Mantovani A, Sozzani S, Locati M, et al. Macrophage polarization: tumor-associated macrophages as a paradigm for polarized M2 mononuclear phagocytes. Trends Immunol. 2002 Nov;23(11):549–555.
  • Wijbrandts CA, Vergunst CE, Haringman JJ, et al. Absence of changes in the number of synovial sublining macrophages after ineffective treatment for rheumatoid arthritis: implications for use of synovial sublining macrophages as a biomarker. Arthritis Rheum. 2007 Nov;56(11):3869–3871.
  • Farahat MN, Yanni G, Poston R, et al. Cytokine expression in synovial membranes of patients with rheumatoid arthritis and osteoarthritis. Ann Rheum Dis. 1993 Dec;52(12):870–875.
  • Bell AL, Magill MK, McKane WR, et al. Measurement of colony-stimulating factors in synovial fluid: potential clinical value. Rheumatol Int. 1995;14(5):177–182.
  • Berenbaum F, Rajzbaum G, Amor B, et al. Evidence for GM-CSF receptor expression in synovial tissue. An analysis by semi-quantitative polymerase chain reaction on rheumatoid arthritis and osteoarthritis synovial biopsies. Eur Cytokine Netw. 1994 Jan-Feb;5(1):43–46.
  • Wright HL, Bucknall RC, Moots RJ, et al. Analysis of SF and plasma cytokines provides insights into the mechanisms of inflammatory arthritis and may predict response to therapy. Rheumatology (Oxford). 2012 Mar;51(3):451–459.
  • Xu WD, Firestein GS, Taetle R, et al. Cytokines in chronic inflammatory arthritis. II. Granulocyte-macrophage colony-stimulating factor in rheumatoid synovial effusions. J Clin Invest. 1989 Mar;83(3):876–882.
  • Alvaro-Gracia JM, Zvaifler NJ, Brown CB, et al. Cytokines in chronic inflammatory arthritis. VI. Analysis of the synovial cells involved in granulocyte-macrophage colony-stimulating factor production and gene expression in rheumatoid arthritis and its regulation by IL-1 and tumor necrosis factor-alpha. J Immunol. 1991 May;146(10):3365–3371.
  • Campbell IK, Bendele A, Smith DA, et al. Granulocyte-macrophage colony stimulating factor exacerbates collagen induced arthritis in mice. Ann Rheum Dis. 1997 Jun;56(6):364–368.
  • de Vries EG, Willemse PH, Biesma B, et al. Flare-up of rheumatoid arthritis during GM-CSF treatment after chemotherapy. Lancet. 1991 Aug 24;338(8765):517–518.
  • Hazenberg BP, Van Leeuwen MA, Van Rijswijk MH, et al. 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 Dec;74(8):2769–2770.
  • Codarri L, Gyulveszi G, Tosevski V, et al. RORgammat drives production of the cytokine GM-CSF in helper T cells, which is essential for the effector phase of autoimmune neuroinflammation. Nat Immunol. 2011 Jun;12(6):560–567.
  • El-Behi M, Ciric B, Dai H, et al. The encephalitogenicity of T(H)17 cells is dependent on IL-1- and IL-23-induced production of the cytokine GM-CSF. Nat Immunol. 2011 Jun;12(6):568–575.
  • Campbell IK, Rich MJ, Bischof RJ, et al. The colony-stimulating factors and collagen-induced arthritis: exacerbation of disease by M-CSF and G-CSF and requirement for endogenous M-CSF. J Leukoc Biol. 2000 Jul;68(1):144–150.
  • Campbell IK, Rich MJ, Bischof RJ, et al. Protection from collagen-induced arthritis in granulocyte-macrophage colony-stimulating factor-deficient mice. J Immunol. 1998 Oct;161(7):3639–3644.
  • Greven DE, Cohen ES, Gerlag DM, et al. Preclinical characterisation of the GM-CSF receptor as a therapeutic target in rheumatoid arthritis. Ann Rheum Dis. 2015 Oct;74(10):1924–1930.
  • Cook AD, Louis C, Robinson MJ, et al. Granulocyte macrophage colony-stimulating factor receptor alpha expression and its targeting in antigen-induced arthritis and inflammation. Arthritis Res Ther. 2016 Dec 1;18(1):287.
  • van Nieuwenhuijze AE, van de Loo FA, Walgreen B, et al. Complementary action of granulocyte macrophage colony-stimulating factor and interleukin-17A induces interleukin-23, receptor activator of nuclear factor-kappaB ligand, and matrix metalloproteinases and drives bone and cartilage pathology in experimental arthritis: rationale for combination therapy in rheumatoid arthritis. Arthritis Res Ther. 2015 Jun 17;17:163.
  • Nakano K, Okada Y, Saito K, et al. Rheumatoid synovial endothelial cells produce macrophage colony-stimulating factor leading to osteoclastogenesis in rheumatoid arthritis. Rheumatology (Oxford). 2007 Apr;46(4):597–603.
  • Crotti C, Raimondo MG, Becciolini A, et al. Spotlight on mavrilimumab for the treatment of rheumatoid arthritis: evidence to date. Drug Des Devel Ther. 2017;11:211–223.
  • Nair JR, Edwards SW, Moots RJ. Mavrilimumab, a human monoclonal GM-CSF receptor-alpha antibody for the management of rheumatoid arthritis: a novel approach to therapy. Expert Opin Biol Ther. 2012 Dec;12(12):1661–1668.
  • Burmester GR, Feist E, Sleeman MA, et al. Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-alpha, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study. Ann Rheum Dis. 2011 Sep;70(9):1542–1549.
  • Burmester GR, Weinblatt ME, McInnes IB, et al. Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis. Ann Rheum Dis. 2013 Sep 1;72(9):1445–1452.
  • Takeuchi T, Tanaka Y, Close D, et al. Efficacy and safety of mavrilimumab in Japanese subjects with rheumatoid arthritis: findings from a Phase IIa study. Mod Rheumatol. 2015 Jan;25(1):21–30.
  • Jin DC, Wu C-Y, Roskos LK, et al. Exposure–efficacy analysis of mavrilimumab in rheumatoid arthritis: modeling and simulation of phase II clinical data [abstract]. Ann Rheum Dis. 2015;74(Suppl2):S1043–S1043.
  • Burmester GR, McInnes IB, Kremer J, et al. A randomised phase IIb study of mavrilimumab, a novel GM-CSF receptor alpha monoclonal antibody, in the treatment of rheumatoid arthritis. Ann Rheum Dis. 2017 Jun;76(6):1020–1030.
  • Weinblatt ME, McInnes IB, Kremer JM, et al. A randomized phase IIb study of mavrilimumab and golimumab in rheumatoid arthritis. Arthritis Rheumatol. 2018 Jan;70(1):49–59.
  • Burmester GR, McInnes IB, Kremer JM, et al. Mavrilimumab, a fully human granulocyte-macrophage colony-stimulating factor receptor alpha monoclonal antibody: long-term safety and efficacy in patients with rheumatoid arthritis. Arthritis Rheumatol. 2018 May;70(5):679–689.
  • Ryan PC, Sleeman MA, Rebelatto M, et al. Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: relevance for human safety. Toxicol Appl Pharmacol. 2014 Sep;279(2):230–239.
  • Trapnell BC, Carey BC, Uchida K, et al. Pulmonary alveolar proteinosis, a primary immunodeficiency of impaired GM-CSF stimulation of macrophages. Curr Opin Immunol. 2009 Oct;21(5):514–521.
  • Kay J, Fleischmann R, Keystone E, et al. Golimumab 3-year safety update: an analysis of pooled data from the long-term extensions of randomised, double-blind, placebo-controlled trials conducted in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis. Ann Rheum Dis. 2015 Mar;74(3):538–546.
  • Guo X, Higgs BW, Bay-Jensen AC, et al. Blockade of GM-CSF pathway induced sustained suppression of myeloid and T cell activities in rheumatoid arthritis. Rheumatology (Oxford). 2018 01;57(1):175–184.
  • Guo X, Wang S, Godwood A, et al. Pharmacodynamic biomarkers and differential effects of TNF- and GM-CSF-targeting biologics in rheumatoid arthritis. Int J Rheum Dis. 2018; Oct 22(4):646-653.
  • MJH DH, Jacobs JWG, Schoneveld JLM, et al. Difficult-to-treat rheumatoid arthritis: an area of unmet clinical need. Rheumatology (Oxford). 2017 Oct.
  • Nam JL, Takase-Minegishi K, Ramiro S, et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2017 Jun;76(6):1113–1136.
  • Kiely PD. Biologic efficacy optimization–a step towards personalized medicine. Rheumatology (Oxford). 2016 May;55(5):780–788.
  • Mortensen JH, Guo X, De Los Reyes M, et al. The VICM biomarker is released from activated macrophages and inhibited by anti-GM-CSFRα-mAb treatment in rheumatoid arthritis patients. Clin Exp Rheumatol. 2018

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.