Tocilizumab for the treatment of giant cell arteritis

References

• Salvarani C, Cantini F, Hunder GG. Polymyalgia rheumatica and giant-cell arteritis. Lancet. 2008;372:234–245.
   PubMed Web of Science ®Google Scholar
• Soriano A, Muratore F, Pipitone N, et al. Visual loss and other cranial ischaemic complications in giant cell arteritis. Nat Rev Rheumatol. 2017;13:476–484.
   PubMed Web of Science ®Google Scholar
• Nuenninghoff DM, Hunder GG, Christianson TJH, et al. Mortality of large-artery complication (aortic aneurysm, aortic dissection, and/or large-artery stenosis) in patients with giant cell arteritis: a population-based study over 50 years. Arthritis Rheum. 2003;48:3532–3537.
   PubMed Web of Science ®Google Scholar
• Hunder GG, Bloch DA, Michel BA, et al. The American College of Rheumatology 1990 criteria for the classification of giant cell arteritis. Arthritis Rheum. 1990;33:1122–1128.
   PubMed Web of Science ®Google Scholar
• Salvarani C, Soriano A, Muratore F, et al. Is PET/CT essential in the diagnosis and follow-up of temporal arteritis? Autoimmun Rev. 2017;16:1125–1130.
   PubMed Web of Science ®Google Scholar
• Dejaco C, Ramiro S, Duftner C, et al. EULAR recommendations for the use of imaging in large vessel vasculitis in clinical practice. Ann Rheum Dis. 2018;77:636–643.
   Google Scholar
• Weyand CM, Goronzy JJ. Giant-cell arteritis and polymyalgia rheumatica. Ann Intern Med. 2003;139:505–515.
   PubMed Web of Science ®Google Scholar
• Cinar I, Wang H, Stone JR. Clinically isolated aortitis: pitfalls, progress, and possibilities. Cardiovasc Pathol. 2017;29:23–32.
   PubMed Web of Science ®Google Scholar
• Dasgupta B, Panayi GS. Interleukin-6 in serum of patients with polymyalgia rheumatica and giant cell arteritis. Br J Rheumatol. 1990;29:456–458.
   PubMedGoogle Scholar
• Rossi J-F, Lu Z-Y, Jourdan M, et al. Interleukin-6 as a Therapeutic Target. Clin Cancer Res. 2015;21:1248–1257.
   PubMed Web of Science ®Google Scholar
• Paul-Pletzer K. Tocilizumab: blockade of interleukin-6 signaling pathway as a therapeutic strategy for inflammatory disorders. Drugs of Today. 2006;42:559.
   PubMed Web of Science ®Google Scholar
• Tanaka T, Narazaki M, Kishimoto T. Anti-interleukin-6 receptor antibody, tocilizumab, for the treatment of autoimmune diseases. FEBS Lett. 2011;585:3699–3709.
   PubMed Web of Science ®Google Scholar
• Pipitone N, Salvarani C. Improving therapeutic options for patients with giant cell arteritis. Curr Opin Rheumatol. 2008;20:17–22.
   PubMed Web of Science ®Google Scholar
• Mukhtyar C, Guillevin L, Cid MC, et al. EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2009;68:318–323.
   PubMed Web of Science ®Google Scholar
• Muratore F, Pipitone N, Hunder GG, et al. Discontinuation of therapies in polymyalgia rheumatica and giant cell arteritis. Clin Exp Rheumatol. 2013;31:S86–92.
   PubMed Web of Science ®Google Scholar
• Proven A, Gabriel SE, Orces C, et al. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003;49:703–708.
   PubMed Web of Science ®Google Scholar
• Andersson R, Malmvall BE, Bengtsson BA. Long-term corticosteroid treatment in giant cell arteritis. Acta Med Scand. 1986;220:465–469.
   PubMedGoogle Scholar
• Wilson JC, Sarsour K, Collinson N, et al. Serious adverse effects associated with glucocorticoid therapy in patients with giant cell arteritis (GCA): a nested case–control analysis. Semin Arthritis Rheum. 2017;46:819–827.
   PubMed Web of Science ®Google Scholar
• Hunder GG, Sheps SG, Allen GL, et al. Daily and alternate-day corticosteroid regimens in treatment of giant cell arteritis: comparison in a prospective study. Ann Intern Med. 1975;82:613–618.
   PubMed Web of Science ®Google Scholar
• Muratore F, Pipitone N, Salvarani C. Standard and biological treatment in large vessel vasculitis: guidelines and current approaches. Expert Rev Clin Immunol. 2017;13:345–360.
   PubMed Web of Science ®Google Scholar
• Spiera RF, Mitnick HJ, Kupersmith M, et al. A prospective, double-blind, randomized, placebo controlled trial of methotrexate in the treatment of giant cell arteritis (GCA). Clin Exp Rheumatol. 2001;19:495–501.
   PubMed Web of Science ®Google Scholar
• Jover JA, Hernández-García C, Morado IC, et al. Combined treatment of giant-cell arteritis with methotrexate and prednisone a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001;134:106–114.
   PubMed Web of Science ®Google Scholar
• Hoffman GS, Cid MC, Hellmann DB, et al. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum. 2002;46:1309–1318.
   PubMed Web of Science ®Google Scholar
• Mahr AD, Jover JA, Spiera RF, et al. Adjunctive methotrexate for treatment of giant cell arteritis: an individual patient data meta-analysis. Arthritis Rheum. 2007;56:2789–2797.
   PubMed Web of Science ®Google Scholar
• Dasgupta B, Borg FA, Hassan N, et al. BSR and BHPR guidelines for the management of giant cell arteritis. Rheumatology. 2010;49:1594–1597.
   PubMed Web of Science ®Google Scholar
• Bienvenu B, Ly KHH, Lambert M, et al. Management of giant cell arteritis: recommendations of the French study group for Large Vessel Vasculitis (GEFA). Rev Med Interne. 2016;37:154–165.
   PubMed Web of Science ®Google Scholar
• Hoffman GS, Cid MC, Rendt-Zagar KE, et al. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial. Ann Intern Med. 2007;146:621–630.
   PubMed Web of Science ®Google Scholar
• Seror R, Baron G, Hachulla E, et al. Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial. Ann Rheum Dis. 2014;73:2074–2081.
   PubMed Web of Science ®Google Scholar
• Martínez-Taboada VM, Rodríguez-Valverde V, Carreño L, et al. A double-blind placebo controlled trial of etanercept in patients with giant cell arteritis and corticosteroid side effects. Ann Rheum Dis. 2008;67:625–630.
   PubMed Web of Science ®Google Scholar
• Langford CA, Cuthbertson D, Ytterberg SR, et al. A randomized, double-blind trial of abatacept (CTLA-4Ig) for the treatment of giant cell arteritis. Arthritis Rheumatol. 2017;69:837–845.
   PubMed Web of Science ®Google Scholar
• Conway R, O’Neill L, O’Flynn E, et al. Ustekinumab for the treatment of refractory giant cell arteritis. Ann Rheum Dis. 2016;75:1578–1579.
   PubMed Web of Science ®Google Scholar
• Ly K-H-H, Stirnemann JÔ, Liozon E, et al. Interleukin-1 blockade in refractory giant cell arteritis. Jt Bone Spine. 2014;81:76–78.
   PubMed Web of Science ®Google Scholar
• Muratore F, Pazzola G, Soriano A, et al. Unmet needs in the pathogenesis and treatment of vasculitides. Clin Rev Allergy Immunol. 2017. DOI:10.1007/s12016-017-8643–2.
   Web of Science ®Google Scholar
• Andonopoulos AP, Meimaris N, Daoussis D, et al. Experience with infliximab (anti-TNF alpha monoclonal antibody) as monotherapy for giant cell arteritis. Ann Rheum Dis. 2003;62:1116.
   Google Scholar
• Uthman I, Kanj N, Atweh S. Infliximab as monotherapy in giant cell arteritis. Clin Rheumatol. 2006;25:109–110.
   PubMed Web of Science ®Google Scholar
• Scheinecker C, Smolen J, Yasothan U, et al. Tocilizumab. Nat Rev Drug Discov. 2009;8:273–274.
   PubMed Web of Science ®Google Scholar
• Venkiteshwaran A. Tocilizumab. MAbs. 2009;1:432–438.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency - Find medicine - RoActemra. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000955/human_med_001042.jsp&mid=WC0b01ac058001d124. Accessed 2017 Nov 18
   Google Scholar
• U.S. Food & Drug Administration (2017) FDA approves first drug to specifically treat giant cell arteritis In: web page. . https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm559791.htm. Accessed 2017 Oct 30
   Google Scholar
• European Medicines Agency (CHMP) (2016) Tocilizumab (RoActemra) 20 mg/ml concentrate for solution for infusion: summary of product characteristics. https://ec.europa.eu/health/documents/community-register/2016/20160729135481/anx_135481_en.pdf.Accessed 2018 Jan 5
   Google Scholar
• Ogata A, Hirano T, Hishitani Y, et al. Safety and efficacy of tocilizumab for the treatment of rheumatoid arthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2012;5:27–42.
   PubMedGoogle Scholar
• Wagner AD, Goronzy JJ, Weyand CM. Functional profile of tissue-infiltrating and circulating CD68+ cells in giant cell arteritis Evidence for two components of the disease. J Clin Invest. 1994;94:1134–1140.
   PubMed Web of Science ®Google Scholar
• Roche NE, Fulbright JW, Wagner AD, et al. Correlation of interleukin-6 production and disease activity in polymyalgia rheumatica and giant cell arteritis. Arthritis Rheum. 1993;36:1286–1294.
   PubMed Web of Science ®Google Scholar
• Weyand CM, Fulbright JW, Hunder GG, et al. Treatment of giant cell arteritis: interleukin-6 as a biologic marker of disease activity. Arthritis Rheum. 2000;43:1041.
   PubMed Web of Science ®Google Scholar
• Hernández-Rodríguez J, García-Martínez A, Casademont J, et al. A strong initial systemic inflammatory response is associated with higher corticosteroid requirements and longer duration of therapy in patients with giant-cell arteritis. Arthritis Rheum. 2002;47:29–35.
   PubMed Web of Science ®Google Scholar
• Emilie D, Liozon E, Crevon MC, et al. Production of interleukin 6 by granulomas of giant cell arteritis. Hum Immunol. 1994;39:17–24.
   PubMed Web of Science ®Google Scholar
• Brack A, Rittner HL, Younge BR, et al. Glucocorticoid-mediated repression of cytokine gene transcription in human arteritis-SCID chimeras. J Clin Invest. 1997;99:2842–2850.
   PubMed Web of Science ®Google Scholar
• Deng J, Younge BR, Olshen RA, et al. Th17 and Th1 T-cell responses in giant cell arteritis. Circulation. 2010;121:906–915.
   PubMed Web of Science ®Google Scholar
• Samson M, Audia S, Fraszczak J, et al. Th1 and Th17 lymphocytes expressing CD161 are implicated in giant cell arteritis and polymyalgia rheumatica pathogenesis. Arthritis Rheum. 2012;64:3788–3798.
   PubMed Web of Science ®Google Scholar
• Terrier B, Geri G, Chaara W, et al. Interleukin-21 modulates Th1 and Th17 responses in giant cell arteritis. Arthritis Rheum. 2012;64:2001–2011.
   PubMed Web of Science ®Google Scholar
• Espígol-Frigolé G, Corbera-Bellalta M, Planas-Rigol E, et al. Increased IL-17A expression in temporal artery lesions is a predictor of sustained response to glucocorticoid treatment in patients with giant-cell arteritis. Ann Rheum Dis. 2013;72:1481–1487.
   PubMed Web of Science ®Google Scholar
• Guggino G, Giardina AR, Raimondo S, et al. Targeting IL-6 signalling in early rheumatoid arthritis is followed by Th1 and Th17 suppression and Th2 expansion. Clin Exp Rheumatol. 2014;32:77–81.
   PubMed Web of Science ®Google Scholar
• Samson M, Audia S, Janikashvili N, et al. Brief report: inhibition of interleukin-6 function corrects Th17/Treg cell imbalance in patients with rheumatoid arthritis. Arthritis Rheum. 2012;64:2499–2503.
   PubMed Web of Science ®Google Scholar
• Miyabe C, Miyabe Y, Strle K, et al. An expanded population of pathogenic regulatory T cells in giant cell arteritis is abrogated by IL-6 blockade therapy. Ann Rheum Dis. 2017;76:898–905.
   PubMed Web of Science ®Google Scholar
• Salvarani C, Casali B, Farnetti E, et al. Interleukin-6 promoter polymorphism at position −174 in giant cell arteritis. J Rheumatol. 2005;32:2173–2177.
   PubMed Web of Science ®Google Scholar
• González-Gay MA, Amoli MM, Garcia-Porrua C, et al. Genetic markers of disease susceptibility and severity in giant cell arteritis and polymyalgia rheumatica. Semin Arthritis Rheum. 2003;33:38–48.
   PubMed Web of Science ®Google Scholar
• Abdallah H, Hsu JC, Lu P, et al. Pharmacokinetic and pharmacodynamic analysis of subcutaneous tocilizumab in patients with rheumatoid arthritis from 2 randomized, controlled trials: SUMMACTA and BREVACTA. J Clin Pharmacol. 2017;57:459–468.
   PubMed Web of Science ®Google Scholar
• Zhang X, Georgy A, Rowell L. Pharmacokinetics and pharmacodynamics of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, following single-dose administration by subcutaneous and intravenous routes to healthy subjects. Int J Clin Pharmacol Ther. 2013;51:443–455.
   PubMed Web of Science ®Google Scholar
• Scott LJ. Tocilizumab: a review in rheumatoid arthritis. Drugs. 2017;77:1865–1879.
   PubMed Web of Science ®Google Scholar
• Kim S, Östör AJK, Nisar MK. Interleukin-6 and cytochrome-P450, reason for concern? Rheumatol Int. 2012;32:2601–2604.
   PubMed Web of Science ®Google Scholar
• Schmitt C, Kuhn B, Zhang X, et al. Disease–drug–drug interaction involving tocilizumab and Simvastatin in patients with rheumatoid arthritis. Clin Pharmacol Ther. 2011;89:735–740.
   PubMed Web of Science ®Google Scholar
• Unizony S, Stone JH, Stone JR. New treatment strategies in large-vessel vasculitis. Curr Opin Rheumatol. 2013;25:3–9.
   PubMed Web of Science ®Google Scholar
• Osman M, Pagnoux C, Dryden DM, et al. The role of biological agents in the management of Large Vessel Vasculitis (LVV): a systematic review and meta-analysis. PLoS One. 2014;9:e115026.
   PubMed Web of Science ®Google Scholar
• Loricera J, Blanco R, Castañeda S, et al. Tocilizumab in refractory aortitis: study on 16 patients and literature review. Clin Exp Rheumatol. 2014;32:S79–89.
   PubMed Web of Science ®Google Scholar
• Elourimi G, Soussan M, Warzocha U, et al. Efficacy of tocilizumab highlighted by FDG-PET/CT in a patient with relapsing polychondritis-associated aortitis. Rheumatol Int. 2017;37:1931–1935.
   PubMed Web of Science ®Google Scholar
• Bechman K, Gopalan D, Nihoyannopoulos P, et al. A cohort study reveals myocarditis to be a rare and life-threatening presentation of large vessel vasculitis. Semin Arthritis Rheum. 2017;47:241–246.
   PubMed Web of Science ®Google Scholar
• Vionnet J, Buss G, Mayer C, et al. Tocilizumab for giant cell arteritis with corticosteroid-resistant progressive anterior ischemic optic neuropathy. Jt Bone Spine. 2017;84:615–619.
   PubMed Web of Science ®Google Scholar
• Besada E, Nossent JC. Ultrasonographic resolution of the vessel wall oedema with modest clinical improvement in a large-vessel vasculitis patient treated with tocilizumab. Clin Rheumatol. 2012;31:1263–1265.
   PubMed Web of Science ®Google Scholar
• Salvarani C, Magnani L, Catanoso M, et al. Tocilizumab: a novel therapy for patients with large-vessel vasculitis. Rheumatology. 2012;51:151–156.
   PubMed Web of Science ®Google Scholar
• Henes JC, Schulze-Koops H, Witt M, et al. Off-label-Biologikatherapie bei Patienten mit Großgefäßvaskulitiden und/oder Polymyalgia rheumatica. Z Rheumatol. 2017. DOI:10.1007/s00393-017-0325-1.
   Google Scholar
• Villiger PM, Adler S, Kuchen S, et al. Tocilizumab for induction and maintenance of remission in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2016;387:1921–1927.
   PubMed Web of Science ®Google Scholar
• Collinson N, Tuckwell K, Habeck F, et al. Development and implementation of a double-blind corticosteroid-tapering regimen for a clinical trial. Int J Rheumatol. 2015;2015:1–6.
   Google Scholar
• Stone JH, Klearman M, Collinson N, et al. Trial of Tocilizumab in Giant-cell arteritis. N Engl J Med. 2017;377:317–328.
   PubMed Web of Science ®Google Scholar
• McLaughlin M, Östör’s A. Safety of subcutaneous versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Expert Opin Drug Saf. 2015;14:429–437.
   PubMed Web of Science ®Google Scholar
• Campbell L, Chen C, Bhagat SS, et al. Risk of adverse events including serious infections in rheumatoid arthritis patients treated with tocilizumab: a systematic literature review and meta-analysis of randomized controlled trials. Rheumatology. 2011;50:552–562.
   PubMed Web of Science ®Google Scholar
• Xie F, Yun H, Bernatsky S, et al. Brief report: risk of gastrointestinal perforation among rheumatoid arthritis patients receiving tofacitinib, tocilizumab, or other biologic Treatments. Arthritis Rheumatol. 2016;68:2612–2617.
   PubMed Web of Science ®Google Scholar
• Strangfeld A, Richter A, Siegmund B, et al. Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs. Ann Rheum Dis. 2017;76:504–510.
   PubMed Web of Science ®Google Scholar
• Gout T, Ajk Ö, Nisar MK. Lower gastrointestinal perforation in rheumatoid arthritis patients treated with conventional DMARDs or tocilizumab: a systematic literature review. Clin Rheumatol. 2011;30:1471–1474.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Terao K, Mima T, et al. 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. 2008;112:3959–3964.
   PubMed Web of Science ®Google Scholar
• Bari SF, Khan A, Lawson T. C reactive protein may not be reliable as a marker of severe bacterial infection in patients receiving tocilizumab. Case Reports. 2013;2013:bcr2013010423–bcr2013010423.
   PubMedGoogle Scholar
• Berger CT, Recher M, Daikeler T. Interleukin-6 flags infection in tocilizumab-treated giant cell arteritis. Rheumatology. 2017. DOI:10.1093/rheumatology/kex336
   Web of Science ®Google Scholar
• Shovman O, Shoenfeld Y, Langevitz P. Tocilizumab-induced neutropenia in rheumatoid arthritis patients with previous history of neutropenia: case series and review of literature. Immunol Res. 2015;61:164–168.
   PubMed Web of Science ®Google Scholar
• Moots RJ, Sebba A, Rigby W, et al. Effect of tocilizumab on neutrophils in adult patients with rheumatoid arthritis: pooled analysis of data from phase 3 and 4 clinical trials. Rheumatology. 2016;56:541–549.
   Google Scholar
• Vitiello G, Orsi Battaglini C,Radice A et al. Sustained tocilizumab-induced hypofibrinogenemia and thrombocytopenia. Jt Bone Spine. 2017;84:649–650.
   PubMed Web of Science ®Google Scholar
• Burmester GR, Choy E, Kivitz A, et al. Low immunogenicity of tocilizumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76:1078–1085.
   PubMed Web of Science ®Google Scholar
• Alten R, Maleitzke T. Tocilizumab: A novel humanized anti-interleukin 6 (IL-6) receptor antibody for the treatment of patients with non-RA systemic, inflammatory rheumatic diseases. Ann Med. 2013;45:357–363.
   PubMed Web of Science ®Google Scholar
• Adler S, Reichenbach S, Kuchen S, et al. Termination of Tocilizumab-treatment in giant cell arteritis: follow-up of patients after the RCT (ClinicalTrials.gov registration number: NCT01450137)[abstract]. Arthritis Rheumatol. 2016;68:suppl.10.
   Web of Science ®Google Scholar
• Unizony S, Arias-Urdaneta L, Miloslavsky E, et al. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012;64:1720–1729.
   PubMed Web of Science ®Google Scholar
• Reichenbach S, Adler S, Bonel H, et al. Magnetic resonance angiography in giant cell arteritis: results of a randomized controlled trial of tocilizumab in giant cell arteritis. Rheumatology. 2018. DOI:10.1093/rheumatology/key015.
   Google Scholar
• Pazzola G, Padovano I, Boiardi L, et al. Tocilizumab in glucocorticoid-naïve large-vessel vasculitis. Clin Exp Rheumatol. 2013;31:S59–61.
   PubMed Web of Science ®Google Scholar
• Seitz MM, Reichenbach S, Bonel HMH, et al. Rapid induction of remission in large vessel vasculitis by IL-6 blockade. Swiss Med Wkly. 2011;141:w13156.
   PubMed Web of Science ®Google Scholar
• Tuckwell K, Collinson N, Dimonaco S, et al. Newly diagnosed vsrelapsing giant cell arteritis: baseline data from the GiACTA trial. Semin Arthritis Rheum. 2017;46:657–664.
   PubMed Web of Science ®Google Scholar
• Seeliger B, Sznajd J, Robson JC, et al. Are the 1990 American College of Rheumatology vasculitis classification criteria still valid? Rheumatology. 2017;56:1154–1161.
   PubMed Web of Science ®Google Scholar
• Cid MC, Hernández-Rodríguez J, Esteban M-J, et al. Tissue and serum angiogenic activity is associated with low prevalence of ischemic complications in patients with giant-cell arteritis. Circulation. 2002;106:1664–1671.
   PubMed Web of Science ®Google Scholar
• Hernandez-Rodriguez J, Segarra M, Vilardell C, et al. Elevated production of Interleukin-6 is associated with a lower incidence of disease-related ischemic events in patients with giant-cell arteritis: angiogenic activity of Interleukin-6 as a potential protective mechanism. Circulation. 2003;107:2428–2434.
   PubMed Web of Science ®Google Scholar
• Nakashima Y, Kondo M, Miyahara H, et al. Drug delivery options to increase patient adherence and satisfaction in the management of rheumatoid arthritis - focus on subcutaneous tocilizumab. Drug Des Devel Ther. 2014;8:913–919.
   PubMed Web of Science ®Google Scholar