Corticosteroid-free treatment of tocilizumab monotherapy for microscopic polyangiitis: a single-arm, single-center, clinical trial

References

• Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, et al. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013;65:1–11.
   PubMed Web of Science ®Google Scholar
• Kallenberg CGM. Key advances in the clinical approach to ANCA-associated vasculitis. Nat Rev Rheumatol. 2014;10:484–93.
   PubMed Web of Science ®Google Scholar
• Holle JU, Gross WL. Treatment of ANCA-associated vasculitides (AAV). Autoimmun Rev. 2013;12:483–6.
   PubMed Web of Science ®Google Scholar
• Schönermarck U, Gross WL, de Groot K. Treatment of ANCA-associated vasculitis. Nat Rev Nephrol. 2014;10:25–36.
   PubMed Web of Science ®Google Scholar
• Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, et al. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992;116:488–98.
   PubMed Web of Science ®Google Scholar
• Little MA, Nightingale P, Verburgh CA, Hauser T, De Groot K, Savage C, et al. Early mortality in systemic vasculitis: relative contribution of adverse events and active vasculitis. Ann Rheum Dis. 2010;69:1036–43.
   PubMed Web of Science ®Google Scholar
• Tesar V, Hruskova Z. Limitations of standard immunosuppressive treatment in ANCA-associated vasculitis and lupus nephritis. Nephron Clin Pract. 2014;128:205–15.
   PubMedGoogle Scholar
• Luqmani RA. State of the art in the treatment of systemic vasculitides. Front Immunol. 2014;5:471.
   PubMed Web of Science ®Google Scholar
• Jones RB, Tervaert JWC, Hauser T, Luqmani R, Morgan MD, Peh CA, et al. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010;363:211–20.
   PubMed Web of Science ®Google Scholar
• Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363:221–32.
   PubMed Web of Science ®Google Scholar
• Buch MH, Smolen JS, Betteridge N, Breedveld FC, Burmester G, Dörner T, et al. Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70:909–20.
   PubMed Web of Science ®Google Scholar
• Rafailidis PI, Kakisi OK, Vardakas K, Falagas ME. Infectious complications of monoclonal antibodies used in cancer therapy: a systematic review of the evidence from randomized controlled trials. Cancer. 2007;109:2182–9.
   PubMed Web of Science ®Google Scholar
• Walsh M, Merkel PA, Mahr A, Jayne D. Effects of duration of glucocorticoid therapy on relapse rate in antineutrophil cytoplasmic antibody-associated vasculitis: a meta-analysis. Arthritis Care Res (Hoboken). 2010;62:1166–73.
   PubMed Web of Science ®Google Scholar
• Wada T, Hara A, Arimura Y, Sada K-E, Makino H. Research Group of Intractable Vasculitis, Ministry of Health, Labor, and Welfare of Japan. Risk factors associated with relapse in Japanese patients with microscopic polyangiitis. J Rheumatol. 2012;39:545–51.
   PubMed Web of Science ®Google Scholar
• Sakai R, Shibata A, Chino K, Kondo T, Okuyama A, Takei H, et al. Corticosteroid- and cyclophosphamide-free treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis using tocilizumab. Mod Rheumatol. 2015;25:810–1.
   PubMed Web of Science ®Google Scholar
• Berti A, Cavalli G, Campochiaro C, Guglielmi B, Baldissera E, Cappio S, et al. Interleukin-6 in ANCA-associated vasculitis: Rationale for successful treatment with tocilizumab. Semin Arthritis Rheum. 2015;45:48–54.
   PubMed Web of Science ®Google Scholar
• Sumida K, Ubara Y, Suwabe T, Hayami N, Hiramatsu R, Hasegawa E, et al. Complete remission of myeloperoxidase-anti-neutrophil cytoplasmic antibody-associated crescentic glomerulonephritis complicated with rheumatoid arthritis using a humanized anti-interleukin 6 receptor antibody. Rheumatology (Oxford). 2011;50:1928–30.
   PubMed Web of Science ®Google Scholar
• Takenaka K, Ohba T, Suhara K, Sato Y, Nagasaka K. Successful treatment of refractory aortitis in antineutrophil cytoplasmic antibody-associated vasculitis using tocilizumab. Clin Rheumatol. 2014;33:287–9.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Kishimoto T. Humanized antihuman IL-6 receptor antibody, tocilizumab. Handb Exp Pharmacol. 2008;181:151–60.
   PubMedGoogle Scholar
• Kang S, Tanaka T, Kishimoto T. Therapeutic uses of anti-interleukin-6 receptor antibody. Int Immunol. 2015;27:21–9.
   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;45:357–63.
   PubMed Web of Science ®Google Scholar
• Sakai R, Cho S-K, Nanki T, Watanabe K, Yamazaki H, Tanaka M, et al. Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice: results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry. Arthritis Res Ther. 2015;17:74.
   PubMed Web of Science ®Google Scholar
• Watts R, Lane S, Hanslik T, Hauser T, Hellmich B, Koldingsnes W, et al. Development and validation of a consensus methodology for the classification of the ANCA-associated vasculitides and polyarteritis nodosa for epidemiological studies. Ann Rheum Dis. 2007;66:222–7.
   PubMed Web of Science ®Google Scholar
• Koike R, Harigai M, Atsumi T, Amano K, Kawai S, Saito K, et al. Japan College of Rheumatology 2009 guidelines for the use of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, in rheumatoid arthritis. Mod Rheumatol. 2009;19:351–7.
   PubMed Web of Science ®Google Scholar
• Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, et al. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008;371:998–1006.
   PubMed Web of Science ®Google Scholar
• Mukhtyar C, Lee R, Brown D, Carruthers D, Dasgupta B, Dubey S, et al. Modification and validation of the Birmingham Vasculitis Activity Score (version 3). Ann Rheum Dis. 2009;68:1827–32.
   PubMed Web of Science ®Google Scholar
• Luqmani R. Maintenance of clinical remission in ANCA-associated vasculitis. Nat Rev Rheumatol. 2012;9:127–32.
   PubMed Web of Science ®Google Scholar
• Exley AR, Bacon PA, Luqmani RA, Kitas GD, Gordon C, Savage CO, et al. Development and initial validation of the Vasculitis Damage Index for the standardized clinical assessment of damage in the systemic vasculitides. Arthritis Rheum. 1997;40:371–80.
   PubMed Web of Science ®Google Scholar
• Hellmich B, Flossmann O, Gross WL, Bacon P, Cohen-Tervaert JW, Guillevin L, et al. EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis. Ann Rheum Dis. 2007;66:605–17.
   PubMed Web of Science ®Google Scholar
• Berden AE, Ferrario F, Hagen EC, Jayne DR, Jennette JC, Joh K, et al. Histopathologic classification of ANCA-associated glomerulonephritis. J Am Soc Nephrol. 2010;21:1628–36.
   PubMed Web of Science ®Google Scholar
• Sada K, Yamamura M, Harigai M, Fujii T, Dobashi H, Takasaki Y, et al. Classification and characteristics of Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis in a nationwide, prospective, inception cohort study. Arthritis Res Ther. 2014;16(2):R101.
   PubMed Web of Science ®Google Scholar
• Condon MB, Ashby D, Pepper RJ, Cook HT, Levy JB, Griffith M, et al. Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids. Ann Rheum Dis. 2013;72:1280–6.
   PubMed Web of Science ®Google Scholar
• Sakai R, Nagasawa H, Nishi E, Okuyama A, Takei H, Kurasawa T, et al. Successful treatment of adult-onset Still’s disease with tocilizumab monotherapy: two case reports and literature review. Clin Rheumatol. 2012;31:569–74.
   PubMed Web of Science ®Google Scholar
• Arimura Y, Minoshima S, Kamiya Y, Tanaka U, Nakabayashi K, Kitamoto K, et al. Serum myeloperoxidase and serum cytokines in anti-myeloperoxidase antibody-associated glomerulonephritis. Clin Nephrol. 1993;40:256–64.
   PubMed Web of Science ®Google Scholar
• Ohlsson S, Wieslander J, Segelmark M. Circulating cytokine profile in anti-neutrophilic cytoplasmatic autoantibody-associated vasculitis: prediction of outcome? Mediators Inflamm. 2004;13:275–83.
   PubMed Web of Science ®Google Scholar
• Booth AD, Wallace S, McEniery CM, Yasmin, Brown J, Jayne DRW, et al. Inflammation and arterial stiffness in systemic vasculitis: a model of vascular inflammation. Arthritis Rheum. 2004;50:581–8.
   PubMed Web of Science ®Google Scholar
• Nagao T, Kusunoki R, Iwamura C, Kobayashi S, Yumura W, Kameoka Y, et al. Correlation of interleukin-6 and monocyte chemotactic protein-1 concentrations with crescent formation and myeloperoxidase-specific anti-neutrophil cytoplasmic antibody titer in SCG/Kj mice by treatment with anti-interleukin-6 receptor antibody or mizoribine. Microbiol Immunol. 2013;57:640–50.
   PubMed Web of Science ®Google Scholar
• Nishina N, Kikuchi J, Hashizume M, Yoshimoto K, Kameda H, Takeuchi T. Baseline levels of soluble interleukin-6 receptor predict clinical remission in patients with rheumatoid arthritis treated with tocilizumab: implications for molecular targeted therapy. Ann Rheum Dis. 2013;73:945–7.
   PubMed Web of Science ®Google Scholar
• Enevold C, Baslund B, Linde L, Josephsen NL, Tarp U, Lindegaard H, et al. Interleukin-6-receptor polymorphisms rs12083537, rs2228145, and rs4329505 as predictors of response to tocilizumab in rheumatoid arthritis. Pharmacogenet Genom. 2014;24:401–5.
   PubMed Web of Science ®Google Scholar
• Sanayama Y, Ikeda K, Saito Y, Kagami SI, Yamagata M, Furuta S, et al. Prediction of therapeutic responses to tocilizumab in patients with rheumatoid arthritis: Biomarkers identified by analysis of gene expression in peripheral blood mononuclear cells using genome-wide DNA microarray. Arthritis Rheumatol. 2014;66:1421–31.
   PubMed Web of Science ®Google Scholar
• Kikuchi J, Hashizume M, Kaneko Y, Yoshimoto K, Nishina N, Takeuchi T. Peripheral blood CD4(+)CD25(+)CD127(low) regulatory T cells are significantly increased by tocilizumab treatment in patients with rheumatoid arthritis: increase in regulatory T cells correlates with clinical response. Arthritis Res Ther. 2015;17:10.
   PubMed Web of Science ®Google Scholar
• Genovese MC, Cohen S, Moreland L, Lium D, Robbins S, Newmark R, et al. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate. Arthritis Rheum. 2004;50:1412–9.
   PubMed Web of Science ®Google Scholar
• Weinblatt M, Schiff M, Goldman A, Kremer J, Luggen M, Li T, et al. Selective costimulation modulation using abatacept in patients with active rheumatoid arthritis while receiving etanercept: a randomised clinical trial. Ann Rheum Dis. 2007;66:228–34.
   PubMed Web of Science ®Google Scholar
• Endo A, Hoshino J, Suwabe T, Sumida K, Mise K, Hiramatsu R, et al. Significance of small renal artery lesions in patients with antineutrophil cytoplasmic antibody-associated glomerulonephritis. J Rheumatol. 2014;41:1140–6.
   PubMed Web of Science ®Google Scholar