Clinical pharmacology of tocilizumab for the treatment of polyarticular-course juvenile idiopathic arthritis

References

• Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007;369:767–778.
   PubMed Web of Science ®Google Scholar
• Petty RE, Southwood TR, Manners P, et al. International league of associations for rheumatology classification of juvenile idiopathic arthritis: second revision, edmonton, 2001. J. Rheumatol. 2004;31:390–392.
   PubMed Web of Science ®Google Scholar
• Macaubas C, Nguyen K, Milojevic D, et al. Oligoarticular and polyarticular JIA: epidemiology and pathogenesis. Nat. Rev. Rheumatol. 2009;5:616–626.
   PubMed Web of Science ®Google Scholar
• Beukelman T, Patkar NM, Saag KG, et al. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res. 2011;63(4):465–482.
   PubMed Web of Science ®Google Scholar
• Ungar WJ, Costa V, Burnett HF, et al. The use of biologic response modifiers in polyarticular-course juvenile idiopathic arthritis: a systematic review. Semin. Arthritis Rheum. 2013;42(6):597–618.
   PubMed Web of Science ®Google Scholar
• Actemra® (tocilizumab). Tokyo: Chugai Pharmaceutical Co. Ltd; 2008.
   Google Scholar
• Actemra® (tocilizumab injection, for intravenous infusion). South San Francisco, CA: Genentech, Inc; 2011.
   Google Scholar
• RoActemra® (tocilizumab). Summary of product characteristics. Welwyn Garden City, UK: Roche Registration Limited; 2011.
   Google Scholar
• Imagawa N, Yokota S, Mori M, et al. Safety and efficacy of tocilizumab, an anti-IL-6-receptor monoclonal antibody, in patients with polyarticular-course juvenile idiopathic arthritis. Mod. Rheumatol. 2012;22(1):109–115.
   PubMed Web of Science ®Google Scholar
• Brunner HI, Ruperto N, Zuber Z, et al. Paediatric Rheumatology International Trials Organisation (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial. Ann. Rheum. Dis. 2015;74(6):1110–1117.
   PubMed Web of Science ®Google Scholar
• Brunner H, Ruperto N, Zuber Z, et al. Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: 2-year data from CHERISH [abstract]. Arthritis Rheum. 2013;65(10):S682.
   Google Scholar
• National Institute for Health Research. Tocilizumab (RoActemra) for active polyarticular juvenile idiopathic arthritis – second line. July 2012. http://www.hsric.nihr.ac.uk/topics/tocilizumab-roactemra-for-active-polyarticular-juvenile-idiopathic-arthritis-second-line/. Accessed September 14, 2016.
   Google Scholar
• Mangge H, Kenzian H, Gallistl S, et al. Serum cytokines in juvenile rheumatoid arthritis: correlation with conventional inflammation parameters and clinical subtypes. Arthritis Rheum. 1995;38(2):211–220.
   PubMed Web of Science ®Google Scholar
• De Benedetti F. Targeting interleukin-6 in pediatric rheumatic diseases. Curr. Opin. Rheumatol. 2009;21(5):533–537.
   PubMed Web of Science ®Google Scholar
• Yokota S. Effective application of anti-IL-6-monoclonal antibody for children with systemic-onset juvenile idiopathic arthritis. Nihon Rinsho Meneki Gakkai Kaishi. 2004;27(1):22–27.
   PubMedGoogle Scholar
• Madson KL, Moore TL, Lawrence JM, et al. Cytokine levels in serum and synovial fluid of patients with juvenile rheumatoid arthritis. J. Rheumatol. 1994;21(12):2359–2363.
   PubMed Web of Science ®Google Scholar
• Lepore L, Pennesi M, Saletta S, et al. Study of IL-2, IL-6, TNF alpha, IFN gamma and beta in the serum and synovial fluid of patients with juvenile chronic arthritis. Clin. Exp. Rheumatol. 1994;12(5):561–565.
   PubMed Web of Science ®Google Scholar
• Sato K, Tsuchiya M, Saldanha J, et al. Reshaping a human antibody to inhibit the interleukin 6-dependent tumor cell growth. Cancer Res. 1993;53:851–856.
   Google Scholar
• Hushaw LL, Sawaqed R, Sweis G, et al. Critical appraisal of tocilizumab in the treatment of moderate to severe rheumatoid arthritis. Ther. Clin. Risk Manage. 2010;6:143–152.
   PubMed Web of Science ®Google Scholar
• Nishimoto N, Kishimoto T. Humanized antihuman IL-6 receptor antibody, tocilizumab. Handb. Exp. Pharmacol. 2008;181:151–160.
   PubMedGoogle Scholar
• Le Goff B, Blanchard F, Berthelot JM, et al. Role for interleukin-6 in structural joint damage and systemic bone loss in rheumatoid arthritis. Joint Bone Spine. 2010;77:201–205.
   PubMed Web of Science ®Google Scholar
• Rose-John S, Waetzig GH, Scheller J, et al. The IL-6/sIL-6R complex as a novel target for therapeutic approaches. Exp. Opin. Ther. Targets. 2007;11:613–624.
   PubMed Web of Science ®Google Scholar
• Sebba A. Tocilizumab:the first interleukin-6-receptor inhibitor. Am. J. Health Syst. Pharm. 2008;65:1413–1418.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Assessment report for RoActemra. 2009. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000955/WC500054888.pdf. Accessed January 25, 2017.
   Google Scholar
• Zhang X, Peck R. Clinical pharmacology of tocilizumab for the treatment of patients with rheumatoid arthritis. Exp. Rev. Clin. Pharmacol. 2011;4:539–558.
   PubMedGoogle Scholar
• Nakamura I, Omata Y, Naito M, et al. Blockade of interleukin 6 signaling induces marked neutropenia in patients with rheumatoid arthritis. J. Rheumatol. 2009;36:459–460.
   PubMed Web of Science ®Google Scholar
• Biffl WL, Moore EE, Moore FA, et al. Interleukin-6 suppression of neutrophil apoptosis is neutrophil concentration dependent. J. Leukoc. Biol. 1995;58:582–584.
   PubMed Web of Science ®Google Scholar
• McLoughlin RM, Hurst SM, Nowell MA, et al. Differential regulation of neutrophil-activating chemokines by IL-6 and its soluble receptor isoforms. J. Immunol. 2004;172:5676–5683.
   PubMed Web of Science ®Google Scholar
• Zhang X, Morcos P, Saito T, et al. Clinical pharmacology of tocilizumab for the treatment of systemic juvenile idiopathic arthritis. Expert Rev. Clin. Pharmacol. 2013;6(2):123–137.
   PubMed Web of Science ®Google Scholar
• Zhang X, Hsu J, Brunner H et al. Pharmacokinetics (PK) and pharmacodynamics (PD) of tocilizumab (TCZ) in polyarticular-course juvenile idiopathic arthritis (pcJIA). Presented at: Annual Meeting of the American Society of Clinical Pharmacology and Therapeutics; Indianapolis, IN: March 6–9, 2013.
   Google Scholar
• Robak T, Gladalska A, Stepien H, et al. Serum levels of interleukin-6 type cytokines and soluble interleukin-6 receptor in patients with rheumatoid arthritis. Mediat. Inflamm. 1998;7:347–353.
   PubMed Web of Science ®Google Scholar
• Uchiyama Y, Yoshida H, Koike N, et al. Anti-IL-6 receptor antibody increases blood IL-6 level via the blockade of IL-6 clearance, but not via the induction of IL-6 production. Int. Immunopharmacol. 2008;8:1595–1601.
   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
• 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
• Morcos P, Mcintyre C, Bittner B, et al. Pharmacokinetics (PK) and pharmacodynamics (PD) of single subcutaneous doses of tocilizumab (TCZ) administered with and without rHuPH20, a recombinant human hyaluronidase, in healthy volunteers [abstract]. Clin. Pharmacol. Ther. 2011;89:S57.
   Web of Science ®Google Scholar
• Yokota S, Imagawa T, Mori M, 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
• De Benedetti F, Brunner HI, Ruperto N, et al. PRINTO; PRCSG. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis. N. Engl. J. Med. 2012;367(25):2385–2395.
   PubMed Web of Science ®Google Scholar
• Frey N, Grange S, Woodworth T. Population pharmacokinetic analysis of tocilizumab in patients with rheumatoid arthritis. J. Clin. Pharmacol. 2010;50:754–766.
   PubMed Web of Science ®Google Scholar
• Zhang X, Terao K, Harari OA, inventors; Chugai Seiyaku Kabushiki Kaisha, Hoffmann-La Roche, Inc., assignees. Subcutaneously administered anti-IL-6 receptor antibody. US patent application 2014/0056883 A1. February 27, 2014. http://www.google.com/patents/US20140056883. Accessed January 25, 2017.
   Google Scholar