Tocilizumab: A review of its use in the treatment of juvenile idiopathic arthritis

Pediatric Drugs

Volumn 15, Issue 6, 2013, Pages 515-531

  Frampton, James E ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; CANAKINUMAB; CORTICOSTEROID; ETANERCEPT; INTERLEUKIN 6; INTERLEUKIN 6 RECEPTOR; METHOTREXATE; OMEPRAZOLE; SIMVASTATIN; TOCILIZUMAB;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL LABORATORY; DAS28; DISEASE DURATION; DRUG CLEARANCE; DRUG EFFICACY; DRUG TOLERABILITY; FEVER; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; INTRACELLULAR SIGNALING; JUVENILE RHEUMATOID ARTHRITIS; LEUKOCYTOSIS; MACROPHAGE ACTIVATION SYNDROME; NEUTROPENIA; PRIORITY JOURNAL; PULMONARY HYPERTENSION; RASH; REVIEW; SIDE EFFECT; SYSTEMATIC REVIEW; THROMBOCYTOSIS; TREATMENT DURATION; VISUAL ANALOG SCALE;

ADOLESCENT; ANTIBODIES, MONOCLONAL, HUMANIZED; ARTHRITIS, JUVENILE; CHILD; CHILD, PRESCHOOL; COMMUNICABLE DISEASES; DRUG INTERACTIONS; HUMANS; RECEPTORS, INTERLEUKIN-6;

EID: 84890501711     PISSN: 11745878     EISSN: 11792019     Source Type: Journal    
DOI: 10.1007/s40272-013-0053-1     Document Type: Review

References (83)

1. Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007;369(9563):767-78.
2. Woo P. Systemic juvenile idiopathic arthritis: diagnosis, management, and outcome. Nat Clin Pract Rheumatol. 2006;2(1):28-34.
3. Packham JC, Hall MA. Long-term follow-up of 246 adults with juvenile idiopathic arthritis: functional outcome. Rheumatology (Oxford). 2002;41:1428-35.
4. Foster HE, Marshall N, Myers A, et al. Outcome in adults with juvenile idiopathic arthritis: a quality of life study. Arthritis Rheum. 2003;48:767-75.
5. 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(2):390-2.
6. Gurion R, Lehman TJA, Moorthy LN. Systemic arthritis in children: a review of clinical presentation and treatment. Int J Inflam. 2012. doi: 10.1155/2012/271569. http://www.hindawi.com/journals/iji/2012/271569/cta/. Accessed 2 Sep 2013.
7. Kimura Y, Weiss JE, Haroldson KL, et al. Pulmonary hypertension and other potentially fatal pulmonary complications in systemic juvenile idiopathic arthritis. Arthritis Care Res. 2013;65(5):745-52.
8. Hoffart C, Sherry DD. More aggressive treatment for juvenile idiopathic arthritis. J Musculoskel Med. 2010;27:106-8.
9. Lee PPW, Lee TL, Wong WHS, et al. The use of methotrexate in juvenile idiopathic arthritis: a single center experience. HK J Pediatr. 2006;11(3):191-8.
10. Ilowite NT. Current treatment of juvenile rheumatoid arthritis. Pediatrics. 2002;109:109-15.
11. Hashkes PJ, Laxer RM. Medical treatment of juvenile idiopathic arthritis. JAMA. 2005;294:1671-84.
12. Murakami M, Tomiita M, Nishimoto N. Tocilizumab in the treatment of systemic juvenile idiopathic arthritis. Open Access Rheumatol Res Rev. 2012;4:71-9.
13. Zhang X, Morcos PN, Saito T, et al. Clinical pharmacology of tocilizumab for the treatment of systemic juvenile idiopathic arthritis. Expert Rev Clin Pharmacol. 2013;6(2):123-37.
14. Siddiqui MAA. The efficacy and tolerability of newer biologics in rheumatoid arthritis. Curr Opin Rheumatol. 2007;19(3):308-13.
15. Md Yusof MY, Emery P. Targeting interleukin-6 in rheumatoid arthritis. Drugs. 2013;73:341-56.
16. De Benedetti F, Martini A. Targeting the interleukin-6 receptor: a new treatment for systemic juvenile idiopathic arthritis? Arthritis Rheum. 2005;52(3):687-93.
17. Lovell DJ, Giannini EH, Reiff A, et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. N Engl J Med. 2000;342:763-9.
18. Lovell DJ, Ruperto N, Goodman S, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008;359(8):810-20.
19. Immunex Corporation. Enbrel® (etanercept) solution for subcutaneous use. US prescribing information. 2013. http://pi.amgen.com/united-states/enbrel/ derm/enbrel-pi.pdf. Accessed 2 Sep 2013.
20. AbbVie Inc. HUMIRA (adalimumab) injection, for subcutaneous use. US prescribing information. 2013. http://www.rxabbvie.com/pdf/humira.pdf. Accessed 4 Sep 2013.
21. Pfizer Limited. Enbrel 25 mg powder and solvent for solution for injection. EU summary of product characteristics. 2010. http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Product-Information/human/000262/ WC500027361.pdf. Accessed 2 Sep 2013.
22. AbbVie Ltd. Humira 40 mg/0.8 ml solution for injection for paediatric use. EU summary of product characteristics. 2013. http://www.ema.europa.eu/docs/ en-GB/document-library/EPAR-Product-Information/human/000481/WC500050870.pdf. Accessed 4 Sep 2013.
23. Ruperto N, Lovell DJ, Cuttica R, et al. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2007;56(9):3096-106.
24. Ruperto N, Lovell DJ, Quartier P, et al. Abatacept in children with juvenile idiopathic arthritis: a randomized, double-blind, placebo-controlled withdrawal trial. N Engl J Med. 2008;372(9636):383-91.
25. Bristol-Myers Squibb Company. ORENCIA (abatacept) for injection for intravenous use; injection, for subcutaneous use. US prescribing information. 2013. http://packageinserts.bms.com/pi/pi-orencia.pdf. Accessed 4 Sep 2013.
26. Bristol-Myers Squibb Pharma EEIG. ORENCIA 250 mg powder for concentrate for solution for infusion. EU summary of product characteristics. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000701/WC500048935.pdf. Accessed 4 Sep 2013.
27. Ruperto N, Brunner HI, Quartier P, et al. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012;367(25):2396-406.
28. Novartis Pharmaceuticals Corporation. ILARIS (canakinumab) injection for subcutaneous use. US prescribing information. 2013. http://www.pharma.us. novartis.com/product/pi/pdf/ilaris.pdf. Accessed 4 Sep 2013.
29. Novartis Europharm Limited. ILARIS 150 mg powder for solution for injection. EU summary of product characteristics. 2009. http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Product-Information/human/001109/ WC500031680.pdf. Accessed 14 Oct 2013.
30. Quartier P, Allantaz F, Cimaz R, et al. A multicentre, randomized, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial). Ann Rheum Dis. 2011;70(5):747-54.
31. Lovell DJ, Giannini EH, Reiff AO, et al. Long-term safety and efficacy of rilonacept in patients with systemic juvenile idiopathic arthritis (sJIA). Arthritis Rheum. 2013;65(9):2486-96.
32. Oldfield V, Dhillon S, Plosker GL. Tocilizumab: a review of its use in the management of rheumatoid arthritis. Drugs. 2009;69(5):609-32.
33. Yokota S, Tanaka T, Kishomoto T. Efficacy, safety and tolerability of tocilizumab in patients with systemic juvenile idiopathic arthritis. Ther Adv Musculoskelet Dis. 2012;4(6):387-97.
34. Genentech Inc. ACTEMRA® (tocilizumab) injection, for intravenous infusion. US prescribing information. 2013. http://www.gene.com/download/pdf/ actemra-prescribing.pdf. Accessed 2 Sep 2013.
35. Roche Pharma AG. RoActemra 20 mg/mL concentrate for solution for infusion. EU summary of product characteristics 2013. http://www.ema.europa.eu/ docs/en-GB/document-library/EPAR-Product-Information/human/000955/WC500054890. pdf. Accessed 2 Sep 2013.
36. Zhang X, Peck R. Clinical pharmacology of tocilizumab for the treatment of patients with rheumatoid arthritis. Expert Rev Clin Pharmacol. 2011;4(5):539-58.
37. Zhang X, Hsu J, Brunner H, et al. Pharmacokinetics (PK) and pharmacodynamics (PD) of tocilizumab (TCZ) in polyarticular-course juvenile idiopathic arthritis (PCJIA) [abstract no. PIII-2]. Clin Pharmacol Ther. 2013;93:S88-9.
38. De Benedetti F, Ruperto N, Brunner H, et al. Tocilizumab improves systemic and laboratory features of systemic juvenile idiopathic arthritis: 12-week data from the phase 3 TENDER trial [abstract no. P138]. Clin Exp Rheumatol. 2011;29(2):415.
39. Brunner H, Ruperto N, Zuber Z, et al. Efficacy and safety of tocilizumab in patients with polyarticular juvenile idiopathic arthritis: data from a phase 3 trial [abstract no. 1597]. Arthritis Rheum. 2012;64:S682.
40. Kishimoto T. IL-6: from its discovery to clinical applications. Int Immunol. 2010;22(5):347-52.
41. Mihara M, Hashizume M, Yoshida H, et al. IL-6/IL-6R receptor system and its role in physiological and pathophysiological conditions. Clin Sci. 2012;122(4):143-59.
42. Rose-John S. IL-6 trans-signalling via the soluble IL-6 receptor: importance for the pro-inflammatory activities of IL-6. Int J Biol Sci. 2012;8:1237-47.
43. Rose-John S, Waetzig GH, Scheller J, et al. The IL-6/sIL-6R complex as a novel target for therapeutic approaches. Expert Opin Ther Targets. 2007;11(5):613-24.
44. Rose-John S, Scheller J, Elson G, et al. Interleukin-6 biology is coordinated by membrane-bound and soluble receptors: role in inflammation and cancer. J Leuk Biol. 2006;80:227-36.
45. Jones SA, Scheller J, Rose-John S. Therapeutic strategies for the clinical blockade of IL-6/gp-130 signalling. J Clin Invest. 2011;121(9):3375-83.
46. Dayer J-M, Choy E. Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor. Rheumatology. 2010;49:15-24.
47. Mihara M, Kasutani K, Okazaki M, et al. Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family. Int Immunopharmacol. 2005;5(12):1731-40.
48. Roy P. Clinical pharmacology review. Actemra. http://www.fda.gov/ downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM259750.pdf. Accessed 2 Sep 2013.
49. Zhang X, Morcos PN, De Benedetti F, et al. Pharmacokinetics and pharmacodynamics of tocilizumab in systemic juvenile idiopathic arthritis [abstract no. 255E]. Pharmacotherapy. 2011;31(10):381e-2e.
50. Zhang X, Morcos PN, De Benedetti F, et al. Pharmacokinetics (PK) and pharmacodynamics (PD) of tocilizumab (TCZ) in systemic juvenile idiopathic arthritis (sJIA) [abstract no. OII-A-2]. Clin Pharmacol Ther. 2011;89(Suppl. 1):S36.
51. Zhang X, Morcos PN, De Benedetti F, et al. Pharmacokinetics (PK) and pharmacodynamics (PD) of tocilizumab (TCZ) in systemic juvenile idiopathic arthritis (sJIA) [abstract no. FRI0200]. Ann Rheum Dis. 2011;70.
52. Decelle K, Horton ER. Tocilizumab for the treatment of juvenile idiopathic arthritis. Ann Pharmacother. 2012;46(6):822-9.
53. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Assessment report: RoActemra. International non-proprietary name: tocilizumab. Procedure no. EMEA/H/C/000955/II/0026. 2013. http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Assessment-Report-Variation/human/000955/ WC500145204.pdf. Accessed 2 Sep 2013.
54. De Benedetti F, Brunner HI, Ruperto N, et al. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012;367(25):2385-95.
55. Ruperto N, De Benedetti F, Brunner H, et al. Tocilizumab is efficacious in patients with systemic juvenile idiopathic arthritis (sJIA) across baseline disease characteristics and prior/baseline treatments: 12-week data from the phase 3 TENDER trial [abstract no. O13]. Clin Exp Rheumatol. 2011;29(2):370-1.
56. De Benedetti F, Brunner H, Ruperto N, et al. Efficacy and safety of tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (sJIA): TENDER 52-week data [abstract]. Pediatr Rheum. 2011;10(Suppl. 1):A58.
57. De Benedetti F, Brunner H, Allen R, et al. The efficacy of tocilizumab in patients with systemic juvenile idiopathic arthritis: 52-week data from a phase 3 clinical trial [abstract no. 68]. Rheumatology. 2012;51(Suppl. 3):iii76.
58. De Benedetti F, Brunner H, Ruperto N, et al. Efficacy and safety of tocilizumab in patients with systemic juvenile idiopathic arthritis: 2-year data from a phase III clinical trial [abstract no. L12]. Arthritis Rheum. 2011;63(12):4047. Slides accompanying this abstract are available online at: https://acr.confex.com/acr/2011/recordingredirect.cgi/id/806.
59. Hoffman-La Roche. A study of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis [ClinicalTrials.gov identifier NCT00642460]. US National Institutes of Health, ClinicalTrials.gov [online]. 2012. http://clinicaltrials.gov/ct2/show/study/NCT00642460. Accessed 2 Sep 2013.
60. Hoffman-La Roche. Roche trials database. Clinical trial result information. Protocol number: WA18221. 2011. http://www.roche-trials.com/ studyResultGet.action?studyResultNumber=WA18221. Accessed 2 Sep 2013.
61. Hoffman-La Roche. A study of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis [ClinicalTrials.gov identifier NCT00988221]. US National Institutes of Health, ClinicalTrials.gov [online]. 2012. http://clinicaltrials.gov/ct2/show/record/NCT00988221. Accessed 2 Sep 2013.
62. Hoffman-La Roche. Roche trials database. Clinical trial result information. Protocol number: WA19977. 2012. http://www.roche-trials.com/ studyResultGet.action?studyResultNumber=WA19977. Accessed 2 Sep 2013.
63. Chugai Pharmaceutical. Study of MRA for systemic juvenile idiopathic arthritis (sJIA) [ClinicalTrials.gov identifier NCT00144599]. US National Institutes of Health, ClinicalTrials.gov [online]. 2008. http://clinicaltrials. gov/ct2/show/NCT00144599. Accessed 2 Sep 2013.
64. Chugai Pharmaceutical. Long-term treatment study of MRA for systemic juvenile idiopathic arthritis (sJIA) [ClinicalTrials.gov identifier NCT00144612]. US National Institutes of Health, ClinicalTrials.gov [online]. 2009. http://clinicaltrials.gov/ct2/show/NCT00144612. Accessed 2 Sep 2013.
65. 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(9617):998-1006.
66. Yokota S, Imagawa T, Mori M, et al. Long-term treatment of systemic juvenile idiopathic arthritis with tocilizumab: results of an open-label extension study in Japan. Ann Rheum Dis. 2013;72(4):627-8.
67. Chugai Pharmaceutical. Study of MRA for polyarticular juvenile idiopathic arthritis (pJIA) [ClinicalTrials.gov identifier NCT00144664]. US National Institutes of Health, ClinicalTrials.gov [online]. 2008. http://clinicaltrials. gov/ct2/show/NCT00144664. Accessed 2 Sep 2013.
68. Chugai Pharmaceutical. Long-term treatment study of MRA for polyarticular juvenile idiopathic arthritis (pJIA) [ClinicalTrials.gov identifier NCT00144625]. US National Institutes of Health, ClinicalTrials.gov [online]. 2009. http://clinicaltrials.gov/ct2/show/NCT00144625. Accessed 2 Sep 2013.
69. Imagawa T, 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):109-15.
70. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Assessment report for RoActemra. International non-proprietary name: tocilizumab. Procedure no. type II variation EMEA/H/C/955/II/15. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Assessment-Report- Variation/human/000955/WC500111086.pdf. Accessed 17 Sep 2013.
71. De Benedetti F, Ruperto N, Brunner HI, et al. Tapering and withdrawal of tocilizumab in patients with systemic JIA in inactive disease: results from an alternative dosing regimen in the TENDER study [abstract no. 2139]. 20th Congress of the European Paediatric Rheumatology Society; Ljubljana; 2013.
72. De Benedetti F, Ruperto N, Espada G, et al. Catch-up growth during tocilizumab therapy for systemic juvenile idiopathic arthritis: 2-year data from a phase 3 clinical trial [abstract no. 760]. Arthritis Rheum. 2012;64:S327.
73. Miyamae T, Nozawa T, Kikuchi M, et al. Tocilizumab-effects on growth impairment in systemic juvenile idiopathic arthritis [abstract]. Pediatr Rheumatol. 2011;9(Suppl. 1):P130.
74. Inaba Y, Ozawa R, Imagawa T, et al. Radiographic improvement of damaged large joints in children with systemic juvenile idiopathic arthritis following tocilizumab treatment. Ann Rheum Dis. 2011;70(9):1693-5.
75. Shinoki T, Hara R, Kaneko U, et al. Safety and response to influenza vaccine in patients with systemic-onset juvenile idiopathic arthritis receiving tocilizumab. Mod Rheumatol. 2012;22(6):871-6.
76. Yokota S, Imagawa T, Takei S, et al. Guidance on using tocilizumab for juvenile idiopathic arthritis. Mod Rheumatol. 2011;21(6):563-71.
77. Isaacs D. Infectious risks associated with biologics. Adv Exp Med Biol. 2013;764:151-8.
78. De Keyer F. Choice of biologic therapy for patients with rheumatoid arthritis: the infection perspective. Curr Rheumatol Rev. 2011;7:77-87.
79. Shimizu M, Nakagishi Y, Kasai K, et al. Tocilizumab masks the clinical symptoms of systemic juvenile idiopathic arthritis-associated macrophage activation syndrome: the diagnostic significance of interleukin-18 and interleukin-6. Cytokine. 2012;58(2):287-94.
80. De Benedetti F. Comment on: Tocilizumab for systemic juvenile idiopathic arthritis. N Engl J Med. 2013;368(13):1256-7.
81. Hoffman-La Roche. A study to compare subcutaneous versus intravenous administration of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis [ClinicalTrials.gov identifier NCT01194414]. US National Institutes of Health, ClinicalTrials.gov [online]. 2013. http://clinicaltrials.gov/ct2/show/results/NCT01194414. Accessed 2 Sep 2013.
82. Zhang X, Chen YC, Fettner S, et al. Pharmacokinetics and pharmacodynamics of tocilizumab after subcutaneous administration in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2013;51(8):620-30.
83. Chugai Pharmaceutical Co. Ltd. Launch of subcutaneous injection formulation, Actemra®, for a treatment of rheumatoid arthritis. The first anti-IL-6 receptor antibody in subcutaneous market [media release]. 24 May 2013. www.roche.com/inv-update-2013-05-24-annex.pdf.