Subcutaneous tocilizumab for the treatment of rheumatoid arthritis

Expert Review of Clinical Immunology

Volumn 12, Issue 2, 2016, Pages 103-114

  Mitchell, Emma ^a   Jones, Graeme ^b  

^a ROYAL HOBART HOSPITAL   (Australia)

^b UNIVERSITY OF TASMANIA   (Australia)

Author keywords

IL 6; Rheumatoid; Subcutaneous; Tocilizumab; Trial

Indexed keywords

BILIRUBIN; PLACEBO; TOCILIZUMAB; INTERLEUKIN 6 RECEPTOR; MONOCLONAL ANTIBODY;

ARTICLE; BACTERIAL ARTHRITIS; BILIRUBIN BLOOD LEVEL; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; HUMAN; HYPERSENSITIVITY; HYPERTRANSAMINASEMIA; IMMUNOGENICITY; INJECTION SITE REACTION; INTERSTITIAL LUNG DISEASE; MONOTHERAPY; MULTICENTER STUDY (TOPIC); NEUTROPENIA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; IMMUNOLOGY; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL, HUMANIZED; ARTHRITIS, RHEUMATOID; HUMANS; INJECTIONS, SUBCUTANEOUS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTORS, INTERLEUKIN-6; TREATMENT OUTCOME;

EID: 84957599806     PISSN: 1744666X     EISSN: 17448409     Source Type: Journal    
DOI: 10.1586/1744666X.2016.1127159     Document Type: Article

References (57)

1. Rudan I, Sidhu S, Papana A, et al. Prevalence of rheumatoid arthritis in low-and middle-income countries: a systematic review and analysis. J Glob Health. 2015 Jun;5(1):010409.
2. Shetty A, Hanson R, Korsten P, et al. Tocilizumab in the treatment of rheumatoid arthritis and beyond. Drug Des Devel Ther. 2014;8:349-364.
3. Turner JD, Filer A. The role of the synovial fibroblast in rheumatoid arthritis pathogenesis. Curr Opin Rheumatol. 2015 Mar;27(2):175-182.
4. Smolen JS, Landewe 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.
5. Smolen JS, van der Heijde D, Machold KP, et al. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Ann Rheum Dis. 2014 Jan;73(1):3-5.
6. Ogata A, Tanimura K, Sugimoto T, et al. Phase III study of the efficacy and safety of subcutaneous versus intravenous tocilizumab monotherapy in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014 Mar;66 (3):344-354.
7. Dougados M, Kissel K, Sheeran T, et al. AdDing tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013 Jan;72(1):43-50.
8. Jones G, Ding C. Tocilizumab: a review of its safety and efficacy in rheumatoid arthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2010;3:81-89.
9. Kivitz A, Olech E, Borofsky M, et al. Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014 Nov;66 (11):1653-1661.
10. McLaughlin M, Ostor'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 Mar;14 (3):429-437.
11. Lee EB, Fleischmann R, Hall S, et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014 Jun 19;370(25):2377-2386.
12. 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 Mar;6(2):123-137.
13. Zhang X, Peck R. Clinical pharmacology of tocilizumab for the treatment of patients with rheumatoid arthritis. Expert Rev Clin Pharmacol. 2011 Sep;4(5):539-558.
14. Van Rhee F, Casper C, Voorhees PM, et al. A phase 2, open-label, multicenter study of the long-term safety of siltuximab (an anti-interleukin-6 monoclonal antibody) in patients with multicentric Castleman disease. Oncotarget. 2015 Oct 6;6(30):30408-30419.
15. Kim GW, Lee NR, Pi RH, et al. IL-6 inhibitors for treatment of rheumatoid arthritis: past, present, and future. Arch Pharm Res. 2015 Feb 4;38(5):575-584.
16. Pesce B, Soto L, Sabugo F, et al. Effect of interleukin-6 receptor blockade on the balance between regulatory T cells and T helper type 17 cells in rheumatoid arthritis patients. Clin Exp Immunol. 2013 Mar;171(3):237-242.
17. Maneiro RJ, Salgado E, Carmona L, et al. Rheumatoid factor as predictor of response to abatacept, rituximab and tocilizumab in rheumatoid arthritis: systematic review and meta-analysis. Semin Arthritis Rheum. 2013 Aug;43(1):9-17.
18. Pers YM, Fortunet C, Constant E, et al. Predictors of response and remission in a large cohort of rheumatoid arthritis patients treated with tocilizumab in clinical practice. Rheumatology (Oxford). 2014 Jan;53(1):76-84.
19. Smolen JS, Aletaha D. Interleukin-6 receptor inhibition with tocilizumab and attainment of disease remission in rheumatoid arthritis: the role of acute-phase reactants. Arthritis Rheum. 2011 Jan;63(1):43-52.
20. Smolen JS, Schoels MM, Nishimoto N, et al. Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin-6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions. Ann Rheum Dis. 2013 Apr;72(4):482-492.
21. Conaghan PG, Peterfy C, Olech E, et al. The effects of tocilizumab on osteitis, synovitis and erosion progression in rheumatoid arthritis: results from the ACT-RAY MRI substudy. Ann Rheum Dis. 2014 May;73(5):810-816.
22. Kume K, Amano K, Yamada S, et al. The effect of tocilizumab on bone mineral density in patients with methotrexate-resistant active rheumatoid arthritis. Rheumatology (Oxford). 2014 May;53(5):900-903.
23. Garnero P, Thompson E, Woodworth T, et al. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43.
24. Bay-Jensen AC, Platt A, Byrjalsen I, et al. Effect of tocilizumab combined with methotrexate on circulating biomarkers of synovium, cartilage, and bone in the LITHE study. Semin Arthritis Rheum. 2014 Feb;43(4):470-478.
25. Yanagida M, Kawasaki M, Fujishiro M, et al. Serum proteome analysis in patients with rheumatoid arthritis receiving therapy with tocilizumab: an anti-interleukin-6 receptor antibody. Biomed Res Int. 2013;2013:607137.
26. Navarro G, Taroumian S, Barroso N, et al. Tocilizumab in rheumatoid arthritis: a meta-analysis of efficacy and selected clinical conundrums. Semin Arthritis Rheum. 2014 Feb;43(4):458-469.
27. Mori S, Yoshitama T, Hidaka T, et al. Effectiveness and safety of tocilizumab therapy for patients with rheumatoid arthritis and renal insufficiency: a real-life registry study in Japan (the ACTRA-RI study). Ann Rheum Dis. 2015 Mar;74(3):627-630.
28. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995 Jun;38 (6):727-735.
29. Nishimoto N, Yoshizaki K, Maeda K, et al. Toxicity, pharmacokinetics, and dose-finDing study of repetitive treatment with the humanized anti-interleukin 6 receptor antibody MRA in rheumatoid arthritis. Phase I/II clinical study. J Rheumatol. 2003 Jul;30(7):1426-1435.
30. van der Heijde DM, Van 'T Hof MA, Van Riel PL, et al. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Dis. 1990 Nov;49(11):916-920.
31. van der Heijde DM, Van't Hof MA, Van Riel PL, et al. Validity of single variables and composite indices for measuring disease activity in rheumatoid arthritis. Ann Rheum Dis. 1992 Feb;51(2):177-181.
32. Maini RN, Taylor PC, Szechinski J, et al. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum. 2006 Sep;54(9):2817-2829.
33. Nishimoto N, Miyasaka N, Yamamoto K, et al. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study. Ann Rheum Dis. 2009 Oct;68(10):1580-1584.
34. Nishimoto N, Hashimoto J, Miyasaka N, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007 Sep;66(9):1162-1167.
35. Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to antitumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-1523.
36. Kremer JM, Blanco R, Brzosko M, et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011 Mar;63(3):609-621.
37. Fleischmann RM, Halland AM, Brzosko M, et al. Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results. J Rheumatol. 2013 Feb;40(2):113-126.
38. Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan;69(1):88-96.
39. Jones G. The AMBITION trial: tocilizumab monotherapy for rheumatoid arthritis. Expert Rev Clin Immunol. 2010 Mar;6(2):189-195.
40. Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008 Oct;58(10):2968-2980.
41. Nishimoto N, Miyasaka N, Yamamoto K, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serumvascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009;19(1):12-19.
42. Smolen JS, Beaulieu A, Rubbert-Roth A, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008 Mar 22;371(9617):987-997.
43. Pincus T, Summey JA, Soraci SA Jr., et al. Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum. 1983 Nov;26(11):1346-1353.
44. Fries JF, Spitz P, Kraines RG, et al. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137-145.
45. 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.
46. Genetech. Actemra: starting SC injections: giving an Actemra SC injection [Internet]. 2015 [cited 2015 Sep 24]. Available from: https://www. actemra. com/ra/takingactemra/ taking-actemra-sc-injections. html
47. Burmester GR, Rubbert-Roth A, Cantagrel A, et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis. 2014 Jan;73(1):69-74.
48. Zhang X, Georgy A, Rowell L. Pharmacokinetics and pharmacodynamics of tocilizumab, a humanized antiinterleukin-6 receptor monoclonal antibody, following single-dose administration by subcutaneous and intravenous routes to healthy subjects. Int J Clin Pharmacol Ther. 2013 Jun;51(6):443-455.
49. 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 Aug;51(8):620-630.
50. 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.
51. Ohta S, Tsuru T, Terao K, et al. Mechanism-based approach using a biomarker response to evaluate tocilizumab subcutaneous injection in patients with rheumatoid arthritis with an inadequate response to synthetic DMARDs (MATSURI study). J Clin Pharmacol. 2014 Jan;54(1):109-119.
52. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-324.
53. Steinbrocker O, Traeger CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949 Jun 25;140(8):659-662.
54. Aletaha D, Nell VP, Stamm T, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther. 2005;7(4):R796R806.
55. Ogata A, Amano K, Dobashi H, et al. Longterm safety and efficacy of subcutaneous tocilizumab monotherapy: results from the 2-year open-label extension of the MUSASHI study. J Rheumatol. 2015 Apr 1;42(5):799-809.
56. Ogata A, Atsumi T, Fukuda T, et al. Results of switching from intravenous to subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis: extension of the MUSASHI study. Arthritis Care Res (Hoboken). 2015 Apr 1;67(10):1354-1362.
57. Gabay C, Emery P, van Vollenhoven R, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013 May 4;381(9877):1541-1550.