Critical appraisal of tocilizumab in the treatment of moderate to severe rheumatoid arthritis

Therapeutics and Clinical Risk Management

Volumn 6, Issue 1, 2010, Pages 143-152

  Hushaw, Linda L ^a   Sawaqed, Ray ^a   Sweis, Ghaleb ^a   Reigle, Jori ^a   Gopal, Anjali ^a   Brandt, Daniel ^a   Sweis, Nadia ^a   Curran, James ^a   Niewold, Timothy B ^a   Sweiss, Nadera J ^a  

^a UNIVERSITY OF CHICAGO   (United States)

Author keywords

IL 6; Methotrexate; Rheumatoid arthritis; Tocilizumab

Indexed keywords

CERTOLIZUMAB PEGOL; CORTICOSTEROID; DISEASE MODIFYING ANTIRHEUMATIC DRUG; INTERLEUKIN 6; INTERLEUKIN 6 RECEPTOR; METHOTREXATE; OCRELIZUMAB; PLACEBO; PREDNISONE; RITUXIMAB; TOCILIZUMAB;

ABNORMAL LABORATORY RESULT; AREA UNDER THE CURVE; AUTOIMMUNE DISEASE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; COUGHING; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ECZEMA; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERTENSION; INFECTION; INFESTATION; INJECTION SITE REACTION; LIPID BLOOD LEVEL; LOW DRUG DOSE; MONOTHERAPY; MOUTH ULCER; NAUSEA; NEUTROPENIA; OSTEOCLASTOGENESIS; OUTCOME ASSESSMENT; PARONYCHIA; PEPTIC ULCER; PERIPHERAL EDEMA; PHARYNX DISEASE; PRURITUS; RECOMMENDED DRUG DOSE; REVIEW; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SIGNAL TRANSDUCTION; SOMNOLENCE; SPINAL CORD COMPRESSION; STEADY STATE; STOMATITIS; SYNOVIUM; UPPER RESPIRATORY TRACT INFECTION;

EID: 77950842174     PISSN: 11766336     EISSN: 1178203X     Source Type: Journal    
DOI: None     Document Type: Review

References (45)

1. Helmick CG, Felson DT, Lawrence RC, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;58:15-25.
2. Arthritis F. Rheumatoid arthritis fact sheet. 2009. http://www.arthritis. org/media/newsroom/media-kits/Rheumatoid_Arthritis_Fact_Sheet.pdf
3. Olivieri I, Palazzi C, Peruz G, Padula A. Management issues with elderly-onset rheumatoid arthritis: an update. Drugs Aging. 2005;22:809-822.
4. Jackson CG, Williams HJ. Disease-modifying antirheumatic drugs. Using their clinical pharmacological effects as a guide to their selection. Drugs. 1998;56:337-344.
5. Nurmohamed MT, Dijkmans BA. Efficacy, tolerability and cost effec-tiveness of disease-modifying antirheumatic drugs and biologic agents in rheumatoid arthritis. Drugs. 2005;65:661-694.
6. Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001;344:907-916.
7. Van Snick J. Interleukin-6: an overview. Annu Rev Immunol. 1990;8:253-278.
8. Genovese MC, Kaine JL, Lowenstein MB, et al. Ocrelizumab, a human-ized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008;58:2652-2661.
9. Hirano T, Matsuda T, Turner M, et al. Excessive production of interleukin 6/B cell stimulatory factor-2 in rheumatoid arthritis. Eur J Immunol. 1988;18:1797-1801.
10. Agency EM. RoActemra (Tocilizumab: summary of product charac-teristics): summary of product characteristics. 2009.
11. A proposed revision to the ACR20: the hybrid measure of Ameri-can College of Rheumatology response. Arthritis Rheum. 2007;57: 193-202.
12. McInnes IB, Schett G. Cytokines in the pathogenesis of rheumatoid arthritis. Nat Rev Immunol. 2007;7:429-442.
13. Nielen MM, van Schaardenburg D, Reesink HW, et al. Simultaneous development of acute phase response and autoantibodies in preclinical rheumatoid arthritis. Ann Rheum Dis. 2006;65:535-537.
14. Niewold TB, Harrison MJ, Paget SA. Anti-CCP antibody testing as a diagnostic and prognostic tool in rheumatoid arthritis. QJM. 2007;100:193-201.
15. Lally F, Smith E, Filer A, et al. A novel mechanism of neutrophil recruit-ment in a coculture model of the rheumatoid synovium. Arthritis Rheum. 2005;52:3460-3469.
16. Romano M, Sironi M, Toniatti C, et al. Role of IL-6 and its soluble receptor in induction of chemokines and leukocyte recruitment. Immu-nity. 1997;6:315-325.
17. Kaplanski G, Marin V, Montero-Julian F, Mantovani A, Farnarier C. IL-6: a regulator of the transition from neutrophil to monocyte recruitment during inflammation. Trends Immunol. 2003;24:25-29.
18. Mihara M, Kasutani K, Okazaki M, et al. Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the recep-tors of other members of IL-6 cytokine family. Int Immunopharmacol. 2005;5:1731-1740.
19. Sack U, Kinne RW, Marx T, Heppt P, Bender S, Emmrich, F. Interleu-kin-6 in synovial fluid is closely associated with chronic synovitis in rheumatoid arthritis. Rheumaltology Int. 1993;13:45-51.
20. Streetz KL, Tacke F, Leifeld L, et al. Interleukin 6/gp130-dependent pathways are protective during chronic liver diseases. Hepatology. 2003;38:218-229.
21. Castell JV, Gomez-Lechon MJ, David M, et al. Interleukin-6 is the major regulator of acute phase protein synthesis in adult human hepatocytes. FEBS Lett. 1989;242:237-239.
22. Gauldie J, Sauder DN, McAdam KP, Dinarello CA. Purified interleukin-1 (IL-1) from human monocytes stimulates acute-phase protein synthe-sis by rodent hepatocytes in vitro. Immunology. 1987;60:203-207.
23. Ridker PM, Cook N. Clinical usefulness of very high and very low levels of C-reactive protein across the full range of Framingham Risk Scores. Circulation. 2004;109:1955-1959.
24. Ridker PM, Rifai N, Stampfer MJ, Hennekens CH. Plasma concentra-tion of interleukin-6 and the risk of future myocardial infarction among apparently healthy men. Circulation. 2000;101:1767-1772.
25. Biasucci LM, Liuzzo G, Fantuzzi G, et al. Increasing levels of interleukin (IL)-1Ra and IL-6 during the first 2 days of hospitalization in unstable angina are associated with increased risk of in-hospital coronary events. Circulation. 1999;99:2079-2084.
26. Nishimoto N, Kishimoto T. Humanized antihuman IL-6 receptor anti-body, tocilizumab. Handb Exp Pharmacol. 2008:151-160.
27. Hibi M, Murakami M, Saito M, Hirano T, Taga T, Kishimoto T. Molecu-lar cloning and expression of an IL-6 signal transducer, gp130. Cell. 1990;63:1149-1157.
28. Choy EH, Isenberg DA, Garrood T, et al. Therapeutic benefit of blocking interleukin-6 activity with an anti-interleukin-6 receptor monoclonal antibody in rheumatoid arthritis: a randomized, double-blind, placebo-controlled, dose-escalation trial. Arthritis Rheum. 2002;46:3143-3150.
29. 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;54: 2817-2829.
30. Fleishman R. Tocilizumab inhibits radiographic progression and improves physical function in rheumatoid arthritis patients at 2 years with increasing clinical efficacy over time. Proceedings ACR, Philadelphia, PA Oct 18, 2009.
31. Nishimoto N, Hashimoto J, Miyasaka N, et al. Study of active con-trolled 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;66:1162-1167.
32. 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 serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009;19:12-19.
33. 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;371:987-997.
34. Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008;67:1516-1523.
35. 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;58: 2968-2980.
36. Jones G, Sebba A, Gu J, et al. Comparison of tocilizumab mono-therapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study. Ann Rheum Dis. 2010;69:88-96.
37. Nishimoto N, Yoshizaki K, Miyasaka N, et al. Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum. 2004;50:1761-1769.
38. Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54:1390-1400.
39. Smolen JS, Han C, van der Heijde DM, et al. Radiographic changes in rheumatoid arthritis patients attaining different disease activity states with methotrexate monotherapy and infliximab plus methotrexate: the impacts of remission and tumour necrosis factor blockade. Ann Rheum Dis. 2009;68:823-827.
40. Kanda J, Kawabata H, Yamaji Y, et al. Reversible cardiomyopathy associated with Multicentric Castleman disease: successful treatment with tocilizumab, an anti-interleukin 6 receptor antibody. Int J Hematol. 2007;85:207-211.
41. Hoffmeister A, Rothenbacher D, Kunze M, Brenner H, Koenig W. Prognostic value of inflammatory markers alone and in combination with blood lipids in patients with stable coronary artery disease. Eur J Intern Med. 2005;16:47-52.
42. Larsson PT, Hallerstam S, Rosfors S, Wallen NH. Circulating markers of inflammation are related to carotid artery atherosclerosis. Int Angiol. 2005;24:43-51.
43. Hedman A, Larsson, Thomas P, et al. Do preoperative inflammatory parameters predict early graft occlusion and late cardiovascular events? Cat Ins. 2007.
44. Conway DS, Buggins P, Hughes E, Lip GY. Prognostic significance of raised plasma levels of interleukin-6 and C-reactive protein in atrial fibrillation. Am Heart J. 2004;148:462-466.
45. Bhatt DL, Fox KA, Hacke W, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006;354:1706-1717.