The role of tocilizumab monotherapy in the management of rheumatoid arthritis: A review

International Journal of Clinical Rheumatology

Volumn 7, Issue 1, 2012, Pages 9-19

  Nisar, Muhammad K ^a   Östör, Andrew Jk ^a  

^a ADDENBROOKE S HOSPITAL   (United Kingdom)

Author keywords

biologics; efficacy; monotherapy; rheumatoid arthritis; tocilizumab; tolerability

Indexed keywords

ADALIMUMAB; DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; GOLIMUMAB; INTERLEUKIN 6; METHOTREXATE; PLACEBO; TOCILIZUMAB;

ABNORMAL LABORATORY RESULT; ADD ON THERAPY; APPLICATION SITE REACTION; AREA UNDER THE CURVE; CHOLESTEROL BLOOD LEVEL; COMBINATION CHEMOTHERAPY; DIGESTIVE SYSTEM PERFORATION; DOSE RESPONSE; DRUG APPROVAL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG MECHANISM; DRUG MEGADOSE; DRUG RECEPTOR BINDING; DRUG RESPONSE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; INFECTION; INFECTION COMPLICATION; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NEUTROPENIA; NONHUMAN; PHARMACODYNAMICS; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; QUALITY OF LIFE; RECOMMENDED DRUG DOSE; REVIEW; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SKIN INFECTION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION;

EID: 84856632958     PISSN: 17584272     EISSN: 17584280     Source Type: Journal    
DOI: 10.2217/ijr.11.66     Document Type: Review

References (49)

1. Spector TD. Rheumatoid arthritis. Rheum. Dis. Clin. N. Am. 16, 513-537 (1990). (Pubitemid 20330584)
2. Wolfe F, Rasker JJ, Boers M, Wells GA, Michaud K. Minimal disease activity, remission, and the long-term outcomes of rheumatoid arthritis. Arthritis Rheum. 57, 935-942 (2007). (Pubitemid 47237319)
3. Sokka T, Kautiainen H, Mottonen T et al. Work disability in rheumatoid arthritis 10 years after the diagnosis. J. Rheumatol. 26, 1681-1685 (1999). (Pubitemid 29367305)
4. Lundkvist J, Kastang F, Kobelt G. The burden of rheumatoid arthritis and access to treatment: health burden and costs. Eur. J. Health Econ. 8(Suppl. 2), S49-S60 (2008).
5. Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N. Engl. J. Med. 344, 907-916 (2001). (Pubitemid 32224400)
6. Smolen JS, Aletaha D, Bijlsma JW et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann. Rheum. Dis. 69, 631-637 (2010).
7. Saag KG, Teng GG, Patkar NM et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthrit. Rheum. 59, 762-784 (2008). (Pubitemid 351847559)
8. Pincus T, Yazici Y, Sokka T, Aletaha D, Smolen JS. Methotrexate as the "anchor drug" for the treatment of early rheumatoid arthritis. Clin. Exp. Rheumatol. 21(5 Suppl. 31), S179-S185 (2003). (Pubitemid 37265610)
9. Salliot C, van der Heijde D. Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research. Ann. Rheum. Dis. 68, 1100-1104 (2009).
10. Choy E. Interleukin 6 receptor as a target for the treatment of rheumatoid arthritis. Ann. Rheum. Dis. 62(Suppl. 2), ii68-ii69 (2003).
11. Nishimoto M, Kishimoto T. Interleukin 6: from bench to bedside. Nat. Clin. Pract. Rheumatol. 2, 619-626 (2006). (Pubitemid 44650950)
12. Houssiau F, Devogelaer JP, Van Damme J, Nagant de Deuxchaisnes C, Van Snick J. Interleukin 6 in synovial fluid and serum of patients with rheumatoid arthritis and other inflammatory arthritides. Arthrit. Rheum. 31, 784-788 (1988).
13. Kotake S, Sato K, Kim KJ et al. Interleukin-6 and soluble interleukin-6 receptors in the synovial fluids from rheumatoid arthritis patients are responsible for osteoclast-like cell formation. J. Bone Miner. Res. 11, 88-95 (1996). (Pubitemid 26026748)
14. Nishimoto N, Kishimoto T, Yoshizaki K. Anti-interleukin 6 receptor antibody treatment in rheumatic disease. Ann. Rheum. Dis. 59(Suppl. 1), i21-i27 (2000).
15. Xing Z, Gauldie J, Cox G et al. IL-6 is an antiinflammatory cytokine required for controlling local or systemic acute inflammatory responses. J. Clin. Invest. 101, 311-320 (1998). (Pubitemid 28067327)
16. Mihara M, Kasutani K, Okazaki M et al. Tocilizumab inhibits signal transduction mediated by both mIL6-R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family. Int. Immunopharmacol. 5(12), 1731-1740 (2005). (Pubitemid 41116745)
17. 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 112, 3959-3964 (2008).
18. 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. Arthrit. Rheum. 50(6), 1761-1769 (2004). (Pubitemid 38725087)
19. Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J. 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. 68, 1580-1584 (2009).
20. 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. Arthrit. Rheum. 54, 2817-2829 (2006). (Pubitemid 44497760)
21. 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 371, 987-997 (2008). (Pubitemid 351392039)
22. 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. 67, 1516-1523 (2008).
23. 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. Arthrit. Rheum. 58, 2968-2980 (2008).
24. Kremer J Fleischmann R, Brzezicki J et al. Tocilizumab inhibits structural joint damage, improves physical function, and increases DAS28 remission rates in RA patients who respond inadequately to methotrexate: the LITHE study. Ann. Rheum. Dis. 68(Suppl. 3), 122 (2009).
25. 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. 69, 88-96 (2010).
26. 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. 19, 12-19 (2009).
27. 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. 66, 1162-1167 (2007). (Pubitemid 47309731)
28. Dougados M, Huizinga T, Sheeran T et al. Tocilizumab (TCZ) plus methotrexate (MTX) does not have superior clinical efficacy to TCZ alone in RA patients with inadequate response to MTX: 24-week results of the ACT-RAY study. Ann. Rheum. Dis. 70(Suppl. 3), S73 (2011).
29. Sibilia J, Graninger W, Ostor A et al. Comparison of tocilizumab as monotherapy or with add-on DMARDS in patients with rheumatoid arthritis and an inadequate response to previous treatments: ACT-SURE results. Ann. Rheum. Dis. 70(Suppl. 3), 466 (2009).
30. Gout T, Ostor AJ, Nisar MK. Lower gastrointestinal perforation in rheumatoid arthritis patients treated with conventional DMARDs or tocilizumab: a systematic literature review. Clin. Rheumatol. 30(11), 1471-1474 (2011).
31. Nishimoto N, Ito K, Takagi N. Safety and efficacy profiles of tocilizumab monotherapy in Japanese patients with rheumatoid arthritis: meta-analysis of six initial trials and five long-term extensions. Mod. Rheumatol. 20, 222-232 (2010).
32. Patel AM, Moreland AW. Interleukin-6 inhibition for the treatment of rheumatoid arthritis: a review of tocilzumab therapy. Drug Des. Devel. Ther. 4, 263-278 (2010).
33. Bathon JM, Martin RW, Fleischmann RM et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N. Eng. J. Med. 343, 1586-1593 (2000). (Pubitemid 32162981)
34. Klareskog L, van der Heidje D, de Jager JP et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 363, 675-681 (2004). (Pubitemid 38296553)
35. van der Heijde D, Klareskog L, Rodriguez-Vlaverde V et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthrit. Rheum. 54, 1063-1074 (2006). (Pubitemid 43672919)
36. Emery P, Breedveld FC, Hall S et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet 372, 375-382 (2008).
37. Emery P, Breedveld FC, van der Heijde D et al. Two-year clinical and radiographic results with combination etanercept-methotrexate therapy versus monotherapy in early rheumatoid arthritis: a two-year, double-blind, randomized study. Arthrit. Rheum. 62, 674-682 (2010).
38. van Riel PL, Taggart AJ, Sany J et al. Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study. Ann. Rheum. Dis. 65, 1478-1483 (2006). (Pubitemid 44629126)
39. Breedveld FC, Weisman MH, Kavanaugh AF et al. The PREMIER study: a multicenter, randomised, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthrit. Rheum. 54, 26-37 (2006). (Pubitemid 43122183)
40. Emery P, Fleischmann RM, Moreland LW et al. Golimumab, a human anti-tumour necrosis factor a monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naïve patients with active rheumatoid arthritis: twenty-four-week results of a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthrit. Rheum. 60, 2272-2283 (2009).
41. Keystone EC, Genovese MC, Klareskog L et al. Golimumab, a human antibody to tumour necrosis factor a given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD study. Ann. Rheum. Dis. 68, 789-796 (2009).
42. Rheumatoid arthritis. The management of rheumatoid arthritis in adults. www.nice.org.uk/nicemedia/pdf/CG79NICEGuideline.pdf (Accessed 15 August 2011)
43. BSR and BHPR rheumatoid arthritis guidelines on eligibility criteria for the first biological therapy. www.rheumatology.org.uk/includes/documents/cm- docs/2010/r/2-ra-guidelines-on-eligibility-criteria-for-the-first-biological- therapy.pdf (Accessed 19 January 2012)
44. Genentech Actemra® Prescribing Information. www.gene.com/gene/ products/information/actemra/pdf/pi.pdf (Accessed 15 August 2011)
45. Australian public assessment report for tocilizumab. www.tga.gov.au/pdf/ auspar/auspar-actemra. pdf (Accessed 18 August 2011)
46. Tocilizumab trial registration information. http://clinicaltrials.gov/ ct2/results?term=tocilizumab&pg=2
47. Annex I. Summary of product characteristics. www.ema.europa.eu/docs/en- GB/document-library/EPAR-Product-Information/human/000955/WC500054890.pdf (Accessed 18 August 2011)
48. Highlights of prescribing information. www.accessdata.fda.gov/drugsatfda- docs/label/2011/125276s0022s0023lbl.pdf (Accessed 18 August 2011)
49. NICE. Final appraisal determination. Tocilizumab for the treatment of rheumatoid arthritis. www.nice.org.uk/nicemedia/live/12033/49584/49584.pdf (Accessed 18 August 2011)