Efficacy and safety of tocilizumab in the treatment of active rheumatoid arthritis_West China Medical Journal

Authors：

HUANG Yupeng ,  LIU Gang

Department of Rheumatism and Immunology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding?author：

LIU Gang, Email: neoliugang@163.com

Keywords：

Tocilizumab; Rheumatoid arthritis; Efficacy

DOI：

10.7507/1002-0179.201510071

Video：

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ObjectiveTo evaluate the efficacy and safety of tocilizumab for treating active rheumatoid arthritis (RA).MethodsSeventy-seven patients with active RA who treated from November 2013 to April 2015 in the Outpatient Department of Rheumatology in West China Hospital of Sichuan Universiy with follow-up data were involved. Their clinical data were retrospectively analyzed. Tocilizumab was infused every 4 weeks at a dose of 8 mg/kg and concomitant use of other disease-modifying anti-rheumatic drugs (DMARDs) was allowed. Activity and efficacy were evaluated by Disease Activity Score-28 (DAS28) and European League Against Rheumatism (EULAR) response.ResultAfter the treatment, the DAS28 devreased from the baseline 6.88±1.09 to 4.99±1.53 (4th week), 4.31±1.37 (8th week), 3.74±1.15 (12th week) and 2.66±0.68 (24th week) (P<0.05). The disease activity level assessed by DAS28 was 11.1%, and the low activity was 9.5%, and the values were 10.5%, 32.2% and 66.6%, 16.7% (P<0.05) respectively at the 12th and 24th week. EULAR good/moderate response rates were 17.5%/76.2%, 39.0%/57.4% and 66.7%/33.3% at 8, 12 and 24 weeks. The differences in the decline over time in tender joint count, swollen joint count visual analogue score, Health Assessment Questionnaire score, erythrocyte sedimentation rate and C-reactive protein before and after the treatment were statistically significant (P<0.05). Adverse event was found in 21 cases who were alleviated after the treatment (1 anaphylactic reaction, and the other were mild).ConclusionTocilizumab is safe and effective in treatment of active RA patients.

Citation： HUANG Yupeng, LIU Gang. Efficacy and safety of tocilizumab in the treatment of active rheumatoid arthritis. West China Medical Journal, 2017, 32(7): 988-992. doi: 10.7507/1002-0179.201510071 Copy

1.	Dayer JM, Choy E. Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor. Rheumatology (Oxford), 2010, 49(1): 15-24.
2.	Moots RJ, Ost?r AJ, Isaacs JD. Will treatment of rheumatoid arthritis with an IL-6R inhibitor help facilitate the " age of remission”?. Expert Opin Investig Drugs, 2009, 18(11): 1687-1699.
3.	王立, 張奉春. 白細胞介素-6 受體阻滯劑與自身免疫性疾病. 中華臨床免疫和變態反應雜志, 2010, 4(1): 55-60.
4.	Aletaha D, Neogi T, Silman AJ, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum, 2010, 69(9): 1580-1588.
5.	van Gestel AM, Prevoo ML, Van’t Hof MA, et al. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum, 1996, 39(1): 34-40.
6.	Nishimoto N, Kishimoto T. Interleukin 6: from bench to bedside. Nat Clin Pract Rheumatol, 2006, 2(11): 619-626.
7.	Wolfe F, Michaud K. Anemia and renal function in patients with rheumatoid arthritis. J Rheumatol, 2006, 33(8): 1516-1522.
8.	Jongen-Lavrencic M, Peeters HR, Rozemuller H, et al. IL-6-induced anaemia in rats: possible pathogenetic implications for anemia observed in chronic inflammations. Clin Exp Immunol, 1996, 103(2): 328-334.
9.	Heinrich PC, Behrmann I, Haan S, et al. Principles of interleukin (IL)-6-type cytokine signalling and its regulation. Biochem J, 2003, 374(Pt 1): 1-20.
10.	Colmegna I, Ohata BR, Menard HA. Current understanding of rheumatoid arthritis therapy. Clin Pharmacol Ther, 2012, 91(4): 607-620.
11.	Horton SC, Walsh CA, Emery P. Established rheumatoid arthritis: rationale for best practice: physicians’ perspective of how to realise tight control in clinical practice. Best Pract Res Clin Rheumatol, 2011, 25(4): 509-521.
12.	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(11): 1516-1523.
13.	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, 66(9): 1162-1167.
14.	Smolen JS, Landewé 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, 73(3): 492-509.
15.	趙巖, 黃烽, 張奉春, 等. 托珠單抗治療類風濕關節炎的專家建議. 中華風濕病學雜志, 2013, 17(7): 436-438.
16.	Yamanaka H, Tanaka Y, Inoue E, et al. Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study). Mod Rheumatol, 2011, 21(2): 122-133.
17.	Leffers HC, Ostergaard M, Glintborg B, et al. Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry. Ann Rheum Dis, 2011, 70(7): 1216-1222.
18.	Backhaus M, Kaufmann J, Richter C, et al. Comparison of tocilizumab and tumour necrosis factor inhibitors in rheumatoid arthritis: a retrospective analysis of 1603 patients managed in routine clinical practice. Clin Rheumatol, 2015, 34(4): 673-681.
19.	Rom?o VC, Santos MJ, Polido-Pereira J, et al. Comparative effectiveness of tocilizumab and TNF inhibitors in rheumatoid arthritis patients: data from the rheumatic diseases Portuguese register, reuma. pt. Biomed Res Int, 2015, 2015: 279890.
20.	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(2): 459-460.
21.	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(9): 2817-2829.
22.	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(9617): 987-997.
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. Arthritis Rheum, 2008, 58(10): 2968-2980.
24.	史群, 鮑巖, 趙春德, 等. 托珠單抗聯合改善病情抗風濕藥治療類風濕關節炎的中心、隨機、雙盲、安慰劑對照臨床研究. 中華內科雜志, 2013, 52(4): 323-329.

1. Dayer JM, Choy E. Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor. Rheumatology (Oxford), 2010, 49(1): 15-24.
2. Moots RJ, Ost?r AJ, Isaacs JD. Will treatment of rheumatoid arthritis with an IL-6R inhibitor help facilitate the " age of remission”?. Expert Opin Investig Drugs, 2009, 18(11): 1687-1699.
3. 王立, 張奉春. 白細胞介素-6 受體阻滯劑與自身免疫性疾病. 中華臨床免疫和變態反應雜志, 2010, 4(1): 55-60.
4. Aletaha D, Neogi T, Silman AJ, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum, 2010, 69(9): 1580-1588.
5. van Gestel AM, Prevoo ML, Van’t Hof MA, et al. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum, 1996, 39(1): 34-40.
6. Nishimoto N, Kishimoto T. Interleukin 6: from bench to bedside. Nat Clin Pract Rheumatol, 2006, 2(11): 619-626.
7. Wolfe F, Michaud K. Anemia and renal function in patients with rheumatoid arthritis. J Rheumatol, 2006, 33(8): 1516-1522.
8. Jongen-Lavrencic M, Peeters HR, Rozemuller H, et al. IL-6-induced anaemia in rats: possible pathogenetic implications for anemia observed in chronic inflammations. Clin Exp Immunol, 1996, 103(2): 328-334.
9. Heinrich PC, Behrmann I, Haan S, et al. Principles of interleukin (IL)-6-type cytokine signalling and its regulation. Biochem J, 2003, 374(Pt 1): 1-20.
10. Colmegna I, Ohata BR, Menard HA. Current understanding of rheumatoid arthritis therapy. Clin Pharmacol Ther, 2012, 91(4): 607-620.
11. Horton SC, Walsh CA, Emery P. Established rheumatoid arthritis: rationale for best practice: physicians’ perspective of how to realise tight control in clinical practice. Best Pract Res Clin Rheumatol, 2011, 25(4): 509-521.
12. 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(11): 1516-1523.
13. 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, 66(9): 1162-1167.
14. Smolen JS, Landewé 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, 73(3): 492-509.
15. 趙巖, 黃烽, 張奉春, 等. 托珠單抗治療類風濕關節炎的專家建議. 中華風濕病學雜志, 2013, 17(7): 436-438.
16. Yamanaka H, Tanaka Y, Inoue E, et al. Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study). Mod Rheumatol, 2011, 21(2): 122-133.
17. Leffers HC, Ostergaard M, Glintborg B, et al. Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry. Ann Rheum Dis, 2011, 70(7): 1216-1222.
18. Backhaus M, Kaufmann J, Richter C, et al. Comparison of tocilizumab and tumour necrosis factor inhibitors in rheumatoid arthritis: a retrospective analysis of 1603 patients managed in routine clinical practice. Clin Rheumatol, 2015, 34(4): 673-681.
19. Rom?o VC, Santos MJ, Polido-Pereira J, et al. Comparative effectiveness of tocilizumab and TNF inhibitors in rheumatoid arthritis patients: data from the rheumatic diseases Portuguese register, reuma. pt. Biomed Res Int, 2015, 2015: 279890.
20. 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(2): 459-460.
21. 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(9): 2817-2829.
22. 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(9617): 987-997.
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. Arthritis Rheum, 2008, 58(10): 2968-2980.
24. 史群, 鮑巖, 趙春德, 等. 托珠單抗聯合改善病情抗風濕藥治療類風濕關節炎的中心、隨機、雙盲、安慰劑對照臨床研究. 中華內科雜志, 2013, 52(4): 323-329.

West China Medical Journal

Efficacy and safety of tocilizumab in the treatment of active rheumatoid arthritis

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