Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting

Modern Rheumatology

Volumn 28, Issue 5, 2018, Pages 780-788

  Atsumi, Tatsuya ^a   Fujio, Keishi ^b   Yamaoka, Kunihiro ^c   Tomobe, Minako ^d   Kuroyanagi, Kazuyuki ^d   Kameda, Hideto ^e  

^a HOKKAIDO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b UNIVERSITY OF TOKYO   (Japan)

^c KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d CHUGAI PHARMACEUTICAL CO LTD   (Japan)

^e TOHO UNIVERSITY OHASHI MEDICAL CENTER   (Japan)

Author keywords

interleukin 6; postmarketing surveillance; Rheumatoid arthritis; subcutaneous; tocilizumab

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; IMMUNOGLOBULIN E; TOCILIZUMAB; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ACUTE RESPIRATORY TRACT DISEASE; ADULT; ARTICLE; BODY WEIGHT; BREAST CANCER; CLINICAL DISEASE ACTIVITY INDEX; CLINICAL TRIAL; COMORBIDITY; DAS28; DIABETES MELLITUS; DISEASE ACTIVITY SCORE; DIVERTICULITIS; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EPILEPSY; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; HUMAN; INFECTION; INFESTATION; LUNG TUMOR; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MULTICENTER STUDY; MYOCLONUS EPILEPSY; NEUROLOGIC DISEASE; OBSERVATIONAL STUDY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; AGED; JAPAN; MIDDLE AGED; SUBCUTANEOUS DRUG ADMINISTRATION;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; JAPAN; MALE; MIDDLE AGED; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 85040999465     PISSN: 14397595     EISSN: 14397609     Source Type: Journal    
DOI: 10.1080/14397595.2017.1416760     Document Type: Article

References (30)

1. Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, 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
2. Singh JA, Saag KG, Bridges SL, Jr, Akl EA, Bannuru RR, Sullivan MC, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016;68(1):1–26
3. Choy E., Understanding the dynamics: pathways involved in the pathogenesis of rheumatoid arthritis. Rheumatology (Oxford). 2012;51(Suppl 5):v3–11
4. Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, 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):1516–23
5. Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, 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):2968–80
6. Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010;69(1):88–96
7. Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, 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;63(3):609–21
8. Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, 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):987–97
9. Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J, 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(1):12–19
10. Nishimoto N, Terao K, Mima T, Nakahara H, Takagi N, Kakehi T., 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. 2008;112(10):3959–64
11. Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, Radominski SC, et al. Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014;66(11):1653–61
12. Ogata A, Tanimura K, Sugimoto T, Inoue H, Urata Y, Matsubara 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;66(3):344–54
13. Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, 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;73(1):69–74
14. Bykerk VP, Ostor AJ, Alvaro-Gracia J, Pavelka K, Ivorra JA, Graninger W, et al. Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice. Ann Rheum Dis. 2012;71(12):1950–4
15. Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Effectiveness and safety of tocilizumab: postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan. J Rheumatol. 2014;41(1):15–23
16. Pappas D, John A, Curtis J, Reed G, Karki C, Magner R, et al. Dosing of intravenous tocilizumab in a real-world setting of rheumatoid arthritis: analyses from the Corrona registry. Rheumatol Ther. 2016;3:103–15
17. Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, et al. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016;75(1):68–74
18. Ogata A, Atsumi T, Fukuda T, Hirabayashi Y, Inaba M, Ishiguro N, et al. Sustainable efficacy of switching from intravenous to subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015;67(10):1354–62
19. Iwamoto N, Fukui S, Umeda M, Nishino A, Nakashima Y, Suzuki T, et al. Evaluation of switching from intravenous to subcutaneous formulation of tocilizumab in patients with rheumatoid arthritis. Mod Rheumatol. 2016;26(5):662–6
20. ACTEMRA (tocilizumab) injection, for intravenous use injection, for subcutaneous use [package insert]. South San Francisco, CA: Genentech, Inc; 2017
21. Aletaha D, Smolen J., The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): A review of their usefulness and validity in rheumatoid arthritis. Clin Exp Rheumatol. 2005;23(5Suppl39):S100–S8
22. van der Heijde DM, van’t Hof MA, van Riel PL, van Leeuwen MA, van Rijswijk MH, van de Putte LB., Validity of single variables and composite indices for measuring disease activity in rheumatoid arthritis. Ann Rheum Dis. 1992;51(2):177–81
23. Aletaha D, Nell VP, Stamm T, Uffmann M, Pflugbeil S, Machold K, 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):R796–806
24. Yamamoto K, Goto H, Hirao K, Nakajima A, Origasa H, Tanaka K, et al. Longterm safety of tocilizumab: results from 3 years of followup postmarketing surveillance of 5573 patients with rheumatoid arthritis in Japan. J Rheumatol. 2015;42(8):1368–75
25. Genovese MC, Rubbert-Roth A, Smolen JS, Kremer J, Khraishi M, Gomez-Reino J, et al. Longterm safety and efficacy of tocilizumab in patients with rheumatoid arthritis: a cumulative analysis of up to 4.6 years of exposure. J Rheumatol. 2013;40(6):768–80
26. Abdallah H, Hsu JC, Lu P, Fettner S, Zhang X, Douglass W, et al. Pharmacokinetic and pharmacodynamic analysis of subcutaneous tocilizumab in patients with rheumatoid arthritis from 2 randomized, controlled trials: SUMMACTA and BREVACTA. J Clin Pharmacol. 2017;57(4):459–68
27. Burmester GR, Rigby WF, van Vollenhoven RF, Kay J, Rubbert-Roth A, Kelman A, et al. Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial. Ann Rheum Dis. 2016;75(6):1081–91
28. Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, Mola EM, 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;72(1):43–50
29. 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;63(1):43–52
30. Moller HJ., Effectiveness studies: advantages and disadvantages. Dialogues Clin Neurosci. 2011;13(2):199–207