Longterm safety of tocilizumab: Results from 3 years of followup postmarketing surveillance of 5573 patients with rheumatoid arthritis in Japan

Journal of Rheumatology

Volumn 42, Issue 8, 2015, Pages 1368-1375

  Yamamoto, Kazuhiko ^a   Goto, Hajime ^b   Hirao, Kenzo ^c   Nakajima, Atsuo ^d   Origasa, Hideki ^e   Tanaka, Kunihiko ^f   Tomobe, Minako ^f   Totsuka, Kyoichi ^g  

^a UNIVERSITY OF TOKYO   (Japan)

^b Japan Anti Tuberculosis Association   (Japan)

^c TOKYO MEDICAL AND DENTAL UNIVERSITY   (Japan)

^d TOKYO METROPOLITAN POLICE HOSPITAL   (Japan)

^e TOYAMA MEDICAL AND PHARMACEUTICAL UNIVERSITY   (Japan)

^f CHUGAI PHARMACEUTICAL CO LTD   (Japan)

^g Kitatama Hospital   (Japan)

Author keywords

Interleukin 6; Postmarketing product surveillance; Rheumatoid arthritis; Tocilizumab

Indexed keywords

TOCILIZUMAB; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY;

ADOLESCENT; ADULT; AGE; AGED; ALL CAUSE MORTALITY RATE; ANGINA PECTORIS; ARTICLE; ATYPICAL MYCOBACTERIOSIS; BACTERIAL PNEUMONIA; CAUSE OF DEATH; CELLULITIS; COMORBIDITY; DISEASE DURATION; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HEART DISEASE; HEART FAILURE; HEART INFARCTION; HERPES ZOSTER; HUMAN; INFECTION; INTESTINE PERFORATION; ISCHEMIC HEART DISEASE; JAPAN; LONG TERM CARE; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MORTALITY; OBSERVATIONAL STUDY; PNEUMOCYSTIS PNEUMONIA; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RESPIRATORY TRACT DISEASE; RHEUMATOID ARTHRITIS; SEPSIS; STANDARDIZED INCIDENCE RATIO; STANDARDIZED MORTALITY RATIO; TUBERCULOSIS; ARTHRITIS, RHEUMATOID; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TIME FACTOR; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; FEMALE; HUMANS; JAPAN; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TIME FACTORS; YOUNG ADULT;

EID: 84940639463     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.141210     Document Type: Article

References (21)

1. 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;67:1516-23.
2. 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;58:2968-80.
3. 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;69:88-96.
4. 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;63:609-21.
5. 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;371:987-97.
6. Nishimoto N, Hashimoto J, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, 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;66:1162-7.
7. 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;19:12-9.
8. Schiff MH, Kremer JM, Jahreis A, Vernon E, Isaacs JD, van Vollenhoven RF. Integrated safety in tocilizumab clinical trials. Arthritis Res Ther 2011;13:R141.
9. 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;41:15-23.
10. Nakajima A, Inoue E, Tanaka E, Singh G, Sato E, Hoshi D, et al. Mortality and cause of death in Japanese patients with rheumatoid arthritis based on a large observational cohort, IORRA. Scand J Rheumatol 2010;39:360-7.
11. 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;40:768-80.
12. Smitten AL, Simon TA, Hochberg MC, Suissa S. A meta-analysis of the incidence of malignancy in adult patients with rheumatoid arthritis. Arthritis Res Ther 2008;10:R45.
13. Yamada T, Nakajima A, Inoue E, Tanaka E, Taniguchi A, Momohara S, et al. Incidence of malignancy in Japanese patients with rheumatoid arthritis. Rheumatol Int 2011;31:1487-92.
14. Harigai M, Nanki T, Koike R, Tanaka M, Watanabe K, Komano Y, et al. Biological agents in rheumatoid arthritis and risk of malignancy - results from the nation-wide cohort study in Japan [abstract]. Arthritis Rheum 2011;63 Suppl:S41.
15. 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 2011;30:1471-4.
16. Barnabe C, Martin BJ, Ghali WA. Systematic review and meta-analysis: anti-tumor necrosis factor alpha therapy and cardiovascular events in rheumatoid arthritis. Arthritis Care Res 2011;63:522-9.
17. Westlake SL, Colebatch AN, Baird J, Kiely P, Quinn M, Choy E, et al. The effect of methotrexate on cardiovascular disease in patients with rheumatoid arthritis: a systematic literature review. Rheumatology 2010;49:295-307.
18. Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis 2008;67:189-94.
19. Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. Mod Rheumatol 2011;21:343-51.
20. Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of 7740 patients. Mod Rheumatol 2014;24:390-8.
21. 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 2009; 68:1580-4.