Efficacy and safety of extending intravenous tocilizumab intervals from 4 to 6 weeks in rheumatoid arthritis patients with good response to 4-week intervals
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A period of 4 weeks (w) has been recommended for rheumatoid arthritis (RA) patients as the interval between intravenous (IV) tocilizumab (TCZ, 8 mg/kg). In a previous paper, we showed the possibility that the interval between successive IV TCZ can be extended from 4 to 6 weeks in more than 60% of patients with low diseases activity (LDA) at 4-week intervals. Herein, we aimed to investigate the efficacy and safety of extending the interval from 4 to 6 weeks. A retrospective observational study was conducted by enrolling patients in whom the intervals of TCZ infusions could be extended from 4 to 6 weeks with an LDA for more than 2 years. We compared the efficacy and side effects of TCZ infusions at intervals of 4 and 6 weeks in a cohort of patients. We also examined serum lipid, platelet, IL-6, and trough TCZ levels. A total of 125 patients with an LDA at 4 weeks intervals were enrolled in this study, of which 78 patients maintained LDA at 6-week intervals of TCZ infusion. After extending the infusion intervals, the efficacy of the treatment was maintained, and the side effects decreased significantly. In addition, the levels of total cholesterol and triglyceride were returned to normal, and the serum trough levels of TCZ became undetectable at 6-week intervals. We proved that intervals between TCZ infusions can be extended from 4 to 6 weeks in more than 60% of RA patients along with a decrease in the side effects, thus suggesting the need to change the infusion intervals in suitable patients.
KeywordsIntravenous tocilizumab Rheumatoid arthritis Extension of intervals Efficacy Safety
The authors would like to acknowledge Dr. Taro Kinoshita of Department of Immunoregulation, Research Institute for Microbial Diseases, Osaka University for his kind suggestion.
Osamu Saiki was responsible for the concept and design of the study, and wrote the draft. Osamu Saiki and Hiroshi Uda contributed to the acquisition, analysis, and interpretation of data. We have no external editing support to acknowledge.
Compliance with ethical standards
Conflict of interest
Hiroshi Uda and Osamu Saiki declare that they have no conflict of interest.
- 5.Nishimoto N, Terao K, Mima T, Nakahara H, Takagi N, Kakehi T (2008) 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 112:3959–3964CrossRefGoogle Scholar
- 6.Nishimoto N, Hashimoto J, Miyasaka N et al (2007) 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 66:1162–1167CrossRefGoogle Scholar
- 7.Genovese MC, McKay JD, Nasonov EL et al (2008) 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 58:2968–2980CrossRefGoogle Scholar
- 8.Nishimoto N, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, Azuma J (2009) 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 68:1580–1584CrossRefGoogle Scholar
- 10.Dougados M, Kissel K, Sheeran T et al (2013) 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 72:43–50CrossRefGoogle Scholar
- 14.European Medical Agency (2018) Tocilizumab (RoActemura) 20 mg/ml concentrate solution for infusion/162 mg solution for injection in pre-filled syringe: summary of product characteristicsGoogle Scholar