Evaluation of switching from intravenous to subcutaneous formulation of tocilizumab in patients with rheumatoid arthritis

Iwamoto, Naoki; Fukui, Shoichi; Umeda, Masataka; Nishino, Ayako; Nakashima, Yoshikazu; Suzuki, Takahisa; Horai, Yoshiro; Nonaka, Fumiaki; Okada, Akitomo; Koga, Tomohiro; Kawashiri, Shin‐ya; Fujikawa, Keita; Aramaki, Toshiyuki; Ichinose, Kunihiro; Hirai, Yasuko; Tamai, Mami; Nakamura, Hideki; Terada, Kaoru; Nakashima, Munetoshi; Mizokami, Akinari; Origuchi, Tomoki; Eguchi, Katsumi; Ueki, Yukitaka; Kawakami, Atsushi

doi:10.3109/14397595.2015.1129692

Cited by 19 publications

(16 citation statements)

References 19 publications

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“…Similar results were observed in the 84-week open-label extension period of the phase III MUSASHI study, as well as in a real-world comparison of DAS28-ESR clinical response in patients at baseline and 3 months after switching from TCZ-IV to TCZ-SC [18,19]. TCZ-SC potentially reduced disease activity in TCZ-naïve patients.…”

Section: Discussionsupporting

confidence: 81%

“…However, data from these clinical trials may not fully represent the safety and effectiveness of TCZ-SC in patients in real-world clinical settings. To date, there has been one real-world study that evaluated TCZ effectiveness when switching from IV to SC administration; the investigators found that TCZ-SC maintained a favorable RA disease activity level previously achieved with TCZ-IV [19]. In order to further understand the real-world safety and effectiveness data of TCZ-SC, including patients who may switch from TCZ-IV, the Japanese health authority requested a postmarketing surveillance (PMS) study.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Atsumi

Fujio

Yamaoka

et al. 2018

Modern Rheumatology

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Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

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

Atsumi

Fujio

Yamaoka

et al. 2018

Modern Rheumatology

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“…Studies in RA show comparable serum trough levels for both TCZ-IV and TCZ-SC [ 17 ], but a higher area under the curve (AUC) for TCZ-IV [ 18 ]. Furthermore, it was shown that the efficacy of TCZ-SC could be worse in patients with high body weight [ 19 ]. Only one of the three patients, who relapsed in our study under TCZ-SC, was obese with a body weight of 100 kg, the two other patients weighed only 61 and 57.5 kg respectively.…”

Section: Discussionmentioning

confidence: 99%

Tocilizumab in Large Vessel Vasculitis – Different Routes of Administration

Schmalzing

Gadeholt

Gernert

et al. 2018

TORJ

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Background:Tocilizumab is increasingly used in the treatment of large vessel vasculitis with recent approval for giant cell arteritis.Objective:To determine the efficacy and safety of tocilizumab in large vessel vasculitis in a real-life setting using different routes of administration.Methods:Retrospective analysis of consecutive patients at a tertiary rheumatology department who received tocilizumab for large vessel vasculitis.Results:A total of 11 patients were treated with tocilizumab (8 giant cell arteritis, 2 large vessel vasculitis associated with rheumatoid arthritis, 1 Takayasu arteritis) after a median of 2 other steroid-sparing agents (range 1-4). Of these, 9 received tocilizumab as salvage therapy for active vasculitis and 2 due to the toxicity of their former steroid-sparing medication. After a mean follow-up of 23 months 7 patients were in remission as to vasculitis under a mean prednisolone dose of 1.7 ± 1.5 mg; one patient relapsed after long term remission having discontinued tocilizumab for elective surgery; one patient stopped tocilizumab after attributable infectious complications, and two patients died: one due to complications of vascular surgery, probably not attributable to tocilizumab; and the other due to sepsis secondary to sigmoiditis. Only 3 relapses occurred under continuous tocilizumab treatment. In all these 3 cases, renewed remission could be achieved by switching from subcutaneous (162 mg qw) to intravenous tocilizumab (8mg/kg q4w).Conclusion:Tocilizumab is efficacious in patients with large vessel vasculitis in a real-life situation. Safety appears to be acceptable, but infectious complications have to be considered. Intravenous tocilizumab may be used in patients who relapse under subcutaneous application.

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“…59 In this study disease control of RA was maintained without serious safety concerns, however it did note that the efficacy may be reduced in patients with heavier body weights. 59 These concerns were reflected in a similar study conducted by Iwamoto et al 60 On the other hand, Burmester et al, following the SUMMACTA study demonstrated comparable long-term efficacy and safety of TCZ SC compared with IV TCZ. 46 Advantages and disadvantages of tocilizumab relative to other products available to treat the same disease A number of biologic monoclonal antibodies targeting different inflammatory cytokines are available to treat RA.…”

Section: Product Availability and Dosing Schedulementioning

confidence: 96%

Tocilizumab (Actemra)

Sheppard

Laskou

Stapleton

et al. 2017

Human Vaccines & Immunotherapeutics

220

190

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Tocilizumab (TCZ), is a recombinant humanized anti-interleukin-6 receptor (IL-6R) monoclonal antibody which has a main use in the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA). This article provides an overview of TCZ including looking into the past at the discovery of interleukin-6 (IL-6) as a pro-inflammatory cytokine. It also looks at how tocilizumab was developed, manufactured and tested to ensure both safety and efficacy in a human population. The article then explores the advantages and disadvantages of using TCZ when compared to other biologics approved in RA, sJIA and pJIA and finally looks ahead to the future and the emerging role of IL-6 and its blockade by TCZ as a treatment for giant cell arteritis (GCA), polymyalgia rheumatica (PMR) and large vessel vasculitis (LVV).

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Evaluation of switching from intravenous to subcutaneous formulation of tocilizumab in patients with rheumatoid arthritis

Abstract: Caution should be exercised in the high-body-weight subjects, but these data indicate that TCZ-SC maintains the favorable RA disease activity established using TCZ-IV.

Cited by 19 publications

References 19 publications

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

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

Tocilizumab in Large Vessel Vasculitis – Different Routes of Administration

Tocilizumab (Actemra)

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