Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study

Ogata, Atsushi; Amano, Koichi; Dobashi, Hiroaki; Inoo, Masayuki; Ishii, Tomonori; Kasama, Tsuyoshi; Kawai, Shinichi; Kawakami, Atsushi; Koike, Tatsuya; Miyahara, Hisaaki; Miyamoto, Toshiaki; Munakata, Yasuhiko; Murasawa, Akira; Nishimoto, Norihiro; Ogawa, Noriyoshi; Ojima, Tomohiro; Sano, Hajime; Shi, Kenrin; Shono, Eisuke; Suematsu, Eiichi; Takahashi, Hiroki; Tanaka, Yoshiya; Tsukamoto, Hiroshi; Nomura, Akihiro

doi:10.3899/jrheum.140665

Cited by 40 publications

(34 citation statements)

References 24 publications

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“…With the exception of ISR, the safety profile of the TCZ-SC arm in our study was consistent with the known safety profile of TCZ-IV and was comparable with that observed in the longterm extension of the TCZ-SC trials 8,9 . The death rates were similar between the TCZ-SC and PBO-TCZ-SC groups, with wide and overlapping CI (1.14/100 PY, 95% CI 0.46-2.34 and 0.65/100 PY, 95% CI 0.02-3.61).…”

Section: Discussionsupporting

confidence: 88%

“…The percentage of patients with anti-TCZ antibodies remained low, comparable across the treatment arms and similar to those in other TCZ-SC studies 8,9 . No correlation between antibody development, hypersensitivity reactions, or loss of efficacy was observed.…”

Section: Discussionsupporting

confidence: 85%

“…The safety and efficacy of TCZ-SC are comparable with TCZ-IV as monotherapy and with DMARD, and TCZ-SC has been approved for use globally 5,6,7,8,9 .…”

mentioning

confidence: 99%

“…At 2 years, the phase III TCZ-SC trials SUMMACTA 8 [weekly (qw) with DMARD)] and MUSASHI 9 [every 2 weeks (q2w) as monotherapy] showed that TCZ-SC maintained efficacy and safety comparable to TCZ-IV. The phase III BREVACTA study evaluated the efficacy and safety of biweekly TCZ-SC in combination with DMARD in patients with moderate to severe RA and an inadequate response to DMARD 6 .…”

mentioning

confidence: 99%

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Two-year Efficacy and Safety of Subcutaneous Tocilizumab in Combination with Disease-modifying Antirheumatic Drugs Including Escalation to Weekly Dosing in Rheumatoid Arthritis

Kivitz

Olech²,

Borofsky³

et al. 2017

J Rheumatol

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Objective.To evaluate the longterm efficacy and safety of subcutaneous tocilizumab (TCZ-SC) every 2 weeks (q2w) over 2 years in patients with rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARD).Methods.Patients (n = 656) were randomized 2:1 to TCZ-SC 162 mg q2w or placebo-SC q2w plus DMARD. After a 24-week double-blind period, patients (n = 457) were rerandomized to open-label TCZ-SC q2w by means of prefilled syringe or autoinjector. Escape therapy with weekly TCZ-SC was available for patients with inadequate efficacy from Week 12. Maintenance of response and safety to 2 years was assessed. Analyses used nonresponder imputation.Results.The American College of Rheumatology (ACR) 20 response after TCZ-SC was maintained beyond Week 24 and was > 70% at each timepoint. ACR50/70, 28-joint Disease Activity Score remission, and ≥ 0.30 decrease from baseline in the Health Assessment Questionnaire–Disability Index response rates were also maintained after Week 24 in the TCZ-SC arm (≥ 50%, > 25%,> 32% and > 56%, respectively). Following escape for inadequate efficacy, many patients achieved ACR20 at the end of the study, 35% after escape from TCZ-SC, and 63% from placebo. The rates of serious adverse events [(11.20/100 patient-years (PY)] including serious infections (3.25/100 PY) were stable through Week 96. No association between anti-TCZ antibody development and loss of efficacy or adverse events was observed.Conclusion.Efficacy and safety of TCZ-SC q2w was maintained up to 2 years and remained comparable with previously published data for intravenous TCZ. Dose escalation to weekly TCZ-SC was associated with ACR responses in prior nonresponders and was well tolerated.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 85%

“…The safety and efficacy of TCZ-SC are comparable with TCZ-IV as monotherapy and with DMARD, and TCZ-SC has been approved for use globally 5,6,7,8,9 .…”

mentioning

confidence: 99%

mentioning

confidence: 99%

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Two-year Efficacy and Safety of Subcutaneous Tocilizumab in Combination with Disease-modifying Antirheumatic Drugs Including Escalation to Weekly Dosing in Rheumatoid Arthritis

Kivitz

Olech²,

Borofsky³

et al. 2017

J Rheumatol

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“…Since TCZ‐SC is a fixed‐dose regimen, in order to maintain the efficacy, weekly administration of TCZ‐SC may be beneficial for restoring a sufficient serum concentration of TCZ in patients with high body weights who have inadequate responses to biweekly TCZ‐SC. Weekly administration of TCZ would be expected to be tolerable, because the safety profile of administration of TCZ‐SC 162 mg/2 weeks was similar to that of TCZ‐IV 8 mg/kg/4 weeks, except for injection site reactions, in the SUMMACTA study 10 and the open‐label extension of the MUSASHI study 15. Further studies are needed to investigate the potential benefits and adverse events of TCZ administered weekly.…”

Section: Discussionmentioning

confidence: 99%

Sustainable Efficacy of Switching From Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis

Ogata

Atsumi

Fukuda

et al. 2015

Arthritis Care & Research

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ObjectiveTo evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients.MethodsPatients who had completed 24 weeks of TCZ‐SC (162 mg/2 weeks) or TCZ‐IV (8 mg/kg/4 weeks) monotherapy in the double‐blind period of the MUSASHI study were enrolled in an 84‐week open‐label extension period. All received TCZ‐SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching).ResultsOverall, 319 patients received ≥1 dose of TCZ‐SC during the open‐label extension period; 160 switched from TCZ‐IV to TCZ‐SC (TCZ IV/SC) and 159 continued TCZ‐SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5% (100 of 160) for TCZ IV/SC and 50.0% (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100 of 160) and 57.0% (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9% of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥70 kg, the percentage with a sufficient serum TCZ concentration (≥1 μg/ml) decreased from 90.9% (10 of 11) at week 24 to 45.5% (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC.ConclusionEfficacy is adequately maintained in most patients switching from TCZ‐IV (8 mg/kg/4 weeks) to TCZ‐SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ‐IV can switch to TCZ‐SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight.

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Interaction of Anti-COVID-19 Drugs with Cardiovascular Therapy

Leskovar¹,

Pećin²,

Reiner³

2022

Contemporary Cardiology

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Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study

Abstract: TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

Cited by 40 publications

References 24 publications

Two-year Efficacy and Safety of Subcutaneous Tocilizumab in Combination with Disease-modifying Antirheumatic Drugs Including Escalation to Weekly Dosing in Rheumatoid Arthritis

Two-year Efficacy and Safety of Subcutaneous Tocilizumab in Combination with Disease-modifying Antirheumatic Drugs Including Escalation to Weekly Dosing in Rheumatoid Arthritis

Sustainable Efficacy of Switching From Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis

Interaction of Anti-COVID-19 Drugs with Cardiovascular Therapy

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