PT  - JOURNAL ARTICLE
AU  - Atsushi Ogata
AU  - Koichi Amano
AU  - Hiroaki Dobashi
AU  - Masayuki Inoo
AU  - Tomonori Ishii
AU  - Tsuyoshi Kasama
AU  - Shinichi Kawai
AU  - Atsushi Kawakami
AU  - Tatsuya Koike
AU  - Hisaaki Miyahara
AU  - Toshiaki Miyamoto
AU  - Yasuhiko Munakata
AU  - Akira Murasawa
AU  - Norihiro Nishimoto
AU  - Noriyoshi Ogawa
AU  - Tomohiro Ojima
AU  - Hajime Sano
AU  - Kenrin Shi
AU  - Eisuke Shono
AU  - Eiichi Suematsu
AU  - Hiroki Takahashi
AU  - Yoshiya Tanaka
AU  - Hiroshi Tsukamoto
AU  - Akira Nomura
AU  - the MUSASHI Study Investigators
TI  - Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study
AID  - 10.3899/jrheum.140665
DP  - 2015 May 01
TA  - The Journal of Rheumatology
PG  - 799--809
VI  - 42
IP  - 5
4099  - http://www.jrheum.org/content/42/5/799.short
4100  - http://www.jrheum.org/content/42/5/799.full
SO  - J Rheumatol2015 May 01; 42
AB  - Objective. To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA). Methods. Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks. Results. The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy. Conclusion. 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.