RT Journal Article
SR Electronic
T1 Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.140665
DO 10.3899/jrheum.140665
A1 Atsushi Ogata
A1 Koichi Amano
A1 Hiroaki Dobashi
A1 Masayuki Inoo
A1 Tomonori Ishii
A1 Tsuyoshi Kasama
A1 Shinichi Kawai
A1 Atsushi Kawakami
A1 Tatsuya Koike
A1 Hisaaki Miyahara
A1 Toshiaki Miyamoto
A1 Yasuhiko Munakata
A1 Akira Murasawa
A1 Norihiro Nishimoto
A1 Noriyoshi Ogawa
A1 Tomohiro Ojima
A1 Hajime Sano
A1 Kenrin Shi
A1 Eisuke Shono
A1 Eiichi Suematsu
A1 Hiroki Takahashi
A1 Yoshiya Tanaka
A1 Hiroshi Tsukamoto
A1 Akira Nomura
YR 2015
UL http://www.jrheum.org/content/early/2015/03/25/jrheum.140665.abstract
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.