皮下注射托珠单抗单药治疗的长期安全性和有效性：武藏研究2年开放标签扩展研究结果
Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study.
作者信息
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 Akira
机构信息
From the Department of Respiratory Medicine, Allergy and Rheumatic Disease, Osaka University Graduate School of Medicine and Department of Immunopathology, WPI Immunology Frontier Research Center, Osaka University, Osaka; Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama; Department of Internal Medicine, Division of Endocrinology and Metabolism, Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University; Department of Rheumatology, Utazu-Hama Clinic, Kagawa; Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai; Division of Rheumatology, Department of Medicine, Showa University School of Medicine; Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo; Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki; Department of Rheumatosurgery, Osaka City University, Graduate School of Medicine, Osaka; Department of Internal Medicine and Rheumatology, National Hospital Organization Kyushu Medical Center, Fukuoka; Department of Rheumatology, Seirei Hamamatsu General Hospital, Shizuoka; Munakata Yasuhiko Clinic, Miyagi; Department of Rheumatology, Niigata Rheumatic Center, Niigata; Osaka Rheumatology Clinic, Osaka; Third Department of Internal Medicine, Hamamatsu University School of Medicine, Shizuoka; Department of Orthopedic Surgery, Fukui General Hospital, Fukui; Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo; Department of Orthopedic Surgery, Osaka University Graduate School of Medicine, Osaka; Shono Rheumatology Clinic, Fukuoka; First Department of Internal Medicine, Sapporo Medical University School of Medicine, Hokkaido; The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Fukuoka; Department of Medicine and Biosy
出版信息
J Rheumatol. 2015 May;42(5):799-809. doi: 10.3899/jrheum.140665. Epub 2015 Apr 1.
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.
目的
评估皮下注射托珠单抗（TCZ-SC）单药治疗类风湿关节炎（RA）患者的长期安全性和疗效。
方法
在346例接受24周双盲治疗的患者中，一组接受TCZ-SC单药治疗，每2周162mg；另一组接受静脉注射托珠单抗（TCZ-IV）单药治疗，每4周8mg/kg。319例患者在武藏研究（JAPICCTI-101117）的84周开放标签扩展（OLE）阶段继续接受每2周一次的TCZ-SC治疗。对所有接受托珠单抗治疗108周的患者进行疗效、安全性和免疫原性评估。
结果
在第24周达到美国风湿病学会20/50/70反应、低疾病活动度[28关节疾病活动评分（DAS28）≤3.2]或缓解（DAS28<2.6）的患者比例维持到第108周。不良事件和严重不良事件的发生率分别为每100患者年498.3次和16.9次。TCZ-SC单药治疗的总体安全性与TCZ-IV单药治疗相似。至108周的注射部位反应（ISR）发生率与至24周时相似。ISR为轻度，未导致任何患者退出治疗。未发生严重过敏事件（包括过敏反应）。接受TCZ-SC单药治疗的患者中2.1%出现抗TCZ抗体。
结论
在整个108周的研究中，TCZ-SC单药治疗保持了良好的安全性和持续疗效。与TCZ-IV一样，TCZ-SC可为RA患者提供另一种治疗选择。
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