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Potential patient benefit of a subcutaneous formulation of tocilizumab for the treatment of rheumatoid arthritis: a critical review

机译：托珠单抗皮下制剂治疗类风湿关节炎的潜在患者获益：一项重要综述

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Abstract: Treatment of rheumatoid arthritis (RA) was revolutionized during the last decade with the development of new biologic disease-modifying anti-rheumatic drugs (DMARDs) enabling the targeting of immune cells and cytokines other than tumor necrosis factor (TNF). Subcutaneous formulations of the newer biologic DMARDs facilitate not only patients’ emancipation from the hospital, but reduce both societal and medical costs. Intravenous tocilizumab (TCZ) in RA has an efficacy and safety profile similar to anti-TNF in both the short and long-term. However, TCZ can be administered in monotherapy without loss of efficacy when patients do not tolerate methotrexate or synthetic DMARDs. TCZ is consistently found superior to methotrexate and possibly superior to adalimumab in monotherapy in randomized controlled trials. Subcutaneous administration of TCZ is as effective and safe as its intravenous administration in RA patients during the first year of treatment. Similar to intravenous TCZ, patients’ weight and possibly previous use of anti-TNF influence the efficacy of subcutaneous TCZ. Additionally, combination with synthetic DMARDs seems to expose RA patients to more adverse events independently of its administration route. Pharmacokinetics of different administration routes could potentially lead to differences in efficacy, adverse events, and auto-immunogenicity. The concentration of free TCZ before new TCZ dose (C trough) is higher in the subcutaneous route, while the maximal concentration of free TCZ is higher in the intravenous route. The subcutaneous dosages of TCZ 162 mg every week, and every 2 weeks in RA patients with low body weight (<60 kg) work well. Nevertheless, dosage and intervals of subcutaneous TCZ administration could be adjusted during the course of treatment since 80% of non-Japanese RA patients with usually higher body weight achieved similar efficacy with the low TCZ dosage in combination with a synthetic DMARD. Patients want effective, easy-to-administer therapy with sustained prolonged efficacy without the need of polypharmacy and with minimal to no side effects. Subcutaneous TCZ in RA patients in monotherapy seems to live up to patients’ expectations.
机译：摘要：在过去的十年中，随着新的生物疾病修饰抗风湿药（DMARDs）的开发，风湿性关节炎（RA）的治疗发生了革命性变化，该药物能够靶向除肿瘤坏死因子（TNF）以外的免疫细胞和细胞因子。新型生物DMARD的皮下制剂不仅可以帮助患者从医院中解放出来，还可以降低社会和医疗成本。 RA的静脉内Tocilizumab（TCZ）在短期和长期方面均具有类似于抗TNF的功效和安全性。但是，当患者不耐受甲氨蝶呤或合成DMARD时，TCZ可以单药治疗而不会失去疗效。在随机对照试验中，在单一疗法中始终发现TCZ优于甲氨蝶呤，并且可能优于阿达木单抗。在治疗的第一年中，TCZ的皮下给药与RA病人的静脉给药一样有效和安全。与静脉TCZ相似，患者的体重以及可能先前使用的抗TNF都会影响皮下TCZ的疗效。此外，与合成DMARD联合使用似乎使RA患者不依赖其给药途径而遭受更多的不良事件。不同给药途径的药代动力学可能会导致功效，不良事件和自身免疫原性的差异。在皮下途径中，新的TCZ剂量（C谷）之前的游离TCZ浓度较高，而在静脉内途径中，游离TCZ的最大浓度较高。低体重（<60 kg）的RA患者每周皮下注射TCZ 162 mg，每2周皮下给药效果良好。但是，在治疗过程中可以调整皮下注射TCZ的剂量和间隔时间，因为80％通常体重较高的非日本RA患者在低TCZ剂量下与合成DMARD联合使用可获得相似的疗效。患者需要有效，易于管理的疗法，持续疗效持久，而无需多药店且副作用极小或没有。接受单一疗法的RA患者皮下TCZ似乎可以达到患者的期望。

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