Terribili Riccardo, Grazzini Silvia, Conticini Edoardo, Falsetti Paolo, Biasi Giovanni, Fabiani Claudia, Cantarini Luca, Frediani Bruno
Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Ophthalmology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Biologics. 2024 Oct 3;18:297-305. doi: 10.2147/BTT.S470107. eCollection 2024.
Tocilizumab (TCZ) is the only biologic drug approved for the treatment of giant cell arteritis (GCA), having clinical trials and real-life studies proved its efficacy and safety. However, the optimal duration of the treatment has yet to be determined, being its early interruption associated with an increased risk of relapse. Conversely, prolonged schemes of therapy may rise safety concerns. The aim of the study was to evaluate the incidence of adverse events (AEs) and remission/relapse rate in a cohort of GCA patients treated with TCZ and an accelerated steroid tapering scheme, followed for 24 months.
We retrospectively included patients referring to our clinic from January 2019 to November 2021 who were diagnosed with GCA and started subcutaneous TCZ treatment (162 mg/week). They also received up to 62,5 mg of prednisone (PDN), tapered following an accelerated six-month scheme.
We collected 38 patients, with a mean age of 76,4 years, treated with TCZ for an average of 22,3 months. AEs occurred in 11 (29%) subjects, and only one serious AE was reported; 7 (18%) patients permanently discontinued TCZ. At the end of the follow-up, all the patients continuing treatment showed clinical remission, with a PDN dosage <5mg. We registered 3 (8%) minor relapses under TCZ, after an average of 15 months.
Our data support the evidence of a safe and effective long-term use of TCZ in GCA patients, especially when combined with moderate GCs doses for the shortest possible duration.
托珠单抗（TCZ）是唯一被批准用于治疗巨细胞动脉炎（GCA）的生物药物，临床试验和真实世界研究已证实其有效性和安全性。然而，治疗的最佳持续时间尚未确定，早期中断治疗会增加复发风险。相反，延长治疗方案可能会引发安全问题。本研究的目的是评估在接受TCZ和加速激素减量方案治疗并随访24个月的GCA患者队列中不良事件（AE）的发生率以及缓解/复发率。
我们回顾性纳入了2019年1月至2021年11月到我们诊所就诊、被诊断为GCA并开始皮下注射TCZ治疗（162毫克/周）的患者。他们还接受了最高62.5毫克的泼尼松（PDN），按照加速的六个月方案逐渐减量。
我们收集了38例患者，平均年龄为76.4岁，接受TCZ治疗的平均时间为22.3个月。11例（29%）受试者发生了AE，仅报告了1例严重AE；7例（18%）患者永久停用了TCZ。随访结束时，所有继续治疗的患者均表现出临床缓解，PDN剂量<5毫克。在TCZ治疗期间，我们记录到3例（8%）轻度复发，平均发生在15个月后。
我们的数据支持了TCZ在GCA患者中长期安全有效使用的证据，尤其是在尽可能短的时间内联合中等剂量糖皮质激素（GCs）使用时。
