Safety and Efficacy of Long-Term Tocilizumab in a Cohort of Patients with Giant Cell Arteritis: An Italian Monocentric Retrospective Study.

IF 5.3 Q1 MEDICINE, RESEARCH & EXPERIMENTAL Biologics : Targets & Therapy Pub Date : 2024-10-03 eCollection Date: 2024-01-01 DOI:10.2147/BTT.S470107
Riccardo Terribili, Silvia Grazzini, Edoardo Conticini, Paolo Falsetti, Giovanni Biasi, Claudia Fabiani, Luca Cantarini, Bruno Frediani
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Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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巨细胞动脉炎患者长期使用托昔单抗的安全性和有效性:意大利单中心回顾性研究。
研究目的托西珠单抗(Tocilizumab,TCZ)是唯一获准用于治疗巨细胞动脉炎(GCA)的生物制剂药物,临床试验和实际研究证明了它的有效性和安全性。然而,治疗的最佳持续时间仍有待确定,因为过早中断治疗会增加复发风险。反之,延长疗程可能会引发安全问题。本研究旨在评估一组接受 TCZ 和类固醇加速减量方案治疗的 GCA 患者的不良事件(AEs)发生率和缓解/复发率,并随访 24 个月:我们回顾性地纳入了2019年1月至2021年11月期间转诊到我们诊所的患者,他们被诊断为GCA并开始接受皮下TCZ治疗(162毫克/周)。他们还接受了最多 62.5 毫克的泼尼松 (PDN),并按照为期 6 个月的加速计划逐渐减少剂量:我们共收集了 38 名患者,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%)受试者出现了不良反应,仅报告了1例严重不良反应;7例(18%)患者永久停用了TCZ。在随访结束时,所有继续接受治疗的患者都出现了临床缓解,PDN剂量也有所下降:我们的数据支持 TCZ 在 GCA 患者中长期使用安全有效的证据,尤其是在尽可能短的持续时间内与中等剂量的 GCs 联用时。
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来源期刊
Biologics : Targets & Therapy
Biologics : Targets & Therapy MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
8.30
自引率
0.00%
发文量
22
审稿时长
16 weeks
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