Strategic drug therapy for rheumatoid arthritis (RA) patients with prolonged remission is not well defined. According to recent guidelines, tapering biological Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) may be considered. We aimed to evaluate the effectiveness of long-term maintenance of tocilizumab (TCZ) treatment after the progressive tapering of infusions. We conducted an exploratory, prospective, single-center, open-label study, on RA patients with sustained remission of at least 3 months and treated with TCZ infusions every 4 weeks. The initial re-treatment interval was extended to 6 weeks for the first 3 months. Thereafter, the spacing between infusions was determined by the clinician. Successful long-term maintenance following the tapering of TCZ infusions was defined by patients still treated after two years by TCZ with a minimum dosing interval of 5 weeks. Thirteen patients were enrolled in the study. Eight out of thirteen were still treated by TCZ after two years. Successful long-term maintenance was possible in six patients, with four patients maintaining a re-treatment interval of 8-weeks or more. We observed 5 patients with TCZ withdrawal: one showing adverse drug reaction (neutropenia) and four with secondary failure. Patients achieving successful long-term maintenance with TCZ were significantly younger than those with secondary failure (p < 0.05). In addition, RA patients with positive rheumatoid factor and anti-citrullinated peptide antibodies, experienced a significantly greater number of flares during our 2-year follow-up (p < 0.01). A progressive tapering of TCZ infusions may be possible for many patients. However, larger studies, including more patients, are needed to confirm this therapeutic option. NCT02909998. Date of registration: October 2008.

中文翻译：

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通过逐渐减少托珠单抗输注成功实现长期缓解：一项单中心前瞻性研究

长期缓解的类风湿关节炎 (RA) 患者的战略药物治疗尚不明确。根据最近的指南，可以考虑逐渐减少生物疾病修饰抗风湿药物 (bDMARDs)。我们旨在评估在逐渐减少输注后长期维持托珠单抗 (TCZ) 治疗的有效性。我们对持续缓解至少 3 个月并每 4 周接受 TCZ 输注治疗的 RA 患者进行了一项探索性、前瞻性、单中心、开放标签研究。最初的再治疗间隔在前 3 个月延长至 6 周。此后，输注之间的间隔由临床医生确定。TCZ 输注逐渐减少后的成功长期维持定义为患者在两年后仍接受 TCZ 治疗，最小给药间隔为 5 周。十三名患者参加了这项研究。两年后，13 人中有 8 人仍在接受 TCZ 治疗。6 名患者可以成功进行长期维持，其中 4 名患者维持 8 周或更长时间的再治疗间隔。我们观察到 5 名 TCZ 撤药患者：1 名出现药物不良反应（中性粒细胞减少），4 名出现继发性失败。成功长期维持 TCZ 的患者明显比继发性失败的患者年轻（p < 0.05）。此外，类风湿因子和抗瓜氨酸肽抗体阳性的 RA 患者，在我们 2 年的随访期间经历了明显更多的耀斑（p < 0.01）。许多患者可能会逐渐减少 TCZ 输注。然而，需要包括更多患者在内的更大规模的研究来证实这种治疗选择。NCT02909998。注册日期：2008 年 10 月。