Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.
Clin Exp Rheumatol. 2022 Sep;40(9):1733-1737. doi: 10.55563/clinexprheumatol/7y5ku8. Epub 2021 Dec 7.
Low disease activity status and remission are crucial treat-to-target (T2T) endpoints in systemic lupus erythematosus (SLE). To evaluate the efficacy of metformin add-on in attaining T2T among Chinese patients with mild-to-moderate lupus, a post-hoc analysis combining our previous two randomised trials was carried out.
Data from the open-labeled proof-of-concept trial (ChiCTR-TRC-12002419) and placebo-controlled trial (NCT02741960) were integrated together. Disease flares were compared between patients attaining T2T or not at baseline. The efficacy of metformin versus placebo/nil add-on to standard therapy in SLE patients who did not meet the T2T criteria at baseline was evaluated in terms of attaining T2T at 12-month follow-up.
Of 253 SLE patients, 43.8% (n=89) attained T2T at baseline. During the 12 months, 15 patients flared in the T2T group, which was significantly lower than that in the non-T2T group (16.9% vs. 36.0%, p=0.001). For 164 patients who did not meet the T2T criteria at entry, 59.0% and 43.6% of the 78 patients taking metformin in this population attained the lupus low disease activity status (LLDAS) and remission endpoints at last visit, respectively, as compared to 37.2% and 24.4% of the 86 patients in the placebo/nil group (LLDAS p=0.008; remission p=0.013). Over time, metformin helped patients achieving T2T earlier and maintain longer T2T duration over placebo/nil (LLDAS duration: 44.9% vs. 26.4%, p=0.002; remission duration:19.1% vs. 10.7%, p=0.014).
This post-hoc analysis suggested that metformin might be an adjuvant therapy in achieving treat-to-target in SLE patients.
低疾病活动状态和缓解是系统性红斑狼疮（SLE）治疗目标（T2T）的关键终点。为了评估二甲双胍在实现中国轻中度狼疮患者 T2T 中的疗效，我们对之前的两项随机试验进行了事后分析。
将开放标签概念验证试验（ChiCTR-TRC-12002419）和安慰剂对照试验（NCT02741960）的数据整合在一起。比较基线时达到 T2T 与未达到 T2T 的患者之间的疾病发作情况。在基线时未达到 T2T 标准的 SLE 患者中，评估二甲双胍与安慰剂/无添加标准治疗相比在 12 个月随访时达到 T2T 的疗效。
在 253 例 SLE 患者中，43.8%（n=89）基线时达到 T2T。在 12 个月期间，T2T 组中有 15 例患者发作，明显低于非 T2T 组（16.9%比 36.0%，p=0.001）。对于 164 例入组时未达到 T2T 标准的患者，在该人群中服用二甲双胍的 78 例患者中，分别有 59.0%和 43.6%的患者在最后一次就诊时达到狼疮低疾病活动状态（LLDAS）和缓解终点，而安慰剂/无添加组的 86 例患者中分别为 37.2%和 24.4%（LLDAS p=0.008；缓解 p=0.013）。随着时间的推移，二甲双胍帮助患者更早地达到 T2T，并比安慰剂/无添加维持更长的 T2T 持续时间（LLDAS 持续时间：44.9%比 26.4%，p=0.002；缓解持续时间：19.1%比 10.7%，p=0.014）。
这项事后分析表明，二甲双胍可能是 SLE 患者实现 T2T 的辅助治疗。
