Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials. Issue 1 (22nd October 2020)

• Record Type: Journal Article
• Authors: Sun, Fangfang; Geng, Shikai; Wang, Haiting; Wang, Huijing; Liu, Zhe; Wang, Xiaodong; Li, Ting; Wan, Weiguo; Lu, Liangjing; Teng, Xiangyu; Morel, Laurence; Ye, Shuang
• Is Part Of: Lupus science & medicine. Volume 7:Issue 1(2020)
• Publication Date: 2020-10-22
• Subjects: lupus erythematosus -- systemic -- autoantibodies -- therapeutics; Systemic lupus erythematosus -- Periodicals; 616.772005
• DOI: 10.1136/lupus-2020-000429
• Languages: English
• ISSNs: 2398-8851

Abstract

Abstract : Objective: To confirm that metformin prevents flares in patients with SLE with low disease activity, we performed a post hoc analysis combining our previous two randomised trials. Methods: Post hoc analyses were performed on data from the open-labelled proof-of-concept trial (n=113, ChiCTR-TRC-12002419) and placebo-controlled 'Met Lupus' trial (n=140, NCT02741960 ) comparing the efficacy of metformin versus placebo/nil add-on to standard therapy in patients with SLE with low disease activity (SELENA-SLEDAI ≤4). The primary endpoint was defined by the SELENA-SLEDAI Flare Index at 12-month follow-up. A subgroup analysis was performed. Results: Overall, 201 eligible patients were included, with 99 allocated to metformin group and 102 allocated to the placebo/nil group. By 12 months of follow-up, 21 patients (21.2%) flared in the metformin group, as compared with 36 (35.3%) in the placebo/nil group (p=0.027, risk ratio=0.68, 95% CI 0.46 to 0.96). Subgroup analysis showed that patients with negative anti-dsDNA antibody and normal complement at baseline, and a disease duration <5 years with concomitant use of hydroxychloroquine had a better response to metformin. Conclusion: Post hoc pooled analyses suggested that metformin reduced subsequent disease flares in patients with SLE with low disease activity, especially for serologically quiescent patients.