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  • Safety and efficacy of the SGLT2 inhibitor dapagliflozin in patients with systemic lupus erythematosus: a phase I/II trial

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Lupus
Original research
Safety and efficacy of the SGLT2 inhibitor dapagliflozin in patients with systemic lupus erythematosus: a phase I/II trial
  1. Huijing Wang1,
  2. Ting Li1,
  3. Fangfang Sun1,
  4. Zhe Liu1,
  5. Danting Zhang1,
  6. Xiangyu Teng1,
  7. Laurence Morel2,
  8. Xiaodong Wang1 and
  9. Shuang Ye1
  1. 1Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
  2. 2Department of Microbiology, Immunology, and Molecular Genetics, University of Texas Health San Antonio, San Antonio, Texas, USA
  1. Correspondence to Dr Shuang Ye; ye_shuang2000{at}163.com; Xiaodong Wang; wangxiaodong{at}renji.com

Abstract

Objective Sodium-glucose cotransporter-2 inhibitors have been identified profound renal/cardiac protective effects in different diseases. Here, we assessed the safety and efficacy of dapagliflozin among adult patients with systemic lupus erythematosus (SLE).

Methods We conducted a single-arm, open-label, investigator-initiated phase I/II trial of dapagliflozin in Chinese patients with SLE with/without lupus nephritis (LN). Patients received oral dapagliflozin at a daily dose of 10 mg added to the standard of care for 6 months. The primary end point was the safety profile. The secondary efficacy end points were composite assessments of disease activity.

Results A total of 38 eligible patients were enrolled. Overall, 19 (50%) adverse events (AEs) were recorded, including 8 (21%) AEs leading to drug discontinuation, of which 4 (10.5%) were attributed to dapagliflozin. Two serious AEs (one of major lupus flare and one of fungal pneumonia) were recorded. Lower urinary tract infection was observed in one (2.63%) patient. The secondary end points revealed no improvement of SLE Disease Activity Index scores or proteinuria (among 17 patients with LN); the cumulative lupus flare rate was 18%, and a reduction of ~30% in the prednisone dose was captured. Net changes in body mass index (−0.50 kg/m2), systolic blood pressure (−3.94 mm Hg) and haemoglobin levels (+8.26 g/L) were detected. The overall estimated glomerular filtration rate (eGFR) was stable, and there was an improvement in the eGFR slope among patients with LN with a baseline eGFR <90 mL/min/1.73 m2.

Conclusion Dapagliflozin had an acceptable safety profile in adult patients with SLE. Its possible renal/cardiac protective effects and long-term safety issues in patients with SLE, patients with LN in particular, call for further exploration.

Trial registration number ChiCTR1800015030.

  • lupus erythematosus, systemic
  • lupus nephritis
  • outcome and process assessment, health care

Data availability statement

Data are available on reasonable request. Data generated and/or analysed during the current study are available from the corresponding author on reasonable request.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/rmdopen-2022-002686

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    Data availability statement

    Data are available on reasonable request. Data generated and/or analysed during the current study are available from the corresponding author on reasonable request.

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    Footnotes

    • HW, TL and FS are joint first authors.

    • HW, TL and FS contributed equally.

    • Contributors All authors read the manuscript, revised the manuscript and approved the final report. HW, XT, ZL and SY contributed to the design of the study, patient recruitment and follow-up; HW, ZL, XT, LM, XW and TL performed the literature review, data collection and analysis; HW, DZ and FS helped data analysis and evaluation. Author responsible for the overall content as the guarantor: SY.

    • Funding This study was supported by a grant from Clinical Research Plan of SHDC (no. SHDC2020CR1015B to SY; a grant from Shanghai Municipal Health Commission (no. 202040291) to FS.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.