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

Huijing Wang, Ting Li, Fangfang Sun, Zhe Liu, Danting Zhang, Xiangyu Teng, Laurence Morel, Xiaodong Wang, Shuang Ye

Producción científica: Articlerevisión exhaustiva

14 Citas (Scopus)

Resumen

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/m 2), 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 m 2. 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.

Idioma originalEnglish (US)
Número de artículo002686
PublicaciónRMD Open
Volumen8
N.º2
DOI
EstadoPublished - oct 26 2022

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

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