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Objectives <p>To evaluate the relationship between Hydroxychloroquine (HCQ) dosage and the incidence of flares in Systemic Lupus Erythematosus (SLE) flare incidence.</p> Methods <p>This retrospective cohort study analysed 703 SLE patients (Systemic Lupus Erythematosus Disease Activity Index 2000, SLEDAI-2&#xa0;K ≥ 4) from multiple Chinese centres (2020–2023). Patients were stratified by HCQ dose into low-dose (≤ 6.5&#xa0;mg/kg/day) and high-dose (&gt; 6.5&#xa0;mg/kg/day) HCQ groups. The primary outcome was SLE flare incidence (therapy augmentation, SLEDAI-2&#xa0;K increase ≥ 4, or SLE-related hospitalisation.</p> Results <p>Among the 703 patients, 45.5% experienced flares. Flare incidence was significantly lower in the high-dose group (41.0% vs. 51.5%, <i>P</i> = 0.006). High-dose HCQ reduced flare risk (fully adjusted HR 0.77, 95% CI 0.61–0.97, <i>P</i> = 0.024) and prolonged flare-free survival (<i>P</i> = 0.011). Dose-response analysis showed a linear reduction in flare risk with increasing HCQ doses. Sensitivity analyses using 5&#xa0;mg/kg/day cutoff and cumulative dose yielded consistent results.</p> Conclusions <p>Higher HCQ dosages are associated with a reduced SLE flares risk, and improved flare-free survival, supporting individualized dosing within safety guidelines.</p> Clinical trial registration <p>Not applicable.</p>

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Associations between hydroxychloroquine dose and risk of flares in systemic lupus erythematosus

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月21日

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  • Yadan Zou,
  • Yuanhong Peng,
  • Yuchao Zhong,
  • Sheng-Guang Li,
  • Zhongxing Zhao,
  • Haihong Yao

摘要

Objectives

To evaluate the relationship between Hydroxychloroquine (HCQ) dosage and the incidence of flares in Systemic Lupus Erythematosus (SLE) flare incidence.

Methods

This retrospective cohort study analysed 703 SLE patients (Systemic Lupus Erythematosus Disease Activity Index 2000, SLEDAI-2 K ≥ 4) from multiple Chinese centres (2020–2023). Patients were stratified by HCQ dose into low-dose (≤ 6.5 mg/kg/day) and high-dose (> 6.5 mg/kg/day) HCQ groups. The primary outcome was SLE flare incidence (therapy augmentation, SLEDAI-2 K increase ≥ 4, or SLE-related hospitalisation.

Results

Among the 703 patients, 45.5% experienced flares. Flare incidence was significantly lower in the high-dose group (41.0% vs. 51.5%, P = 0.006). High-dose HCQ reduced flare risk (fully adjusted HR 0.77, 95% CI 0.61–0.97, P = 0.024) and prolonged flare-free survival (P = 0.011). Dose-response analysis showed a linear reduction in flare risk with increasing HCQ doses. Sensitivity analyses using 5 mg/kg/day cutoff and cumulative dose yielded consistent results.

Conclusions

Higher HCQ dosages are associated with a reduced SLE flares risk, and improved flare-free survival, supporting individualized dosing within safety guidelines.

Clinical trial registration

Not applicable.