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Introduction /objectives <p>Telitacicept provides a promising therapeutic option for&#xa0;systemic lupus erythematosus (SLE). This study aims to evaluate the real-world&#xa0;effectiveness and safety of telitacicept in Chinese patients with SLE.</p> Methods <p>This retrospective study included 38 SLE patients treated with telitacicept&#xa0;for at least six months. Disease activity was assessed using the Systemic Lupus&#xa0;Erythematosus Disease Activity Index (SLEDAI), Physician’s Global Assessment&#xa0;(PGA), British Isles Lupus Assessment Group (BILAG) index, and the Systemic Lupus&#xa0;Erythematosus Responder Index 4 (SRI–4).</p> Results <p>Telitacicept significantly reduced SLEDAI score from a median of 8.50&#xa0;(interquartile range [IQR] 6.25–12.00) at baseline to 2.00 (IQR 0.00–4.00) at six months&#xa0;(<i>p</i>&lt;0.001). At three months, 65.8% of patients achieved a ≥4–point reduction in&#xa0;SLEDAI scores, which increased to 81.6% at six months. PGA scores decreased from&#xa0;a median of 1.80 (IQR 1.60-2.60) at baseline to 0.90 (IQR 0.60–1.30) at six months&#xa0;(<i>p</i>&lt;0.001). BILAG scores improved from a median of 4.00 (IQR 4.00–9.00) at baseline&#xa0;to 0.00 (IQR 0.00–1.00) at six months (<i>p</i>&lt;0.001). The SRI–4 response rates were 65.8%&#xa0;at three months and 78.9% at six months. Concomitant glucocorticoid use decreased&#xa0;notably, with 41.2% of patients experiencing a dose reduction of at least 25%, and 38.2%&#xa0;experiencing glucocorticoid discontinuation altogether. The reported AEs were mild,&#xa0;including injection site reactions and mild diarrhea.</p> Conclusions <p>This real-world study indicates that telitacicept is effective and well–tolerated&#xa0;in the management of SLE, with substantial improvements in disease activity&#xa0;and reductions in glucocorticoid and immunosuppressant use.</p>

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Effectiveness and safety of telitacicept in patients with systemic lupus erythematosus: a single center, retrospective, real-world study

  • 期刊论文

  • 发表日期：

    2025年2月4日

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  • Fang Fang,
  • Hongmei Duan,
  • Shuang Ding

摘要

Introduction /objectives

Telitacicept provides a promising therapeutic option for systemic lupus erythematosus (SLE). This study aims to evaluate the real-world effectiveness and safety of telitacicept in Chinese patients with SLE.

Methods

This retrospective study included 38 SLE patients treated with telitacicept for at least six months. Disease activity was assessed using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Physician’s Global Assessment (PGA), British Isles Lupus Assessment Group (BILAG) index, and the Systemic Lupus Erythematosus Responder Index 4 (SRI–4).

Results

Telitacicept significantly reduced SLEDAI score from a median of 8.50 (interquartile range [IQR] 6.25–12.00) at baseline to 2.00 (IQR 0.00–4.00) at six months (p<0.001). At three months, 65.8% of patients achieved a ≥4–point reduction in SLEDAI scores, which increased to 81.6% at six months. PGA scores decreased from a median of 1.80 (IQR 1.60-2.60) at baseline to 0.90 (IQR 0.60–1.30) at six months (p<0.001). BILAG scores improved from a median of 4.00 (IQR 4.00–9.00) at baseline to 0.00 (IQR 0.00–1.00) at six months (p<0.001). The SRI–4 response rates were 65.8% at three months and 78.9% at six months. Concomitant glucocorticoid use decreased notably, with 41.2% of patients experiencing a dose reduction of at least 25%, and 38.2% experiencing glucocorticoid discontinuation altogether. The reported AEs were mild, including injection site reactions and mild diarrhea.

Conclusions

This real-world study indicates that telitacicept is effective and well–tolerated in the management of SLE, with substantial improvements in disease activity and reductions in glucocorticoid and immunosuppressant use.