Introduction Antiphospholipid syndrome (APS) is a common complication of systemic lupus erythematosus (SLE). Current treatment mainly relies on anticoagulation. Whether telitacicept can reduce antiphospholipid antibodies (aPLs) and its mechanism remain understudied. This study aims to investigate the effect of telitacicept on reducing aPLs and its impact on B lymphocyte subsets in patients with APS secondary to SLE. Method This exploratory, multicenter, prospective, single-arm, pre-post design study enrolled patients with APS secondary to SLE. Subcutaneous telitacicept 160 mg once weekly was added to stable standard therapy, with a 6-month follow-up. Standard treatment included glucocorticoids, hydroxychloroquine, immunosuppressants for SLE, and antiplatelet or anticoagulant therapy for APS. Medication types and doses had remained stable for at least 2 months within the 6 months prior to enrollment. Primary outcome measures included changes in aPLs, B lymphocyte subsets, and incidence of new thrombotic events and adverse reactions. Results This study enrolled 11 female patients. At 6 months of treatment, anticardiolipin antibodies (aCLs)-IgG/IgM and anti-β2-glycoprotein I antibodies (anti-β2GPI)-IgG/IgM were significantly reduced (P < 0.05). Lupus anticoagulant (LA) showed a decreasing trend but without statistical significance. Total B cells, transitional B cells, and naive B cells decreased significantly. Erythrocyte sedimentation rate (ESR) improved significantly at 6 months. No new thrombotic events or adverse reactions occurred during follow-up. Conclusions Telitacicept is associated with a reduction in aPLs levels in patients with APS secondary to SLE, potentially by inhibiting total B cells, transitional B cells, and naive B cells, with a favorable safety profile. <Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="left" colname="c1" colnum="1" /> <colspec align="left" colname="c2" colnum="2" /> <tbody> <row> <entry align="left" nameend="c2" namest="c1"> Key Points • Telitacicept is widely used for SLE in mainland China. Our study shows it is also effective in SLE patients with APS, filling an evidence gap. • Standard APS therapy does not lower autoantibody levels. Telitacicept reduces aPLs (including aCL and anti-β2GPI), offering a novel immunological strategy. • Our findings suggest telitacicept lowers aPLs by inhibiting B cell differentiation and maturation, providing mechanistic insights into its efficacy in APS secondary to SLE. </entry> </row> </tbody> </tgroup> </Table>

A pilot study on the efficacy and mechanism of telitacicept in systemic lupus erythematosus with antiphospholipid syndrome

期刊论文
发表日期：

2026年6月15日

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Haihui Gao,
Qian Xing,
Xiaodong Wang,
Qingrui Yang,
Liqin Wang,
Hongyan Feng,
Jing Dong

摘要

Introduction

Antiphospholipid syndrome (APS) is a common complication of systemic lupus erythematosus (SLE). Current treatment mainly relies on anticoagulation. Whether telitacicept can reduce antiphospholipid antibodies (aPLs) and its mechanism remain understudied. This study aims to investigate the effect of telitacicept on reducing aPLs and its impact on B lymphocyte subsets in patients with APS secondary to SLE.

Method

This exploratory, multicenter, prospective, single-arm, pre-post design study enrolled patients with APS secondary to SLE. Subcutaneous telitacicept 160 mg once weekly was added to stable standard therapy, with a 6-month follow-up. Standard treatment included glucocorticoids, hydroxychloroquine, immunosuppressants for SLE, and antiplatelet or anticoagulant therapy for APS. Medication types and doses had remained stable for at least 2 months within the 6 months prior to enrollment. Primary outcome measures included changes in aPLs, B lymphocyte subsets, and incidence of new thrombotic events and adverse reactions.

Results

This study enrolled 11 female patients. At 6 months of treatment, anticardiolipin antibodies (aCLs)-IgG/IgM and anti-β2-glycoprotein I antibodies (anti-β2GPI)-IgG/IgM were significantly reduced (P < 0.05). Lupus anticoagulant (LA) showed a decreasing trend but without statistical significance. Total B cells, transitional B cells, and naive B cells decreased significantly. Erythrocyte sedimentation rate (ESR) improved significantly at 6 months. No new thrombotic events or adverse reactions occurred during follow-up.

Conclusions

Telitacicept is associated with a reduction in aPLs levels in patients with APS secondary to SLE, potentially by inhibiting total B cells, transitional B cells, and naive B cells, with a favorable safety profile.

Key Points

• Telitacicept is widely used for SLE in mainland China. Our study shows it is also effective in SLE patients with APS, filling an evidence gap.

• Standard APS therapy does not lower autoantibody levels. Telitacicept reduces aPLs (including aCL and anti-β2GPI), offering a novel immunological strategy.

• Our findings suggest telitacicept lowers aPLs by inhibiting B cell differentiation and maturation, providing mechanistic insights into its efficacy in APS secondary to SLE.