Objective To evaluate whether low-to-moderate dose glucocorticoids provide additional benefit in primary Sjögren’s syndrome patients treated with hydroxychloroquine and/or iguratimod. Methods Using the Chinese Rheumatism Data Center database, we emulated a pragmatic trial including 395 patients with primary Sjögren’s syndrome treated between May 2016 and August 2025. All patients received hydroxychloroquine and/or iguratimod as background therapy. Patients were categorized by glucocorticoid use: HCQ/IGU plus glucocorticoid group (≤ 30 mg/day prednisone equivalent, n = 188) or HCQ/IGU group (n = 207). Primary outcome was ESSDAI score change at 1 month. Secondary outcomes included ESSPRI scores and laboratory parameters. Treatment effects were estimated using overlap weighting of propensity scores. Stratified analyses examined subgroups by baseline ESSDAI, IgG levels, and arthritis status. Results After propensity score weighting, baseline characteristics were well-balanced. At 1 month, glucocorticoids provided no additional benefit in ESSDAI change compared to hydroxychloroquine/iguratimod (Cohen’s d = − 0.12; 95% CI, − 0.32 to 0.08; p = 0.270). ESSPRI scores showed no improvement (Cohen’s d = − 0.20; 95% CI, − 0.39 to 0.00; p = 0.077). While glucocorticoids increased white blood cell counts (Cohen’s d = 0.57; p < 0.001) and decreased IgG levels (Cohen’s d = − 0.33; p = 0.004), these changes did not translate into clinical benefits. Stratified analyses revealed no additional benefit from glucocorticoids in any subgroup, including patients with higher disease activity (ESSDAI ≥ 5), elevated IgG, or arthritis. Conclusion Low-to-moderate dose glucocorticoids (≤ 30 mg/day prednisone equivalent) provide no additional short-term clinical benefit at 1-month follow-up in primary Sjögren’s syndrome patients receiving background hydroxychloroquine and/or iguratimod therapy. <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 • Low-to-Moderate dose glucocorticoids show no additional benefit over hydroxychloroquine/iguratimod therapy in primary Sjögren's syndrome patients. </entry> </row> </tbody> </tgroup> </Table>

Low-to-moderate dose glucocorticoids in primary Sjögren’s syndrome patients on hydroxychloroquine/iguratimod therapy: a target trial emulation study

期刊论文
发表日期：

2026年4月13日

查看全文

Xiangpeng Wang,
Shihao He,
Xiao Liang,
Yizhen Huang,
Wei Bai,
Jiuliang Zhao,
Qian Wang,
Dong Xu,
Xinping Tian,
Wen Zhang,
Mengtao Li,
Xiaofeng Zeng,
Xiaomei Leng

摘要

Objective

To evaluate whether low-to-moderate dose glucocorticoids provide additional benefit in primary Sjögren’s syndrome patients treated with hydroxychloroquine and/or iguratimod.

Methods

Using the Chinese Rheumatism Data Center database, we emulated a pragmatic trial including 395 patients with primary Sjögren’s syndrome treated between May 2016 and August 2025. All patients received hydroxychloroquine and/or iguratimod as background therapy. Patients were categorized by glucocorticoid use: HCQ/IGU plus glucocorticoid group (≤ 30 mg/day prednisone equivalent, n = 188) or HCQ/IGU group (n = 207). Primary outcome was ESSDAI score change at 1 month. Secondary outcomes included ESSPRI scores and laboratory parameters. Treatment effects were estimated using overlap weighting of propensity scores. Stratified analyses examined subgroups by baseline ESSDAI, IgG levels, and arthritis status.

Results

After propensity score weighting, baseline characteristics were well-balanced. At 1 month, glucocorticoids provided no additional benefit in ESSDAI change compared to hydroxychloroquine/iguratimod (Cohen’s d = − 0.12; 95% CI, − 0.32 to 0.08; p = 0.270). ESSPRI scores showed no improvement (Cohen’s d = − 0.20; 95% CI, − 0.39 to 0.00; p = 0.077). While glucocorticoids increased white blood cell counts (Cohen’s d = 0.57; p < 0.001) and decreased IgG levels (Cohen’s d = − 0.33; p = 0.004), these changes did not translate into clinical benefits. Stratified analyses revealed no additional benefit from glucocorticoids in any subgroup, including patients with higher disease activity (ESSDAI ≥ 5), elevated IgG, or arthritis.

Conclusion

Low-to-moderate dose glucocorticoids (≤ 30 mg/day prednisone equivalent) provide no additional short-term clinical benefit at 1-month follow-up in primary Sjögren’s syndrome patients receiving background hydroxychloroquine and/or iguratimod therapy.

Key Points

• Low-to-Moderate dose glucocorticoids show no additional benefit over hydroxychloroquine/iguratimod therapy in primary Sjögren's syndrome patients.