Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis
Objective: To provide real-world data and summarize current clinical evidence on the efficacy and safety of sirolimus in active systemic lupus erythematosus (SLE) patients. Methods: This was a prospective real-world clinical study. Included SLE patients should have Systemic Lupus Erythematosus Disea...
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Series: | Therapeutic Advances in Musculoskeletal Disease |
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doaj-feb0db1b8e6245deb78a7037acb69bed2021-07-14T11:04:39ZengSAGE PublishingTherapeutic Advances in Musculoskeletal Disease1759-72182020-09-011210.1177/1759720X20953336Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysisLiying PengChanyuan WuRuping HongYiduo SunJunyan QianJiuliang ZhaoQian WangXinping TianYanhong WangMengtao LiXiaofeng ZengObjective: To provide real-world data and summarize current clinical evidence on the efficacy and safety of sirolimus in active systemic lupus erythematosus (SLE) patients. Methods: This was a prospective real-world clinical study. Included SLE patients should have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ⩾ 2. They were treated with sirolimus and followed up regularly. The SLEDAI-2K, Physician Global Assessment (PGA), serological activity indices, and remission of organ manifestations were evaluated. We also performed a meta-analysis to integrate current evidence of sirolimus in SLE. Results: A total of 49 patients were included in the final analysis. After treatment, the SLEDAI-2K (6.2 ± 3.1 versus 4.0 ± 3.4, p = 0.001) decreased significantly, and the prednisone dosage was tapered successfully (9.9 ± 8.8 mg/day versus 5.9 ± 4.0 mg/day, p = 0.002). Serological activity indices also improved [complement 3 (C3): 0.690 ± 0.209 g/l versus 0.884 ± 0.219 g/l, p < 0.001; complement 4: 0.105 ± 0.059 g/l versus 0.141 ± 0.069 g/l, p < 0.001; anti-dsDNA antibody, 200 ± 178 IU/ml versus 156 ± 163 IU/ml, p = 0.022]. The remission proportions of arthritis, skin rash, and thrombocytopenia were 100%, 88.8%, and 46.2%, respectively. A total of 41.2% of lupus nephritis (LN) patients achieved renal remission, but the average 24-h urine protein level was not significantly changed. Meta-analysis enrolled five studies with 149 patients included, and revealed similar results regarding the changes of SLEDAI-2K [−3.5 (−5.0, −2.1)], C3 [0.224 (0.136, 0.311) g/l] and daily dosage of prednisone [−12.7 (−19.9, −5.6) mg/day]. Conclusion: Sirolimus might be effective and tolerated in SLE. The role of sirolimus in LN requires further study.https://doi.org/10.1177/1759720X20953336 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Liying Peng Chanyuan Wu Ruping Hong Yiduo Sun Junyan Qian Jiuliang Zhao Qian Wang Xinping Tian Yanhong Wang Mengtao Li Xiaofeng Zeng |
spellingShingle |
Liying Peng Chanyuan Wu Ruping Hong Yiduo Sun Junyan Qian Jiuliang Zhao Qian Wang Xinping Tian Yanhong Wang Mengtao Li Xiaofeng Zeng Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis Therapeutic Advances in Musculoskeletal Disease |
author_facet |
Liying Peng Chanyuan Wu Ruping Hong Yiduo Sun Junyan Qian Jiuliang Zhao Qian Wang Xinping Tian Yanhong Wang Mengtao Li Xiaofeng Zeng |
author_sort |
Liying Peng |
title |
Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis |
title_short |
Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis |
title_full |
Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis |
title_fullStr |
Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis |
title_full_unstemmed |
Clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis |
title_sort |
clinical efficacy and safety of sirolimus in systemic lupus erythematosus: a real-world study and meta-analysis |
publisher |
SAGE Publishing |
series |
Therapeutic Advances in Musculoskeletal Disease |
issn |
1759-7218 |
publishDate |
2020-09-01 |
description |
Objective: To provide real-world data and summarize current clinical evidence on the efficacy and safety of sirolimus in active systemic lupus erythematosus (SLE) patients. Methods: This was a prospective real-world clinical study. Included SLE patients should have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ⩾ 2. They were treated with sirolimus and followed up regularly. The SLEDAI-2K, Physician Global Assessment (PGA), serological activity indices, and remission of organ manifestations were evaluated. We also performed a meta-analysis to integrate current evidence of sirolimus in SLE. Results: A total of 49 patients were included in the final analysis. After treatment, the SLEDAI-2K (6.2 ± 3.1 versus 4.0 ± 3.4, p = 0.001) decreased significantly, and the prednisone dosage was tapered successfully (9.9 ± 8.8 mg/day versus 5.9 ± 4.0 mg/day, p = 0.002). Serological activity indices also improved [complement 3 (C3): 0.690 ± 0.209 g/l versus 0.884 ± 0.219 g/l, p < 0.001; complement 4: 0.105 ± 0.059 g/l versus 0.141 ± 0.069 g/l, p < 0.001; anti-dsDNA antibody, 200 ± 178 IU/ml versus 156 ± 163 IU/ml, p = 0.022]. The remission proportions of arthritis, skin rash, and thrombocytopenia were 100%, 88.8%, and 46.2%, respectively. A total of 41.2% of lupus nephritis (LN) patients achieved renal remission, but the average 24-h urine protein level was not significantly changed. Meta-analysis enrolled five studies with 149 patients included, and revealed similar results regarding the changes of SLEDAI-2K [−3.5 (−5.0, −2.1)], C3 [0.224 (0.136, 0.311) g/l] and daily dosage of prednisone [−12.7 (−19.9, −5.6) mg/day]. Conclusion: Sirolimus might be effective and tolerated in SLE. The role of sirolimus in LN requires further study. |
url |
https://doi.org/10.1177/1759720X20953336 |
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