Systematic review with meta-analysis: Efficacy and safety of biological treatment on salivary gland function in primary Sjögren’s syndrome
Objective: The study aimed to assess the efficacy and safety of clinical trials of biologics in improving the salivary gland (SG) function in primary Sjögren’s syndrome (pSS), which has not been analyzed critically and systematically.Methods: PubMed, Web of Science, ClinicalTrials.gov, the EU Clinic...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-02-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1093924/full |
| _version_ | 1811163821252804608 |
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| author | Xiaoyan Wang Xiaoyan Wang Xiang Lin Xiang Lin Yingying Su Hao Wang |
| author_facet | Xiaoyan Wang Xiaoyan Wang Xiang Lin Xiang Lin Yingying Su Hao Wang |
| author_sort | Xiaoyan Wang |
| collection | DOAJ |
| description | Objective: The study aimed to assess the efficacy and safety of clinical trials of biologics in improving the salivary gland (SG) function in primary Sjögren’s syndrome (pSS), which has not been analyzed critically and systematically.Methods: PubMed, Web of Science, ClinicalTrials.gov, the EU Clinical Trials Register, and the Cochrane Library were searched for clinical trials that reported effects of biological treatment on the SG function and safety in pSS patients. Inclusion criteria were defined following participants, interventions, comparisons, outcome, and study design (PICOS) recommendations. The objective index (the change of unstimulated whole saliva (UWS) flow) and the serious adverse event (SAE) were assessed as main outcome measures. A meta-analysis of the efficacy and safety of the treatment was conducted. Quality assessment, sensitivity analysis, and publication bias were assessed. The effect size together with a 95% confidence interval was used to estimate the efficacy and safety of biological treatment and was plotted as a forest plot.Results: The literature search yielded 6,678 studies, nine of which fulfilled the inclusion criteria, with seven randomized controlled trials (RCTs) and two non-RCT clinical studies. Generally, biologics do not significantly increase UWS from the baseline of pSS patients compared to the control group at a matched time point (p = 0.55; standard mean difference, SMD = 0.05; 95% confidence interval, CI: −0.11 and 0.21). However, pSS patients with shorter disease duration (≤3 years; SMD = 0.46; 95% CI: 0.06 and 0.85) were prone to have a better response to biological treatment by showing higher increased UWS than patients with longer disease duration (> 3 years; SMD = −0.03; 95% CI: −0.21 and 0.15) (p = 0.03). For the meta-analysis of the safety of biological treatment, the SAEs in the biologics group were significantly higher than those of the control group (p = 0.0021; log odds ratio, OR = 1.03; 95% CI: 0.37 and 1.69).Conclusion: Biological intervention during the early course of the disease may benefit pSS patients better than that during the late course. Significantly, more SAEs in the biologics group indicate that the safety of biologics needs to be addressed for future biological clinical trials and treatment. |
| first_indexed | 2024-04-10T15:11:57Z |
| format | Article |
| id | doaj.art-8843d187ea9a4e87865cebec7ef893c8 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-10T15:11:57Z |
| publishDate | 2023-02-01 |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-8843d187ea9a4e87865cebec7ef893c82023-02-14T19:47:29ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-02-011410.3389/fphar.2023.10939241093924Systematic review with meta-analysis: Efficacy and safety of biological treatment on salivary gland function in primary Sjögren’s syndromeXiaoyan Wang0Xiaoyan Wang1Xiang Lin2Xiang Lin3Yingying Su4Hao Wang5Department of Stomatology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Biochemistry and Molecular Biology, School of Basic Medicine, Capital Medical University, Beijing, ChinaSchool of Chinese Medicine, The University of Hong Kong, Hong Kong, ChinaThe University of Hong Kong-Shenzhen Institute of Research and Innovation (HKU-SIRI), Shenzhen, ChinaDepartment of Stomatology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaDepartment of Stomatology, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaObjective: The study aimed to assess the efficacy and safety of clinical trials of biologics in improving the salivary gland (SG) function in primary Sjögren’s syndrome (pSS), which has not been analyzed critically and systematically.Methods: PubMed, Web of Science, ClinicalTrials.gov, the EU Clinical Trials Register, and the Cochrane Library were searched for clinical trials that reported effects of biological treatment on the SG function and safety in pSS patients. Inclusion criteria were defined following participants, interventions, comparisons, outcome, and study design (PICOS) recommendations. The objective index (the change of unstimulated whole saliva (UWS) flow) and the serious adverse event (SAE) were assessed as main outcome measures. A meta-analysis of the efficacy and safety of the treatment was conducted. Quality assessment, sensitivity analysis, and publication bias were assessed. The effect size together with a 95% confidence interval was used to estimate the efficacy and safety of biological treatment and was plotted as a forest plot.Results: The literature search yielded 6,678 studies, nine of which fulfilled the inclusion criteria, with seven randomized controlled trials (RCTs) and two non-RCT clinical studies. Generally, biologics do not significantly increase UWS from the baseline of pSS patients compared to the control group at a matched time point (p = 0.55; standard mean difference, SMD = 0.05; 95% confidence interval, CI: −0.11 and 0.21). However, pSS patients with shorter disease duration (≤3 years; SMD = 0.46; 95% CI: 0.06 and 0.85) were prone to have a better response to biological treatment by showing higher increased UWS than patients with longer disease duration (> 3 years; SMD = −0.03; 95% CI: −0.21 and 0.15) (p = 0.03). For the meta-analysis of the safety of biological treatment, the SAEs in the biologics group were significantly higher than those of the control group (p = 0.0021; log odds ratio, OR = 1.03; 95% CI: 0.37 and 1.69).Conclusion: Biological intervention during the early course of the disease may benefit pSS patients better than that during the late course. Significantly, more SAEs in the biologics group indicate that the safety of biologics needs to be addressed for future biological clinical trials and treatment.https://www.frontiersin.org/articles/10.3389/fphar.2023.1093924/fullmeta-analysisbiologicsprimary Sjögren’s syndromesalivary gland functionefficacysafety |
| spellingShingle | Xiaoyan Wang Xiaoyan Wang Xiang Lin Xiang Lin Yingying Su Hao Wang Systematic review with meta-analysis: Efficacy and safety of biological treatment on salivary gland function in primary Sjögren’s syndrome Frontiers in Pharmacology meta-analysis biologics primary Sjögren’s syndrome salivary gland function efficacy safety |
| title | Systematic review with meta-analysis: Efficacy and safety of biological treatment on salivary gland function in primary Sjögren’s syndrome |
| title_full | Systematic review with meta-analysis: Efficacy and safety of biological treatment on salivary gland function in primary Sjögren’s syndrome |
| title_fullStr | Systematic review with meta-analysis: Efficacy and safety of biological treatment on salivary gland function in primary Sjögren’s syndrome |
| title_full_unstemmed | Systematic review with meta-analysis: Efficacy and safety of biological treatment on salivary gland function in primary Sjögren’s syndrome |
| title_short | Systematic review with meta-analysis: Efficacy and safety of biological treatment on salivary gland function in primary Sjögren’s syndrome |
| title_sort | systematic review with meta analysis efficacy and safety of biological treatment on salivary gland function in primary sjogren s syndrome |
| topic | meta-analysis biologics primary Sjögren’s syndrome salivary gland function efficacy safety |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1093924/full |
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