Efficacy and safety of IL-17 inhibitors for the treatment of ankylosing spondylitis: a meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Yufeng Yin ◽  
Mingjun Wang ◽  
Mengru Liu ◽  
Erye Zhou ◽  
Tian Ren ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Infectious Diseases ◽  
Randomized Controlled Trials ◽  
Response Rate ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
End Point ◽  
Increased Risk

Abstract Objectives: To systematically assess the efficacy and safety of IL-17 inhibitors in patients with active ankylosing spondylitis.Methods: Electronic databases were searched for randomized controlled trials (RCTs) concerning IL-17 inhibitors in patients with ankylosing spondylitis. The efficacy and safety of the IL-17 inhibitors in the treatment of these patients were compared to those of a placebo. The primary end point was predefined as the proportion of patients with at least 20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) response criteria at week 16, and the secondary end point was defined as ASAS40 at week 16.Results: Six phase III randomized, double-blind, placebo-controlled trials including 1733 patients (1153 patients received IL-17 inhibitors, including secukinumab or ixekizumab, whereas 580 patients received a placebo as comparators) were included. At week 16, the IL-17 inhibitor regimen produced a significant increase in the ASAS20 response rate (RR=1.63, 95% CI 1.45 to 1.84, p=0.00) and the secondary endpoint ASAS40 response rate (RR=2.12, 95% CI 1.75 to 2.56, p=0.00) versus those for the placebo. With respect to the safety profile, more infectious diseases were described after treatment with IL-17 inhibitors than after treatment with placebo (RR=1.82, 95% CI 1.40 to 2.37, p<0.001), while no increased risk of other adverse events was indicated after IL-17 inhibitor therapy, including treatment-emergent adverse events, death, discontinuation due to adverse event, serious adverse events, or total adverse events.Conclusions: IL-17 inhibitors produced favourable response rates but an increased risk of infectious diseases in the treatment of active ankylosing spondylitis.

scholarly journals Efficacy and safety of IL-17 inhibitors for the treatment of ankylosing spondylitis: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Yufeng Yin ◽  
Mingjun Wang ◽  
Mengru Liu ◽  
Erye Zhou ◽  
Tian Ren ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Response Rate ◽  
Phase Iii ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
End Point ◽  
Increased Risk ◽  
Severe Infections

Abstract Objectives: To systematically assess the efficacy and safety of IL-17 inhibitors in patients with active ankylosing spondylitis. Methods: A systematic review of the literature was performed for randomized controlled trials (RCTs) concerning IL-17 inhibitors in patients with ankylosing spondylitis. Meta-analyses were used to determine the efficacy and safety of the IL-17 inhibitors in the treatment of these patients. The primary end point was predefined as the proportion of patients with at least 20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) response criteria at week 16, and the secondary end point was defined as ASAS40 at week 16. Results: Six phase III randomized, double-blind, placebo-controlled trials including 1733 patients (1153 patients received IL-17 inhibitors, including secukinumab or ixekizumab, whereas 580 patients received a placebo as comparators) were included. At week 16, the IL-17 inhibitor regimen produced a significant increase in the ASAS20 response rate (RR=1.63, 95% CI 1.45 to 1.84, p=0.00) and the secondary endpoint ASAS40 response rate (RR=2.12, 95% CI 1.75 to 2.56, p=0.00) versus those for the placebo. With respect to the safety profile, more treatment-emergent adverse events (RR=1.11, 95% CI 1.01 to 1.22, p=0.03) and non-severe infections (RR=1.82, 95% CI 1.40 to 2.37, p<0.001) were described after treatment with IL-17 inhibitors than after treatment with placebo, while no increased risk of other adverse events was indicated after IL-17 inhibitor therapy, including death, discontinuation due to adverse events, or serious adverse events. Conclusions: IL-17 inhibitors produced favourable response rates but an increased risk of non-severe infections in the treatment of active ankylosing spondylitis.

scholarly journals Efficacy and safety of interleukin-17A inhibitors in patients with ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Peng Wang ◽  
Shuo Zhang ◽  
Binwu Hu ◽  
Weijian Liu ◽  
Xiao Lv ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Randomized Controlled Trials ◽  
Fixed Effects ◽  
Response Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Interleukin 17A ◽  
Mean Differences

AbstractTo assess the efficacy and safety of interleukin (IL)-17A inhibitors in patients with ankylosing spondylitis (AS). PubMed, EMBASE, and Web of Science were searched up to 5 February 2020 for randomized controlled trials (RCTs) that assessed the efficacy and safety of IL-17A inhibitors in patients with AS. We used a meta-analytic approach to perform a random effects analysis or fixed effects analysis according to heterogeneity. Subgroup analyses between studies included medication, time to primary endpoint, and data source. Odds ratios (ORs) or mean differences (MDs) were used to assess the efficacy and safety of IL-17A inhibitors in AS. A total of ten RCTs with 2613 patients were eligible for inclusion in the analysis (six for secukinumab, two for ixekizumab, one for netakimab, and one for bimekizumab). Compared to placebo, IL-17A inhibitors improved ASAS20 response rate (OR = 2.58; p < 0.01) and ASAS40 response rate (OR = 2.80; p < 0.01), and significantly increased the risk of AEs (OR = 1.23; p = 0.03) and nasopharyngitis (OR = 1.72; p < 0.01), but not SAEs (OR = 0.87; p = 0.60). IL-17A inhibitors demonstrated better efficacy in patients with AS in several evaluation indicators. However, the safety of IL-17A inhibitors remains to be further studied in studies with larger sample size and longer follow-up times.

scholarly journals Benefits and Risks of Chloroquine and Hydroxychloroquine in The Treatment of Viral Diseases: A Meta-Analysis of Placebo Randomized Controlled Trials

2020 ◽  
Author(s):  
Jing Wang ◽  
Li Yu ◽  
Kefeng Li
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Viral Diseases ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Increased Risk

AbstractBackground and ObjectiveRecently, in the scramble to find drugs to treat COVID-19, chloroquine (CQ) and its derivative hydroxychloroquine (HCQ) have rapidly gained the public’s attention. In this study, we conducted a meta-analysis of randomized clinical trials (RCTs) to evaluate the efficacy and safety of CQ and HCQ in the treatment of viral diseases.MethodsWe searched PubMed, EMBASE, Cochrane Central, Web of Science, Clinical Trials Registries, CNKI, Wanfang Data, CQVIP, and Preprint Servers through April 4, 2020, for randomized controlled trials (RCTs) that examined the efficacy and safety of CQ and HCQ against viral infection. We analyzed pooled data on the overall efficacy, the relative risks over the placebo, and the prevalence of adverse events. Trial sequential analysis (TSA) was also performed to evaluate the random errors in the meta-analysis. Potential moderators of drug-placebo efficacy differences were analyzed by meta-regression.ResultsThe analysis included 11 RCTs with 2613 adult patients. Both the plasma viral load (standard mean difference: 0.29, 95% CI: −1.19 - 1.76, P = 0.70) and the improvement of clinical symptoms (odds ratio: 2.36, 95% CI: 0.81 - 6.92, P = 0.11) were not different between the intervention and placebo arm. There was significant heterogeneity for the efficacy assessment, which was primarily explained by the mean patients’ age and the sample size. Compared to the placebo, CQ and HCQ had increased risk of mild adverse events (risk ratio: 1.51, 95% CI: 1.35 - 1.70, P < 0.05, TSA adjusted 95% CI: 1.31 - 2.19), which were statistically significant in nervous, integumentary, and gastrointestinal systems. The most common adverse events were observed in the nervous system, with the pooled prevalence of 31.4 % (95% CI: 10.5% - 56.7%).ConclusionsInsufficient data were available to support the antiviral efficacy of CQ and HCQ due to the high heterogeneity caused by patients’ age. Mild side effects are expected for the current antiviral dose regimens of CQ and HCQ. Treatment outcomes may be enhanced by better-selected patients based on age and well-controlled adverse events.This meta-analysis was registered on OSF (ID: https://osf.io/386aw)

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals Efficacy and Safety of Sinomenine Preparation for Ankylosing Spondylitis: A Systematic Review and Meta-Analysis of Clinical Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-16
Author(s):  
Shan-Shan Lin ◽  
Chun-Xiang Liu ◽  
Jun-Hua Zhang ◽  
Hui Wang ◽  
Jing-Bo Zhai ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Randomized Controlled Trials ◽  
Methodological Quality ◽  
Morning Stiffness ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Objectives. To systematically evaluate the efficacy and safety of sinomenine preparation (SP) for treating ankylosing spondylitis (AS). Methods. Clinical randomized controlled trials (RCTs) of SP for treating AS were systematically identified in six electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wanfang Databases from the inception up to 31 October 2019. Cochrane’s risk of bias tool was used to assess the methodological quality and Review Manager 5.3 software was used to analyze data. Results. A total of 12 RCTs involving 835 patients were finally included. According to interventions, RCTs were divided into two types. The intervention in 10 RCTs was SP combined with conventional pharmacotherapy (CPT) versus CPT and that in 2 RCTs was SP alone versus CPT. The results of the meta-analysis showed that, compared with CPT alone, SP combined with oral CPT has better improvement in BASDAI (WMD = −1.84, 95% CI [−3.31, −0.37], P=0.01), morning stiffness time (WMD = −13.46, 95% CI [−16.12, −10.79], P<0.00001), the Schober test (WMD = 1.26, 95% CI [0.72, 1.80], P<0.00001), the occipital wall test (WMD = −0.55, 95% CI [−0.96, −0.14], P=0.009), the finger-to-ground distance (WMD = −3.28, 95% CI [−5.64, −0.93], P=0.006), 15 m walking time (WMD = −8.81, 95% CI [−13.42, −4.20], P=0.0002), the C-reactive protein (CRP) (WMD = −1.84, 95% CI [−3.24, −0.45], P=0.01), and the total effective rate (RR = 1.10, 95% CI [1.01, 1.20], P=0.03). Besides, it also showed that oral SP alone may be more effective in improving morning stiffness time (WMD = −31.89, 95% CI [−34.91, −28.87], P<0.00001) compared with CPT alone. However, this study cannot provide evidence that loading the injectable SP based on CPT can significantly increase the efficacy due to the insufficient number of studies included. In terms of adverse events, there was no statistically significant difference between the experimental group and the control group. Conclusions. This study shows that oral SP may be effective and safe in the treatment of AS. Due to the low methodological quality of the included RCTs and the limitations of the meta-analysis, it is still necessary to carry out more multicenter, large-sample, and high-quality RCTs to further verify the conclusions. The review protocol was registered on PROSPERO (CRD42018099170), and the review was constructed following the PRISMA guidelines (Annex 1).

scholarly journals Topical Diclofenac Solution for Osteoarthritis of the Knee: An Updated Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Tao Ling ◽  
Jiao Jiao Li ◽  
Rui-Juan Xu ◽  
Bin Wang ◽  
Wei-Hong Ge
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Physical Function ◽  
Vehicle Control ◽  
Womac Pain ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Skin Reactions ◽  
Randomized Controlled ◽  
Topical Diclofenac

This study was performed to assess the efficacy and safety of a topical diclofenac solution in patients with knee osteoarthritis (OA). PubMed, Embase, Cochrane Library, Web of Science, and Scopus databases were searched for randomized controlled trials until June 2020. The WOMAC pain, stiffness, physical function subscales, pain on walking, and the occurrence of adverse events were pooled to comprehensively analyse the efficacy and safety of topical diclofenac solution. All statistical analyses were conducted using Review Manager 5.3 software. Five RCTs were included, which provided high-quality evidence. In comparison to the vehicle control, the mean differences for WOMAC pain, stiffness, and physical function subscales, as well as pain on walking, were all statistically significant in favor of topical diclofenac solution. The safety of topical diclofenac solution was similar to the vehicle control, apart from adverse events involving application-site skin reactions. Topical diclofenac solution is effective and safe for use in patients with knee OA, but may cause minor skin reactions.

Efficacy and safety of bempedoic acid in patients with hypercholesterolemia: A systematic review and meta-analysis of randomized controlled trials

2020 ◽  
pp. 204748732093058 ◽  
Author(s):  
Lei Dai ◽  
Yuyue Zuo ◽  
Qiqi You ◽  
Hesong Zeng ◽  
Shiyi Cao
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Fixed Effects ◽  
Therapeutic Option ◽  
Meta Analysis ◽  
Lipid Lowering ◽  
Oral Drug ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled

Aim Bempedoic acid is a novel oral drug, which has been increasingly researched to play an important role in the treatment of hypercholesterolemia recently. However, results from original studies were inconsistent and inconclusive. We aimed to conduct a meta-analysis to quantitatively appraise the efficacy and safety of bempedoic acid. Methods PubMed, Embase, Web of Science and Scopus were searched from inception to 30 January 2020. We included randomized controlled trials that compared the efficacy and safety of bempedoic acid with placebo in patients with hypercholesterolemia. Results from trials were presented as mean differences or odds ratios (ORs) with 95% confidence intervals (CIs) and were pooled by random or fixed effects model. The risk of bias and heterogeneity among trials were also assessed and analyzed. Results Pooled analysis of 10 eligible trials showed that bempedoic acid treatment resulted in greater lowering of the low-density lipoprotein cholesterol level than the placebo group (mean difference –23.16%, 95% CI –26.92% to –19.04%). We also found that improvements in lipid parameters and biomarkers were still maintained at weeks 24 and 52 from the long-term trials. As for safety, bempedoic acid did not increase the risk of overall adverse events (OR 1.02, 95% CI 0.88 to 1.18). However, the incidence of adverse events leading to discontinuation was higher in the bempedoic acid group (OR 1.44, 95% CI 1.14 to 1.82). Conclusions Available evidence from randomized controlled trials suggests that bempedoic acid provides a well-tolerated and effective therapeutic option for lipid lowering in patients with hyperlipidemia

scholarly journals Pridopidine for the Improvement of Motor Function in Patients With Huntington's Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Shujun Chen ◽  
Tianyu Liang ◽  
Tao Xue ◽  
Shouru Xue ◽  
Qun Xue
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Motor Score ◽  
Randomized Controlled

Background: Huntington's disease (HD) is a progressive neurodegenerative disorder. Generally, it is characterized by deficits in cognition, behavior, and movement. Recent studies have shown that pridopidine is a potential and effective drug candidate for the treatment of HD. In the present study, we performed a meta-analysis to evaluate the efficacy and safety of pridopidine in HD.Methods: The MEDLINE, EMBASE, CENTRAL, and Clinicaltrials.gov databases were searched for randomized controlled trials (RCTs) which had that evaluated pridopidine therapy in HD patients.Results: We pooled data from 1,119 patients across four RCTs. Patients in the pridopidine group had a significantly lower Unified Huntington's Disease Rating Scale (UHDRS)-modified Motor Score (mMS) (MD −0.79, 95% CI = −1.46 to −0.11, p = 0.02) than those in the placebo group. Additionally, no differences were observed in the UHDRS-Total Motor Score (TMS) (MD −0.91. 95% CI = −2.03 to 0.21, p = 0.11) or adverse events (RR 1.06, 95% CI = 0.96 to 1.16, p = 0.24) in the pridopidine and placebo groups. In the subgroup analysis, the short-term (≤12 weeks) and long-term (&gt;12 weeks) subgroups exhibited similar efficacy and safety with no statistical significance in TMS, mMS, or adverse events. However, TMS (MD −1.50, 95% CI = −2.87 to −0.12, p = 0.03) and mMS (MD −1.03, 95% CI = −1.87 to −0.19, p = 0.02) were observed to be improved significantly when the dosage of pridopidine ≥90 mg/day. Additionally, pridopidine (≥90 mg/day) increased total adverse events (RR 1.11, 95% CI = 1.00 to 1.22, p = 0.04) compared with placebo. On this basis, we analyzed the incidence of various adverse events when the dosage was ≥90 mg/day. Nonetheless, these results were within the acceptable threshold, although patients developed symptoms, such as nasopharyngitis and insomnia.Conclusion: Pridopidine improved mMS and had no statistical significance in association with TMS or adverse events. Pridopidine (≥90 mg/day) improved TMS and mMS but increased adverse events, such as nasopharyngitis and insomnia. More RCTs were expected to assess pridopidine in HD.

Efficacy and Safety of Sofosbuvir-containing Regimens in Chronic Hepatitis C Patients with Genotype 2 and 3: a Comprehensive Analysis of 18 Randomized Controlled Trials

2018 ◽  
Vol 27 (2) ◽  
pp. 159-168 ◽  
Author(s):  
Haozhi Fan ◽  
Peng Huang ◽  
Ting Tian ◽  
Jingjing Wu ◽  
Xueshan Xia ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Svr12 Rate ◽  
Randomized Controlled ◽  
Genotype 2 ◽  
Ns5b Polymerase Inhibitor ◽  
Hcv Ns5b

Background and Aim: Sofosbuvir is a hepatitis C virus (HCV) NS5B polymerase inhibitor. The objective of this study was to explore the efficacy and safety of sofosbuvir for HCV genotype (GT) 2 and 3 infected patients.Method: We searched randomized controlled trials (RCTs) which analyzed the efficacy and safety of sofosbuvircontaining regimens for HCV GT 2/3 infected patients and collected data. The endpoints were sustained virological response 12- and 24-weeks after the cessation of therapy (SVR12 and SVR24), the adverse events (AEs) and the severe adverse events (SAEs).Results: Eighteen trials comprising 2,975 HCV GT 2/3 infected patients were included. The pooled estimate SVR12, SVR24, AEs and SAEs rates were 84.6% (95% CI: 83.2-86.0), 83.7% (95% CI: 82.0-85.2), 83.8 (95% CI: 82.3-85.3) and 3.9 (95% CI: 3.2-4.8). The SVR12 rate of sofosbuvir-containing regimens for HCV GT 2 infection was higher than that for HCV GT 3 infection (95.7% vs. 80.8%). The sofosbuvir combined with velpatasvir (with or without ribavirin) regimen presented a higher SVR12 rate and lower AEs rate than the sofosbuvir combined with ribavirin (with or without peg-IFN) regimen (94.9% vs. 80.7% for SVR12 rate; 69.3% vs. 87.7% for AEs rate).Conclusions: The sofosbuvir-containing regimens in patients with HCV GT 2 infection have better efficacy than in patients with HCV GT 3 infection.

scholarly journals Efficacy and Safety of the Combination Treatment of Rituximab and Dexamethasone for Adults with Primary Immune Thrombocytopenia (ITP): A Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Jia Wang ◽  
Ya Li ◽  
Chong Wang ◽  
Yayue Zhang ◽  
Chong Gao ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Combination Treatment ◽  
Immune Thrombocytopenia ◽  
Response Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Primary Immune Thrombocytopenia

Objective.To conduct a meta-analysis, assessing the efficacy and safety of the combination treatment of dexamethasone and rituximab for adults with ITP (primary immune thrombocytopenia).Methods.Randomized controlled trials that compared rituximab and dexamethasone combination treatment to dexamethasone monotherapy in the treatment of adults with ITP were collected by searching Pubmed, Embase, Cochrane, China National Knowledge (CNKI), Wanfang database, and Sino Med. We conducted pooled analyses on OR (overall response) rate, CR (complete response) rate, PR (partial response) rate, SR (sustained response) rate, R (relapse) rate, change in Treg cell count (mean [SD]), and AE (adverse event). GRADE pro scale was used to assess the quality of the evidence. Publication bias was assessed with Egger’s test method.Results.A total of 11 randomized controlled trials were eligible for inclusion. The overall efficacy estimates favored combination arm in terms of OR rate at month 3, CR rate at week 4 and month 3, SR rate, and Treg cell count at week 2. Subgroup analysis showed that females obtained a higher OR rate than males did at week 4. No significant difference was found in pooled analysis of relapse rate between combination arm and monotherapy arm. The comparison of serious AE and other AEs showed no significant difference either. A total of 19 outcomes were assessed by GRADE pro software, of which 79% (15/19) was scaled as moderate-to-high level. Publication bias existed in studies on OR at week 4 (P=0.025), CR at week 4 (P=0.017), infection (P=0.006), and rash (P=0.028) of the AEs.Conclusion.Dexamethasone combined with rituximab can provide a better long-term response in the treatment of adults with ITP and will not increase the risk of adverse effects.

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