Efficacy and Safety of Monoclonal Antibody Therapy in Neuromyelitis Optica Spectrum Disorders: Evidence from Randomized Controlled Trials

2020 ◽  
Vol 43 ◽  
pp. 102166 ◽  
Author(s):  
Tao Xue ◽  
Yanbo Yang ◽  
Qiran Lu ◽  
Bixi Gao ◽  
Zhouqing Chen ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Randomized Controlled Trials ◽  
Neuromyelitis Optica ◽  
Antibody Therapy ◽  
Controlled Trials ◽  
Monoclonal Antibody Therapy ◽  
Neuromyelitis Optica Spectrum Disorders ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Spectrum Disorders

scholarly journals Different Targets of Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders: A Meta-Analysis Evidenced From Randomized Controlled Trials

2020 ◽  
Vol 11 ◽  
Author(s):  
Tao Xue ◽  
Jiahao Yu ◽  
Shujun Chen ◽  
Zilan Wang ◽  
Yanbo Yang ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Neuromyelitis Optica ◽  
Meta Analysis ◽  
Antibody Therapy ◽  
Controlled Trials ◽  
Monoclonal Antibody Therapy ◽  
Randomized Controlled

Background: Neuromyelitis optica spectrum disorder (NMOSD), an autoimmune inflammatory disorder of the central nervous system, often leads to vision loss or paralysis. This meta-analysis focused on the assessment of the monoclonal antibody therapy in NMOSD and compared different targets of monoclonal antibodies with each other in terms of efficacy and safety outcomes.Method: We searched through the databases of MEDLINE, EMBASE, Central Register of Controlled Trials (CENTRAL), and clinicaltrials.gov for randomized controlled trials (RCTs) evaluating monoclonal antibody therapy in NMOSD up to April 2020.Results: We identified seven randomized controlled trials (RCTs), including 775 patients (monoclonal antibody group, n = 485 and placebo group, n = 290). Monoclonal antibody therapy decreased relapse risk (RR 0.33, 95% CI 0.21–0.52, P < 0.00001), annualized relapse rate (ARR) (mean −0.28, 95% CI −0.35−0.20, P < 0.00001), expanded disability status scale score (EDSS) (mean −0.19, 95% CI −0.32−0.07, P = 0.002) and serious adverse events (RR 0.78, 95% CI 0.61–1.00, P = 0.05). However, we did not observe any significant difference in terms of adverse events or mortality. Further, the subgroup analysis demonstrated that the anti-complement protein C5 monoclonal antibody (eculizumab) might have a lower relapse risk (RR 0.07, 95% CI 0.02–0.23, P < 0.0001) in the AQP4 seropositive patients, and anti-interleukin-6 receptor monoclonal antibodies (satralizumab and tocilizumab) showed decreased EDSS score (mean −0.17, 95% CI −0.31−0.02, P = 0.02) more effectively than other monoclonal antibodies.Conclusions: Monoclonal antibodies were effective and safe in NMOSD. Different targets of monoclonal antibodies might have their own advantages.

scholarly journals Monoclonal Antibody Therapy in Neuromyelitis Optica Spectrum Disorders: a Meta-analysis of Randomized Control Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Fanxin Kong ◽  
Jianjun Wang ◽  
Haotao Zheng ◽  
Haobin Cai ◽  
Jun Hua ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Neuromyelitis Optica ◽  
Antibody Therapy ◽  
Cochrane Library ◽  
Control Group ◽  
Monoclonal Antibody Therapy ◽  
Neuromyelitis Optica Spectrum Disorders ◽  
Spectrum Disorders

Background: To update the efficacy and safety data of monoclonal antibodies for the treatment of neuromyelitis optica spectrum disorders (NMOSD) and explore the differences in the effect of treatment between patients seropositive and seronegative for AQP4-IgG. Methods: PubMed, Embase, and the Cochrane Library published up to July 2020 were searched for randomized controlled trials (RCTs) of monoclonal antibodies treatment (mAb) in patients with NMOSD. The primary outcome was the hazard ratio (HR) for relapse. The secondary outcomes included Expanded Disability Status Scale (EDSS) changes from baseline, adverse events (AEs), and serious adverse events (SAEs). A random-effects model was applied for the effect of heterogeneity among trials. Results: We included 603 patients (monoclonal antibody group, n=382, and control group, n=221) from seven RCTs. There were fewer relapses in the mAb group (HR=0.32, 95% CI: 0.23-0.46, p<0.001), as well as in the AQP4-IgG-seropositive patients (HR=0.18, 95% CI: 0.10–0.32, p<0.001), but not in AQP4-IgG-seronegative NMOSD. Similar results were observed when considering satralizumab only. The mAb had no impact on the changes in EDSS scores from baseline (WMD=−0.21, 95% CI: −0.50-0.09, p=0.176). The mAb did not lead to a higher frequency of AEs (OR=1.18, 95% CI: 0.70–1.98, p=0.529) or SAEs (OR=0.99, 95% CI: 0.63–1.56, p=0.975) compared with the control group. Conclusions: Compared to the control arm, monoclonal antibody therapy showed a significantly better outcome in restraining the HR for relapse among patients with NMOSD but insignificant effects in NMOSD patients with seronegative APQ4-IgG. The safety profile in each arm had no significant difference.

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 radiofrequency ablation for treatment of knee osteoarthritis: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110066
Author(s):  
Hua Zhang ◽  
Bo Wang ◽  
Jie He ◽  
Zhongju Du
Keyword(s):  
Radiofrequency Ablation ◽  
Knee Osteoarthritis ◽  
Randomized Controlled Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Cochrane Review ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Randomized Controlled

Objective To evaluate the efficacy and safety of radiofrequency ablation for the treatment of knee osteoarthritis. Methods A literature review was conducted using the PubMed, Cochrane Review, Embase, and Google Scholar databases. Two reviewers independently assessed the eligibility of all retrieved studies. The research was reported based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to ensure the reliability and verity of the results. The statistical analysis was performed using STATA version 13.0. Results Nine randomized controlled trials were collected for the data extraction and meta-analysis. Significant differences in the pain score at 4, 12, and 24 weeks were found between patients treated with radiofrequency ablation and those treated with placebo. Furthermore, the use of radiofrequency ablation was associated with an improved outcome of the Western Ontario and McMaster Universities Arthritis Index at 4, 12, and 24 weeks. No serious adverse events were observed in any patients who underwent radiofrequency ablation. Conclusion Radiofrequency ablation is efficacious and safe for reducing pain and improving knee function in patients with knee osteoarthritis, without increasing the risk of adverse effects.

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