Outcomes of allogeneic hematopoietic cell transplantation in patients with myelofibrosis: A systematic review and meta-analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7045-7045
Author(s):  
Jan Philipp Bewersdorf ◽  
Amar Sheth ◽  
Shaurey Vetsa ◽  
Alyssa Grimshaw ◽  
Smith Giri ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Meta Analysis ◽  
Controlled Vocabulary ◽  
Hematopoietic Cell ◽  
Cochrane Library ◽  
Free Text ◽  
Cell Transplant ◽  
Efficacy And Safety ◽  
Significant Difference

7045 Background: Allogeneic hematopoietic cell transplant (allo-HCT) remains the only potentially curative therapeutic modality for patients with primary or secondary myelofibrosis (MF). However, many patients (pts) are ineligible for allo-HCT and transplant-related mortality can be substantial. Data on the efficacy and safety of allo-HCT are mixed and largely derived from retrospective studies. Methods: To synthesize the available evidence, we conducted a systematic review and meta-analysis searching Cochrane Library, Google Scholar, Ovid Medline, Ovid Embase, PubMed, Scopus, and Web of Science Core Collection from inception to October 11, 2020 for studies on allo-HCT in MF. Databases were searched using a combination of controlled vocabulary and free text terms for relevant studies on the efficacy and safety of allo-HCT in pts with primary and secondary MF. This study protocol has been registered on PROSPERO (CRD42020188706). Random-effects models were used to pool response rates for the co-primary outcomes of 1-year, 2-year and 5-year overall survival (OS). Results: We identified 4247 studies after duplicate removal. 393 studies were assessed as full-texts for eligibility and 43 studies (38 retrospective, 1 prospective study, 4 phase II clinical trials) with 8739 pts were included in this meta-analysis. Study quality was limited by the absence of randomized clinical trials and retrospective design of most studies. Rates of 1-year, 2-year, and 5-year OS were 66.7% (95% confidence interval: 63.5-69.8%), 64.4% (57.6-70.6%), and 55.0% (51.8-58.3%), respectively. Rates of 1-year, 2-year, and 5-year non-relapse mortality were 25.9% (23.3-28.7%), 29.7% (24.5-35.4%), and 30.5% (25.9-35.5%), respectively. Among evaluable studies, rates of 1-year, 2-year, and 5-year relapse-free survival were 65.3% (56.5-73.1%), 56.2% (41.6-69.8%), and 53.6% (39.9-66.9%), respectively. Adverse events related to all-HCT were manageable with rates of acute and chronic graft-versus-host disease in 44.0% (39.6-48.4%; grade III/IV: 15.2%) and 46.5% of patients (42.2-50.8%; extensive or moderate/severe: 26.1%), respectively. Subgroup analyses did not show any significant difference between conditioning regimen intensity (myeloablative vs reduced-intensity), median patient age, and proportion of DIPSS-intermediate-2/high pts. Conclusions: Given the poor prognosis of patients not receiving transplant and in the absence of curative non-transplant therapies, our results support consideration of allo-HCT for eligible pts with MF. However, additional studies in pre- and post-allo-HCT setting are necessary to enhance patient selection (e.g. by incorporation of molecular markers), to optimize transplant strategies (e.g. peri-transplant ruxolitinib, conditioning regimens, and donor selection), symptom management and decrease non-relapse mortality.

scholarly journals A Systematic Review and Meta-Analysis of Therapeutic Efficacy and Safety of Alirocumab and Evolocumab on Familial Hypercholesterolemia

2021 ◽  
Vol 2021 ◽  
pp. 1-16
Author(s):  
Xiaoyue Ge ◽  
Tiantian Zhu ◽  
Hao Zeng ◽  
Xin Yu ◽  
Juan Li ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Familial Hypercholesterolemia ◽  
Meta Analysis ◽  
Density Lipoprotein ◽  
Apolipoprotein A1 ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Apo B ◽  
Significant Difference

Objectives. The aim of this study was to provide the first study to systematically analyze the efficacy and safety of PCSK9-mAbs in the treatment of familial hypercholesterolemia (FH). Methods. A computer was used to search the electronic Cochrane Library, PubMed/MEDLINE, and Embase databases for clinical trials using the following search terms: “AMG 145”, “evolocumab”, “SAR236553/REGN727”, “alirocumab”, “RG7652”, “LY3015014”, “RN316/bococizumab”, “PCSK9”, and “familial hypercholesterolemia” up to November 2020. Study quality was assessed with the Cochrane Collaboration’s tool, and publication bias was evaluated by a contour-enhanced funnel plot and the Harbord modification of the Egger test. After obtaining the data, a meta-analysis was performed using R software, version 4.0.3. Results. A meta-analysis was performed on 7 clinical trials (926 total patients). The results showed that PCSK9-mAbs reduced the LDL-C level by the greatest margin, WMD −49.14%, 95% CI: −55.81 to −42.47%, on FH versus control groups. PCSK9-mAbs also significantly reduced lipoprotein (a) (Lp (a)), total cholesterol (TC), triglycerides (TG), apolipoprotein-B (Apo-B), and non-high-density lipoprotein cholesterol (non-HDL-C) levels and increased HDL-C and apolipoprotein-A1 (Apo-A1) levels of beneficial lipoproteins. Moreover, no significant difference was found between PCSK9-mAbs treatment and placebo in common adverse events, serious events, and laboratory adverse events. Conclusion. PCSK9-mAbs significantly decreased LDL-C and other lipid levels with satisfactory safety and tolerability in FH treatment.

scholarly journals Repurposing of drugs for Covid-19: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Pinky Kotecha ◽  
Alexander Light ◽  
Enrico Checcucci ◽  
Daniele Amparore ◽  
Cristian Fiori ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Cochrane Library ◽  
Control Group ◽  
Significant Difference

AbstractObjectiveThe aim of this systematic review is to evaluate the data currently available regarding the repurposing of different drugs for Covid-19 treatment. Participants with suspected or diagnosed Covid-19 will be included. The interventions being considered are drugs being repurposed, and comparators will include standard of care treatment or placebo.MethodsWe searched Ovid-MEDLINE, EMBASE, Cochrane library, clinical trial registration site in the UK(NIHR), Europe (clinicaltrialsregister.eu), US (ClinicalTrials.gov) and internationally (isrctn.com), and reviewed the reference lists of articles for eligible articles published up to April 22, 2020. All studies in English that evaluated the efficacy of the listed drugs were included. Cochrane RoB 2.0 and ROBINS-I tool were used to assess study quality. This systematic review adheres to the PRISMA guidelines. The protocol is available at PROSPERO (CRD42020180915).ResultsFrom 708 identified studies or clinical trials, 16 studies and 16 case reports met our eligibility criteria. Of these, 6 were randomized controlled trials (763 patients), 7 cohort studies (321 patients) and 3 case series (191 patients). Chloroquine (CQ) had a 100% discharge rate compared to 50% with lopinavir-ritonavir at day 14, however a trial has recommended against a high dosage due to cardiotoxic events. Hydroxychloroquine (HCQ) has shown no significant improvement in negative seroconversion rate which is also seen in our meta-analysis (p=0.68). Adverse events with HCQ have a significant difference compared to the control group (p=0.001). Lopinavir-ritonavir has shown no improvement in time to clinical improvement which is seen in our meta-analyses (p=0.1). Remdesivir has shown no significant improvement in time to clinical improvement but this trial had insufficient power.DiscussionDue to the paucity in evidence, it is difficult to establish the efficacy of these drugs in the treatment of Covid-19 as currently there is no significant clinical effectiveness of the repurposed drugs. Further large clinical trials are required to achieve more reliable findings. A risk-benefit analysis is required on an individual basis to weigh out the potential improvement in clinical outcome and viral load reduction compared to the risks of the adverse events. (1-16)

Efficacy and Safety of Subcutaneous Immunotherapy for Local Allergic Rhinitis: A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
pp. 194589242110505
Author(s):  
Wanting Zhu ◽  
Pei Gao ◽  
Qidi Zhang ◽  
Jianjun Chen
Keyword(s):  
Clinical Trials ◽  
Allergic Rhinitis ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Subcutaneous Immunotherapy ◽  
Life Questionnaire ◽  
Immunologic Response ◽  
Efficacy And Safety ◽  
Local Allergic Rhinitis ◽  
Significant Difference

Background Subcutaneous immunotherapy (SCIT) has been used for treating local allergic rhinitis (LAR) patients. However, the clinical efficacy and safety were still questioned. Objective This study was designed to estimate the efficacy and safety of SCIT for treating LAR patients through meta-analysis. Methods We systemically searched MEDLINE, Cochrane Library, and Embase publications. Randomized, double-blind, clinical trials for the efficacy and safety of Allergen Immunotherapy (AIT) for LAR were included. A meta-analysis of 4 clinical endpoints (combined symptom and medication scores [CSMS], symptom scores [SS], medication scores [MS] and rhinoconjunctivitis quality of life questionnaire [RQLQ]) and adverse events (AEs)) was performed after bias and heterogeneity assessments. The immunologic response results were summarized. Results Four RCTs with 134 patients were included. Four studies for analyzing primary outcomes (CSMS, SS, MS) and AEs, three for RQLQ results. The results indicated an important significant difference between SCIT and placebo groups, list as follows: CSMS (SMD = −2.42, 95% CI: −3.60 to −1.25, P < .0001), SS (SMD = −2.08, 95% CI −3.68 to −0.48, P = .01), MS (SMD = −1.43, 95% CI: −2.65 to −0.21, P = 0.02), RQLQ (SMD = −0.70, 95% CI −1.29 to −0.12, P = .02), Local AEs (RR = 4.13, 95% CI 1.08 to 15.77, P = .04). For immunologic response, significantly increased serum sIgG4 levels and improvements of allergen tolerance was observed after SCIT. Conclusions Our meta-analysis suggests that SCIT has a significant effect on improving symptoms and reducing medicine consumption for LAR patients. Larger and multicenter clinical trials are needed to clarify the safety and long-term efficacy.

scholarly journals Efficacy and Safety of Tocilizumab in Patients with COVID-19 : A Systematic Review and Meta-Analysis.

2020 ◽  
Author(s):  
Zhenlu Li ◽  
Qianqiu Che ◽  
Mao Li ◽  
Jianping Liu ◽  
Rao Du ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Mortality Rate ◽  
Disease Severity ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Case Control Studies ◽  
Significant Difference ◽  
Critical Patients

Abstract Background Tocilizumab (TCZ) is an anti-interleukin-6 antibody that has been used to treat patients with 2019 coronavirus disease (COVID-19). Numerous retrospective studies have shown beneficial treatment efficacy. Several recent randomized clinical trials have questioned the efficacy of TCZ in patients with COVID-19. Therefore, we performed an updated systematic review and meta-analysis to explore the effectiveness and safety of tocilizumab recently used for treating patients with COVID-19. Methods Randomized clinical trials (RCTs) and comparative studies that compared the outcomes between TCZ and standard of care (SOC) were analysed. PubMed, EMBASE, and the Cochrane Library (inception to November 20, 2020) were systematically searched. Primary outcomes included mortality and the rate of requirement for mechanical ventilation (MV). In addition, several subgroup analyses stratified by disease severity, publication type and TCZ administration were performed. Results Three RCTs, twenty-one cohort studies and nine case-control studies including 11,206 patients were finally included. The TCZ group included 2,794 patients (24.93%) and the SOC group included 8,412 patients (75.07%). The mortality rate (>14 days) of the TCZ group, 29.63% (590/1,991), was lower than the SOC group, 41.51% (2,380/5,734) (OR 0.64, 0.57 to 0.73; p <0.00001). However, no significant difference in-14-day mortality rates was observed between the two groups (13.53% vs 22.92%, p = 0.21). Meanwhile, the rate of MV was significantly decreased in the TCZ group compared with the SOC group (OR 0.42, 0.22 to 0.83; p = 0.01). According to the results of the subgroup analysis stratified by disease severity, TCZ only reduced the mortality rate for critical patients with COVID-19 compared with SOC (OR 0.60, 0.52 to 0.71; P < 0.00001), particularly for patients in the intensive care unit (ICU) or patients requiring MV. No statistically significant increase was recognized in the rates of secondary infections or thrombosis between the two groups. Conclusions This systematic review and meta-analysis found that the addition of tocilizumab to the SOC might reduce mortality after 14 days in patients with COVID-19, particularly critical patients requiring MV. More extensive RCTs with longer follow-up periods are needed to validate these findings.

scholarly journals Hydroxychloroquine plus standard care compared with the standard care alone in COVID-19: a meta-analysis of randomized controlled trials

2020 ◽  
Author(s):  
Bahman Amani ◽  
Ahmad Khanijahani ◽  
Behnam Amani
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Standard Care ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

AbstractBackground & ObjectiveThe efficacy and safety of Hydroxychloroquine (HCQ) in treating coronavirus disease COVID-19 pandemic is disputed. This study aimed to examine the efficacy and safety of HCQ plus the standard of care in COVID-19 patients.MethodsPubMed, The Cochrane Library, Embase, and web of sciences were searched up to June 1, 2020. The references list of the key studies was reviewed for additional relevant resources. Clinical studies registry databases were searched for identifying potential clinical trials. The quality of the included studies was evaluated using the Cochrane Collaboration’s tool. Meta-analysis was performed using RevMan software (version 5.3).ResultsThree randomized controlled trials with total number of 242 patients were identified eligible for meta-analysis. No significant differences were observed between HCQ and standard care in terms of viral clearance (Risk ratio [RR] = 1.03; 95% confidence interval [CI] = 0.91, 1.16; P = 0.68), disease progression (RR = 0.92; 95% CI = 0.10, 0.81; P = 0.94), Chest CT (RR = 1.40; 95% CI = 1.03, 1.91; P = 0.03). There is a significant difference between HCQ and standard care for adverse events (RR = 2.88; 95% CI = 1.50, 5.54; P = 0.002).ConclusionAlthough the current meta-analysis failed to confirm the efficacy and safety of HCQ in the treatment of COVID-19 patients, further rigorous randomized clinical trials are necessary to evaluate conclusively the efficacy and safety of HCQ against COVID-19.

scholarly journals Efficacy and safety of Azithromycin and Amoxicillin/clavulanate for otitis media in children: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Gabriel Tesfai ◽  
Solomon Abay ◽  
Eyasu Makonnen
Keyword(s):  
Systematic Review ◽  
Otitis Media ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Statistical Significant Difference ◽  
Effect Measure ◽  
Significant Difference ◽  
Amoxicillin Clavulanate

Abstract BackgroundResistance, prolonged therapy and more adverse reactions made amoxicillin less preferred for treating otitis media. The aim of this study was to compare the efficacy and safety of azithromycin and amoxicillin/clavulanate for treatment of otitis media in children.MethodologyThis study was a systematic review and meta-analysis. PubMed, Cochrane library and Google scholar databases were searched. Comparative RCT studies between azithromycin and amoxicillin/clavulanate to treat otitis media in children published up to 30 September 2019 were included. Risk of bias was assessed and Data was extracted by the first author and checked by second author. Meta-analysis was performed by STATA software version 16, and Mantel-Haenszel statistical method with effect measure odds ratio was employed for analysis.Result751 records were identified and 14 studies were eligible for analysis. In 12 studies azithromycin had equivalent clinical efficacy and 2 had less to amoxicillin/clavulanate. Meta-analysis results showed small statistical difference on efficacy in favor of amoxicillin/clavulanate after completion of treatment OR 0.75, 95% CI (0.62–0.91). On subgroup analysis for children less than 2 year (OR 0.96 95% CI (0.49–2.29), and greater than 2 year (OR 1.40 95% CI (0.93–2.11) and also efficacy on follow up (OR 0.97 95% CI (0.83–1.15) there is no statistical significant difference. The clinical adverse events are more in amoxicillin/clavulanate group than in azithromycin with statistical significant difference OR 0.46 95% CI (0.43–0.56).ConclusionAzithromycin is not inferior to amoxicillin/clavulanate to treat otitis media in children, and it is safer and more tolerable.

scholarly journals Efficacy and safety of thromboprophylaxis in cancer patients: a systematic review and meta-analysis

2020 ◽  
Vol 12 ◽  
pp. 175883592090754
Author(s):  
Miao Liu ◽  
Guiyue Wang ◽  
Yuhang Li ◽  
Hongliang Wang ◽  
Haitao Liu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Patients With Cancer ◽  
Significant Difference ◽  
All Cause Mortality ◽  
The Cochrane Library

Background: Thrombosis is a common complication in patients with cancer. Whether thromboprophylaxis could benefit patients with cancer is unclear. The aim of this systematic review was to determine the efficacy and safety of thromboprophylaxis in patients with cancer undergoing surgery or chemotherapy. Methods: We searched the Cochrane Library, EMBASE, MEDLINE, EBSCOhost, and Web of Science for studies published before May 2018 to investigate whether thromboprophylaxis measures were more effective than a placebo in patients with cancer. Results: In total, 33 trials with 11,942 patients with cancer were identified. In patients with cancer undergoing surgery, the administration of thromboprophylaxis was associated with decreasing trends in venous thromboembolism (VTE) [relative risk (RR) 0.51, 95% confidence interval (CI) 0.32–0.81] and DVT (RR 0.53, 95% CI 0.33–0.87). In patients with cancer undergoing chemotherapy, the administration of thromboprophylaxis reduced the incidences of VTE, DVT, and pulmonary embolism compared with no thromboprophylaxis (RR 0.54, 95% CI 0.40–0.73; RR 0.47, 95% CI 0.31–0.73; RR 0.51, 95% CI 0.32–0.81, respectively). The pooled results regarding major bleeding showed no significant difference between prophylaxis and no prophylaxis in either the surgical or the chemotherapy groups (RR 2.35, 95% CI 0.74–7.52, p = 0.1482, I2 = 0%; RR 1.30, 95% CI 0.93–1.83, p = 0.1274, I2 = 0%, respectively). Conclusion: Thromboprophylaxis did not increase major bleeding events or the incidence of thrombocytopenia. All-cause mortality was not significantly different between those who received thromboprophylaxis and those who did not. This meta-analysis provides evidence that thromboprophylaxis can reduce the number of VTE and DVT events, with no apparent increase in the incidence of major bleeding in patients with cancer.

scholarly journals Systematic review and meta-analysis of second-generation antidepressants for the treatment of older adults with depression: questionable benefit and considerations for frailty

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Laurie Mallery ◽  
Tanya MacLeod ◽  
Michael Allen ◽  
Pamela McLean-Veysey ◽  
Natasha Rodney-Cail ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Adverse Events ◽  
Second Generation ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Frail Older Adults ◽  
Significant Difference

Abstract Background Frail older adults are commonly prescribed antidepressants. Yet, there is little evidence to determine the efficacy and safety of antidepressants to treat depression with concomitant frailty. To better understand this issue, we examined the efficacy and safety of second-generation antidepressants for the treatment of older adults with depression and then considered implications for frailty. Methods Due to the absence of therapeutic studies of frail older adults with depression, we conducted a systematic review and meta-analysis of double-blind, randomized controlled trials that compared antidepressants versus placebo for adults with depression, age 65 years or older. We searched PubMed/MEDLINE, Cochrane Library, reference lists from meta-analyses/studies, hand searches of publication lists, and related articles on PubMed. Outcomes included rates of response, remission, and adverse events. After evaluating the data, we applied a frailty-informed framework to consider how the evidence could be applied to frailty. Results Nine trials were included in the meta-analysis (n = 2704). Subjects had moderate to severe depression. For older adults with depression, there was no statistically significant difference in response or remission to second-generation antidepressants compared to placebo. Response occurred in 45.3% of subjects receiving an antidepressant compared to 40.5% receiving placebo (RR 1.15, 95% CI: 0.96 – 1.37, p = 0.12, I2 = 71%). Remission occurred in 33.1% with antidepressant versus 31.3% with placebo (RR 1.10, 95% CI: 0.92 – 1.31, p = 0.30, I2 = 56%) (Figure 2 and 3). There were more withdrawals due to adverse events with antidepressants, 13% versus 5.8% (RR 2.30, 95% CI: 1.45–3.63; p < 0.001; I2 = 61%; NNH 14, 95% CI:10–28). Implications for frailty Subjects in the meta-analysis did not have obvious characteristics of frailty. Using framework questions to consider the implications of frailty, we hypothesize that, like older adults, frail individuals with depression may not respond to antidepressants. Further, observational studies suggest that those who are frail may be less responsive to antidepressants compared to the non-frail. Given the vulnerability of frailty, adverse events may be more burdensome. Conclusions Second-generation antidepressants have uncertain benefit for older adults with depression and cause more adverse events compared to placebo. Until further research clarifies benefit, careful consideration of antidepressant prescribing with frailty is warranted.

scholarly journals Efficacy and safety of azithromycin and amoxicillin/clavulanate for otitis media in children: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Gabriel Dawit ◽  
Solomon Mequanent ◽  
Eyasu Makonnen
Keyword(s):  
Systematic Review ◽  
Otitis Media ◽  
Adverse Reactions ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Effect Measure ◽  
Significant Difference ◽  
Amoxicillin Clavulanate

Abstract Background Resistance, prolonged therapy, and more adverse reactions made amoxicillin less preferred for treating otitis media. This study aimed to compare the efficacy and safety of azithromycin and amoxicillin/clavulanate for the treatment of otitis media in children. Methodology This study was a systematic review and meta-analysis. PubMed, Cochrane library, and Google scholar databases were searched. Comparative randomized clinical trial studies between azithromycin and amoxicillin/clavulanate to treat otitis media in children published up to 30 September 2019 were included. The risk of bias was assessed and Data was extracted by the first author and checked by the second author. Meta-analysis was performed by STATA software version 16, and Mantel–Haenszel statistical method with effect measure odds ratio was employed for analysis. Result 751 records were identified and 14 studies were eligible for analysis. In 12 studies azithromycin had equivalent clinical efficacy and 2 had less to amoxicillin/clavulanate. Meta-analysis results showed no statistically significant difference in efficacy in favor of amoxicillin/clavulanate after completion of treatment OR 0.75, 95% CI (0.62–0.91). On subgroup analysis for children less than 2 years (OR 0.96 95% CI (0.49–2.29), and greater than 2 years (OR 1.40 95% CI (0.93–2.11) and also efficacy on follow up (OR 0.97 95% CI (0.83–1.15) there is no statistically significant difference. The clinical adverse events are more in the amoxicillin/clavulanate group than in the azithromycin with a statistical significant difference OR 0.46 95% CI (0.43–0.56). Conclusion Azithromycin is comparable to amoxicillin/clavulanate to treat otitis media in children, and it is safer and more tolerable.

scholarly journals Efficacy and Safety of Tocilizumab in Patients with COVID-19: A Systematic Review and Meta-Analysis.

2021 ◽  
Author(s):  
Zhenlu Li ◽  
Qianqiu Che ◽  
Mao Li ◽  
Jianping Liu ◽  
Rao Du ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Mortality Rate ◽  
Disease Severity ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Case Control Studies ◽  
Significant Difference ◽  
Critical Patients

Abstract Background Tocilizumab (TCZ) is an anti-interleukin-6 antibody that has been used to treat patients with 2019 coronavirus disease (COVID-19). Numerous retrospective studies have shown beneficial treatment efficacy. Several recent randomized clinical trials have questioned the efficacy of TCZ in patients with COVID-19. Therefore, we performed an updated systematic review and meta-analysis to explore the effectiveness and safety of tocilizumab recently used for treating patients with COVID-19. Methods Randomized clinical trials (RCTs) and comparative studies that compared the outcomes between TCZ and standard of care (SOC) were analysed. PubMed, EMBASE, and the Cochrane Library (inception to November 20, 2020) were systematically searched. Primary outcomes included mortality and the rate of requirement for mechanical ventilation (MV). In addition, several subgroup analyses stratified by disease severity, publication type and TCZ administration were performed. Results Three RCTs, twenty-one cohort studies and nine case-control studies including 11,206 patients were finally included. The TCZ group included 2,794 patients (24.93%) and the SOC group included 8,412 patients (75.07%). The mortality rate (>14 days) of the TCZ group, 29.63% (590/1,991), was lower than the SOC group, 41.51% (2,380/5,734) (OR 0.64, 0.57 to 0.73; p <0.00001). However, no significant difference in-14-day mortality rates was observed between the two groups (13.53% vs 22.92%, p = 0.21). Meanwhile, the rate of MV was significantly decreased in the TCZ group compared with the SOC group (OR 0.42, 0.22 to 0.83; p = 0.01). According to the results of the subgroup analysis stratified by disease severity, TCZ only reduced the mortality rate for critical patients with COVID-19 compared with SOC (OR 0.60, 0.52 to 0.71; P < 0.00001), particularly for patients in the intensive care unit (ICU) or patients requiring MV. No statistically significant increase was recognized in the rates of secondary infections or thrombosis between the two groups. Conclusions This systematic review and meta-analysis found that the addition of tocilizumab to the SOC might reduce mortality after 14 days in patients with COVID-19, particularly critical patients requiring MV. More extensive RCTs with longer follow-up periods are needed to validate these findings.

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