Abatacept for Rheumatoid Arthritis: A Cochrane Systematic Review

2010 ◽  
Vol 37 (2) ◽  
pp. 234-245 ◽  
Author(s):  
LARA J. MAXWELL ◽  
JASVINDER A. SINGH
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Journal Club ◽  
Absolute Risk ◽  
Group Versus ◽  
Risk Difference ◽  
Cochrane Library ◽  
Control Group ◽  
Number Needed To Treat ◽  
American College Of Rheumatology

Objective.To perform a systematic review of efficacy and safety of abatacept in patients with rheumatoid arthritis (RA).Methods.We searched the Cochrane Library, MEDLINE, EMBASE, ACP Journal Club, and Biosis Previews for randomized controlled trials (RCT) comparing abatacept alone or in combination with disease modifying antirheumatic drugs (DMARD)/biologics to placebo or other DMARD/biologics in patients with RA. Two reviewers independently assessed search results, risk of bias, and extracted data.Results.Seven trials with 2908 patients were included. Compared with placebo, patients with RA treated with abatacept were 2.2 times more likely to achieve an American College of Rheumatology 50% response (ACR50) at one year (relative risk 2.21, 95% CI 1.73, 2.82) with a 21% (95% CI 16%, 27%) absolute risk difference between groups. The number needed to treat to achieve an ACR50 response was 5 (95% CI 4, 7). Significantly greater improvements in physical function, disease activity, pain, and radiographic progression were noted in abatacept-treated patients compared to placebo. Total adverse events (AE) were greater in the abatacept group (RR 1.05, 95% CI 1.01, 1.08). Other harm outcomes were not significant, with the exception of serious infections at 12 months, which were more common in the abatacept group versus control group (Peto odds ratio 1.91, 95% CI 1.07, 3.42). Serious AE were more numerous in the abatacept + etanercept group versus the placebo + etanercept group (RR 2.30, 95% CI 1.15, 4.62).Conclusion.Abatacept seems to be efficacious and safe in the treatment of RA. Abatacept should not be used in combination with other biologics to treat RA. Further longterm studies and postmarketing surveillance are required to assess for longer-term harms and sustained efficacy.

scholarly journals Decreased Mortality in Coronavirus Disease 2019 Patients Treated With Tocilizumab: A Rapid Systematic Review and Meta-analysis of Observational Studies

2020 ◽  
Author(s):  
Jishnu Malgie ◽  
Jan W Schoones ◽  
Bart G Pijls
Keyword(s):  
Side Effects ◽  
Meta Analysis ◽  
Risk Difference ◽  
World Health ◽  
Cochrane Library ◽  
Control Group ◽  
Number Needed To Treat ◽  
Receptor Antagonists ◽  
Increased Risk ◽  
Health Organization

Abstract Background We systematically reviewed the literature to answer the following research questions: (1) Does interleukin 6 (IL-6) (receptor) antagonist therapy reduce mortality in coronavirus disease 2019 (COVID-19) patients compared to patients not treated with IL-6 (receptor) antagonists; and (2) is there an increased risk of side effects in COVID-19 patients treated with IL-6 (receptor) antagonists compared to patients not treated with IL-6 (receptor) antagonists? Methods We systematically searched PubMed, PMC PubMed Central, Medline, World Health Organization COVID-19 Database, Embase, Web of Science, Cochrane Library, Emcare, and Academic Search Premier (through 30 June 2020). Random effects meta-analysis was used to pool the risk ratios and risk differences of individual studies. Risk of bias was appraised using the Methodological Index for Non-randomized Studies (MINORS) checklist. Results The search strategy retrieved 743 unique titles, of which 10 studies (all on tocilizumab [TCZ]) comprising 1358 patients were included. Nine of 10 studies were considered to be of high quality. Meta-analysis showed that the TCZ group had lower mortality than the control group. The risk ratio was 0.27 (95% confidence interval [CI], .12–.59) and the risk difference was 12% (95% CI, 4.6%–20%) in favor of the TCZ group. With only a few studies available, there were no differences observed regarding side effects. Conclusions Our results showed that mortality was 12% lower for COVID-19 patients treated with TCZ compared with those not treated with TCZ. The number needed to treat was 11, suggesting that for every 11 (severe) COVID-19 patients treated with TCZ, 1 death is prevented. These results require confirmation by randomized controlled trials.

Golimumab for Rheumatoid Arthritis: A Systematic Review

2010 ◽  
Vol 37 (6) ◽  
pp. 1096-1104 ◽  
Author(s):  
JASVINDER A. SINGH ◽  
SHAHRZAD NOORBALOOCHI ◽  
GURKIRPAL SINGH
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Adverse Events ◽  
Absolute Risk ◽  
Health Assessment ◽  
Risk Difference ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Serious Adverse Events ◽  
Percentage Difference

Objective.To perform a Cochrane systematic review of benefit (American College of Rheumatology 50% improvement criteria; ACR50) and safety (adverse events and withdrawals) of golimumab in patients with rheumatoid arthritis (RA).Methods.We searched the Cochrane Central Register of Controlled Trials (CENTRAL), OVID Medline, CINAHL, Embase, Science Citation Index (Web of Science), and Current Controlled Trials databases for randomized or controlled clinical trials of golimumab compared to placebo or disease-modifying antirheumatic drug in adults with RA. Two authors independently selected appropriate studies and abstracted study characteristics and safety and efficacy data and performed risk-of-bias assessment. We calculated mean differences for continuous measures, and relative risks for categorical measures.Results.Four randomized controlled trials with 1231 golimumab-treated and 483 placebo-treated patients were included. Of these, 436 were treated with golimumab at 50 mg every 4 weeks [a dosage approved by the US Food and Drug Administration (FDA)]. At an average of 4–6 months, compared to patients treated with placebo and methotrexate (MTX), patients treated with the FDA-approved dosage of golimumab and MTX were 2.6 times more likely to reach ACR50 (p = 0.005, 95% CI 1.3, 4.9; absolute percentage, 38% vs 15%) and 0.5 times as likely to have overall withdrawals (p = 0.005, 95% CI 0.3, 0.8; absolute percentage, 5% vs 10%). Golimumab-treated patients were significantly more likely than those taking placebo to achieve remission (22% vs 4%; p < 0.00001), and to have improvement in functional ability on the Health Assessment questionnaire [0.2 points lower (p < 0.00001, 95% CI 0.25, 0.15); absolute risk difference, −20% (95% CI −25% to −15%); relative percentage difference, −11% (95% CI −14% to −8.3%)]. The studies were too small and short to be powered sufficiently for safety outcomes, but no substantive statistically significant differences were noted between golimumab and placebo regarding adverse events, serious adverse events, infections, serious infections, lung infections, tuberculosis, cancer, withdrawals due to adverse events, and withdrawals due to inefficacy and deaths.Conclusion.At the approved dosage, in patients with active RA taking background MTX, golimumab is significantly more beneficial than placebo. The short-term safety profile is reasonable. Longterm surveillance studies are needed for safety assessment.

Does Nurse-Led Pre-operative Assessment Reduce the Cancellation Rate of Elective Surgical In-Patient Procedures?: A Systematic Review of the Research Literature

2005 ◽  
Vol 6 (3) ◽  
pp. 41-47 ◽  
Author(s):  
Sarah E. Craig
Keyword(s):  
Cohort Studies ◽  
Absolute Risk ◽  
Research Literature ◽  
Cochrane Library ◽  
Control Group ◽  
Number Needed To Treat ◽  
Junior Doctors ◽  
Cancellation Rate ◽  
Randomised Control Trials ◽  
Operative Assessment

Pre-operative assessment (POA) has been advocated for use to achieve a number of goals including reducing cancelled operations on the day of surgery, and therefore waiting lists. POA has historically been provided by junior doctors, but the change in focus of their role in addition to the new roles being taken on by nurses has led to nurse-led POA. The aim of this review was to determine whether nurse-led POA reduces the cancellation rate of elective surgical in-patient procedures. The Cochrane Library, Medline, Cinahl and Embase databases were searched for systematic reviews, randomised control trials and cohort studies examining nurse-led POA. After applying inclusion criteria only four cohort studies were deemed to be suitable to be critically appraised. One study had no cancellations in either the doctor or nurse-led POA groups. Another study had low cancellation rates in the nurse-led POA group, but the control group was not suitably defined for adequate verification as to whether the cancellation rates were lower because they had been pre-assessed. The final two studies revealed similar absolute risk reductions, number needed to treat and odds ratios. In summary nurse-led POA appears to reduce cancellation rates on admission, but the evidence for this is relatively weak, primarily because study samples have been small. Further trials are needed which have samples that are sufficient to detect a true difference between the intervention and control group if one exists.

scholarly journals EXPRESS: Stroke risk following traumatic brain injury: systematic review and meta-analysis

2021 ◽  
pp. 174749302110042
Author(s):  
Grace Mary Turner ◽  
Christel McMullan ◽  
Olalekan Lee Aiyegbusi ◽  
Danai Bem ◽  
Tom Marshall ◽  
...  
Keyword(s):  
Systematic Review ◽  
Stroke Risk ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Cochrane Library ◽  
Control Group ◽  
Large Sample Size ◽  
Hazard Ratios ◽  
Increased Risk ◽  
The Cochrane Library

Aims To investigate the association between TBI and stroke risk. Summary of review We undertook a systematic review of MEDLINE, EMBASE, CINAHL, and The Cochrane Library from inception to 4th December 2020. We used random-effects meta-analysis to pool hazard ratios (HR) for studies which reported stroke risk post-TBI compared to controls. Searches identified 10,501 records; 58 full texts were assessed for eligibility and 18 met the inclusion criteria. The review included a large sample size of 2,606,379 participants from four countries. Six studies included a non-TBI control group, all found TBI patients had significantly increased risk of stroke compared to controls (pooled HR 1.86; 95% CI 1.46-2.37). Findings suggest stroke risk may be highest in the first four months post-TBI, but remains significant up to five years post-TBI. TBI appears to be associated with increased stroke risk regardless of severity or subtype of TBI. There was some evidence to suggest an association between reduced stroke risk post-TBI and Vitamin K antagonists and statins, but increased stroke risk with certain classes of antidepressants. Conclusion TBI is an independent risk factor for stroke, regardless of TBI severity or type. Post-TBI review and management of risk factors for stroke may be warranted.

scholarly journals Impact of interstitial lung disease on mortality in ANCA-associated vasculitis: A systematic literature review and meta-analysis

2021 ◽  
Vol 18 ◽  
pp. 147997312199456
Author(s):  
Peining Zhou ◽  
Jing Ma ◽  
Guangfa Wang
Keyword(s):  
Systematic Review ◽  
Interstitial Lung Disease ◽  
Confidence Interval ◽  
Lung Disease ◽  
Mortality Risk ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Anca Associated Vasculitis ◽  
Retrospective Cohort Studies

Several retrospectivee described the association of interstitial lung disease (ILD) and ANCA-associated vasculitis (AAV). However, the relationship between the ILD and mortality in AAV patients have not been established so far. This study aims to estimate the relevance of AAV-associated-ILD (AAV-ILD) and mortality risk by conducting a systematic review and meta-analysis.A comprehensive systematic review was conducted in accordance with the guidelines of PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses). PubMed, Embase.com and the Cochrane Library (Wiley) were searched for original observational studies. Summary estimates were derived with a random-effects model and reported as risk ratio (RR), tested for publication bias and heterogeneity. Ten retrospective cohort studies were included, comprising 526 AAV-ILD patients enrolled from 1974 to 2018. Meta-analysis yielded a pooled RR of 2.90 (95% confidence interval 1.77–4.74) for death among those with AAV-ILD compared to control group. UIP pattern was associated with an even poorer prognosis in comparison to non-UIP pattern (RR 4.36, 95% confidence interval 1.14–16.78). Sensitivity analysis suggested that the meta-RR result was not skewed by a single dominant study. ILD might be associated with a higher mortality risk in AAV patients.

scholarly journals Testing for non-inferior mortality: a systematic review of non-inferiority margin sizes and trial characteristics

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044480
Author(s):  
Sandra Pong ◽  
Martin Urner ◽  
Robert A Fowler ◽  
Nicholas Mitsakakis ◽  
Winnie Seto ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Outcome ◽  
Absolute Risk ◽  
Methodological Issue ◽  
Medical Specialty ◽  
Risk Difference ◽  
Baseline Risk ◽  
Industry Funding ◽  
Eligibility Criteria ◽  
Randomised Controlled

ObjectiveTo describe the size and variability of non-inferiority margins used in non-inferiority trials of medications with primary outcomes involving mortality, and to examine the association between trial characteristics and non-inferiority margin size.DesignSystematic review.Data sourcesMedline, Medline In Process, Medline Epub Ahead of Print and Embase Classic+Embase databases from January 1989 to December 2019.Eligibility criteriaProspective non-inferiority randomised controlled trials comparing pharmacological therapies, with primary analyses for non-inferiority and primary outcomes involving mortality alone or as part of a composite outcome. Trials had to prespecify non-inferiority margins as absolute risk differences or relative to risks of outcome and provide a baseline risk of primary outcome in the control intervention.Results3992 records were screened, 195 articles were selected for full text review and 111 articles were included for analyses. 82% of trials were conducted in thrombosis, infectious diseases or oncology. Mortality was the sole primary outcome in 23 (21%) trials, and part of a composite primary outcome in 88 (79%) trials. The overall median non-inferiority margin was an absolute risk difference of 9% (IQR 4.2%–10%). When non-inferiority margins were expressed relative to the baseline risk of primary outcome in control groups, the median relative non-inferiority margin was 1.5 (IQR 1.3–1.7). In multivariable regression analyses examining the association between trial characteristics (medical specialty, inclusion of paediatric patients, mortality as a sole or part of a composite primary outcome, presence of industry funding) and non-inferiority margin size, only medical specialty was significantly associated with non-inferiority margin size.ConclusionAbsolute and relative non-inferiority margins used in published trials comparing medications are large, allowing conclusions of non-inferiority in the context of large differences in mortality. Accepting the potential for large increases in outcomes involving mortality while declaring non-inferiority is a challenging methodological issue in the conduct of non-inferiority trials.

scholarly journals Sofosbuvir with daclatasvir and the outcomes of patients with COVID-19: a systematic review and meta-analysis with GRADE assessment

2021 ◽  
pp. postgradmedj-2021-140287
Author(s):  
Ahmad Fariz Malvi Zamzam Zein ◽  
Catur Setiya Sulistiyana ◽  
Wilson Matthew Raffaello ◽  
Arief Wibowo ◽  
Raymond Pranata
Keyword(s):  
Systematic Review ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Invasive Mechanical Ventilation ◽  
Intervention Group ◽  
Control Group ◽  
Reduce Mortality Rate ◽  
Icu Admission ◽  
Clinical Recovery

PurposeThis systematic review and meta-analysis aimed to evaluate the effect of sofosbuvir/daclatasvir (SOF/DCV) on mortality, the need for intensive care unit (ICU) admission or invasive mechanical ventilation (IMV) and clinical recovery in patients with COVID-19.MethodsWe performed a systematic literature search through the PubMed, Scopus and Embase from the inception of databases until 6 April 2021. The intervention group was SOF/DCV, and the control group was standard of care. The primary outcome was mortality, defined as clinically validated death. The secondary outcomes were (1) the need for ICU admission or IMV and (2) clinical recovery. The pooled effect estimates were reported as risk ratios (RRs).ResultsThere were four studies with a total of 231 patients in this meta-analysis. Three studies were randomised controlled trial, and one study was non-randomised. SOF/DCV was associated with lower mortality (RR: 0.31 (0.12, 0.78); p=0.013; I2: 0%) and reduced need for ICU admission or IMV (RR: 0.35 (0.18, 0.69); p=0.002; I2: 0%). Clinical recovery was achieved more frequently in the SOF/DCV (RR: 1.20 (1.04, 1.37); p=0.011; I2: 21.1%). There was a moderate certainty of evidence for mortality and need for ICU/IMV outcome, and a low certainty of evidence for clinical recovery. The absolute risk reductions were 140 fewer per 1000 for mortality and 186 fewer per 1000 for the need for ICU/IMV. The increase in clinical recovery was 146 more per 1000.ConclusionSOF/DCV may reduce mortality rate and need for ICU/IMV in patients with COVID-19 while increasing the chance for clinical recovery.Protocol registrationPROSPERO: CRD42021247510.

scholarly journals Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 939
Author(s):  
Jiaxin Chen ◽  
Yuangui Cai ◽  
Yicong Chen ◽  
Anthony P. Williams ◽  
Yifang Gao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Phase 1 ◽  
Cochrane Library ◽  
Categorical Variables ◽  
Control Group ◽  
Open Label

Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID-19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID-19 vaccination. Methods: A systematic review and meta-analysis of clinical trials on the incidences of NMAEs after COVID-19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Library, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical variables were analyzed using Pearson’s chi-square test. The pooled odds ratio (OR) with the corresponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Results: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open-label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia comprised a considerable measure, although life-threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID-19 vaccination program.

scholarly journals Effectiveness of Suprascapular Nerve Block in the Treatment of Hemiplegic Shoulder Pain: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Yajing Hou ◽  
Yong Wang ◽  
Xiaojing Sun ◽  
Yake Lou ◽  
Ying Yu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Shoulder Pain ◽  
Nerve Block ◽  
External Rotation ◽  
Meta Analysis ◽  
Suprascapular Nerve ◽  
Cochrane Library ◽  
Control Group ◽  
Suprascapular Nerve Block ◽  
Secondary Endpoints

Purpose: We aimed to investigate the effectiveness of suprascapular nerve block (SSNB) in patients with hemiplegic shoulder pain (HSP).Background: SSNB is widely used in various shoulder pains, but whether it is effective in HSP remains unknown.Methods: PubMed, Cochrane Library, and Embase databases were searched to identify potential citations. Randomized controlled trials meeting the eligible criteria were included in our analysis. The primary endpoint was Visual Analog Scale (VAS) with a maximum value of 100 and a minimum value of 0. Secondary endpoints were passive range of motion (PROM) that pain starts, and the PROM mainly included abduction, flexion, and external rotation. In addition, the upper extremity Fugl-Meyer assessment (FMA) was also included in our secondary endpoints.Results: Eight studies with 281 patients were included in our analysis. For VAS, there was no obvious difference between SSNB group and control group regardless of the follow-up period (&lt;4 weeks or ≥4 weeks), which were −6.62 (−15.76, 2.53; p = 0.16) and 1.78 (−16.18, 19.74; p = 0.85). For shoulder function, the PROM of abduction, flexion, and external rotation was similar between groups. However, motor function indicator FMA is lower in SSNB control than that in control group, with a mean difference (and 95% CI) of −2.59 (−4.52, −0.66; p = 0.008).Conclusion: SSNB is an effective way for HSP patients.Systematic Review Registration: Registration ID: CRD42021252429.

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