scholarly journals Efficacy and safety of guselkumab for the treatment of patients with moderate-to-severe plaque psoriasis: A metaanalysis of randomized clinical trials

2020 ◽  
Vol 19 (2) ◽  
pp. 433-440
Author(s):  
Xing-Bao Tao ◽  
Yin-Qiu Huang ◽  
Yi-Hong Zhou ◽  
Lv-Lang Zhang ◽  
Yao-Kai Chen

Purpose: To conduct a systematic analysis on data from randomized controlled trials (RCTs) on different doses of guselkumab, and provide high-quality evidence for its use in the treatment of patients with moderate-to-severe plaque psoriasis (PsO). Methods: Related studies were searched using online search engines including MEDLINE, PubMed, and central registry of Cochrane controlled trials from January 2001 to October 2017. Only randomized, placebo-controlled, double-blind clinical trials involving guselkumab- and placebo-treated PsO subjects were included. Results: Five eligible double-blind, randomized, and placebo-controlled trials involving patients with moderate-to-severe PsO subjects treated with guselkumab were included. Compared with the placebo groups, the proportion of patients with improvements in Psoriasis Area and Severity Index (PASI) 75 (RR= 12.14; 95% CI= 9.11-16.16; p < 0.001); PASI 90 (RR= 23.26; 95% CI =14.57-37.13; p < 0.001), and PASI 100 (RR = 37.66; 95% CI = 15.81-89.69; p < 0.001) were significantly higher than those in guselkumab-treated groups. Furthermore, the guselkumab-treated groups showed significant decreases in Physician’s Global Assessment (PGA) score (RR = 10.46; 95% CI = 7.96-13.83; p < 0.001) and the Dermatology Life Quality Index (DLQI) score (SMD = -1.3; 95% CL = -1.4 to -1.19; p < 0.001), when compared with the placebo groups. However, there were no significant differences in adverse events (AEs) (RR = 1.01; 95% CL = 0.93-1.11; p > 0.05); severe adverse events (SAEs) (RR = 1.32; 95% CI =0.69-2.54; p > 0.05) and study discontinuations (RR = 0.79; 95% CI = 0.42-1.48; p > 0.05) between the two groups. Conclusion: This meta-analysis summarizes available evidence for the use of guselkumab in psoriasis. The results suggest that guselkumab is superior to placebo in moderate-to-severe psoriasis, and is welltolerated, effective, and safe in improving the severity of disease and quality of life. Keywords: Guselkumab, Effectiveness, Safety, Plaque psoriasis, Meta-analysis, Quality of life

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ismail Zul Khairul Azwadi ◽  
Mohd Noor Norhayati ◽  
Mohd Shafie Abdullah

AbstractAcute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters), hospitalisation duration, quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.


2020 ◽  
Author(s):  
ZUL KHAIRUL AZWADI ISMAIL ◽  
NORHAYATI MOHD NOOR ◽  
MOHD SHAFIE ABDULLAH

Abstract Acute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters and hospitalisation duration), quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.


2019 ◽  
Vol 2019 ◽  
pp. 1-25 ◽  
Author(s):  
Fan Bai ◽  
Gang Gang Li ◽  
Qingmin Liu ◽  
Xinwu Niu ◽  
Ruilian Li ◽  
...  

Background. The role of interleukin-12 (IL-12), interleukin-23 (IL-23), and interleukin-17 (IL-17) has been recognized in psoriasis pathogenesis, and new drugs targeting this axis have already been developed which may provide a new therapeutic approach for patients with moderate to severe psoriasis. Objective. To compare the direct and indirect evidences of the efficacy and safety of brodalumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tildrakizumab, and risankizumab in the short-term treatment of moderate to severe plaque psoriasis using network meta-analysis (NMA). Methods. A comprehensive literature search was performed in PubMed, EMBASE, and Cochrane Central Register of Controlled Trials for the available relevant studies. NMA was conducted by Stata 15.0 software using relative risks (RR) with 95% confidence interval to assess the clinical effectiveness and safety. Ranked the efficacy and safety for each drug accordance with the surface under the cumulative ranking curve (SUCRA). Results. This meta-analysis included 28 studies. All the interventions performed better than placebo in short-term achievement. Based on the result of SUCRA, ixekizumab 80 mg every 2 weeks ranked the highest in short-term achievement of PASI 75 (SUCRA = 93.0%). Brodalumab 210 mg ranked the highest in short-term achievement of PASI 100 (SUCRA = 85.0%). Secukinumab 300 mg ranked the highest in short-term achievement of sPGA 0/1 or IGA 0/1 or PGA 0/1 (SUCRA = 98.1%). In terms of having a risk of adverse events, the rates were higher in brodalumab, secukinumab, ixekizumab, and ustekinumab 45 mg compared with placebo. Ixekizumab 80 mg every 4 weeks ranked the highest in the risk of adverse events during short-term treatment (SUCRA = 4.5%). Guselkumab 50 mg ranked the highest in the risk of serious adverse events during short-term treatment (SUCRA = 25.9%). Ixekizumab 80 mg every 4 weeks ranked the highest in the risk of discontinuations due to adverse events during short-ter treatment (SUCRA = 10.7%). Conclusions. IL-17, IL-12/23, and IL-23 inhibitors had high efficacy in the achievement of PASI 75, PASI 100, and sPGA 0/1 or IGA 0/1 or PGA 0/1 in moderate to severe plaque psoriasis after 12 or 16 weeks of treatment. IL-17 inhibitors showed superior efficacy. However, its clinical safety was poor. Risankizumab appeared to have relatively high efficacy and low risk. The clinical tolerance of other biological agents needs to be further observed.


2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Luis Guillermo Gómez-Escobar ◽  
Hansel Mora-Ochoa ◽  
Andrea Vargas Villanueva ◽  
Loukia Spineli ◽  
Gloria Sanclemente ◽  
...  

Abstract Background Atopic dermatitis (AD) is an inflammatory chronic condition that affects the skin of children and adults and has an important impact on the quality of life. Treatments for AD are based on environmental controls, topical and systemic therapies, and allergen-specific immunotherapy (AIT). However, it remains unclear the effectiveness and adverse events of AIT and all conventional topical treatments compared with placebo and each other for AD. Methods We will search five electronic databases [Central Cochrane register of controlled trials (CENTRAL), MEDLINE, EMBASE, CINAHL, and LILACS] from inception until November 2019 with no language restriction, and we will include experimental studies [randomized controlled trials (RCTs), and quasi-RCTs]. The primary outcome is global and specific skin symptoms assessment. Secondary outcomes are hospital length of stay, quality of life, and adverse events. Reviewers independently will extract data from the studies that meet our inclusion criteria and will assess the risk of bias of individual primary studies. We will conduct random effects pairwise meta-analyses for the observed pairwise comparisons with at least two trials. Then, we will perform random-effects Bayesian network meta-analysis (NMA) to obtain treatment effects for all possible comparisons and to provide a hierarchy of all interventions for each outcome. Possible incoherence between direct and indirect sources of evidence will be investigated locally (if possible) and globally. To investigate sources of statistical heterogeneity, we will perform a series of meta-regression analyses based on pre-specified important effect modifiers. Two authors will appraise the certainty of the evidence for each outcome applying the GRADE’s framework for NMA. Discussion The findings of this systematic review will shed the light on the effectiveness and adverse events of all possible comparisons for treating AD and on the quality of the collated evidence for recommendations. It will also provide critical information to health care professionals to comprehend and manage this disease at different age stages, treatment type, duration, and severity of atopic dermatitis. Systematic review registration PROSPERO Protocol ID CRD42019147106


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Claudia Gulea ◽  
Rosita Zakeri ◽  
Vanessa Alderman ◽  
Alexander Morgan ◽  
Jack Ross ◽  
...  

Abstract Background Beta-blockers are associated with reduced mortality in patients with cardiovascular disease but are often under prescribed in those with concomitant COPD, due to concerns regarding respiratory side-effects. We investigated the effects of beta-blockers on outcomes in patients with COPD and explored within-class differences between different agents. Methods We searched the Cochrane Central Register of Controlled Trials, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Medline for observational studies and randomized controlled trials (RCTs) investigating the effects of beta-blocker exposure versus no exposure or placebo, in patients with COPD, with and without cardiovascular indications. A meta-analysis was performed to assess the association of beta-blocker therapy with acute exacerbations of COPD (AECOPD), and a network meta-analysis was conducted to investigate the effects of individual beta-blockers on FEV1. Mortality, all-cause hospitalization, and quality of life outcomes were narratively synthesized. Results We included 23 observational studies and 14 RCTs. In pooled observational data, beta-blocker therapy was associated with an overall reduced risk of AECOPD versus no therapy (HR 0.77, 95%CI 0.70 to 0.85). Among individual beta-blockers, only propranolol was associated with a relative reduction in FEV1 versus placebo, among 199 patients evaluated in RCTs. Narrative syntheses on mortality, all-cause hospitalization and quality of life outcomes indicated a high degree of heterogeneity in study design and patient characteristics but suggested no detrimental effects of beta-blocker therapy on these outcomes. Conclusion The class effect of beta-blockers remains generally positive in patients with COPD. Reduced rates of AECOPD, mortality, and improved quality of life were identified in observational studies, while propranolol was the only agent associated with a deterioration of lung function in RCTs.


2021 ◽  
pp. 204589402110078
Author(s):  
Lu Yan ◽  
Wence Shi ◽  
Zhi-hong Liu ◽  
Qin Luo ◽  
Zhihui Zhao ◽  
...  

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I ² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peak oxygen uptake  was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control group . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.


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