Asthma: Anti-Immunoglobulin E Therapy with Omalizumab for Asthma

2007 ◽  
Vol 41 (9) ◽  
pp. 1397-1410 ◽  
Author(s):  
Leslie Hendeles ◽  
Christine A Sorkness
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Randomized Clinical Trials ◽  
Inhaled Corticosteroids ◽  
Immunoglobulin E ◽  
Data Extraction ◽  
Symptom Control ◽  
High Dose ◽  
Search Term ◽  
Ige Mediated

Objective: To evaluate data on anti-immunoglobulin E (anti-IgE) therapy for asthma. Data Sources: Information was selected from PubMed from 1989 to May 2007 using the search term omalizumab and included randomized, controlled trials. These studies evaluated asthma treatment with omalizumab and focused on its efficacy, tolerability, and cost-effectiveness in this population. Study Selection and Data Extraction: All randomized clinical trials were reviewed (23 were identified and 19 were included; 3 were not relevant and 1 contained duplicative data). Other articles using the search words anti-IgE therapy and cost-effectiveness were evaluated; relevant information was extracted. Data Synthesis: IgE-dependent mechanisms play an important role in the development and maintenance of airway inflammation in asthma. Omalizumab is a subcutaneously administered monoclonal anti-IgE antibody that reduces unbound IgE concentrations and promotes down-regulation of IgE receptors. Results from clinical trials in adults, adolescents, and children with poorly controlled IgE-mediated asthma have shown that omalizumab improves symptom control and allows patients to be managed with lower doses of inhaled corticosteroids (ICS). It has been well tolerated in clinical trials lasting as long as 52 weeks, but injection-site reactions are common (45% in omalizumab group vs 43% in placebo group) and anaphylaxis has occurred in 0.2% of patients. A consensus expert panel has recommended that omalizumab should be considered for patients 12 years of age or older with allergic asthma who are inadequately controlled on guideline-based therapy and require maintenance therapy with systemic corticosteroids or high-dose ICSs, or who have poor adherence to ICS therapy. Conclusions: Anti-IgE therapy provides an effective and generally safe approach to the treatment of patients with IgE-mediated asthma who are not adequately controlled by conventional guideline-based medications. However, the potential benefit must be weighed against the cost and inconvenience of this new therapy.

Cost-effectiveness analysis of neoadjuvant immune checkpoint inhibition (ICI) versus cisplatin-based chemotherapy (CBC) in muscle-invasive bladder cancer (MIBC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 419-419
Author(s):  
Ali Raza Khaki ◽  
Yong Shan ◽  
Richard Nelson ◽  
Sapna Kaul ◽  
John L. Gore ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Randomized Clinical Trials ◽  
Pathologic Complete Response ◽  
Weighted Average ◽  
Cost Effective ◽  
Cost Effectiveness Analysis ◽  
Sensitivity Analyses ◽  
Effectiveness Analysis

419 Background: Multiple single-arm clinical trials have shown promising pathologic complete response (pCR) rates with neoadjuvant ICIs in MIBC. However, ICIs remain costly. We conducted a cost-effectiveness analysis comparing neoadjuvant ICIs with CBC. Methods: We applied a decision analytic simulation model with a health care payer perspective and two-year time horizon to compare neoadjuvant ICIs vs CBC. For the primary analysis we compared pembrolizumab with dose dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC). We performed a secondary analysis with gemcitabine/cisplatin (GC) as CBC and exploratory analyses with atezolizumab or nivolumab/ipilimumab as ICIs (vs both ddMVAC and GC). We input pCR rates from trials (ICIs) or a weighted average of prior studies (CBC) and costs from average sales price. Outcomes of interest included costs, 2-year recurrence-free survival (RFS), and incremental cost-effectiveness ratio (ICER) of cost per 2-year RFS. A threshold analysis estimated a pCR rate or price reduction for ICI to be cost-effective and one-way and probabilistic sensitivity analyses were performed. Results: Results of the cost effectiveness analysis are shown in the table. The incremental cost of pembrolizumab compared with ddMVAC was $8,042 resulting in an incremental improvement of 0.66% in 2-year RFS for an ICER of $1,218,485 per 2-year RFS. A pCR of 71% or a 26% reduction in cost of pembrolizumab would render it more cost-effective with an ICER of $100,000 per 2-year RFS. GC required a 96% pembrolizumab cost reduction to achieve an ICER of $100,000 per 2-year RFS. Atezolizumab appeared to be more cost-effective than ddMVAC, even though the 2yr RFS was 0.66% worse. Conclusions: ICIs were not cost-effective as neoadjuvant therapies, except when atezolizumab was compared with ddMVAC. Pembrolizumab would approach cost-effective thresholds with 26% or 96% reduction in cost when compared to ddMVAC and GC, respectively. Randomized clinical trials, larger sample sizes and longer follow-up are required to better understand the value of ICIs as neoadjuvant treatments. [Table: see text]

The infant and toddler with wheezing

2019 ◽  
Vol 40 (6) ◽  
pp. 393-395
Author(s):  
Nurcicek Padem ◽  
Rachel Glick Robison
Keyword(s):  
Young Children ◽  
Inhaled Corticosteroids ◽  
Immunoglobulin E ◽  
Bacterial Colonization ◽  
High Dose ◽  
Predictive Index ◽  
Double Blind ◽  
Recurrent Wheezing ◽  
Young Infants ◽  
Tract Infections

Recurrent wheezing is common in young infants and toddlers, with 50% of all children having at least one wheezing episode in the first 6 years of life. Initial wheezing episodes in young children often are linked to respiratory infections due to viral pathogens, such as respiratory syncytial virus, human rhinovirus, human metapneumovirus, and influenza virus. Bacterial colonization of the neonatal airway also may be significant in the late development of recurrent wheeze and asthma. Wheezing in young children can be classified into specific phenotypes based on the onset and persistence of wheezing. Although some children will only wheeze transiently in early childhood, persistent wheezing is often classified as immunoglobulin E (IgE) associated and/or atopic or nonatopic. By using a modified asthma predictive index, future development of asthma can be interpreted, especially in high-risk populations. It is recommended to follow National Asthma Education and Prevention Program (NAEPP) guidelines for initiation of treatment; however, asthma management of young children often requires tailored regimens. Inhaled corticosteroids used as a daily controller medication have been shown to aid symptoms and exacerbation control; however, these do not change the natural course of the disease or progression to asthma. Although randomized double-blind studies in preschoolers investigated a role of macrolide antibiotics in early infection as well as high-dose inhaled corticosteroids during severe lower respiratory tract infections, more research is needed in this field to understand mechanisms of asthma development and optimal treatment in this young age group.

Diagnosis and Management of Severe Asthma

2018 ◽  
Vol 39 (01) ◽  
pp. 091-099 ◽  
Author(s):  
Kian Fan Chung
Keyword(s):  
Severe Asthma ◽  
Inhaled Corticosteroids ◽  
Immunoglobulin E ◽  
High Dose ◽  
Blood Eosinophil ◽  
Exhaled Breath ◽  
Eosinophilic Asthma ◽  
Severe Eosinophilic Asthma ◽  
Asthma Patients ◽  
Long Acting

AbstractSevere therapy-resistant asthma has been defined as “asthma which requires treatment with high dose inhaled corticosteroids (ICSs) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy”. Patients who usually present with ‘difficult-to-treat asthma’ should first be assessed to determine whether he/she has asthma with the exclusion of other diagnoses and if so, whether the asthma can be classified as severe therapy-resistant. This necessitates an assessment of adherence to medications, confounding factors, and comorbidities. Increasingly, management of severe therapy-resistant asthma will be helped by the determination of phenotypes to optimize responses to existing and new therapies. Severe asthma patients are usually on a combination of high dose ICS and long-acting β-agonist (LABA) and, in addition, are often on a maintenance dose of oral corticosteroids. Phenotyping can be informed by measuring blood eosinophil counts and the level of nitric oxide in exhaled breath, and the use of sputum granulocytic counts. Severe allergic asthma and severe eosinophilic asthma are two defined phenotypes for which there are efficacious targeted biologic therapies currently available, namely anti-immunoglobulin E (IgE) and anti-interleukin (IL)-5 antibodies, respectively. Further progress will be realized with the definition of noneosinophilic or non-T2 phenotypes. It will be important for patients with severe asthma to be ultimately investigated and managed in specialized severe asthma centers.

scholarly journals The Efficacy of Retention Appliances after Fixed Orthodontic Treatment: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 10 (9) ◽  
pp. 3107 ◽  
Author(s):  
Antonino Lo Giudice ◽  
Gaetano Isola ◽  
Lorenzo Rustico ◽  
Vincenzo Ronsivalle ◽  
Marco Portelli ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Orthodontic Treatment ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Mean Difference ◽  
Anterior Crowding ◽  
Study Selection ◽  
Statistical Heterogeneity ◽  
Fixed Retainers

The purpose of this article is to evaluate the amount of the relapse of anterior crowding and the efficacy of retention appliances by reviewing the best available scientific evidence. A survey of articles published up to November 2019 about the stability of dental alignment and retention after fixed orthodontic treatment was performed using seven electronic databases. Study Selection: Only randomized clinical trials investigating patients previously treated with multi-bracket appliances with a follow-up period longer than 6 months were included. Data Extraction: Two authors independently performed the study selection, data extraction, and risk of bias assessment. All pooled data analyses were performed using a random-effects model. Statistical heterogeneity was evaluated. In total, eight randomized clinical trials (RCTs) were included, grouping data from 987 patients. The ages of the patients varied across the studies, ranging between 13 and 17 years. The observation period ranged between 6 and 24 months. The data showed no significant intercanine width modifications during the retention period with both fixed and removable retainers. A significant modification of Little’s Index was found for the mandibular removable retainers with a mean difference of 0.72 mm (95% Cl, 0.47 to 0.98) and for the maxillary removable retainers with a mean difference of 0.48 mm (95% Cl, 0.27 to 0.68). No significant changes were found by evaluating Little’s Index modification for the mandibular fixed retainers. The results of this meta-analysis showed that all the considered retainers were effective in maintaining dental alignment after fixed orthodontic treatment. However, fixed retainers showed greater efficacy compared to removable retainers.

scholarly journals Evaluation of the pharmacoeconomics of drugs used for the treatment of long-term complications of sulfur mustard

2016 ◽  
Vol 10 ◽  
Author(s):  
Yunes Panahi ◽  
Mostafa Ghanei ◽  
Milad Vakili Zarch ◽  
Zohreh Poursaleh ◽  
Shahram Parvin ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Inhaled Corticosteroids ◽  
Sulfur Mustard ◽  
Cost Effective ◽  
Chemical Warfare Agent ◽  
Pulmonary Complications ◽  
High Dose ◽  
Chemical Injuries ◽  
Long Acting

Sulfur mustard (SM), a cytotoxic vesicant chemical warfare agent, has powerful irritant and blistering effects on the skin, eyes and respiratory tract. Since during the Iraq-Iran war, many Iranian soldiers and civilians were exposed to SM, there are several victims still suffering from long-term cutaneous, ocular and pulmonary complications. Currently, there is no definite treatment for long-term complications of SM, and only supportive medical care is being taken to minimize the symptoms. In this study, we compared the cost-effectiveness of common drugs that are used against long-term SM-induced complications in Iranian patients. In this review article, electronic databases were checked using the following key words: sulfur mustard, lung, skin, eye, cost-effectiveness, pharmacoeconomics and treatment. Abstracts of non-English papers and proceedings of congresses on SM were also assessed. Among the studied drugs, high-dose oral N-acetyl cysteine and long-acting inhaled corticosteroids against respiratory complications, topical corticosteroids and oral antihistamines against cutaneous complications and NSAIDS and corticosteroids ophthalmic drops against ocular complications were found to be cost-effective. Usage of different drugs in the treatment of SM injuries in Iran, have imposed a significant economic burden to patients and their families because many drugs that are effective against chemical injuries are not covered by insurance. In addition, development of more effective drugs in this field is considered as an urgent demand that should be noticed by the pharmaceutical industry.

scholarly journals Carbon dioxide versus air insufflation enteroscopy: a systematic review and meta-analysis based on randomized controlled trials

2018 ◽  
Vol 06 (06) ◽  
pp. E637-E645 ◽  
Author(s):  
Julio Aquino ◽  
Wanderley Bernardo ◽  
Diogo de Moura ◽  
Flávio Morita ◽  
Rodrigo Rocha ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Ambient Air ◽  
Quality Analysis ◽  
Cochrane Library ◽  
Eligibility Criteria ◽  
Co2 Insufflation ◽  
Significant Difference

Abstract Objectives To compare the insufflation of CO2 and ambient air in enteroscopy. Search sources The investigators researched the electronic databases MedLine, Cochrane Library, Central, LILACS, BVS, Scopus and Cinahl. The grey search was conducted in the base of theses of the University of São Paulo, books of digestive endoscopy and references of selected articles and in previous systematic revisions. Study eligibility criteria The evaluation of eligibility was performed independently, in a non-blind manner, by two reviewers, firstly by title and abstract, followed by complete text. Disagreements between the reviewers were resolved by consensus. Data collection and analysis method Through the spreadsheet of data extraction, where one author extracted the data and a second author checked the extraction. Disagreements were resolved by debate between the two reviewers. The quality analysis of the studies was performed using the Jadad score. The software RevMan 5 version 5.3 was used for the meta-analysis. Results Four randomized clinical trials were identified, totaling 473 patients submitted to enteroscopy and comparing insufflation of CO2 and ambient air. There was no statistical difference in the intubation depth between the two groups. When CO2 insufflation was reduced, there was a significant difference in pain levels 1 hour after the procedure (95 % IC, –2.49 [–4.72, –0.26], P: 0.03, I2: 20%) and 3 hours after the procedure (95% IC, –3.05 [–5.92, –0.18], P: 0.04, I2: 0 %). There was a usage of lower propofol dosage in the CO2 insufflation group, with significant difference (95 % IC, –67.68 [–115.53, –19.84], P: 0.006, I2: 0 %). There was no significant difference between the groups in relation to the use of pethidine and to the oxygen saturation. Limitations Restricted number of randomized clinical trials and nonuniformity of data were limitations to the analysis of the outcomes. Conclusion The use of CO2 as insufflation gas in enteroscopy reduces the pain levels 1 hour and 3 hours after the procedure, in addition to the reduction of the sedation (propofol) dosage used.

Primary Stroke Prevention in Nonvalvular Atrial Fibrillation: Implementing the Clinical Trial Findings

1997 ◽  
Vol 31 (10) ◽  
pp. 1187-1196 ◽  
Author(s):  
Patricia A Howard ◽  
Pamela W Duncan
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Cost Effectiveness ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Randomized Clinical Trials ◽  
Nonvalvular Atrial Fibrillation ◽  
Risk Patients

OBJECTIVE: To review the clinical trials evaluating warfarin for primary stroke prophylaxis in nonvalvular atrial fibrillation (NVAF), to discuss the relative benefits and risks of warfarin versus aspirin therapy, and to review the clinical practice guidelines and identify potential barriers to their implementation in clinical practice. DATA SOURCES: A MEDLINE literature search was performed to identify clinical trials of antithrombotic therapy for NVAF, clinical practice guidelines, studies evaluating physician practices and attitudes, cost-effectiveness studies, and pertinent review articles. Key search terms included atrial fibrillation, stroke, antithrombotic, warfarin, aspirin, and cost-effectiveness. DATA EXTRACTION: Prospective, randomized clinical trials were selected for analysis. Clinical practice guidelines from recognized panels of experts were reviewed. Comprehensive review articles were selected. DATA SYNTHESIS: NVAF is a common arrhythmia that is associated with a substantial risk for stroke. Seven prospective, randomized, clinical trials have conclusively demonstrated the efficacy of warfarin for stroke prevention. The greatest benefits are achieved in older patients and those with comorbidities that increase their risk for stroke. The potential benefits of preventing a devastating stroke, however, must be weighed against the potential for bleeding complications. Warfarin has been shown to be cost-effective in high-risk patients, provided the rate of complications is minimized. Nonetheless, many physicians remain hesitant to implement warfarin therapy in older, high-risk patients. The clinical data on aspirin are less consistent than those observed with warfarin. Aspirin appears to be most effective in younger individuals or those considered to be at low risk for stroke. CONCLUSIONS: In patients with NVAF, the personal, social, and economic consequences of stroke are often devastating. Clinical trials have provided definitive proof that the risks of stroke can be significantly reduced through the use of appropriate antithrombotic therapy. Despite this evidence and the recommendations of a number of clinical practice guidelines, variations in care exist that continue to place patients at risk. Additional outcomes research is needed to evaluate the impact of the clinical trial findings and practice guidelines on clinical practice and to develop methods for overcoming barriers to implementation.

scholarly journals Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials

2016 ◽  
Vol 16 (2) ◽  
pp. 135-146 ◽  
Author(s):  
Tae-Young Choi ◽  
Jong In Kim ◽  
Hyun-Ja Lim ◽  
Myeong Soo Lee
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Sleep Quality ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Sham Acupuncture ◽  
Risk Of Bias ◽  
The Other ◽  
Level Of Evidence

Background. Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods. A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results. Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion. There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.

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