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  1 / 1140 MEDLINE  
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PMID:28918644
Autor:Rivero A; Liang J
Endereço:1 Kaiser Permanente, Oakland, California, USA.
Título:Anti-IgE and Anti-IL5 Biologic Therapy in the Treatment of Nasal Polyposis: A Systematic Review and Meta-analysis.
Fonte:Ann Otol Rhinol Laryngol; 126(11):739-747, 2017 Nov.
ISSN:1943-572X
País de publicação:United States
Idioma:eng
Resumo:OBJECTIVE: To determine the role of biologic therapy on sinonasal symptoms and objective outcomes in chronic rhinosinusitis with nasal polyposis (CRSwNP). METHODS: PubMed, OVID MEDLINE, and Cochrane Central were reviewed from 2000 to 2015. Inclusion criteria included English-language studies containing original data on biologic therapy in CRSwNP patients with reported outcome measures. Two investigators independently reviewed all manuscripts and performed quality assessment and quantitative meta-analysis using validated tools. RESULTS: Of 495 abstracts identified, 7 studies fulfilled eligibility: 4 randomized control trials (RCT), 1 case-control, and 2 case series. Outcome measures included nasal polyp score (NPS,6), computer tomography score (5), and symptom scores (5). Meta-analysis was performed on 5 studies: Anti-IL5 therapy (mepolizumab/reslizumab) and anti-IgE therapy (omalizumab) demonstrated a standard mean difference of NPS improvement of -0.66 (95% CI, -1.24 to -0.08) and -0.75 (95% CI, -1.93 to 0.44), respectively, between biologic therapy and placebo. Quality assessment indicated a low to moderate risk of bias for the RCTs. CONCLUSION: Biologic therapies may prove beneficial in the treatment of recalcitrant nasal polyposis in select populations. In meta-analysis, anti-IL5 therapy demonstrates a reduction in nasal polyp score. Anti-IgE therapy reduces nasal polyp score in patients with severe comorbid asthma. Additional high-level evidence is needed to assess clinical efficacy.
Tipo de publicação: JOURNAL ARTICLE; META-ANALYSIS; REVIEW
Nome de substância:0 (Anti-Asthmatic Agents); 0 (Antibodies, Monoclonal, Humanized); 0 (Interleukin-5); 2P471X1Z11 (Omalizumab); 35A26E427H (reslizumab); 37341-29-0 (Immunoglobulin E); 90Z2UF0E52 (mepolizumab)


  2 / 1140 MEDLINE  
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PMID:28877019
Autor:Israel E; Reddel HK
Endereço:From the Pulmonary and Critical Care Medicine Division-Division of Rheumatology, Immunology, and Allergy, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (E.I.); and the Clinical Management Group and Centre for Research Excellence in Severe Asthma, Woolcock Institute of Medical Research, University of Sydney, Sydney (H.K.R.).
Título:Severe and Difficult-to-Treat Asthma in Adults.
Fonte:N Engl J Med; 377(10):965-976, 2017 Sep 07.
ISSN:1533-4406
País de publicação:United States
Idioma:eng
Tipo de publicação: JOURNAL ARTICLE; REVIEW
Nome de substância:0 (Adrenergic beta-Agonists); 0 (Anti-Asthmatic Agents); 0 (Anti-Inflammatory Agents); 0 (Glucocorticoids); 0 (Interleukins); 2P471X1Z11 (Omalizumab); 37341-29-0 (Immunoglobulin E)


  3 / 1140 MEDLINE  
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PMID:28859150
Autor:Bhutani M; Yang WH; Hébert J; de Takacsy F; Stril JL
Endereço:Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Título:The real world effect of omalizumab add on therapy for patients with moderate to severe allergic asthma: The ASTERIX Observational study.
Fonte:PLoS One; 12(8):e0183869, 2017.
ISSN:1932-6203
País de publicação:United States
Idioma:eng
Resumo:BACKGROUND: Omalizumab is a non-steroidal medication indicated for the treatment of poorly controlled moderate-to-severe allergic asthmatics. This observational study examines the "real world" effectiveness of omalizumab in this population. METHODS: This is a one year open-label observational study that compared clinical outcomes including total oral corticosteroid use, exacerbation history, measures of quality of life and inflammation in patients with moderate-to-severe allergic asthma, who were prescribed omalizumab as part of their treatment with the year prior to therapy. RESULTS: A total of 99 patients were enrolled at 25 sites in Canada. During the study period, the mean total annual OCS dose was reduced from 2301.5 mg (prednisone equivalents) in the year prior to omalizumab to 1130.0 mg (p<0.0001). There was a 71% reduction in asthma exacerbations and 56% of patients on omalizumab remained exacerbation free when compared to the year prior to study entry. Associated with this was reduced health care utilization. There were significant improvements in the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life questionnaire (AQLQ) Patients with an elevated FeNO at baseline showed a better response to treatment. No new safety issues were identified during the study period. CONCLUSION: Our study demonstrates that in "real world" clinical practice, after initiating omalizumab, there is a reduction in total OCS use and exacerbation frequency in patients with moderate-to-severe allergic asthma. Patients on treatment reported improved asthma control and quality of life. FeNO may be a useful biomarker to identify patients who may benefit with omalizumab treatment.
Tipo de publicação: JOURNAL ARTICLE; MULTICENTER STUDY; OBSERVATIONAL STUDY
Nome de substância:0 (Anti-Asthmatic Agents); 0 (Biomarkers); 0 (Glucocorticoids); 2P471X1Z11 (Omalizumab); 31C4KY9ESH (Nitric Oxide); VB0R961HZT (Prednisone)


  4 / 1140 MEDLINE  
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PMID:28671445
Autor:Schaefer P
Endereço:University of Toledo College of Medicine and Life Sciences, Toledo, OH, USA.
Título:Acute and Chronic Urticaria: Evaluation and Treatment.
Fonte:Am Fam Physician; 95(11):717-724, 2017 Jun 01.
ISSN:1532-0650
País de publicação:United States
Idioma:eng
Resumo:Urticaria commonly presents with intensely pruritic wheals, sometimes with edema of the subcutaneous or interstitial tissue. It has a lifetime prevalence of about 20%. Although often self-limited and benign, it can cause significant discomfort, continue for months to years, and uncommonly represent a serious systemic disease or life-threatening allergic reaction. Urticaria is caused by immunoglobulin E- and non-immunoglobulin E-mediated release of histamine and other inflammatory mediators from mast cells and basophils. Diagnosis is made clinically; anaphylaxis must be ruled out. Chronic urticaria is idiopathic in 80% to 90% of cases. Only a limited nonspecific laboratory workup should be considered unless elements of the history or physical examination suggest specific underlying conditions. The mainstay of treatment is avoidance of triggers, if identified. The first-line pharmacotherapy is second-generation H1 antihistamines, which can be titrated to greater than standard doses. First-generation H1 antihistamines, H2 antihistamines, leukotriene receptor antagonists, high-potency antihistamines, and brief corticosteroid bursts may be used as adjunctive treatment. In refractory chronic urticaria, patients can be referred to subspecialists for additional treatments, such as omalizumab or cyclosporine. More than one-half of patients with chronic urticaria will have resolution or improvement of symptoms within a year.
Tipo de publicação: JOURNAL ARTICLE; REVIEW
Nome de substância:0 (Dermatologic Agents); 0 (Histamine H1 Antagonists); 2P471X1Z11 (Omalizumab); 83HN0GTJ6D (Cyclosporine)


  5 / 1140 MEDLINE  
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PMID:28652400
Autor:Schroeder JT; Bieneman AP
Endereço:Division of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins Asthma and Allergy Center, Johns Hopkins University School of Medicine, Baltimore, MD 21224 schray@jhmi.edu.
Título:Activation of Human Basophils by A549 Lung Epithelial Cells Reveals a Novel IgE-Dependent Response Independent of Allergen.
Fonte:J Immunol; 199(3):855-865, 2017 Aug 01.
ISSN:1550-6606
País de publicação:United States
Idioma:eng
Resumo:Evidence for epithelial cell (EC)-derived cytokines (e.g., thymic stromal lymphopoietin [TSLP]) activating human basophils remains controversial. We therefore hypothesize that ECs can directly activate basophils via cell-to-cell interaction. Basophils in medium alone or with IL-3 ± anti-IgE were coincubated with TSLP, IL-33, or IL-25. Analogous experiments cocultured basophils (1-72 h) directly with EC lines. Supernatants were tested for mediators and cytokines. Abs targeting receptors were tested for neutralizing effects. Lactic acid (pH 3.9) treatment combined with passive sensitization tested the role of IgE. Overall, IL-33 augmented IL-13 secretion from basophils cotreated with IL-3, with minimal effects on histamine and IL-4. Conversely, basophils (but not mast cells) released histamine and marked levels of IL-4/IL-13 (10-fold) when cocultured with A549 EC and IL-3, without exogenous allergen or IgE cross-linking stimuli. The inability to detect IL-33 or TSLP, or to neutralize their activity, suggested a unique mode of basophil activation by A549 EC. Half-maximal rates for histamine (4 h) and IL-4 (5 h) secretion were slower than observed with standard IgE-dependent activation. Ig stripping combined with passive sensitization ± omalizumab showed a dependency for basophil-bound IgE, substantiated by a requirement for cell-to-cell contact, aggregation, and FcεRI-dependent signaling. A yet unidentified IgE-binding lectin associated with A549 EC is implicated after discovering that LacNAc suppressed basophil activation in cocultures. These findings point to a lectin-dependent activation of basophil requiring IgE but independent of allergen or secreted cytokine. Pending further investigation, we predict this unique mode of activation is linked to inflammatory conditions whereby IgE-dependent activation of basophils occurs despite the absence of any known allergen.
Tipo de publicação: JOURNAL ARTICLE
Nome de substância:0 (Allergens); 0 (Antibodies, Anti-Idiotypic); 0 (Cytokines); 0 (FcepsilonRI alpha-chain, human); 0 (IL25 protein, human); 0 (IL3 protein, human); 0 (IL33 protein, human); 0 (Interleukin-13); 0 (Interleukin-17); 0 (Interleukin-3); 0 (Interleukin-33); 0 (Lectins); 0 (Receptors, IgE); 0 (anti-IgE antibodies); 0 (interleukin-13, human); 0 (thymic stromal lymphopoietin); 207137-56-2 (Interleukin-4); 2P471X1Z11 (Omalizumab); 33X04XA5AT (Lactic Acid); 37341-29-0 (Immunoglobulin E)


  6 / 1140 MEDLINE  
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PMID:28647457
Autor:Vigl B; Salhat N; Parth M; Pankevych H; Mairhofer A; Bartl S; Smrzka OW
Endereço:AFFiRiS AG, Karl-Farkas-Gasse 22, 1030 Vienna, Austria. Electronic address: benjamin.vigl@affiris.com.
Título:Quantitative in vitro and in vivo models to assess human IgE B cell receptor crosslinking by IgE and EMPD IgE targeting antibodies.
Fonte:J Immunol Methods; 449:28-36, 2017 Oct.
ISSN:1872-7905
País de publicação:Netherlands
Idioma:eng
Resumo:Targeting plasma IgE by therapeutic mABs like Omalizumab (Xolair ) is current clinical practice for severe allergic conditions or other IgE related diseases like chronic urticaria. As an alternative to soluble IgE targeting, IgE supply can be lowered by targeting the Extracellular Membrane Proximal Domain (EMPD) of the IgE B cell receptor (BCR) present on IgE switched B cells. This ultimately leads to apoptosis of these cells upon IgE BCR crosslinking. Since tools to selectively assess the efficacy of IgE BCR crosslinking by IgE targeting antibodies are limited, a readily quantifiable cell model was developed that allows to specifically address IgE BCR crosslinking activity in vitro. The new cell model allowed for a direct quantitative comparison of anti-EMPD IgE therapeutic prototype antibody 47H4 with anti-IgE(Ce3) directed therapeutic antibody Omalizumab and with a newly selected anti-human EMPD IgE monoclonal antibody, designated mAB 15cl12. Furthermore, a complementing mouse model was developed that allows for in vivo validation of antibodies addressing human EMPD IgE. It carries a targetable humanized EMPD IgE sequence that has been introduced by seamless genomic replacement of the endogenous EMPD encoding sequence. The model allowed to directly compare IgE lowering activity of two anti-human EMPD IgE therapeutic antibodies in vivo. Our tools provide the means for quantitative assessment of IgE BCR crosslinking activity which is increasingly gaining attention with respect to forthcoming second generation anti-IgE clinical candidates such as Ligelizumab or other clinical candidates featuring additional effector functions such as IgE BCR crosslinking activity.
Tipo de publicação: JOURNAL ARTICLE
Nome de substância:0 (Anti-Allergic Agents); 0 (Antibodies, Anti-Idiotypic); 0 (Cross-Linking Reagents); 0 (Receptors, Antigen, B-Cell); 0 (anti-IgE antibodies); 2P471X1Z11 (Omalizumab); 37341-29-0 (Immunoglobulin E)


  7 / 1140 MEDLINE  
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PMID:28608756
Autor:Esquivel A; Busse WW; Calatroni A; Togias AG; Grindle KG; Bochkov YA; Gruchalla RS; Kattan M; Kercsmar CM; Khurana Hershey G; Kim H; Lebeau P; Liu AH; Szefler SJ; Teach SJ; West JB; Wildfire J; Pongracic JA; Gern JE
Endereço:1 University of Wisconsin, Madison, Madison, Wisconsin.
Título:Effects of Omalizumab on Rhinovirus Infections, Illnesses, and Exacerbations of Asthma.
Fonte:Am J Respir Crit Care Med; 196(8):985-992, 2017 Oct 15.
ISSN:1535-4970
País de publicação:United States
Idioma:eng
Resumo:RATIONALE: Allergic inflammation has been linked to increased susceptibility to viral illnesses, but it is unclear whether this association is causal. OBJECTIVES: To test whether omalizumab treatment to reduce IgE would shorten the frequency and duration of rhinovirus (RV) illnesses in children with allergic asthma. METHODS: In the PROSE (Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations) study, we examined children with allergic asthma (aged 6-17 yr; n = 478) from low-income census tracts in eight U.S. cities, and we analyzed virology for the groups randomized to treatment with guidelines-based asthma care (n = 89) or add-on omalizumab (n = 259). Weekly nasal mucus samples were analyzed for RVs, and respiratory symptoms and asthma exacerbations were recorded over a 90-day period during the fall seasons of 2012 or 2013. Adjusted illness rates (illnesses per sample) by treatment arm were calculated using Poisson regression. MEASUREMENTS AND MAIN RESULTS: RVs were detected in 97 (57%) of 171 exacerbation samples and 2,150 (36%) of 5,959 nonexacerbation samples (OR, 2.32; P < 0.001). Exacerbations were significantly associated with detection of rhinovirus C (OR, 2.85; P < 0.001) and rhinovirus A (OR, 2.92; P < 0.001), as well as, to a lesser extent, rhinovirus B (OR, 1.98; P = 0.019). Omalizumab decreased the duration of RV infection (11.2 d vs. 12.4 d; P = 0.03) and reduced peak RV shedding by 0.4 log units (95% confidence interval, -0.77 to -0.02; P = 0.04). Finally, omalizumab decreased the frequency of RV illnesses (risk ratio, 0.64; 95% confidence interval, 0.49-0.84). CONCLUSIONS: In children with allergic asthma, treatment with omalizumab decreased the duration of RV infections, viral shedding, and the risk of RV illnesses. These findings provide direct evidence that blocking IgE decreases susceptibility to RV infections and illness. Clinical trial registered with www.clinicaltrials.gov (NCT01430403).
Tipo de publicação: JOURNAL ARTICLE; MULTICENTER STUDY
Nome de substância:0 (Anti-Asthmatic Agents); 2P471X1Z11 (Omalizumab)


  8 / 1140 MEDLINE  
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PMID:28501884
Autor:De Schryver E; Derycke L; Calus L; Holtappels G; Hellings PW; Van Zele T; Bachert C; Gevaert P
Endereço:Upper Airways Research Laboratory, Department Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.
Título:The effect of systemic treatments on periostin expression reflects their interference with the eosinophilic inflammation in chronic rhinosinusitis with nasal polyps.
Fonte:Rhinology; 55(2):152-160, 2017 Jun 01.
ISSN:0300-0729
País de publicação:Netherlands
Idioma:eng
Resumo:BACKGROUND: Periostin is a recently discovered biomarker for eosinophilic inflammation. Chronic rhinosinusitis with nasal polyps is a T-helper 2-skewed chronic inflammatory airway disease. Medical treatments aim to relieve symptoms and maintain clinical control by interfering with the inflammatory cascade. The effect on nasal and serum periostin levels is however yet unknown. We aimed to evaluate the effect of omalizumab, mepolizumab, methylprednisolone and doxycycline on nasal and systemic periostin expression. METHODS: This study is based on 3 previously published trials. Nasal and systemic periostin were assessed in CRSwNP patients, randomly assigned to receive doxycycline (n=14), methylprednisolone (n=14), mepolizumab (n=20) or omalizumab (n=15). There was a control group for each treatment scheme. Doxycycline (200 mg on the first day, followed by 100 mg once daily) and methylprednisolone (32-8 mg once daily) were administered during 20 days; mepolizumab was injected at baseline and at 4 weeks. Omalizumab was injected every 2 or 4 weeks, following the official drug leaflet. RESULTS: Methylprednisolone and omalizumab significantly reduced serum periostin levels at 4 and 8 weeks, respectively, after the start of the treatment. The effect of methylprednisolone was transient. Nasal periostin levels decreased significantly after 8 weeks of treatment with mepolizumab. The periostin expression is in accordance with the previously reported effect on the eosinophilic inflammation and clinical outcome. CONCLUSION: All treatment options distinctly influence periostin expression, reflecting the interference with the local or systemic eosinophilic inflammatory cascade.
Tipo de publicação: JOURNAL ARTICLE
Nome de substância:0 (Anti-Allergic Agents); 0 (Anti-Bacterial Agents); 0 (Anti-Inflammatory Agents); 0 (Antibodies, Monoclonal, Humanized); 0 (Biomarkers); 0 (Cell Adhesion Molecules); 0 (POSTN protein, human); 2P471X1Z11 (Omalizumab); 90Z2UF0E52 (mepolizumab); N12000U13O (Doxycycline); X4W7ZR7023 (Methylprednisolone)


  9 / 1140 MEDLINE  
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PMID:28497679
Autor:Asero R
Endereço:Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano, Italy. E-mail: r.asero@libero.it.
Título:Disappearance of severe oral allergy syndrome following omalizumab treatment.
Fonte:Eur Ann Allergy Clin Immunol; 49(3):143-144, 2017 May.
ISSN:1764-1489
País de publicação:Italy
Idioma:eng
Resumo:Summary: The first case of disappearance of apple-induced oral allergy syndrome in a birch pollen-allergic patient following omalizumab treatment is reported. This observation in a case of type 2 food allergy suggests that omalizumab is potentially an effective preventive treatment for patients with severe, type 1 food allergies.
Tipo de publicação: CASE REPORTS; JOURNAL ARTICLE
Nome de substância:0 (Anti-Allergic Agents); 2P471X1Z11 (Omalizumab)


  10 / 1140 MEDLINE  
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PMID:28477722
Autor:Chipps BE; Lanier B; Milgrom H; Deschildre A; Hedlin G; Szefler SJ; Kattan M; Kianifard F; Ortiz B; Haselkorn T; Iqbal A; Rosén K; Trzaskoma B; Busse WW
Endereço:Capital Allergy and Respiratory Disease Center, Sacramento, Calif. Electronic address: bchipps@capitalallergy.com.
Título:Omalizumab in children with uncontrolled allergic asthma: Review of clinical trial and real-world experience.
Fonte:J Allergy Clin Immunol; 139(5):1431-1444, 2017 May.
ISSN:1097-6825
País de publicação:United States
Idioma:eng
Resumo:Asthma is one of the most common chronic diseases of childhood. Allergen sensitization and high frequencies of comorbid allergic diseases are characteristic of severe asthma in children. Omalizumab, an anti-IgE mAb, is the first targeted biologic therapeutic approved for the treatment of moderate-to-severe persistent allergic asthma (AA) that remains uncontrolled despite high-dose inhaled corticosteroids plus other controller medications. Since its initial licensing for use in adults and adolescents 12 years of age and older, the clinical efficacy, safety, and tolerability of omalizumab have been demonstrated in several published clinical trials in children aged 6 to less than 12 years with moderate-to-severe AA. These studies supported the approval of the pediatric indication (use in children aged ≥6 years) by the European Medicines Agency in 2009 and the US Food and Drug Administration in 2016. After this most recent change in licensing, we review the outcomes from clinical trials in children with persistent AA receiving omalizumab therapy and observational studies from the past 7 years of clinical experience in Europe. Data sources were identified by using PubMed in 2016. Guidelines and management recommendations and materials from the recent US Food and Drug Administration's Pediatric Advisory Committee meeting are also reviewed.
Tipo de publicação: JOURNAL ARTICLE; REVIEW
Nome de substância:0 (Anti-Allergic Agents); 0 (Anti-Asthmatic Agents); 2P471X1Z11 (Omalizumab)



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