scholarly journals Genetically Engineered Biologic Drugs in Management of Children with Bronchial Asthma

2021 ◽  
pp. 364-372
Author(s):  
Svetlana V. Zaytseva ◽  
Anna U. Tomilova ◽  
Olga V. Zaytseva ◽  
Olga B. Voronina ◽  
Olga A. Murtazaeva ◽  
...  
Keyword(s):  
Bronchial Asthma ◽  
Real Life ◽  
Genetically Engineered ◽  
Special Role ◽  
Biologic Drugs ◽  
Effective Response ◽  
Efficacy Analysis ◽  
Response Predictors ◽  
High Doses ◽  
Role Efficacy

Current article represents the modern clinical guidelines on management of severe bronchial asthma (BA) in children and practical use of genetically engineered biologic drugs. Clinical efficacy and safety of omalizumab has its special role. Efficacy analysis was carried out in real-life' clinical setting (considering high economical expenses of biological treatment) to estimate effective response predictors and principles of patients selection for such therapy. Two years of anti-IgE treatment experience in inpatient pediatric department settings demonstrates that omalizumab inclusion to treatment of children with severe asthma resistant to standard therapy allows to solve asthma symptoms, to forgo high doses inhaled glucocorticosteroids, to improve lung function parameters, and to increase significantly quality of life in 95% of our patients.

scholarly journals Genetically Engineered Biologic Drugs in Management of Children with Bronchial Asthma

2021 ◽  
Vol 18 (6) ◽  
pp. 460-468
Author(s):  
Svetlana V. Zaytseva ◽  
Anna U. Tomilova ◽  
Olga V. Zaytseva ◽  
Olga B. Voronina ◽  
Olga A. Murtazaeva ◽  
...  
Keyword(s):  
Bronchial Asthma ◽  
Real Life ◽  
Genetically Engineered ◽  
Special Role ◽  
Biologic Drugs ◽  
Effective Response ◽  
Efficacy Analysis ◽  
Response Predictors ◽  
High Doses ◽  
Role Efficacy

Current article represents the modern clinical guidelines on management of severe bronchial asthma (BA) in children and practical use of genetically engineered biologic drugs. Clinical efficacy and safety of omalizumab has its special role. Efficacy analysis was carried out in real-life' clinical setting (considering high economical expenses of biological treatment) to estimate effective response predictors and principles of patients selection for such therapy. Two years of anti-IgE treatment experience in inpatient pediatric department settings demonstrates that omalizumab inclusion to treatment of children with severe asthma resistant to standard therapy allows to solve asthma symptoms, to forgo high doses inhaled glucocorticosteroids, to improve lung function parameters, and to increase significantly quality of life in 95% of our patients.

Pharmacoeconomic analysis of using genetically engineered biologic drugs for treating adult patients with moderate to severe plaque psoriasis in the Russian Federation

2020 ◽  
pp. 57-65
Author(s):  
Maksim Frolov ◽  
Vladimir Rogov ◽  
Alla Salasyuk
Keyword(s):  
Plaque Psoriasis ◽  
Impact Analysis ◽  
Pharmacoeconomic Analysis ◽  
Certolizumab Pegol ◽  
Genetically Engineered ◽  
Adult Patients ◽  
Comparable Efficacy ◽  
Biologic Drugs ◽  
Severe Plaque Psoriasis ◽  
Cost Minimisation Analysis

The aim of the study was to assess clinical and economic effectiveness of netakimab compared to other genetically engineered biologic drugs (infliximab, adalimumab, etanercept, ustekinumab, secukinumab, ixekizumab, certolizumab pegol) for the treatment of adult patients with moderate to severe plaque psoriasis. We have conducted cost-benefit analysis, cost-minimisation analysis, and budget impact analysis. We have considered only direct medical costs. The results of the study show that netakimab has higher or comparable efficacy and significantly lower costs compared to other biologic drugs, that makes it the most preferable treatment option for patients with moderate to severe plaque psoriasis. Use of netakimab in clinical practice will significantly reduce budget expenditures and increase patient access to biologic therapy.

CLINICAL AND SPIROGRAPHIC FEATURES OF BRONCHIAL ASTHMA IN SCHOOLCHILDREN DEPENDING ON THE DIFFERENT REGIMENS OF BASIC ANTI-INFLAMMATORY THERAPY

2020 ◽  
Vol 73 (1) ◽  
Author(s):  
Olena Koloskova ◽  
Tetiana Bilous ◽  
Galyna Bilyk ◽  
Kristina Buryniuk-Glovyak ◽  
Olena Korotun ◽  
...  
Keyword(s):  
Bronchial Asthma ◽  
Inhaled Corticosteroids ◽  
Persistent Asthma ◽  
High Specificity ◽  
Clinical Feature ◽  
Clinical Group ◽  
Comparison Groups ◽  
Anti Inflammatory ◽  
High Doses ◽  
Persistent Bronchial Asthma

The aim: To study the clinical and spirographic features persistence of the bronchial asthma in schoolchildren against the background of the alternative daily doses of inhaled corticosteroids to increase the effectiveness of anti-inflammatory therapy for this disease. Materials and methods: A complete comprehensive clinical-paraclinical examination of 65 schoolchildren with persistent asthma was conducted. According to the average daily dose of inhaled corticosteroids (ICS) the patients were divided into two clinical groups. The first (I) group consisted of 46 children who received ICS in the regimen of low-to-medium equipotent doses (253.95±9.98 μg per day), and the second (II) comparison group was formed of 19 patients who controlled the pBA using high doses of ICS (494.74±5.56 μg per day). Results: The patients of the І clinical group compared to patients of the ІІ group have a higher risk of the mild bronchial obstructive syndrome during asthma attacks. In assessing the level of control of persistent bronchial asthma using the CIA-scale, it was found that in II group cases of the controlled course of the disease were observed almost two times less than in children of the I group of comparison. In conducting spirography in children of comparison groups, it was shown that the ratio of indices of bronchospasm (FEV1/ FVC) was worse in patients receiving high doses of ICS. Conclusions: So, сharacteristic clinical feature of asthma controlled by high doses of ICS is more severe nature of bronchial obstructive syndrome during the period of exacerbation (OR=1.9-3.0). In the management of persistent bronchial asthma, the Gensler index which has high specificity (94.4%) and accuracy (92.2%) should be used for disease control verification.

scholarly journals POS0675 THE COMPARATIVE 3-YEAR RETENTION RATE OF TARGETED-SYNTHETIC AND BIOLOGIC DRUGS FOR RHEUMATOID ARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN GISEA REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
E. G. Favalli ◽  
F. Iannone ◽  
E. Gremese ◽  
R. Gorla ◽  
R. Foti ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Retention Rate ◽  
Large Population ◽  
Real Life ◽  
Mechanisms Of Action ◽  
Biologic Drugs ◽  
Real Life Setting ◽  
Study Population ◽  
Targeted Drug

Background:Long-term observational data on the real-life use of JAK inhibitors (JAKis) for rheumatoid arthritis (RA) and their comparison with biological drugs are still very limited. Large population-based registries have been increasingly used to investigate the performance of targeted drugs in a real-life setting.Objectives:The aim of this study is to evaluate and compare the 3-year retention rate of JAKis, TNF inhibitors (TNFis) and biologic drugs with other mechanisms of action (OMAs) in the large cohort of RA patients included in the Italian national GISEA registry.Methods:Data of all RA patients treated with targeted synthetic or biologic drugs were prospectively collected in the Italian multicentric GISEA registry. The analysis was limited to patients who started a first- or second-line targeted drug in the period after the first JAKi was marketed in Italy (1st December 2017). The 3-year retention rate was calculated by the Kaplan-Meier method and compared between different drug classes by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 1027 RA patients (79.8% females, mean age [±SD] 56.9 [±13.5] years, mean disease duration 9.8 [±9] years, mean baseline SDAI 17.5 [±11.9], ACPA positive 67.4%, RF positive 62.7%) who received JAKis (baricitinib or tofacitinib, n=297), TNFis (n=365), or OMAs (n=365) as first or second targeted drug. Main baseline characteristics of study population were overall well balanced between treatment groups. Retention rate was numerically but not statistically higher (p=0.18) in patients treated with JAKis compared with TNFis or OMAs (80.6, 78.9 and 76.4% at 1 year and 73, 56.8 and 63.8% at 3 years, respectively) (Figure 1). Drug survival was significantly higher in patients receiving concomitant methotrexate (MTX) compared with monotherapy only in TNFis (66.8 vs 47.1%, p=0.04) but not in JAKis (76.1 vs 70.1%, p=0.54) and OMAs (66.1 vs 61.9%, p=0.41) group. Therapy was discontinued in a total of 211 patients because of ineffectiveness (n=107), adverse events (n=88), or compliance/other reasons (n=16). The most frequent reason for treatment withdrawal was ineffectiveness in both JAKis (n=30 out of 56) and TNFis (n=45 out of 74) groups, whereas OMAs were discontinued more frequently because of adverse events (n=41 out of 81).Conclusion:Our data confirmed in a real-life setting a favorable 3-year retention rate of all available targeted mechanisms of action for RA therapy. As expected, concomitant MTX significantly impacted persistence on therapy of TNFis only. Discontinuations of JAKis for adverse events were infrequent overall, confirming the safety profile observed in randomized clinical trials.Figure 1.Three-year retention rate by treatment groupDisclosure of Interests:None declared

scholarly journals Parkin regulates drug-taking behavior in rat model of methamphetamine use disorder

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Akhil Sharma ◽  
Arman Harutyunyan ◽  
Bernard L. Schneider ◽  
Anna Moszczynska
Keyword(s):  
Neural Substrates ◽  
Genetically Engineered ◽  
Wild Type ◽  
Therapeutic Approaches ◽  
Self Administration ◽  
Methamphetamine Use ◽  
New Therapeutic Approaches ◽  
Extended Access ◽  
High Doses ◽  
Methamphetamine Use Disorder

AbstractThere is no FDA-approved medication for methamphetamine (METH) use disorder. New therapeutic approaches are needed, especially for people who use METH heavily and are at high risk for overdose. This study used genetically engineered rats to evaluate PARKIN as a potential target for METH use disorder. PARKIN knockout, PARKIN-overexpressing, and wild-type young adult male Long Evans rats were trained to self-administer high doses of METH using an extended-access METH self-administration paradigm. Reinforcing/rewarding properties of METH were assessed by quantifying drug-taking behavior and time spent in a METH-paired environment. PARKIN knockout rats self-administered more METH and spent more time in the METH-paired environment than wild-type rats. Wild-type rats overexpressing PARKIN self-administered less METH and spent less time in the METH-paired environment. PARKIN knockout rats overexpressing PARKIN self-administered less METH during the first half of drug self-administration days than PARKIN-deficient rats. The results indicate that rats with PARKIN excess or PARKIN deficit are useful models for studying neural substrates underlying “resilience” or vulnerability to METH use disorder and identify PARKIN as a novel potential drug target to treat heavy use of METH.

scholarly journals Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation

2019 ◽  
Vol 91 (8) ◽  
pp. 41-46
Author(s):  
O V Knyazev ◽  
T V Shkurko ◽  
A V Kagramanova ◽  
A A Lishchinskaya ◽  
M Yu Zvyaglova ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Real Life ◽  
Fecal Calprotectin ◽  
Biologic Drugs ◽  
Real Life Data ◽  
Bowel Diseases ◽  
Significant Clinical Improvement ◽  
One Year

Real - life data on the effectiveness and safety of biosimilar and biologic drugs licensed for treatment of inflammatory bowel diseases (IBD) is lacking. Aim. To investigate efficacy of original Infliximab (IFX) and its biosimilar in treating patients with ulcerative colitis (UC) and determine the frequency of adverse events during 1 year follow - up period. Materials and methods. Our cohort consisted of 98 ulcerative colitis patients, treated with original IFX and its biosimilar since December 2017 till December 2018 years. Original Infliximab was prescribed in 56 UC patients (57.1%) during 5 years and longer; 16 patients (16.3%) were switched to IFX biosimilar; 13 UC bio - naïve patients (13.3%) received original IFX, 29 (29.6%) patients - biosimilar IFX. In 14 patients (14.3%) original infliximab was rotated with biosimilar. We picked out 42 patients to assess efficacy of original IFX and biosimilar. Results and discussion. Twelve patients, received original IFX and 28 patients, treated with its biosimilar, showed significant clinical improvement by decreasing Mayo index from 9.7±0.4 and 10.2±0.2 points to 1.9±0.09 and 2.1±0.1 points, accordingly. Also we noticed positive change in laboratory markers - CRP decrease from 89.6±8.7 mg/l and 77.5±8.0 mg/l to 6.5±0.8 mg/l and 6.9±0.8 mg/l (p>0.05), albumin increase from 30.1±4.7 g/l and 29.6±3.6 g/l to 34.1±6.3 g/l and 32.8±5.9 g/l (p>0.05), increase of serum iron levels from 6.4±0.5 mcg/l and 7.1±0.65 mcg/l to 14.6±4.4 mcg/l and 15.9±5.1 mcg/l (p>0.05), hemoglobin increase from 104.7±9.8 g/l and 102.2±8.8 g/l till 124±11.3 g/l and 121±10.9 g/l (p>0.05), and fecal calprotectin decrease from 1680±134 mcg/g and 1720±126 mcg/g till 245.5±33.4 mcg/g and 230.5±29.8 mcg/g (p>0.05). During 1 year follow - up 12 UC patients, treated with original IFX and its biosimilar, developed adverse events. The majority of adverse events (n=8) were registered in patients, rotating administration of original IFX and its biosimilar. Conclusion. IFX biosimilar is effective as well as original IFX. Frequency of adverse events, occurred in patients, treated with original IFX, was comparable with adverse events frequency in patients, received biosimilar IFX. Frequency of adverse events was significantly higher in UC patients, rotating original IFX and its biosimilar.

Biologics registries

2013 ◽  
pp. 257-263
Author(s):  
David Isenberg ◽  
Angela Zink
Keyword(s):  
Rheumatoid Arthritis ◽  
Life Experience ◽  
Real Life ◽  
Cancer Development ◽  
Controlled Trials ◽  
Side Effect Profile ◽  
Risk Of Infection ◽  
Biologic Drugs ◽  
Double Blind

Double-blind controlled trials undertaken over the past two decades have established the short-term effectiveness and side-effect profile of biologic drugs for patients with rheumatoid arthritis and related diseases. However, the development of biologics registers to capture ’real-life experience’ and explore long-term effectiveness and complications is equally important. In this chapter, we demonstrate how these registers have identified long-term joint benefits, a reduction in cardiovascular mortality, reassurance concerning fears about cancer development, and a balanced view of the risk of infection.

scholarly journals (A284) Improving Hospital Mass Casualty Preparedness through Ongoing Readiness Evaluation

2011 ◽  
Vol 26 (S1) ◽  
pp. s79-s79
Author(s):  
B. Adini ◽  
D. Laor ◽  
T. Hornik-Luria ◽  
A. Goldberg ◽  
D. Schwartz ◽  
...  
Keyword(s):  
Acute Care ◽  
Emergency Preparedness ◽  
Life Experience ◽  
Real Life ◽  
High Standard ◽  
Acute Care Hospitals ◽  
Mass Casualty ◽  
Evaluation Tool ◽  
Effective Response ◽  
Mass Casualty Event

BackgroundIsraeli Hospitals are required to maintain a high level of emergency preparedness.ObjectivesTo investigate the effect of on-going use of an evaluation tool on acute-care hospitals' emergency preparedness for mass casualty events (MCE).MethodsEvaluation of emergency preparedness for MCE was carried out in all acute-care hospitals, based on an evaluation tool consisting of 306 objective and measurable parameters. Two cycles of evaluations were conducted in 2005 to 2009 and the scores were calculated to detect differences.ResultsA significant increase was found in the mean total scores of emergency preparedness between the two cycles of evaluations (from 77.1 to 88.5). An increase was found in scores for standard operating procedures, training and equipment, but the change was significant only in the training category. The relative increase was highest in hospitals that did not experience real MCE.DiscussionThis study offers a structured and practical approach for ongoing improvement of emergency preparedness, based on validated measurable benchmarks. An ongoing assessment of the level of emergency preparedness motivates hospitals' management and staff to improve their capabilities and thus results in a more effective response mechanism for emergency scenarios.ConclusionsUtilization of predetermined and measurable benchmarks allows the institutions being assessed to improve their level of performance in the evaluated areas. The expectation is that these benchmarks will allow for a better response to actual MCEs. The study further demonstrated that even hospitals without “real-life” experience can gear up using preset benchmarks and reach a high standard of mass casualty event preparedness.

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