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Harold Kim - One of the best experts on this subject based on the ideXlab platform.
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A single centre retrospective study of systemic reactions to Subcutaneous Immunotherapy
Allergy asthma and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 2020Co-Authors: Kara Robertson, Nazanin Montazeri, Urvashi Shelke, Samira Jeimy, Harold KimAbstract:Subcutaneous Immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, Immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual. A single centre retrospective chart review was performed for all patients with systemic reactions to Subcutaneous Immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University. 28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen Immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered extract. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance. This is the first Canadian study to review patients with systemic reactions to Subcutaneous Immunotherapy. Several best practice methods were employed throughout the study to optimize Subcutaneous delivery of Immunotherapy extract, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize Immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.
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A Single-Centre Retrospective Study of Systemic Reactions to Subcutaneous Immunotherapy
2020Co-Authors: Kara Robertson, Nazanin Montazeri, Urvashi Shelke, Samira Jeimy, Harold KimAbstract:Abstract Background: Subcutaneous Immunotherapy (SCIT) is the standard approach for treating patients with sensitizations to aeroallergens. However, Immunotherapy can trigger severe systemic reactions if delivered inappropriately or to high risk patients. We sought to characterize and quantify SCIT systemic reactions requiring epinephrine administration during a 6-year period in a Canadian setting following the recommendations for components and dosages published in the 2010 Canadian Society of Allergy and Clinical Immunology (CSACI) Immunotherapy Manual.Methods: A single centre retrospective chart review was performed for all patients with systemic reactions to Subcutaneous Immunotherapy requiring intramuscular epinephrine injection between January 2011 and October 2017. Each systemic reaction requiring epinephrine was reviewed for baseline patient characteristics, details of the reaction, and reaction severity. Research ethics approval was obtained through McMaster University.Results: 28 of 380 patients experienced a systemic reaction requiring epinephrine administration, with an incidence rate of 1 per 1,047 injection visits (0.095%). 26 of the 28 reactions occurred within the mandatory 30-minute observation period post allergen Immunotherapy. Of the 28 patients that experienced a systemic reaction to SCIT, 11 patients had asthma and 5 patients had a history of possible food allergy. All of the systemic reactions occurred during injections from vial number 4, and five patients reacted to their first shot of a re-ordered serum. 10 of the 28 patients required more than one intramuscular injection of epinephrine, and 20 of 28 patients were transferred to the hospital by ambulance.Conclusions: This is the first Canadian study to review patients with systemic reactions to Subcutaneous Immunotherapy. Several best practice methods were employed throughout the study to optimize Subcutaneous delivery of Immunotherapy serum, and our recorded per injection incidence rate for systemic reactions was comparable or below the rate published in similar studies. The recommendations in the CSACI Immunotherapy Manual provide an approach to standardizing prescriptions for SCIT to maximize Immunotherapy efficacy and reduce the risk of systemic reactions, though similar studies in larger multicenter settings are needed to confirm these observations. These observations provide important objective information to clinicians about the potential risks for systemic reactions in patients considering SCIT.
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SYSTEMIC REACTIONS TO Subcutaneous Immunotherapy TREATED WITH EPINEPHRINE: A CANADIAN EXPERIENCE
Annals of Allergy Asthma & Immunology, 2018Co-Authors: Nazanin Montazeri, Urvashi Shelke, Harold KimAbstract:Introduction Subcutaneous Immunotherapy (SCIT) is associated with a risk of systemic reactions. While previous studies have attempted to quantify this risk, Canadian data is lacking. We aimed to quantify and characterize SCIT systemic reactions requiring epinephrine administration in a Canadian setting. Methods We performed a retrospective chart review of patients with reactions to SCIT requiring intramuscular epinephrine from January 2011 to October 2017 at a single allergy practice in Canada. The 2010 WAO grading system was used to grade the reactions. Results 380 patients were on SCIT and there were a total of 29,334 injection visits. 28 (7.37%) patients required epinephrine administration (incidence rate of 1 in 1,047 injection visits or 0.095%). The age range was from 8 to 60 years (median 34 years). There were 19 (68.9%) males and 4 patients were younger than 18. 11 patients had asthma. No patients were on beta-blockers. All the injections were from vial #4 (most concentrated). Five (17.9%) patients reacted to the first shot of a new serum. Two reactions occurred more than 30 minutes after the injection. Three (10.7%) patients experienced grade 4 reactions. Of these, 2 had asthma and 1 had food allergies. Two patients with grade 4 reactions reacted to the first injection from a new vial. All 3 reactions occurred within 30 minutes of the injection. There were no fatalities. Conclusions To our knowledge, this is the first retrospective chart review of patients with SCIT reactions in Canada. Our findings provide a Canadian perspective and complement the available data on SCIT related reactions.
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Administration and Burden of Subcutaneous Immunotherapy for Allergic Rhinitis in U.S. and Canadian Clinical Practice
Journal of managed care & specialty pharmacy, 2015Co-Authors: Steven W. Blume, Harold Kim, Karen Yeomans, Felicia C. Allen-ramey, Nancy Smith, Richard F. Lockey, Michael B. NicholAbstract:BACKGROUND: Allergy Immunotherapy (AIT) is the only available treatment that alters the natural course of allergies and has possible disease-modifying effects. AIT is administered primarily via Subcutaneous injection delivered in a physician’s office. Few studies have been conducted in the United States or Canada to evaluate the costs of Subcutaneous Immunotherapy (SCIT). OBJECTIVES: To (a) describe SCIT administration processes, resources, and costs and (b) characterize the patient population receiving SCIT. METHODS: A multisite, prospective, observational time and motion study was conducted. Injection and wait times were collected by a third-party observer on 1 visit for each patient. Extract preparation processes were also observed. Site staff reported on treatment protocols, administrative time, supplies, and patient medical history. Patients responded to questionnaires on demographics, reasons for treatment, medication use, productivity, and travel time. Costs were estimated by applying unit costs to...
Murray Skinner - One of the best experts on this subject based on the ideXlab platform.
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a novel microcrystalline tyrosine adsorbed mite allergoid Subcutaneous Immunotherapy 1 year follow up report
Immunotherapy, 2016Co-Authors: Albert Roger, Matthew D. Heath, Nathalie Depreux, Yanina Jurgens, Aina T Serra, Gloria Garcia, Murray SkinnerAbstract:Aim: A 1-year follow-up study comparing the safety and tolerability of the dosing schedules, satisfaction and effectiveness of a novel microcrystalline tyrosine-adsorbed mite (Dermatophagoides pteronyssinus)-allergoid Subcutaneous Immunotherapy (Acarovac Plus™) in 30 adult patients (18–65 years) with allergic rhinitis and/or asthma. Materials & methods: The effectiveness of the product was assessed by nasal provocation test measuring peak nasal inspiratory flow/symptoms, in vitro immunologic changes (IgE, IgG4 and IL-10) and Treatment Satisfaction Questionnaire for Medication. Results: No adverse events were reported during dosing schedules. Significant decreases in symptom scores and drop of peak nasal inspiratory flow in follow-up visits (4 weeks and 1 year) were recorded. Significant increases in IgG4-specific antibody titers and IL-10 were exhibited. Conclusion: Significant decreases in clinical symptoms and immunological parameters were observed, accompanying a high level of patient satisfaction and ...
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A novel microcrystalline tyrosine-adsorbed, mite-allergoid Subcutaneous Immunotherapy: 1-year follow-up report.
Immunotherapy, 2016Co-Authors: Albert Roger, Matthew D. Heath, Nathalie Depreux, Yanina Jurgens, Aina T Serra, Gloria Garcia, Murray SkinnerAbstract:Aim: A 1-year follow-up study comparing the safety and tolerability of the dosing schedules, satisfaction and effectiveness of a novel microcrystalline tyrosine-adsorbed mite (Dermatophagoides pteronyssinus)-allergoid Subcutaneous Immunotherapy (Acarovac Plus™) in 30 adult patients (18–65 years) with allergic rhinitis and/or asthma. Materials & methods: The effectiveness of the product was assessed by nasal provocation test measuring peak nasal inspiratory flow/symptoms, in vitro immunologic changes (IgE, IgG4 and IL-10) and Treatment Satisfaction Questionnaire for Medication. Results: No adverse events were reported during dosing schedules. Significant decreases in symptom scores and drop of peak nasal inspiratory flow in follow-up visits (4 weeks and 1 year) were recorded. Significant increases in IgG4-specific antibody titers and IL-10 were exhibited. Conclusion: Significant decreases in clinical symptoms and immunological parameters were observed, accompanying a high level of patient satisfaction and ...
Rongfei Zhu - One of the best experts on this subject based on the ideXlab platform.
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Risk factors and strategies in nonadherence with Subcutaneous Immunotherapy: a real-life study.
International forum of allergy & rhinology, 2018Co-Authors: Yongshi Yang, Yin Wang, Lin Yang, Jingru Wang, Nan Huang, Xiaolong Wang, Qing Jiang, Guanghui Liu, Rongfei ZhuAbstract:BACKGROUND Allergen Immunotherapy (AIT) is still the only causal treatment for allergic diseases. However, conventional Subcutaneous Immunotherapy (SCIT) administration schedules are time-consuming and patient nonadherence is a major barrier to achieving a satisfactory therapeutic effect. Our study aimed to analyze the causes leading to discontinuation of SCIT and to determine risk factors associated with nonadherence in respiratory allergies. METHODS This was a prospective study. Patients with respiratory allergies who had received standardized dust mite SCIT were enrolled from January 2012 to January 2014. And a follow-up study on these subjects was conducted via telephone interviews on an interval of 3 months and online communication through social network applications. Reasons for discontinuation were documented when patients claimed to stop treatment. RESULTS A total of 311 patients were enrolled in the study. The adherence rate at year 3 was 64.6%. Fifty-nine patients (19.0%) dropped out in year 1, 31 (10.0%) in year 2, and 20 (6.4%) in year 3. Reasons for nonadherence included inconvenience (32.7%), ineffectiveness (25.5%), improvement of symptoms (22.7%), and adverse reactions (14.5%). Children had higher adherence than adults (70.7% vs 55.0%) (p < 0.05). The dropout reasons were different among the children and adults groups (p < 0.005). The follow-up work was carefully and thoroughly done. All the 311 (100%) patients accepted the telephone interview, and 296 (95.2%) patients submitted questions and got rapid replies from doctors online. CONCLUSION Adherence to SCIT was less than satisfactory in the real-life study. A close communication between doctors and patients is helpful in enhancing adherence with AIT in clinical practice.
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systemic reactions to dust mite Subcutaneous Immunotherapy a 3 year follow up study
Allergy Asthma and Immunology Research, 2016Co-Authors: Xiang Dong, Yin Wang, Nan Huang, Xiaolong Wang, Guanghui Liu, Ning Xiang, Rongfei ZhuAbstract:PURPOSE The incidence of allergen specific Immunotherapy-related systemic reactions (SRs) varies among different studies, and many factors are likely to contribute to SRs. This study aims to investigate the incidence, characteristics, and risk factors of SRs to standardize dust mite-specific Subcutaneous Immunotherapy (SCIT) in Central China. METHODS All patients receiving standardized dust mites (100-100,000 SQ-U/mL; Alutard SQ, Horsholn, Denmark) Immunotherapy were followed up. Recorded data included demographics, diagnosis, patient status, pulmonary function testing results before and after each injection, allergen dosage, and details of SRs. RESULTS From June 2011 to August 2014, a total of 208 patients received 4,369 injections; 27 (13.0%) patients experienced 48 (1.1%) systemic reactions. Most of the SRs were grade 2 reactions (n=30, 62.5%), followed by grade 1 (n=11, 22.9%), grade 3 (n=7, 14.6%), and no fatal reactions occurred. Forty-six SRs (95.8%) occurred within 30 minutes. Higher SR rates were associated with high concentration extracts (100,000 SQ-U/mL), injections with concomitant local reactions (LRs), children, asthma and high sensitivity (skin prick test 3+/4+ and/or sIgE≥17.5 kUA/L) (P<0.05). The estimated odds of SRs increased in children (OR=6.57; 95% CI: 1.88-22.97, P=0.003), asthmatic patients (OR=4.10; 95% CI: 1.72-9.80, P=0.002), and injections with LRs (OR=2.41; 95% CI: 1.33-4.36, P=0.004). CONCLUSIONS The incidence of SRs to dust mite SCIT was low, and multiple factors were associated with the increased incidence of SRs. Children, asthmatics and patients with concomitant LR may be prone to develop SRs.
Albert Roger - One of the best experts on this subject based on the ideXlab platform.
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a novel microcrystalline tyrosine adsorbed mite allergoid Subcutaneous Immunotherapy 1 year follow up report
Immunotherapy, 2016Co-Authors: Albert Roger, Matthew D. Heath, Nathalie Depreux, Yanina Jurgens, Aina T Serra, Gloria Garcia, Murray SkinnerAbstract:Aim: A 1-year follow-up study comparing the safety and tolerability of the dosing schedules, satisfaction and effectiveness of a novel microcrystalline tyrosine-adsorbed mite (Dermatophagoides pteronyssinus)-allergoid Subcutaneous Immunotherapy (Acarovac Plus™) in 30 adult patients (18–65 years) with allergic rhinitis and/or asthma. Materials & methods: The effectiveness of the product was assessed by nasal provocation test measuring peak nasal inspiratory flow/symptoms, in vitro immunologic changes (IgE, IgG4 and IL-10) and Treatment Satisfaction Questionnaire for Medication. Results: No adverse events were reported during dosing schedules. Significant decreases in symptom scores and drop of peak nasal inspiratory flow in follow-up visits (4 weeks and 1 year) were recorded. Significant increases in IgG4-specific antibody titers and IL-10 were exhibited. Conclusion: Significant decreases in clinical symptoms and immunological parameters were observed, accompanying a high level of patient satisfaction and ...
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A novel microcrystalline tyrosine-adsorbed, mite-allergoid Subcutaneous Immunotherapy: 1-year follow-up report.
Immunotherapy, 2016Co-Authors: Albert Roger, Matthew D. Heath, Nathalie Depreux, Yanina Jurgens, Aina T Serra, Gloria Garcia, Murray SkinnerAbstract:Aim: A 1-year follow-up study comparing the safety and tolerability of the dosing schedules, satisfaction and effectiveness of a novel microcrystalline tyrosine-adsorbed mite (Dermatophagoides pteronyssinus)-allergoid Subcutaneous Immunotherapy (Acarovac Plus™) in 30 adult patients (18–65 years) with allergic rhinitis and/or asthma. Materials & methods: The effectiveness of the product was assessed by nasal provocation test measuring peak nasal inspiratory flow/symptoms, in vitro immunologic changes (IgE, IgG4 and IL-10) and Treatment Satisfaction Questionnaire for Medication. Results: No adverse events were reported during dosing schedules. Significant decreases in symptom scores and drop of peak nasal inspiratory flow in follow-up visits (4 weeks and 1 year) were recorded. Significant increases in IgG4-specific antibody titers and IL-10 were exhibited. Conclusion: Significant decreases in clinical symptoms and immunological parameters were observed, accompanying a high level of patient satisfaction and ...
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Randomized dose-response study of Subcutaneous Immunotherapy with a Dermatophagoides pteronyssinus extract in patients with respiratory allergy.
Immunotherapy, 2016Co-Authors: Victoria Moreno, Albert Roger, Marta Alvariño, Fernando Rodriguez, María Isabel Peña-arellano, Ramón Lleonart, Juan Antonio Pagán, Jose Antonio Navarro, Luis Ángel Navarro, Carmen VidalAbstract:Aim: To evaluate the efficacy of Dermatophagoides pteronyssinus (DPT) Subcutaneous Immunotherapy in allergic rhinoconjunctivitis patients. Patients & methods: This 17-week double-blind study randomized 136 patients (95 evaluable) to five dose groups of DPT depot extract (0.0625–0.75 skin prick test [SPT] units) or placebo, administered in a six updosing schedule. Results: A dose–response was observed for clinical efficacy (allergen concentration needed to induce a positive nasal provocation test response from baseline to final visit) and safety (adverse reactions). Local and systemic reactions occurred with 14.8 and 6.4% of administered doses, respectively; a single anaphylactic reaction occurred in each of Groups 3, 4 and 5 (0.3% of doses). Conclusion: The risk–benefit profile appeared most favorable with a DPT dose of 0.125 SPT units.
Matthew D. Heath - One of the best experts on this subject based on the ideXlab platform.
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A novel microcrystalline tyrosine-adsorbed, mite-allergoid Subcutaneous Immunotherapy: 1-year follow-up report.
Immunotherapy, 2016Co-Authors: Albert Roger, Matthew D. Heath, Nathalie Depreux, Yanina Jurgens, Aina T Serra, Gloria Garcia, Murray SkinnerAbstract:Aim: A 1-year follow-up study comparing the safety and tolerability of the dosing schedules, satisfaction and effectiveness of a novel microcrystalline tyrosine-adsorbed mite (Dermatophagoides pteronyssinus)-allergoid Subcutaneous Immunotherapy (Acarovac Plus™) in 30 adult patients (18–65 years) with allergic rhinitis and/or asthma. Materials & methods: The effectiveness of the product was assessed by nasal provocation test measuring peak nasal inspiratory flow/symptoms, in vitro immunologic changes (IgE, IgG4 and IL-10) and Treatment Satisfaction Questionnaire for Medication. Results: No adverse events were reported during dosing schedules. Significant decreases in symptom scores and drop of peak nasal inspiratory flow in follow-up visits (4 weeks and 1 year) were recorded. Significant increases in IgG4-specific antibody titers and IL-10 were exhibited. Conclusion: Significant decreases in clinical symptoms and immunological parameters were observed, accompanying a high level of patient satisfaction and ...
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a novel microcrystalline tyrosine adsorbed mite allergoid Subcutaneous Immunotherapy 1 year follow up report
Immunotherapy, 2016Co-Authors: Albert Roger, Matthew D. Heath, Nathalie Depreux, Yanina Jurgens, Aina T Serra, Gloria Garcia, Murray SkinnerAbstract:Aim: A 1-year follow-up study comparing the safety and tolerability of the dosing schedules, satisfaction and effectiveness of a novel microcrystalline tyrosine-adsorbed mite (Dermatophagoides pteronyssinus)-allergoid Subcutaneous Immunotherapy (Acarovac Plus™) in 30 adult patients (18–65 years) with allergic rhinitis and/or asthma. Materials & methods: The effectiveness of the product was assessed by nasal provocation test measuring peak nasal inspiratory flow/symptoms, in vitro immunologic changes (IgE, IgG4 and IL-10) and Treatment Satisfaction Questionnaire for Medication. Results: No adverse events were reported during dosing schedules. Significant decreases in symptom scores and drop of peak nasal inspiratory flow in follow-up visits (4 weeks and 1 year) were recorded. Significant increases in IgG4-specific antibody titers and IL-10 were exhibited. Conclusion: Significant decreases in clinical symptoms and immunological parameters were observed, accompanying a high level of patient satisfaction and ...
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Aluminium in allergen-specific Subcutaneous Immunotherapy--a German perspective.
Vaccine, 2014Co-Authors: Matthias F. Kramer, Matthew D. HeathAbstract:We are living in an "aluminium age" with increasing bioavailability of the metal for approximately 125 years, contributing significantly to the aluminium body burden of humans. Over the course of life, aluminium accumulates and is stored predominantly in the lungs, bones, liver, kidneys and brain. The toxicity of aluminium in humans is briefly summarised, highlighting links and possible causal relationships between a high aluminium body burden and a number of neurological disorders and disease states. Aluminium salts have been used as depot-adjuvants successfully in essential prophylactic vaccinations for almost 100 years, with a convincing positive benefit-risk assessment which remains unchanged. However, allergen-specific Immunotherapy commonly consists of administering a long-course programme of Subcutaneous injections using preparations of relevant allergens. Regulatory authorities currently set aluminium limits for vaccines per dose, rather than per treatment course. Unlike prophylactic vaccinations, numerous injections with higher proportions of aluminium-adjuvant per injection are applied in Subcutaneous Immunotherapy (SCIT) and will significantly contribute to a higher cumulative life dose of aluminium. While the human body may cope robustly with a daily aluminium overload from the environment, regulatory cumulative threshold values in Immunotherapy need further addressing. Based on the current literature, predisposing an individual to an unusually high level of aluminium, such as through Subcutaneous Immunotherapy, has the potential to form focal accumulations in the body with the propensity to exert forms of toxicity. Particularly in relation to longer-term health effects, the safety of aluminium adjuvants in Immunotherapy remains unchallenged by health authorities - evoking the need for more consideration, guidance, and transparency on what is known and not known about its safety in long-course therapy and what measures can be taken to prevent or minimise its risks. The possibility of providing an effective means of measuring aluminium accumulation in patients undergoing long-term SCIT treatment as well as reducing their aluminium body burden is discussed.
