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Find video protocols related to scientific articles indexed in Pubmed.
Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience.
Expert Rev Clin Immunol
PUBLISHED: 09-10-2014
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Oralair(®) (OA) (Stallergenes, Antony, France) is a unique pre- and co-seasonal 5-grass-pollen sublingual immunotherapy tablet launched in 2008, and now approved in 31 countries worldwide for the treatment of grass-pollen allergic rhinitis and rhinoconjunctivitis. OA is the first oral treatment with a consistent, well-balanced allergen extract that mimics natural exposure and sensitization. A wealth of data exists from over 5 years of clinical and real-world experience demonstrating the efficacy and safety of OA for grass-pollen-allergy treatment. OA is highly effective from the first pollen season in all patient subgroups, including children and those with comorbid mild asthma, irrespective of sensitization status and symptom severity. OA also has sustained long-term benefits for symptom control and quality of life. This article provides an overview of the pharmacodynamics and pharmacology of OA; its efficacy, safety, tolerability and cost-effectiveness for the treatment of allergic rhinitis and rhinoconjunctivitis and its role in clinical practice.
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Development of ?-lactoglobulin-specific chimeric human IgE? monoclonal antibodies for in vitro safety assessment of whey hydrolysates.
PLoS ONE
PUBLISHED: 08-25-2014
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Cow's milk-derived whey hydrolysates are nutritional substitutes for allergic infants. Safety or residual allergenicity assessment of these whey hydrolysates is crucial. Currently, rat basophilic leukemia RBL-2H3 cells expressing the human IgE receptor ?-chain (huFc?RI?-RBL-2H3), sensitized with serum IgE from cow's milk allergic children, are being employed to assess in vitro residual allergenicity of these whey hydrolysates. However, limited availability and inter-lot variation of these allergic sera impede standardization of whey hydrolysate safety testing in degranulation assays.
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Allergy immunotherapy: what is the evidence for cost saving?
Curr Opin Allergy Clin Immunol
PUBLISHED: 06-18-2014
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Given the widespread prevalence of allergic disease, its substantially associated clinical and economic burden, the unique disease-modifying benefits of allergy immunotherapy (AIT), and increased availability of sublingual immunotherapy (SLIT), a critical update of the evidence for AIT-related cost savings [for both subcutaneous immunotherapy (SCIT) and SLIT] is particularly relevant and timely. The present article reviews the evidence for SCIT-related and SLIT-related cost savings derived from a systematic review of the published literature.
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The diagnosis and management of acute and chronic urticaria: 2014 update.
J. Allergy Clin. Immunol.
PUBLISHED: 02-10-2014
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These parameters were developed by the Joint Task Force on Practice Parameters (JTFPP), representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology. The AAAAI and ACAAI have jointly accepted responsibility for establishing "The diagnosis and management of acute and chronic urticaria: 2014 update." This is a complete and comprehensive document at the current time. The medical environment is a changing environment, and not all recommendations will be appropriate for all patients. Because this document incorporated the efforts of many participants, no single individual, including those who served on the JTFPP, is authorized to provide an official AAAAI or ACAAI interpretation of these practice parameters. Any request for information about or an interpretation of these practice parameters by the AAAAI or ACAAI should be directed to the Executive Offices of the AAAAI, the ACAAI, and the Joint Council of Allergy, Asthma & Immunology. The JTFPP understands that the cost of diagnostic tests and therapeutic agents is an important concern that might appropriately influence the work-up and treatment chosen for a given patient. The JTFPP recognizes that the emphasis of our primary recommendations regarding a medication might vary, for example, depending on third-party payer issues and product patent expiration dates. However, because a given test or agent's cost is so widely variable and there is a paucity of pharmacoeconomic data, the JTFPP generally does not consider cost when formulating practice parameter recommendations. In extraordinary circumstances, when the cost/benefit ratio of an intervention is prohibitive, as supported by pharmacoeconomic data, commentary might be provided. These parameters are not designed for use by pharmaceutical companies in drug promotion. The JTFPP is committed to ensuring that the practice parameters are based on the best scientific evidence that is free of commercial bias. To this end, the parameter development process includes multiple layers of rigorous review. These layers include the workgroup convened to draft the parameter, the task force reviewers, and peer review by members of each sponsoring society. Although the task force has the final responsibility for the content of the documents submitted for publication, each reviewer comment will be discussed, and reviewers will receive written responses to comments, when appropriate. To preserve the greatest transparency regarding potential conflicts of interest, all members of the JTFPP and the practice parameter workgroups will complete a standard potential conflict of interest disclosure form, which will be available for external review by the sponsoring organization and any other interested individual. In addition, before confirming the selection of a Work Group chairperson, the Joint Task Force will discuss and resolve all relevant potential conflicts of interest associated with this selection. Finally, all members of parameter workgroups will be provided a written statement regarding the importance of ensuring that the parameter development process is free of commercial bias. Practice parameters are available online at www.jcaai.org and www.allergyparameters.org.
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Sublingual immunotherapy: World Allergy Organization position paper 2013 update.
World Allergy Organ J
PUBLISHED: 02-07-2014
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We have prepared this document, "Sublingual Immunotherapy: World Allergy Organization Position Paper 2013 Update", according to the evidence-based criteria, revising and updating chapters of the originally published paper, "Sublingual Immunotherapy: World Allergy Organization Position Paper 2009", available at http://www.waojournal.org. Namely, these comprise: "Mechanisms of sublingual immunotherapy;" "Clinical efficacy of sublingual immunotherapy" - reporting all the data of all controlled trials published after 2009; "Safety of sublingual immunotherapy" - with the recently published Grading System for adverse reactions; "Impact of sublingual immunotherapy on the natural history of respiratory allergy" - with the relevant evidences published since 2009; "Efficacy of SLIT in children" - with detailed analysis of all the studies; "Definition of SLIT patient selection" - reporting the criteria for eligibility to sublingual immunotherapy; "The future of immunotherapy in the community care setting"; "Methodology of clinical trials according to the current scientific and regulatory standards"; and "Guideline development: from evidence-based medicine to patients' views" - including the evolution of the methods to make clinical recommendations.Additionally, we have added new chapters to cover a few emerging crucial topics: "Practical aspects of schedules and dosages and counseling for adherence" - which is crucial in clinical practice for all treatments; "Perspectives and new approaches" - including recombinant allergens, adjuvants, modified allergens, and the concept of validity of the single products. Furthermore, "Raising public awareness about sublingual immunotherapy", as a need for our patients, and strategies to increase awareness of allergen immunotherapy (AIT) among patients, the medical community, all healthcare stakeholders, and public opinion, are also reported in detail.
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Oral Immunotherapy for Treatment of Immunoglobulin E-Mediated Food Allergy: The Transition to Clinical Practice.
Pediatr Allergy Immunol Pulmonol
PUBLISHED: 01-27-2014
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Today, there is neither an effective nor an active treatment for food allergy. Allergy immunotherapy has been proposed as an attractive strategy to actively treat food allergy. Oral immunotherapy (OIT), also known as oral desensitization, is a method of inducing the body's immune system to tolerate a food that causes an allergic overreaction. It has been studied for the use in treatment of immunoglobulin E-mediated food allergy to the most common foods, including milk, egg, and peanut. OIT has been able to desensitize subjects to varying degrees. However, many questions remain unanswered, including efficient formulation, optimal dosing, and induction protocol to achieve full tolerance, transition of OIT to clinical practice, and maximal safety profile. This review focuses on the use of OIT as a new and active treatment for food allergy. The possibility of transition of OIT to clinical practice represents, in this field, the next pivotal step with the goal of improving the quality of life of patients with food allergy and their families.
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Sublingual immunotherapy for aeroallergens: status in the United States.
Allergy Asthma Proc
PUBLISHED: 01-18-2014
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Sublingual immunotherapy (SLIT) has been used in the treatment of allergic disease for nearly 30 years and is prescribed at least as frequently as subcutaneous immunotherapy (SCIT). Several large U.S. clinical trials using single allergen tablets (grass and ragweed) or extract solution (ragweed) have met their primary clinical efficacy outcome. In December, 2013 the Federal Drug Administration (FDA) Allergenic Products Advisory Committee favorably reviewed two grass tablet product formulations; the FDA usually follows the recommendations of their advisory committees. Industry-sponsored and investigator-initiated aeroallergen SLIT clinical trials conducted in the United States are the focus of this article. To provide a basis for evaluation of this treatment, SLIT mechanisms, pharmacokinetics, efficacy as reported in systematic reviews, and safety are also discussed. Practical considerations of SLIT in the clinical setting are reviewed. These include patient instructions and adherence, which appear to be as poor as SCIT. Estimated treatment costs based on U.S.-licensed allergen extract manufacturers' list prices and doses reported to be effective in studies using U.S.-licensed allergen extracts or the allergen immunotherapy practice parameters are presented. Unmet needs, which include unknown effective dose for many allergen extracts, optimal schedule (daily versus other) and timing of treatment initiation (perennial versus precoseasonal, ?8 weeks before or just at the start of season), and whether epinephrine autoinjectors should be routinely prescribed for SLIT patients are discussed.
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Specificity and Effector Functions of Human RSV-Specific IgG from Bovine Milk.
PLoS ONE
PUBLISHED: 01-01-2014
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Respiratory syncytial virus (RSV) infection is the second most important cause of death in the first year of life, and early RSV infections are associated with the development of asthma. Breastfeeding and serum IgG have been shown to protect against RSV infection. Yet, many infants depend on bovine milk-based nutrition, which at present lacks intact immunoglobulins.
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A focused parameter update: hereditary angioedema, acquired C1 inhibitor deficiency, and angiotensin-converting enzyme inhibitor-associated angioedema.
J. Allergy Clin. Immunol.
PUBLISHED: 03-11-2013
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These parameters were developed by the Joint Task Force on Practice Parameters (JTFPP), representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma and Immunology. The AAAAI and the ACAAI have jointly accepted responsibility for establishing "A focused parameter update: Hereditary angioedema, acquired C1 inhibitor deficiency, and angiotensin-converting enzyme inhibitor-associated angioedema." This is a complete and comprehensive document at the current time. The medical environment is a changing environment, and not all recommendations will be appropriate for all patients. Because this document incorporated the efforts of many participants, no single individual, including those who served on the JTFPP, is authorized to provide an official AAAAI or ACAAI interpretation of these practice parameters. Any request for information about or an interpretation of these practice parameters by the AAAAI or ACAAI should be directed to the Executive Offices of the AAAAI, the ACAAI, and the Joint Council of Allergy, Asthma and Immunology. The Joint Task Force on Practice Parameters understands that the cost of diagnostic tests and therapeutic agents is an important concern that might appropriately influence the work-up and treatment chosen for a given patient. The JTFPP recognizes that the emphasis of our primary recommendations regarding a medication might vary, for example, depending on third-party payer issues and product patent expiration dates. However, because the cost of a given test or agent is so widely variable and there is a paucity of pharmacoeconomic data, the JTFPP generally does not consider cost when formulating practice parameter recommendations. In some instances the cost benefit of an intervention is considered relevant, and commentary might be provided. These parameters are not designed for use by pharmaceutical companies in drug promotion. The Joint Task Force is committed to ensuring that the practice parameters are based on the best scientific evidence that is free of commercial bias. To this end, the parameter development process includes multiple layers of rigorous review. These layers include the Workgroup convened to draft the parameter, the Task Force Reviewers, and peer review by members of each sponsoring society. Although the Task Force has the final responsibility for the content of the documents submitted for publication, each reviewer comment will be discussed, and reviewers will receive written responses to comments when appropriate. To preserve the greatest transparency regarding potential conflicts of interest, all members of the Joint Task Force and the Practice Parameters Workgroups will complete a standard potential conflict of interest disclosure form, which will be available for external review by the sponsoring organization and any other interested individual. In addition, before confirming the selection of a Workgroup chairperson, the Joint Task Force will discuss and resolve all relevant potential conflicts of interest associated with this selection. Finally, all members of parameter workgroups will be provided a written statement regarding the importance of ensuring that the parameter development process is free of commercial bias.
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Allergy immunotherapy: reduced health care costs in adults and children with allergic rhinitis.
J. Allergy Clin. Immunol.
PUBLISHED: 01-30-2013
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Research demonstrates significant health care cost savings conferred by allergen-specific immunotherapy (AIT) to US children with allergic rhinitis (AR).
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Grading local side effects of sublingual immunotherapy for respiratory allergy: speaking the same language.
J. Allergy Clin. Immunol.
PUBLISHED: 01-28-2013
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Sublingual immunotherapy (SLIT) is increasingly used worldwide. Despite its safety being well ascertained, there is no universally accepted system to grade and classify its adverse events (AEs). According to the literature, it seems reasonable to classify and grade systemic side effects by using the previously published World Allergy Organization recommendations. On the other hand, local side effects are the most frequent with SLIT, sometimes leading to its discontinuation. Therefore grading of the severity of local side effects was perceived as necessary for the purpose of uniform reporting, classification, and quantification of this aspect. A World Allergy Organization Taskforce, after examining the available literature and the postmarketing surveillance data, proposed a clinically based grading of the severity of local AEs caused by SLIT. The use of the Medical Dictionary for Regulatory Activities nomenclature for AEs was also included in this context. The proposed grading system for SLIT-induced local reactions is expected to improve and harmonize surveillance and reporting of the safety of SLIT.
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Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report.
J. Allergy Clin. Immunol.
PUBLISHED: 01-24-2013
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Allergy immunotherapy (AIT) is an effective treatment for allergic asthma and rhinitis, as well as venom-induced anaphylaxis. In addition to reducing symptoms, AIT can change the course of allergic disease and induce allergen-specific immune tolerance. In current clinical practice immunotherapy is delivered either subcutaneously or sublingually; some allergens, such as grass pollen, can be delivered through either route, whereas others, such as venoms, are only delivered subcutaneously. Both subcutaneous and sublingual immunotherapy appear to have a duration of efficacy of up to 12 years, and both can prevent the development of asthma and new allergen sensitivities. In spite of the advances with AIT, safer and more effective AIT strategies are needed, especially for patients with asthma, atopic dermatitis, or food allergy. Novel approaches to improve AIT include use of adjuvants or recombinant allergens and alternate routes of administration. As part of the PRACTALL initiatives, the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology nominated an expert team to develop a comprehensive consensus report on the mechanisms of AIT and its use in clinical practice, as well as unmet needs and ongoing developments in AIT. This resulting report is endorsed by both academies.
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New directions in immunotherapy.
Curr Allergy Asthma Rep
PUBLISHED: 01-15-2013
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Allergen immunotherapy (AIT) is effective in reducing the clinical symptoms associated with allergic rhinitis, asthma and venom-induced anaphylaxis. Subcutaneous (SCIT) and sublingual immunotherapy (SLIT) with unmodified allergen extracts are the most widely prescribed AIT regimens. The efficacy of these 2 routes appears comparable, but the safety profile with SLIT is more favorable allowing for home administration and requiring less patient time. However, both require that the treatment is taken regularly over several years, e.g., monthly in a supervised medical setting with SCIT and daily at home with SLIT. Despite the difference in treatment settings, poor adherence has been reported with both routes. Emerging evidence suggests that AIT may be effective in other allergic conditions such as atopic dermatitis, venom sting-induced large local reactions, and food allergy. Research with oral immunotherapy (OIT) for food allergies suggest that many patients can be desensitized during treatment, but questions remain about whether this can produce long term tolerance. Further studies are needed to identify appropriate patients and treatment regimens with these conditions. Efforts to develop safer and more effective AIT for inhalant allergies have led to investigations with modified allergens and alternate routes. Intralymphatic (ILIT) has been shown to produce long-lasting clinical benefits after three injections comparable to a 3-year course of SCIT. Epicutaneous (EPIT) has demonstrated promising results for food and inhalant allergies. Vaccine modifications, such as T cell epitopes or the use of viral-like particles as an adjuvant, have been shown to provide sustained clinical benefits after a relatively short course of treatment compared to the currently available AIT treatments, SLIT and SCIT. These newer approaches may increase the utilization and adherence to AIT because the multi-year treatment requirement of currently available AIT is a likely deterrent for initiating and adhering to treatment.
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Environmental assessment and exposure reduction of cockroaches: a practice parameter.
J. Allergy Clin. Immunol.
PUBLISHED: 01-03-2013
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This parameter was developed by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology. The AAAAI and the ACAAI have jointly accepted responsibility for establishing "Environmental assessment and remediation: a practice parameter." This is a complete and comprehensive document at the current time. The medical environment is a changing environment, and not all recommendations will be appropriate for all patients. Because this document incorporated the efforts of many participants, no single person, including those who served on the Joint Task Force, is authorized to provide an official AAAAI or ACAAI interpretation of these practice parameters. Any request for information about or an interpretation of these practice parameters by the AAAAI or ACAAI should be directed to the Executive Offices of the AAAAI, the ACAAI, and the Joint Council of Allergy, Asthma & Immunology. These parameters are not designed for use by pharmaceutical companies in drug promotion. The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC).
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Overview of serological-specific IgE antibody testing in children.
Curr Allergy Asthma Rep
PUBLISHED: 09-28-2011
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Allergic diseases are among the most common chronic conditions in the pediatric population. Allergy diagnostic testing is an important part of the evaluation/management of allergic patients because the history may not be precise enough to identify the specific allergen sensitivity. In addition to providing information about specific sensitivities, allergy diagnostic tests have some predictive value in terms of future risk of developing an allergic condition and the severity/persistence of the allergic disease. The two most commonly used methods of confirming allergen sensitization are skin testing and measurement of serum-specific IgE. Both methods have similar diagnostic value in terms of sensitivity and specificity, with both parameters varying with the clinical scenario and allergen tested. Currently, there are three US Food and Drug Administration-cleared, serum-specific IgE assays used in the United States. The three assays report comparable analytic sensitivity, with the coefficients of variation of the precision, reproducibility, and linearity being less than 15%. However, comparative studies have demonstrated significant inter-assay variability, suggesting that they detect different populations of IgE antibody in human sera or do not measure the same antibodies with the same efficiency. Current specific IgE assays utilize allergen extract reagents. Testing with these reagents may identify sensitivity to clinically irrelevant allergens. This diagnostic limitation has spurred the development of molecular diagnostic tests, also referred to as component-resolved diagnostics, which utilize purified native or recombinant allergens to detect IgE sensitivity to individual allergen molecules. These advancements in serum IgE testing may enhance the precision of allergy diagnostic testing, which may decrease the need for oral food challenges and improve the specificity of allergen immunotherapy.
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Specific allergy immunotherapy for allergic rhinitis: subcutaneous and sublingual.
Immunol Allergy Clin North Am
PUBLISHED: 07-09-2011
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Numerous controlled clinical trials have demonstrated the efficacy of specific allergen immunotherapy (SIT) in reducing the clinical symptoms and costs associated with allergic rhinitis. Compared with pharmacotherapy, SIT may provide persistent clinical benefits after treatment discontinuation. Subcutaneous and sublingual immunotherapy are the two most widely prescribed SIT routes worldwide. This review compares the efficacy, safety, preventive effect, immunologic mechanisms, and adherence rates associated with these two forms of SIT.
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The health economics of allergen immunotherapy.
Immunol Allergy Clin North Am
PUBLISHED: 05-03-2011
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In contrast to symptomatic drug treatment, which only temporarily relieves allergy symptoms, allergen-specific immunotherapy (SIT) has the potential to alter the course of allergic disease, thereby reducing the need for long-term treatment, the progression of allergic rhinitis (AR) to asthma, and the development of new allergies. The clinical benefits of SIT have been shown to persist for an additional 3 to 12 years after discontinuation of a 2.5- to 5.0-year treatment. It therefore stands to reason that the clinical benefits of SIT also extend to economic benefits. A growing number of studies have evaluated the economic benefits of SIT in patients with AR and/or asthma. The authors critically examine each of these studies published from 1995 to present.
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Accelerated immunotherapy schedules and premedication.
Immunol Allergy Clin North Am
PUBLISHED: 05-03-2011
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Subcutaneous immunotherapy is divided into a buildup and a maintenance phase. Accelerated immunotherapy has the advantage of a reduced number of office visits. Rush and cluster immunotherapy schedules are the most common accelerated schedules used in the United States. A cluster immunotherapy schedule involves the patient receiving several allergen injections sequentially in a single day of treatment on nonconsecutive days. The maintenance dose is reached in 4 to 8 weeks. In rush immunotherapy protocols, higher doses are administered at intervals of 15 to 60 minutes in a period of 1 to 3 days until the maintenance dose is achieved.
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Allergen immunotherapy practice in the United States: guidelines, measures, and outcomes.
Ann. Allergy Asthma Immunol.
PUBLISHED: 04-20-2011
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To discuss recent issues pertinent to allergen immunotherapy practice in the United States. Allergen extract preparation guidelines, updated allergen immunotherapy practice parameter (AIPP) guidelines, and evolving trends in how immunotherapy outcomes will be measured and assessed. Allergen extract preparation guidelines have been established by 2 entities: the US Pharmacopeia and an American Academy of Allergy, Asthma, and Immunology/American College of Allergy, Asthma, and Immunology/Joint Council of Allergy, Asthma, and Immunology Joint Task Force. Minor differences exist between these guidelines, but both focus on aseptic techniques and require that compounding personnel pass a written examination and annual media fill test. The AIPP third update provides new dosing recommendations for Bermuda grass, imported fire ant, and nonstandardized extracts distinguishing between pollen (0.5 mL of a 1:100 or 1:200 vol/vol) and mold/fungi or cockroach (highest tolerated dose) extracts. Because of limited and sometimes conflicting data on high and low proteolytic-containing extract compatibility, the AIPP continues to recommend against mixing these together. Although the AIPP does not specifically recommend a specific diluent, recent evidence suggests normal saline may not be as effective a stabilizer for extract dilutions as glycerin or human serum albumin. Currently, immunotherapy efficacy is determined with subjective assessments that rely on patient reporting, but this may change as health care reform evolves. It will likely become more important for US allergy/immunology practices to demonstrate immunotherapy comparative-effectiveness and report quality measures. Recent comparative-effectiveness studies have demonstrated the cost-effectiveness of immunotherapy compared with symptomatic drug treatment.
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Diagnostic and epidemiologic analysis of the 2008-2010 investigation of a multi-year outbreak of contagious equine metritis in the United States.
Prev. Vet. Med.
PUBLISHED: 03-11-2011
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Contagious equine metritis (CEM) is a highly contagious venereal disease of horses caused by Taylorella equigenitalis. During testing for semen export purposes, a stallion in Kentucky was found to be T. equigenitalis culture positive in December of 2008. This finding triggered an extensive regulatory investigation to search for additional positive horses, determine the extent of the outbreak, identify the potential source of the outbreak, and ultimately return the United States to CEM-free status. The investigation included over 1000 horses located in 48 states. Diagnostic testing found a total of 22 stallions, 1 gelding and 5 mares culture positive for T. equigenitalis. Epidemiologic analysis indicated that all of the positive horses were linked to a single common source, most likely a Fjord stallion imported into the United States in 2000. The T. equigenitalis strain subsequently spread to other stallions via undetermined indirect mechanisms at shared breeding facilities, and to mares via artificial insemination and live breeding. This CEM outbreak and investigation represent the largest ever in the United States based on the number of exposed horses tested and their geographic distribution.
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Loss of H2A.Z Is Not Sufficient to Determine Transcriptional Activity of Snf2-Related CBP Activator Protein or p400 Complexes.
Int J Cell Biol
PUBLISHED: 01-11-2011
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The p400 and SRCAP (Snf2-related CBP activator protein) complexes remodel chromatin by catalyzing deposition of histone H2A.Z into nucleosomes. This remodeling activity has been proposed as a basis for regulation of transcription by these complexes. Transcript levels of p21 or Sp1 mRNAs after knockdown of p400 or SRCAP reveals that each regulates transcription of these promoters differently. In this study, we asked whether deposition of H2A.Z within specific nucleosomes by p400 or SRCAP dictates transcriptional activity. Our data indicates that nucleosome density at specific p21 or Sp1 promoter positions is not altered by the loss of either remodeling complex. However, knockdown of SRCAP or p400 reduces deposition of H2A.Z?50% into all p21 and Sp1 promoter nucleosomes. Thus, H2A.Z deposition is not targeted to specific nucleosomes. These results indicate that the deposition of H2A.Z by the p400 or SRCAP complexes is not sufficient to determine how each regulates transcription. This conclusion is further supported by studies that demonstrate a SRCAP(?ATP ) mutant unable to deposit H2A.Z has similar transcriptional activity as wild-type SRCAP.
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Stinging insect hypersensitivity: a practice parameter update 2011.
J. Allergy Clin. Immunol.
PUBLISHED: 01-05-2011
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These parameters were developed by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma and Immunology. The AAAAI and the ACAAI have jointly accepted responsibility for establishing "Stinging insect hypersensitivity: a practice parameter update II." Because this document incorporated the efforts of many participants, no single individual, including those who served on the Joint Task Force, is authorized to provide an official AAAAI or ACAAI interpretation of these practice parameters. Any request for information about or an interpretation of these practice parameters by the AAAAI or the ACAAI should be directed to the Executive Offices of the AAAAI, the ACAAI, and the Joint Council of Allergy, Asthma and Immunology. This is a complete and comprehensive document at the current time. The medical environment is a changing environment, and not all recommendations will be appropriate for all patients. These parameters are not designed for use by pharmaceutical companies in drug promotion. The Joint Task Force understands that the cost of diagnostic tests and therapeutic agents is an important concern that may appropriately influence the work-up and treatment chosen for a given patient. The Joint Task Force recognizes that the emphasis of our primary recommendations regarding a medication may vary, for example, depending on third party payer issues and product patent expiration dates. However, since a given test or agents cost is so widely variable, and there is a paucity of pharmacoeconomic data, the Joint Task Force generally does not consider cost when formulating Practice Parameter recommendations. In extraordinary circumstances, when the cost benefit of an intervention is prohibitive as supported by pharmacoeconomic data, commentary may be provided.
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Subcutaneous specific immunotherapy for seasonal allergic rhinitis: a review of treatment practices in the US and Europe.
Curr Med Res Opin
PUBLISHED: 10-27-2010
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Subcutaneous specific immunotherapy (SCIT) is claimed to be successful both in the US and Europe, yet treatment methodology differs.
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The diagnosis and management of anaphylaxis practice parameter: 2010 update.
J. Allergy Clin. Immunol.
PUBLISHED: 04-27-2010
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These parameters were developed by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma and Immunology. The AAAAI and the ACAAI have jointly accepted responsibility for establishing "The Diagnosis and Management of Anaphylaxis Practice Parameter: 2010 Update." This is a complete and comprehensive document at the current time. The medical environment is a changing environment, and not all recommendations will be appropriate for all patients. Because this document incorporated the efforts of many participants, no single individual, including those who served on the Joint Task Force, is authorized to provide an official AAAAI or ACAAI interpretation of these practice parameters. Any request for information about or an interpretation of these practice parameters by the AAAAI or ACAAI should be directed to the Executive Offices of the AAAAI, the ACAAI, or the Joint Council of Allergy, Asthma and Immunology. These parameters are not designed for use by pharmaceutical companies in drug promotion.
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Imaging juvenile idiopathic arthritis: assessing the modalities.
Radiol Technol
PUBLISHED: 03-09-2010
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Traditionally, conventional radiography has been used to identify the structural damage associated with juvenile idiopathic arthritis (JIA). As other modalities have developed, however, the practice of assessing and monitoring JIA with radiographs has been questioned.
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Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective, matched cohort study.
Ann. Allergy Asthma Immunol.
PUBLISHED: 02-11-2010
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Children with allergic rhinitis (AR) often experience significant impairment in quality of life and health, which increases health care utilization.
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Speaking the same language: The World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System.
J. Allergy Clin. Immunol.
PUBLISHED: 02-07-2010
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Subcutaneous allergen immunotherapy (SCIT) is an effective treatment for allergic rhinitis, asthma and venom hypersensitivity and has the potential of producing serious life-threatening anaphylaxis. Adverse reactions are generally classified into 2 categories: local reactions, which can manifest as redness, pruritus, and swelling at the injection site, and systemic reactions (SRs). SRs can range in severity from mild rhinitis to fatal cardiopulmonary arrest. Early administration of epinephrine, which is the treatment of choice to treat anaphylaxis, may prevent the progression of an SR to a more serious life-threatening problem. Although there is little debate about using epinephrine to treat a SCIT SR, there is a lack of consensus about when it should be first used. A uniform classification system for grading SCIT SRs will be helpful in assessing more accurately when epinephrine should be administered. The primary purpose of this article is to discuss the proposed grading system for SCIT SRs.
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Comparison of allergen immunotherapy practice patterns in the United States and Europe.
Ann. Allergy Asthma Immunol.
PUBLISHED: 12-04-2009
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To discuss important differences and similarities in the allergen specific immunotherapy (SIT) treatment practices for aeroallergen sensitivity in the United States and Europe.
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How safe are the biologicals in treating asthma and rhinitis?
Allergy Asthma Clin Immunol
PUBLISHED: 10-01-2009
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A number of biological agents are available or being investigated for the treatment of asthma and rhinitis. The safety profiles of these biologic agents, which may modify allergic and immunological diseases, are still being elucidated. Subcutaneous allergen immunotherapy, the oldest biologic agent in current use, has the highest of frequency of the most serious and life-threatening reaction, anaphylaxis. It is also one of the only disease modifying interventions for allergic rhinitis and asthma. Efforts to seek safer and more effective allergen immunotherapy treatment have led to investigations of alternate routes of delivery and modified immunotherapy formulations. Sublingual immunotherapy appears to be associated with a lower, but not zero, risk of anaphylaxis. No fatalities have been reported to date with sublingual immunotherapy. Immunotherapy with modified formulations containing Th1 adjuvants, DNA sequences containing a CpG motif (CpG) and 3-deacylated monophospholipid A, appears to provide the benefits of subcutaneous immunotherapy with a single course of 4 to 6 preseasonal injections. There were no serious treatment-related adverse events or anaphylaxis in the clinical trials of these two immunotherapy adjuvants. Omalizumab, a monoclonal antibody against IgE, has been associated with a small risk of anaphylaxis, affecting 0.09% to 0.2% of patients. It may also be associated with a higher risk of geohelminth infection in patients at high risk for parasitic infections but it does not appear to affect the response to treatment or severity of the infection. Clinical trials with other biologic agents that have targeted IL-4/IL-13, or IL-5, have not demonstrated any definite serious treatment-related adverse events. However, these clinical trials were generally done in small populations of asthma patients, which may be too small for uncommon side effects to be identified. There is conflicting information about the safety TNF-alpha blocking agents, which have been primarily used in the treatment of rheumatoid arthritis, with serious infections, cardiovascular disease and malignancies being the most frequent serious adverse events. An unfavorable risk-benefit profile led to early discontinuation of a TNF-blocking agent in a double-blind placebo controlled of severe asthmatics. In summary, the risk of anaphylaxis and other treatment-related serious events with of all of the biological agents in this review were relatively small. However, most of the clinical trials were done in relatively small patient populations and were of relatively short duration. Long term studies in large patient populations may help clarify the risk-benefit profile of these biologic agents in the treatment of asthma.
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Recommendations for appropriate sublingual immunotherapy clinical trials.
J. Allergy Clin. Immunol.
PUBLISHED: 04-03-2009
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Sublingual immunotherapy is gaining widespread attention as a viable alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis. In addition, sublingual immunotherapy has been studied in other allergic disorders including asthma. However, a review of published studies indicates that there are deficiencies and considerable heterogeneity in both design and data interpretation of sublingual immunotherapy studies. These deficiencies have made it somewhat difficult to assess the appropriate place of sublingual immunotherapy in guidelines for the therapy of allergic diseases. Moreover, several unpublished oral and sublingual immunotherapy studies in the United States failed to meet primary endpoints. This article reviews data from sublingual immunotherapy trials and makes recommendations about appropriate designs of future sublingual immunotherapy studies. It is hoped that these recommendations will result in more adequately designed sublingual immunotherapy trials to facilitate the appropriate placement of this therapy to treat patients with allergic rhinoconjunctivitis and other allergic diseases.
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100 years of immunotherapy: the Monaco charter. under the high patronage of His Serene Highness Prince Albert II of Monaco.
Int. Arch. Allergy Immunol.
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Aims of the Monaco Charter: (1) to present the current evidence on the efficacy and safety of allergen-specific immunotherapy (SIT) and to address the reasons for its underuse in clinical practice; (2) to develop strategies to increase the awareness about the benefits and the hazards of SIT in allergic patients, lay public and healthcare professionals not trained in allergy, and (3) to make SIT accessible and affordable to eligible patients.
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Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE.
J. Allergy Clin. Immunol.
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Previous trials have demonstrated the efficacy, safety, and optimal dosage of the 5-grass pollen sublingual tablet for adults and children with grass pollen-induced allergic rhinoconjunctivitis.
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Patterns of hypothetical wildlife management priorities as generated by consensus convergence models with ordinal ranked data.
J. Environ. Manage.
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Managing wildlife in a publically acceptable fashion is challenging and frequently results in conflict among stakeholders. Several methods of group decision making or decision-making models have been suggested by philosophers and applied scientists to address such conflict. We propose a modification to the data collection process for consensus convergence models (CCM) that may allow wildlife managers to incorporate the priorities of hundreds of stakeholders into management decisions. Previous CCM have relied on small focus groups that represent the broader community to supply data. We propose collecting data via surveys using rank-ordinal data, which will allow managers to assess the priorities of the broader community rather than relying on representatives. By using survey (especially electronic) data rather than focus groups CCM may be modified into a tool that provides informatic solutions to environmental management. Before the proposed modification of the CCM is applied to any wildlife management decisions, several questions pertaining to how various components of a CCM affect the prioritization of management options must be addressed. We used hypothetical CCM to assess how the number of stakeholders, viewpoints, and level of opposition between viewpoints influences the results of a CCM. We found that while the number of stakeholders alone does not influence the results, the number of unique viewpoints does influence the prioritization of management options. If only two extremely opposed groups of stakeholders are engaged in a conflict, CCM will not aid decision-making because the model forces the two sides to compromise and meet in the middle. If an intermediate group is added to the model, then the CCM will favor the intermediate viewpoint, as the diametrically opposed viewpoints balance out each other. CCM are vulnerable to outliers, which can be mitigated by a large sample of stakeholders. However, CCM also lose clarity as the sample size increases. Therefore, the number of stakeholders included in the model should be determined a priori by power analysis. We conclude that CCM are an advantageous tool for analyzing complicated conflict with numerous viewpoints because they can digest information from hundreds of stakeholders, but that investigators should take care to collect data from a representative sample of stakeholders, including under-represented stakeholders, to avoid problems associated with a forced consensus.
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Costs and benefits of trap-neuter-release and euthanasia for removal of urban cats in Oahu, Hawaii.
Conserv. Biol.
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Our goal was to determine whether it is more cost-effective to control feral cat abundance with trap-neuter-release programs or trap and euthanize programs. Using STELLA 7, systems modeling software, we modeled changes over 30 years in abundance of cats in a feral colony in response to each management method and the costs and benefits associated with each method . We included costs associated with providing food, veterinary care, and microchips to the colony cats and the cost of euthanasia, wages, and trapping equipment in the model. Due to a lack of data on predation rates and disease transmission by feral cats the only benefits incorporated into the analyses were reduced predation on Wedge-tailed Shearwaters (Puffinus pacificus). When no additional domestic cats were abandoned by owners and the trap and euthanize program removed 30,000 cats in the first year, the colony was extirpated in at least 75% of model simulations within the second year. It took 30 years for trap-neuter-release to extirpate the colony. When the cat population was supplemented with 10% of the initial population size per year, the colony returned to carrying capacity within 6 years and the trap and euthanize program had to be repeated, whereas trap-neuter-release never reduced the number of cats to near zero within the 30-year time frame of the model. The abandonment of domestic cats reduced the cost effectiveness of both trap-neuter-release and trap and euthanize. Trap-neuter-release was approximately twice as expensive to implement as a trap and euthanize program. Results of sensitivity analyses suggested trap-neuter-release programs that employ volunteers are still less cost-effective than trap and euthanize programs that employ paid professionals and that trap-neuter-release was only effective when the total number of colony cats in an area was below 1000. Reducing the rate of abandonment of domestic cats appears to be a more effective solution for reducing the abundance of feral cats.
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Subcutaneous allergen immunotherapy for allergic disease: examining efficacy, safety and cost-effectiveness of current and novel formulations.
Immunotherapy
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Subcutaneous immunotherapy (SCIT) is a unique therapy for allergic disease because it provides symptomatic relief while modifying the allergic disease by targeting the underlying immunological mechanism. Its efficacy and safety have been established in the treatment of asthma, allergic rhinitis/rhinoconjunctivitis and stinging insect hypersensitivity in numerous controlled clinical trials. This review evaluates a spectrum of clinical factors, ranging from efficacy to cost-effectiveness, which should be considered in evaluating SCIT. The evidence for SCIT safety and efficacy for these conditions is reviewed in an evaluation of the systematic reviews and meta-analyses. The evidence for the persistent and preventive effects of SCIT is also examined. An overview of the SCIT outcomes measures utilized in clinical trials is presented. The cost-effectiveness of SCIT compared with conventional medication treatment, novel indications and formulations for SCIT are also explored in this review.
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Medical costs and adherence in patients receiving aqueous versus pressurized aerosol formulations of intranasal corticosteroids.
Allergy Asthma Proc
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Intranasal corticosteroid (INS) formulations have different sensory attributes that influence patient preferences, and thereby possibly adherence and health outcomes. This study compares health care use and costs and medication adherence in matched cohorts of patients with allergic rhinitis (AR) using a chlorofluorocarbon-propelled pressurized metered-dose inhaler (pMDI) or aqueous intranasal corticosteroid (A-INS). Florida Medicaid retrospective claims analysis was performed of enrollees aged ?12 years with at least 1 year of continuous enrollment before their initial AR diagnosis, 1 year for continuous enrollment before their index INS claim, and 18 months of continuous enrollment after their index INS claim during which they received either pMDI or A-INS. pMDI and A-INS patients were matched 1:2 using propensity scores. Nonparametric analyses compared outcomes between matched cohorts at 6, 12, and 18 months of follow-up. A total of 585 patients were matched (pMDI = 195, A-INS = 390). pMDI patients were more adherent to INS, as reflected in their higher median medication possession ratio (53.2% versus 32.7%; p < 0.0001) and fewer median days between fills (73 days versus 111 days; p = 0.0003). Significantly lower median per patient pharmacy fills (34.0 versus 50.5; p < 0.05) and costs ($1282 versus $2178; p < 0.01) were observed among pMDI patients versus A-INS patients 18 months after INS initiation and were maintained when analyses excluded INS fills. Adherence to INS and health care utilization and costs following INS initiation for AR differed by type of formulation received. Our findings suggest patient preferences for INS sensory attributes can drive adherence and affect disease control, and ultimately impact health care costs.
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Application of a marketing concept to patient-centered care: co-producing health with heart failure patients.
Online J Issues Nurs
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Increasing numbers of patients are being treated for heart failure each year. One out of four of the heart failure patients who receives care in a hospital is readmitted to the hospital within 30 days of discharge. Effective discharge instruction is critical to prevent these patient readmissions. Co-production is a marketing concept whereby the customer is a partner in the delivery of a good or service. For example, a patient and nurse may partner to co-produce a patient-centered health regimen to improve patient outcomes. In this article we review the cost of treating heart failure patients and current strategies to decrease hospital readmissions for these patients along with the role of the nurse and the concept of co-producing health as related to heart failure patients. Next we describe our study assessing the degree to which discharge processes were co-produced on two hospital units having a preponderance of heart failure patients, and present our findings indicating minimal evidence of co-production. A discussion of our findings, along with clinical implications of these findings, recommendations for change, and suggestions for future research are offered. We conclude that standardized discharge plans lead to a mindset of one size fits all, a mindset inconsistent with the recent call for patient-centered care. We offer co-production as a patient-centered strategy for customizing discharge teaching and improving health outcomes for heart failure patients.
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Generation and administration of HA-1-specific T-cell lines for the treatment of patients with relapsed leukemia after allogeneic stem cell transplantation: a pilot study.
Haematologica
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Since HA-1-specific T cells have been shown to make a significant contribution to the clinical responses in patients with relapsed leukemia, we investigated the feasibility of adoptive transfer of in vitro induced HA-1-specific CD8 positive T cells to patients with relapsed leukemia after allogeneic stem cell transplantation. The in vitro generation of clinical grade HA-1-specific T-cell lines from HA-1 negative donors was seen to be feasible and 3 patients were treated with HA-1-specific T-cell lines. No toxicity after infusion was observed. Although in one patient, during a period of stable disease, HA-1-specific T cells could be detected in the peripheral blood and bone marrow, these patients had no clear clinical response.
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Multiple-allergen and single-allergen immunotherapy strategies in polysensitized patients: looking at the published evidence.
J. Allergy Clin. Immunol.
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In allergen immunotherapy there is debate as to whether polysensitized patients are best treated with many allergens simultaneously (chosen according to the sensitization profile, a predominantly North American approach) or a single allergen (chosen according to the most clinically problematic allergy, a predominantly European approach). In patients seeking treatment for moderate-to-severe respiratory allergies, polysensitization is more prevalent (range, 50% to 80%) than monosensitization in both the United States and Europe. Safe, effective, single-allergen preparations will most likely have been tested in polysensitized patients. In robust, large-scale clinical trials of grass pollen sublingual tablets, polysensitized patients benefited at least as much from allergen immunotherapy as monosensitized patients. A recent review of multiallergen immunotherapy concluded that simultaneous delivery of multiple unrelated allergens can be clinically effective but that there was a need for additional investigation of therapy with more than 2 allergen extracts (particularly in sublingual allergen immunotherapy). More work is also required to determine whether single-allergen and multiallergen immunotherapy protocols elicit distinct immune responses in monosensitized and polysensitized patients. Sublingual and subcutaneous multiallergen immunotherapy in polysensitized patients requires more supporting data to validate its efficacy in practice.
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