Publications by authors named "Linda S Cox"

32 Publications

Rhinosinusitis Diagnosis and Management: The Hoops and Hurdles.

Authors:
Linda S Cox

Immunol Allergy Clin North Am 2020 05 26;40(2):xiii-xv. Epub 2020 Feb 26.

Department of Medicine and Dermatology, 1108 South Wolcott Street, Casper, WY 82601, USA. Electronic address:

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http://dx.doi.org/10.1016/j.iac.2020.02.002DOI Listing
May 2020

Leaps and Bounds in Allergen Immunotherapy.

Immunol Allergy Clin North Am 2020 02;40(1):xv-xvii

Professor of Pediatrics, Allergy and Immunology, Department of Pediatrics, Hassenfeld Children's Hospital, NYU Langone Health, New York, NY, USA; Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum University of Warmia and Mazury, Olsztyn, Poland, 403 East 34th Street, New York, NY 10016, USA. Electronic address:

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http://dx.doi.org/10.1016/j.iac.2019.10.001DOI Listing
February 2020

Allergy Immunotherapy: Are We Making Progress or Just Standing Still?

Authors:
Linda S Cox

Immunol Allergy Clin North Am 2020 02;40(1):xiii-xiv

Department of Medicine and Dermatology, Nova Southeastern University, 1108 South Wolcott Street, Casper, WY 82601, USA. Electronic address:

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http://dx.doi.org/10.1016/j.iac.2019.10.002DOI Listing
February 2020

The Cost-Effectiveness of Allergen Immunotherapy Compared with Pharmacotherapy for Treatment of Allergic Rhinitis and Asthma.

Immunol Allergy Clin North Am 2020 02;40(1):69-85

BioMedEcon, PO Box 129, Moss Beach, CA 94038, USA.

This article evaluates the cost-effectiveness of allergy immunotherapy (AIT) in the treatment of allergic rhinitis, asthma, and other allergic conditions. An extensive search of the PubMed and Medline databases (up to December 2018) was conducted. There is strong evidence in the collective literature, which included individual studies and systematic reviews, that AIT is cost-effective in the management of allergic rhinitis and asthma as compared with standard drug treatment alone. The magnitude of AIT's cost-effectiveness is likely underestimated because most of the studies considered during-treatment costs and not the long-term benefits or preventive or prophylactic effects of AIT.
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http://dx.doi.org/10.1016/j.iac.2019.09.003DOI Listing
February 2020

The Challenge of Managing Atopic Dermatitis in the United States.

Am Health Drug Benefits 2019 Apr;12(2):83-93

Director of US Medical Affairs, Pfizer, Collegeville, PA.

Background: Atopic dermatitis is a chronic inflammatory skin disease that affects up to 13% of children and 10% of adults in the United States. Among patients and their families, atopic dermatitis has a considerable effect on quality of life and represents a substantial economic burden.

Objective: To describe the impact and challenges of atopic dermatitis and to provide nondermatologists in the healthcare community an enhanced understanding of atopic dermatitis to facilitate treatment and pharmacy benefit discussions.

Discussion: Atopic dermatitis is a heterogeneous disease, and its diagnosis is hampered by a lack of objective diagnostic criteria. The current management guidelines address the distinct clinical phenotypes as a single disease and do not incorporate recent clinical advances, such as the targeting of specific inflammatory processes. The treatment guidelines for atopic dermatitis are complex and challenge healthcare providers, patients, and caregivers. Novel treatments can provide additional therapeutic options for patients with atopic dermatitis.

Conclusions: Treatment options for atopic dermatitis are expanding with the development of novel anti-inflammatory therapies. An increased understanding of these advancements is necessary to optimize care for patients with atopic dermatitis.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6485648PMC
April 2019

International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis.

Int Forum Allergy Rhinol 2018 02;8(2):108-352

Otolaryngology, University of Michigan, USA.

Background: Critical examination of the quality and validity of available allergic rhinitis (AR) literature is necessary to improve understanding and to appropriately translate this knowledge to clinical care of the AR patient. To evaluate the existing AR literature, international multidisciplinary experts with an interest in AR have produced the International Consensus statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR).

Methods: Using previously described methodology, specific topics were developed relating to AR. Each topic was assigned a literature review, evidence-based review (EBR), or evidence-based review with recommendations (EBRR) format as dictated by available evidence and purpose within the ICAR:AR document. Following iterative reviews of each topic, the ICAR:AR document was synthesized and reviewed by all authors for consensus.

Results: The ICAR:AR document addresses over 100 individual topics related to AR, including diagnosis, pathophysiology, epidemiology, disease burden, risk factors for the development of AR, allergy testing modalities, treatment, and other conditions/comorbidities associated with AR.

Conclusion: This critical review of the AR literature has identified several strengths; providers can be confident that treatment decisions are supported by rigorous studies. However, there are also substantial gaps in the AR literature. These knowledge gaps should be viewed as opportunities for improvement, as often the things that we teach and the medicine that we practice are not based on the best quality evidence. This document aims to highlight the strengths and weaknesses of the AR literature to identify areas for future AR research and improved understanding.
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http://dx.doi.org/10.1002/alr.22073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7286723PMC
February 2018

Immunotherapy and systemic reactions.

Ann Allergy Asthma Immunol 2017 08;119(2):195

University of Miami Miller School of Medicine at Holy Cross Hospital, Ft Lauderdale, Florida.

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http://dx.doi.org/10.1016/j.anai.2017.04.019DOI Listing
August 2017

Safety Review of 5-Grass Pollen Tablet from Pooled Data of Clinical Trials.

J Allergy Clin Immunol Pract 2017 Nov - Dec;5(6):1717-1727.e1. Epub 2017 Jul 19.

Service de Pneumologie - Allergologie, Hôpital Larrey, CHU de Toulouse, Toulouse, France.

Background: The 5-grass pollen sublingual tablet has been approved for the treatment of grass pollen-induced allergic rhinoconjunctivitis in subjects with or without intermittent asthma.

Objective: To provide a comprehensive analysis of the safety profile of the 5-grass tablet on the basis of pooled data from 8 clinical trials.

Methods: Subjects (5-65 years old) with medically confirmed grass pollen-induced allergic rhinoconjunctivitis were included in the double-blind studies. Those with intermittent asthma not requiring treatment other than inhaled beta-2 agonists could participate. Randomized subjects received a 5-grass or placebo tablet daily 2 or 4 months preseasonally and coseasonally (5 single-season studies, over 3 years in a long-term study) or outside the season (phase I studies). Adverse events were pooled and analyzed descriptively.

Results: Among 2,512 subjects enrolled, 1,514 received the 5-grass tablet. A total of 1,038 adults and 154 pediatric (5-17 years old) subjects were treated with the 300 Index of Reactivity dose (vs 840 and 158 placebo recipients, respectively); 17% had intermittent asthma, and 62% were polysensitized. Adverse reactions (ADRs) reported in more than 10% of actively treated subjects were mild or moderate application-site reactions, for example, oral pruritus 25% (placebo 4%) and throat irritation 21% (placebo 3%). These generally occurred during the first week of treatment and decreased over time. They led to discontinuation in less than 2.5% of subjects. None of the 3 serious ADRs were reports of anaphylaxis. No notable differences were detected in terms of incidence, nature, and severity of ADRs between adult and pediatric populations, nor between subjects with or without asthma.

Conclusions: The pooled analysis in 1,514 subjects from 8 clinical studies demonstrates that the 5-grass pollen sublingual tablet has a similar good safety profile in adult and pediatric patients with or without mild, intermittent asthma.
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http://dx.doi.org/10.1016/j.jaip.2017.04.020DOI Listing
June 2018

Allergen Immunotherapy Clinical Trial Outcomes and Design: Working Toward Harmonization of Methods and Principles.

Curr Allergy Asthma Rep 2017 Mar;17(3):18

ALK, Horsholm, Denmark.

Progress has been made in the harmonization of efficacy and safety outcome measures for allergen immunotherapy (AIT) trials, but unresolved issues still remain. Furthermore, there are discrepancies in recommendations from professional medical societies and regulatory agencies regarding requirements for AIT trials. In this article, we reviewed published recommendations and current data from recent clinical trials, as well as the criteria applied by regulatory authorities for approval of AIT products, to provide updated considerations for conducting phase 3 AIT trials. Topics discussed include analysis of outcomes and trial designs for pediatric and asthma indications, as well as trial designs for perennial allergic rhinoconjunctivitis. In addition, the need for harmonization of safety reporting is emphasized. Considerations presented in this article may further effort to find common ground among professional medical societies and government agencies in developing future recommendations for AIT trial design.
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http://dx.doi.org/10.1007/s11882-017-0687-0DOI Listing
March 2017

Sublingual Immunotherapy for Allergic Rhinitis: Is 2-Year Treatment Sufficient for Long-term Benefit?

Authors:
Linda S Cox

JAMA 2017 02;317(6):591-593

University of Miami Miller School of Medicine at Holy Cross Hospital, Ft Lauderdale, Florida.

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http://dx.doi.org/10.1001/jama.2017.0128DOI Listing
February 2017

Is the Benefit From Prescribing Epinephrine Autoinjectors for Sublingual Immunotherapy Worth the Cost? Lessons Learned From Clinical Trials.

J Allergy Clin Immunol Pract 2017 Jan - Feb;5(1):90-91

Department of Medicine, University of Miami Miller School of Medicine at Holy Cross Hospital, Ft Lauderdale, Fla. Electronic address:

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http://dx.doi.org/10.1016/j.jaip.2016.11.008DOI Listing
October 2018

Sublingual Immunotherapy: Historical Perspective and Practical Guidance.

Authors:
Linda S Cox

J Allergy Clin Immunol Pract 2017 Jan - Feb;5(1):63-65

College of Osteopathic Medicine, Nova Southeastern University, Ft Lauderdale, Fla; Department of Medicine, University of Miami Miller School of Medicine at Holy-Cross Hospital, Ft Lauderdale, Fla. Electronic address:

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http://dx.doi.org/10.1016/j.jaip.2016.11.016DOI Listing
December 2018

World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed?

J Allergy Clin Immunol Pract 2017 Jan - Feb;5(1):58-62.e5

Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida Morsani College of Medicine, Tampa, Fla.

There is no universally accepted grading system to classify the severity of systemic allergic reactions (SARs), including anaphylaxis. Although a consensus definition for anaphylaxis was established in 2005, the signs and symptoms required to define a reaction as anaphylaxis are inconsistently applied in research and clinical practice. As a result, it is difficult to compare and evaluate safety outcomes in surveys, clinical practice and trials, and pharmacovigilance data. In 2010, the World Allergy Organization (WAO) proposed a uniform grading system to classify allergen immunotherapy SARs. The basis of the grading system is the organ system(s) involved and reaction severity. The final grade is determined by the physician/health care professional after the event is over. Although the 2010 WAO grading system was developed to classify allergen immunotherapy SARs, with appropriate modifications, it can be used to classify SARs from any cause. The purpose of this Rostrum is to present a proposed modification of the 2010 WAO SAR grading system that will make it applicable to all SARs due to any cause. The modified grading system allows for classification of less severe SARs, which may be underreported or overreported in clinical trials and surveillance studies, depending on the criteria specified for adverse event reporting. The universal use of the proposed modified SAR grading system will allow for better safety comparisons across different venues and treatment protocols.
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http://dx.doi.org/10.1016/j.jaip.2016.11.009DOI Listing
November 2017

Current Evidence on Safety and Practical Considerations for Administration of Sublingual Allergen Immunotherapy (SLIT) in the United States.

J Allergy Clin Immunol Pract 2017 Jan - Feb;5(1):34-40.e2. Epub 2016 Nov 1.

Department of Pediatric Allergy, Women's and Children's Health, University of Uppsala, Uppsala, Sweden.

Liquid sublingual allergen immunotherapy (SLIT) has been used off-label for decades, and Food and Drug Administration (FDA)-approved grass and ragweed SLIT tablets have been available in the United States since 2014. Potentially life-threatening events from SLIT do occur, although they appear to be very rare, especially for FDA-approved products. Practice guidelines that incorporate safety precautions regarding the use of SLIT in the United States are needed. This clinical commentary attempts to address unresolved issues including controversy regarding the FDA mandate for the prescription of epinephrine autoinjectors for patients on SLIT; how to approach polysensitized patients; optimal timing and duration of SLIT administration; how to address gaps in therapy; whether antihistamines can prevent local reactions, if certain patient populations (such as persistent asthmatics) should not receive SLIT; and when to instruct patients to self-administer epinephrine. Key points are that physicians should focus on educating patients regarding: (1) when not to administer SLIT; (2) how to recognize a potentially serious allergic reaction to SLIT; and (3) when to administer epinephrine and seek emergency care.
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http://dx.doi.org/10.1016/j.jaip.2016.09.017DOI Listing
November 2017

Methodological aspects of a meta-analysis of grass pollen allergen sublingual immunotherapy tablets.

J Allergy Clin Immunol 2016 07 12;138(1):314-315.e4. Epub 2016 Apr 12.

UPRES EA 220, Université de Versailles Saint-Quentin, Foch Hospital, Suresnes, France.

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http://dx.doi.org/10.1016/j.jaci.2016.01.039DOI Listing
July 2016

Allergen-specific Immunotherapy--Turning the Tables on the Immune System.

Immunol Allergy Clin North Am 2016 Feb;36(1):xv-xxi

Department of Medicine, Nova Southeastern University Davie Florida, 5333 North Dixie Highway, Ft. Lauderdale, FL 33334, USA. Electronic address:

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http://dx.doi.org/10.1016/j.iac.2015.09.001DOI Listing
February 2016

Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience.

Expert Rev Clin Immunol 2014 Oct 10;10(10):1309-24. Epub 2014 Sep 10.

Department of Respiratory Diseases, Rangueil-Larrey Hospital, 24 Chemin de Pouvourville - TSA 30030, 31059 Toulouse Cedex 9, France.

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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http://dx.doi.org/10.1586/1744666X.2014.957677DOI Listing
October 2014

Evidence-based evaluation for allergies to avoid inappropriate testing, diagnosis, and treatment.

JAMA Intern Med 2014 Aug;174(8):1223-4

Nova Southeastern University, Fort Lauderdale, Florida.

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http://dx.doi.org/10.1001/jamainternmed.2014.1413DOI Listing
August 2014

Allergy immunotherapy adherence and delivery route: location does not matter.

J Allergy Clin Immunol Pract 2014 Mar-Apr;2(2):156-60

University of South Florida Morsani College of Medicine, Tampa, Fla.

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http://dx.doi.org/10.1016/j.jaip.2014.01.010DOI Listing
May 2014

Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE.

J Allergy Clin Immunol 2012 Dec 31;130(6):1327-34.e1. Epub 2012 Oct 31.

Nova Southeastern University, Fort Lauderdale, FL 33334, USA.

Background: 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.

Objectives: We sought to evaluate the efficacy and safety of 300 index of reactivity (IR) 5-grass pollen sublingual tablet in US adults.

Methods: Adults with grass pollen allergy and Rhinoconjunctivitis Total Symptom Scores of 12 or greater (scale, 0-18) during the previous grass pollen season were randomized in a double-blind, placebo-controlled study to receive 300IR 5-grass pollen sublingual tablet or placebo starting 4 months before and continuing through the pollen season. The primary efficacy end point was the daily Combined Score (CS; scale, 0-3), which integrates symptoms and rescue medication use.

Results: Four hundred seventy-three participants were randomized. The mean daily CS over the pollen period was significantly lower in the active treatment group versus the placebo group (least-squares mean difference: -0.13; 95% CI, -0.19 to -0.06; P = .0003; relative reduction: 28.2%; 95% CI, 13.0% to 43.4%). In placebo-treated participants, the daily CS least-squares mean was 0.32 in the subgroup with baseline timothy grass-specific serum IgE of less than 0.1 kU/L (n = 23) and 0.46 in those with baseline timothy grass-specific serum IgE of 0.1 kU/L or greater (n = 204). The most frequent reported adverse events were oral pruritus, throat irritation, and nasopharyngitis. There were no reports of anaphylaxis, and no actively treated participant received epinephrine.

Conclusion: In US adults with grass pollen-induced allergic rhinoconjunctivitis, preseasonal and coseasonal treatment with 300IR 5-grass pollen sublingual tablet demonstrated clinically meaningful efficacy, especially in study subjects with measurable timothy grass-specific serum IgE. Use of 300IR 5-grass pollen sublingual tablet was safe and well tolerated. A requirement for a measurable level of allergen-specific serum IgE should be considered in future studies in this field.
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http://dx.doi.org/10.1016/j.jaci.2012.08.032DOI Listing
December 2012

Current standards and future directions in immunotherapy: perspectives on challenges and opportunities for the allergist.

Ann Allergy Asthma Immunol 2011 Nov 29;107(5):422-5. Epub 2011 Jun 29.

Department of Internal Medicine, University of Cincinnati College of Medicine, Ohio, USA.

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http://dx.doi.org/10.1016/j.anai.2011.05.026DOI Listing
November 2011

How safe are the biologicals in treating asthma and rhinitis?

Authors:
Linda S Cox

Allergy Asthma Clin Immunol 2009 Oct 22;5(1). Epub 2009 Oct 22.

Department of Medicine, Nova Southeastern University Osteopathic College of Medicine, Fort Lauderdale, Florida, USA.

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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http://dx.doi.org/10.1186/1710-1492-5-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2794848PMC
October 2009

European allergen extract units and potency: review of available information.

Ann Allergy Asthma Immunol 2008 Feb;100(2):137-45

Hospital Médica Sur, Mexico City, Mexico.

Background: There is considerable variability in how allergen extract potency is measured and reported worldwide. In Europe, where many sublingual immunotherapy studies have been conducted, manufacturers report allergen extract potency as units based on an in-house reference, making it difficult to understand the exact doses used and to compare studies.

Objectives: To describe the various methods of expressing extract potency that European allergen extract manufacturers use and to gather reports on the micrograms of major allergen of the in-house units of European allergen extract manufacturers.

Methods: Information was derived from 3 sources: data on extract potency in micrograms of major allergen in articles on sublingual immunotherapy found by PubMed (references through October 2005) and in reference articles, brochures on allergen extracts from the manufacturers, and information provided by structured questionnaires e-mailed to the manufacturers.

Results: All but 1 of the European allergen extract manufacturers use in-house reference standards that are based on titrated skin prick testing of allergic patients. Subsequently, in vitro tests compare the potency of commercial batches with the in-house reference and potency is assigned as arbitrary units. Most manufacturers measure major allergen content of their standardized products but do not release this information with the package insert. Diversity in major allergen content was found.

Conclusions: Micrograms of major allergens given in articles on sublingual immunotherapy to express the dose administered cannot be used to translate the dose to US extracts. Extract potency can only be compared if uniform test methods and reference extracts are used.
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http://dx.doi.org/10.1016/S1081-1206(10)60422-XDOI Listing
February 2008

Sublingual immunotherapy: a comprehensive review.

J Allergy Clin Immunol 2006 May;117(5):1021-35

Nova Southeastern University School of Osteopathic Medicine, Davie, Florida, USA.

Sublingual immunotherapy (SLIT) has been used with increasing frequency in Europe and is viewed with increasing interest by allergists in the United States. To address this interest, a Joint Task Force of the American College of Allergy, Asthma and Immunology and the American Academy of Allergy, Asthma and Immunology's Immunotherapy and Allergy Diagnostic Committees reviewed the available literature on SLIT and prepared this report. The task force concluded that despite clear evidence that SLIT is an effective treatment, many questions remained unanswered, including effective dose, treatment schedules, and overall duration of treatment. Until these have been determined, an assessment of the cost/benefit ratio of the treatment cannot be made. SLIT does appear to be associated with few serious side effects, but it has not been administered in high-risk asthmatic patients, nor in the studies reviewed has it been administered as a mixture of non-cross-reacting allergens. Furthermore, there is currently no allergy extract approved for this use in the United States, nor is there a Current Procedural Terminology code for billing purposes. All of these factors should be given careful consideration by anyone contemplating initiating SLIT treatment for their allergic patients.
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http://dx.doi.org/10.1016/j.jaci.2006.02.040DOI Listing
May 2006