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Objectives: Sublingual immunotherapy (SLIT) has emerged as an effective treatment alternative to subcutaneous immunotherapy (SCIT) given its improved safety profile and more convenient dosing. However, SLIT still relies on daily dosing for many years to optimize effectiveness. This study sought to investigate factors that influence patient completion of SLIT., Methods: We performed an institutional retrospective review of patients who received SLIT (2008-2020). Completion was defined as completing at least 36 months of SLIT. Patient demographics and characteristics, including the number of allergens treated, history of asthma and sinus surgery, number of clinic visits, and total time undergoing SLIT, were documented. Multivariate models were used to analyze predictors of SLIT completion. Subgroup analysis was performed among pediatric patients and patients who discontinued SLIT., Results: Of the 404 total patients, 249 (61.6%) discontinued, 47 (11.6%) completed, and 108 (26.7%) were currently undergoing SLIT. The mean duration of therapy was 11.2 months for those who discontinued and 49.4 months for patients who completed SLIT. The odds of SLIT completion were twice as high with each additional clinic visit (P < .001), and twice as high when the dosage was increased during therapy (P = .06). Pediatric patients younger than age 12 with a history of asthma were over five times more likely to complete therapy (P = .045). Patients with more clinic visits (P < .001) and higher associated costs (P = .003) were less likely to be lost to follow-up., Conclusion: Increasing the frequency of clinic visits, improving therapy availability, and mitigating concerns about clinical efficacy may increase patient completion of SLIT., Level of Evidence: 4 Laryngoscope, 131:E2111-E2115, 2021., (© 2020 American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA).)

With the approval of two grass tablets and one ragweed tablet for sublingual immunotherapy (SLIT) by the US FDA in April 2014, the practice of allergy immunotherapy (AIT) in the USA has dramatically changed. Until this time, there were no approved allergen extracts for sublingual administration and physicians who prescribed SLIT for their patients did so without full knowledge of proper dosing or assurance of its safety. Now sublingual allergen tablets are available that have proven safe and effective doses. This article describes, in detail, the studies that have been conducted with a timothy grass SLIT tablet and draws some comparisons to the alternative 5-grass SLIT tablet. It also attempts to predict what will be the impact of the introduction of these tablets on the practice of AIT in the USA over the next few years.

Background: Estimates of the prevalence of allergic rhinitis in the United States range from 20% to 40%. Allergen-specific immunotherapy (SIT) is typically recommended for patients with allergic rhinitis who fail medical treatment, desire an alternative to pharmacotherapy, or would like to pursue therapy that can potentially change the natural history of the disease. Sublingual immunotherapy (SLIT) involves dosing the allergen under the tongue of the sensitized individual in controlled amounts, frequently, over a period of several years, in order to increase immunologic tolerance and diminish symptoms to that allergen. The U.S. Food and Drug Administration (FDA) approved the use of SLIT tablets in 2014, whereas the use of aqueous SLIT by U.S. practitioners is considered an "off-label" use., Methods: This study is a review of published English language scientific literature, focusing on systematic reviews and randomized controlled trials of SLIT for inhalant allergic rhinitis., Results: SLIT is a safe and effective immune modulating treatment that decreases symptoms and medication use for allergic rhinitis. Further study is needed to determine the relative effectiveness of SLIT compared to subcutaneous immunotherapy, the role of multiple-allergen vs single-allergen SLIT, the use of SLIT in special populations (pregnancy, patients taking beta-blockers), and optimal dosing of U.S. products., Conclusion: SLIT is safe and effective, and offers a convenient alternative to injection immunotherapy for appropriate patients with allergic rhinitis., (© 2014 ARS-AAOA, LLC.)

Purpose of Review: It is likely that approval of allergen preparations for sublingual immunotherapy (SLIT) will soon occur in the United States. This article reviews experience with SLIT in this country, concentrating on the large, multicenter trials that will provide the evidence of safety and efficacy necessary to obtain that approval., Recent Findings: Large multicenter trials have been conducted with both grass and short ragweed. In five single-season studies with sublingual grass tablets, usually starting 4 months prior to and continuing through the pollen season, the combined symptom medication score was improved 20-28% relative to placebo-treated individuals. Short ragweed tablets, initiated 4 months prior to and continued through the pollen season, reduced symptom/medication scores by 24-26%. Similar results have been reported with short ragweed aqueous extract administered sublingually. To date, there has been only one small study each with house dust mite and cat allergen extracts. All of these studies were conducted with a single allergen. One small study, comparing timothy alone to the same dose of timothy combined with nine other pollen extracts, raised still unanswered questions regarding the efficacy of SLIT with multiple allergen mixes., Summary: SLIT is coming to the United States. There will be approved allergen preparations for which the appropriate dosing for efficacy and safety has been established. It would be inappropriate to use the evidence generated by these large studies to justify off-label use of allergen extracts approved for injection or the administration of multiple allergen preparations sublingually.

Asthma affects more than 25 million people in the United States, and 62% of adults with asthma do not have adequately controlled symptoms. Asthma severity and level of control should be assessed at diagnosis and evaluated at subsequent visits using validated tools such as the Asthma Control Test or the asthma APGAR (activities, persistent, triggers, asthma medications, response to therapy) tools. Short-acting beta2 agonists are preferred asthma reliever medications. Controller medications consist of inhaled corticosteroids, long-acting beta2 agonists, long-acting muscarinic antagonists, and leukotriene receptor antagonists. Treatment typically begins with inhaled corticosteroids, and additional medications or dosage increases should be added in a stepwise fashion according to guideline-directed therapy recommendations from the National Asthma Education and Prevention Program or the Global Initiative for Asthma when symptoms are inadequately controlled. Single maintenance and reliever therapy combines an inhaled corticosteroid and long-acting beta2 agonist for controller and reliever treatments. This therapy is preferred for adults and adolescents because of its effectiveness in reducing severe exacerbations. Subcutaneous immunotherapy may be considered for those five years and older with mild to moderate allergic asthma; however, sublingual immunotherapy is not recommended. Patients with severe uncontrolled asthma despite appropriate treatment should be reassessed and considered for specialty referral. Biologic agents may be considered for patients with severe allergic and eosinophilic asthma. (Am Fam Physician. 2023; 107(4): 358–368. Copyright © 2023 American Academy of Family Physicians.) Asthma affects more than 25 million people in the United States, and 62% of adults with asthma do not have adequately controlled symptoms. Asthma severity and level of control should be assessed at diagnosis and evaluated at subsequent visits using validated tools such as the Asthma Control Test or the asthma APGAR (activities, persistent, triggers, asthma medications, response to therapy) tools. Short-acting beta2 agonists are preferred asthma reliever medications. Controller medications consist of inhaled corticosteroids, long-acting beta2 agonists, long-acting muscarinic antagonists, and leukotriene receptor antagonists. Treatment typically begins with inhaled corticosteroids, and additional medications or dosage increases should be added in a stepwise fashion according to guideline-directed therapy recommendations from the National Asthma Education and Prevention Program or the Global Initiative for Asthma when symptoms are inadequately controlled. Single maintenance and reliever therapy combines an inhaled corticosteroid and long-acting beta2 agonist for controller and reliever treatments. This therapy is preferred for adults and adolescents because of its effectiveness in reducing severe exacerbations. Subcutaneous immunotherapy may be considered for those five years and older with mild to moderate allergic asthma; however, sublingual immunotherapy is not recommended. Patients with severe uncontrolled asthma despite appropriate treatment should be reassessed and considered for specialty referral. Biologic agents may be considered for patients with severe allergic and eosinophilic asthma. [ABSTRACT FROM AUTHOR]

The prevalence of food allergies has doubled in the past 10 years. Peanut allergies are a significant public health issue and are the primary reason for food-related anaphylactic reactions that result in death. Evidence supports that early introduction of the peanut protein (or in combination with immunotherapy) to the highly allergic may safely desensitize patients, which could lead to less adverse allergic reactions and alter allergy management overall. [ABSTRACT FROM AUTHOR]

Sublingual Immunotherapy is a form of immunotherapy that involves placing the allergen extract under the tongue. An allergist gives patient small doses of an allergen under the tongue to boost the tolerance to the substance and reduce its symptoms. At present, the only forms of SLIT approved by the FDA are tablets for ragweed, northern pasture grasses like timothy, and dust mites. The safety and efficacy of allergy drops is yet being established by the FDA, and they are only used without label in the United States. The possible advantages of sublingual treatment are those of no use of injections, comparatively few regular doctor visits, possibility of home dosing after the first treatment, also a lower risk of serious reactions. Parents of young children often prefer sublingual immunotherapy as their child does not have to have regular injections. The main disadvantage of this form of treatment is its cost as more allergen needs to be swallowed than injected, this results in the cost per allergen being more expensive than that of injected treatments. [ABSTRACT FROM AUTHOR]

Background: Allergen immunotherapy (AIT) has been in practice for more than 100 years. However, research in novel routes and delivery methods of immunotherapy to treat allergic rhinitis (AR) and conjunctivitis has only recently occurred in the United States, where the predominant form of AIT provided is largely via a subcutaneous immunotherapy (SCIT) route. AIT may prevent new sensitizations, improve symptoms, decrease medication usage, and prevent allergic asthma. Although AIT is the only potentially curative treatment for AR, access and adherence continue to be problematic. Only a fraction of eligible patients actually undergo treatment, and attrition rates are high. An obvious limitation of SCIT includes the requirement of regular injections to be provided in the physician's office due to the potential for anaphylaxis. Sublingual immunotherapy (SLIT) for home administration has been investigated as a potential alternative to address this limitation of SCIT. Methods: A literature review was performed including the current findings from randomized clinical trials and meta-analyses with a discussion of the most recent evidence for the efficacy, safety, and dosing of allergen SLIT. Results: The current data suggest that SLIT is effective for treatment of seasonal allergies, can potentially prevent asthma, and has a favorable safety profile. Head-to-head studies, however, are few, and comparative effectiveness still remains to be answered. Optimal treatment algorithms for SLIT have not yet been established, with wide variation in dosage selection and schedules. Similarly to SCIT, only a few allergens such as ragweed and grass pollen have been found to be effective in large clinical trials. Conclusion: Recent data indicate that SLIT is an effective treatment modality for seasonal AR, improve quality of life, and can potentially prevent asthma but head-to head studies comparing SLIT to SCIT are needed. [ABSTRACT FROM AUTHOR]

Specific allergen immunotherapy has been practiced for allergic rhinoconjunctivitis for over 100 years and is the only treatment option that is disease modifying. In the USA, immunotherapy is usually administered via subcutaneous injection; this is the only route with a US FDA-approved formulation. There is growing interest in developing US-standardized formulations for the sublingual route, but up until recently there have been few US trials. Most of the experience with sublingual immunotherapy (SLIT) comes from Europe, where it is widely used and there is a large body of literature supporting its use. The purpose of this review is to summarize recent adult and pediatric clinical trials of SLIT in the USA. Most of the trials are for inhalant allergies, but there is some early work on SLIT as a novel therapy for food allergies. INSET: Key issues. [ABSTRACT FROM AUTHOR]

Background: Increasing interest in sublingual immunotherapy (SLIT) among practitioners and patients has resulted in numerous publications and clinical trials in recent years. With the clinical growth of SLIT, discussions of its efficacy, safety, and immunologic effects have intensified, as have comparisons to subcutaneous immunotherapy (SCIT). In the United States, SCIT has been the traditional form of immunotherapy for inhalant allergy and is the only immunotherapy method approved by the U.S. Food and Drug Administration at this time. The similarities and differences between SLIT and SCIT are often discussed, yet clinical studies directly comparing these immunotherapy methods are scarce. Methods: A literature review of specific issues and controversies between SLIT and SCIT for allergic rhinitis was conducted. Results: Safety, efficacy, and immunologic effects of these two immunotherapy techniques are reviewed. Conclusion: Unanswered questions relating to SLIT are examined. [ABSTRACT FROM AUTHOR]

The article talks about Oralair, the first sublingual immunotherapy alternative for immunotherapy injections for people 10 to 65 years old who suffer from grass pollen allergies manufactured by French pharmaceutical company Stallergenes, S.A. Oralair was approved by the U.S. Food and Drug Administration and will be marketed in the U.S. in partnership with Greer Laboratories Inc. The drug contains sweet vernal-grass, orchardgrass, ryegrass, timothy or Kentucky bluegrass pollen extracts.

Background: Few trials of sublingual immunotherapy (SLIT) in the United States have been reported. Objective: This randomized, placebo-controlled feasibility SLIT study compared the safety and physiologic effects of high- versus low-dose Dermatophagoides farinae vaccine. Methods: Thirty-one D farinae–sensitive adults with allergic rhinitis with or without mild intermittent asthma were eligible for randomization to high-dose maintenance vaccine (n = 10, 4200 allergen units [approximately 70 μg of Der f 1/d]), low-dose maintenance vaccine (n = 10; 60 allergen units [approximately 1 μg of Der f 1/d]), or placebo (n = 11) over 12 to 18 months. Medication-symptom scores and adverse events were monitored, serum D farinae–specific IgE and IgG4 levels were measured, and bronchial reactivity to D farinae was determined at baseline and 6-month intervals. Results: Of the 31 randomized subjects, 6 withdrew because of non–treatment-ascribed events. Four withdrew because of treatment-ascribed effects: high-dose group, 1 of 10 (gastrointestinal symptoms); low-dose group, 1 of 10 (gastrointestinal symptoms); and placebo group, 2 of 11 (headache and increased nasal symptoms). Thus 21 subjects completed the study: high-dose group, 9; low-dose group, 7; and placebo group, 5. Eleven of the 21 subjects experienced mild-to-moderate gastrointestinal symptoms, throat irritation, or both (high-dose group, 5/9; low-dose group, 4/7; and placebo group, 2/5). No severe systemic reactions were noted. No differences in symptom-medication scores were found. High-dose SLIT increased the bronchial threshold to allergen challenge and increased serum D farinae–specific IgG4 levels, whereas low-dose SLIT and placebo had no significant effect. Conclusions: High-dose D farinae SLIT was generally tolerable, increased serum D farinae–specific IgG4 levels, and improved the bronchial threshold to allergen challenge. Larger US trials are warranted. [ABSTRACT FROM AUTHOR]