Sublingual grass and ragweed immunotherapy: Clinical considerations-a PRACTALL consensus report.

Sublingual allergen immunotherapy provides a new option for patients with allergic rhinitis in the United States. The efficacy of these sublingual immunotherapy tablets in the treatment of allergic rhinitis has been firmly established in large multicenter clinical trials. In addition, the clinical benefits of sublingual immunotherapy might persist after treatment is discontinued. Local reactions, such as gastrointestinal or oropharyngeal symptoms, are common. However, severe anaphylaxis is rare, and therefore the immunotherapy tablets can be administered at home. Sublingual immunotherapy for allergic rhinitis has been used successfully for years in Europe, and these products might be appropriate for patients who do not do well with standard drug therapy or for those who prefer a disease-modifying approach.

Major allergen content consistency of SQ house dust mite sublingual immunotherapy tablets and relevance across geographic regions.

BACKGROUND: Consistency in composition and potency, particularly regarding major allergens, is crucial for the quality of extracts for allergen immunotherapy. OBJECTIVE: To characterize the major allergen composition of house dust mite (HDM) extracts commercially available in the United States and the SQ HDM sublingual immunotherapy (SLIT) tablet, and to relate the composition to patient sensitization patterns. METHODS: Der 1/Der 2 ratios were determined in 10,000- and 30,000-AU/mL HDM extracts from 5 US companies and the SQ HDM SLIT-tablet. Allergen content was analyzed by enzyme-linked immunosorbent assay and compared with an in-house reference. Sensitivity toward Der p 1, Der p 2, and Der p 10 was determined in serum from randomly selected subgroups of 220 individuals from North American and European SQ HDM SLIT-tablet trials. RESULTS: Mean Der 1/Der 2 ratios in US HDM extracts ranged from 0.4 to 20.5. For the SQ HDM SLIT-tablet (20 batches), variability did not exceed 12% regarding content of Der f 1 (SD, 11.9%; 95% confidence interval [CI], 0.94-1.06), Der p 1 (SD, 6.1%; 95% CI, 0.97-1.03), and combined Der 2 allergen (SD, 6.4%; 95% CI, 0.97-1.03), indicating a consistent Der 1/Der 2 ratio. High allergen sensitivity frequencies toward Der p 1 and Der p 2 were observed regardless of geographic region. Efficacy of the SQ HDM SLIT-tablet has been demonstrated in 5 clinical trials. CONCLUSION: The SQ HDM SLIT-tablet has efficacy potential for a broad range of patients because it includes a consistent 1:1 ratio of the 2 major HDM allergens to which individuals were most frequently sensitized across geographic regions. Efficacy has been demonstrated.

Ranking in importance of allergen extract characteristics for sublingual immunotherapy by Italian specialists.

The efficacy of allergen immunotherapy (AIT) is well supported by evidence from trials and meta-analyses. However, its actual performance in daily practice may be diminished by several pitfalls, including inappropriate patient selection, and, especially, the use of allergen extracts of insufficient quality. We performed a survey, the Allergen Immunotherapy Decision Analysis, to evaluate which criteria specialists use to choose products for sublingual immunotherapy (SLIT) in adult patients suffering from allergic respiratory disease. We surveyed a total of 169 Italian allergists randomly chosen from a database belonging to a market research company (Lexis Ricerche, Milan, Italy). The survey was performed between October and November 2012 under the aegis of the European Center for Allergy Research Foundation and consisted of a questionnaire-based electronic survey prepared by a scientific board of 12 AIT experts. The questionnaire comprised two parts, the first of which contained 14 items to be ranked by each participant according to the importance assigned to each when choosing SLIT products. The physicians' rankings assigned major importance to the level of evidence-based validation of efficacy and safety, standardization of the product, efficacy based on personal experience, and defined content(s) of the major allergen(s) in micrograms. The results of this survey show that Italian allergists rank the quality-related characteristics of allergen extracts as highly important when choosing products for AIT. The allergists' preference for high-quality products should be addressed by regulatory agencies and by producers.

ß-Blockers and angiotensin-converting enzyme inhibitors with sublingual immunotherapy: are risks related to individual product safety profile?

PURPOSE OF REVIEW: The objective of this article is to review the available literature regarding the risks associated with sublingual immunotherapy and angiotensin-converting enzyme (ACE) inhibitors or ß-blocker use. It also evaluates for any differences in these risks among the available sublingual immunotherapy (SLIT) tablets. RECENT FINDINGS: A literature search was conducted in PubMed to identify peer-reviewed articles using the following keywords: anaphylaxis, ACE inhibitor, ß-blocker, and sublingual immunotherapy. Minimal data exist regarding their safety of SLIT in patients concomitantly taking ACE inhibitors or ß-blockers. The adverse reaction rates seem similar between SLIT products. SUMMARY: A risk-versus-benefit discussion should be communicated with the patient taking a ß-blocker before beginning SLIT but automatic denial of SLIT to these patients is not warranted.

Hot Topics in Primary Care: Sublingual Immunotherapy: A Guide for Primary Care.

Allergen immunotherapy (AIT), the only potential disease-modifying treatment for allergic disease, has been used for more than a century. Hankin et al showed significant reduction in pharmacy, outpatient, and inpatient resources in the 6 months following vs the 6 months preceding AIT in Medicaid-enrolled children with allergic rhinitis (AR). A 2013 analysis showed sustained cost reduction over 18 months in patients with AR treated with AIT compared with matched control subjects not treated with AIT.

Sublingual immunotherapy (SLIT)--indications, mechanism, and efficacy: Position paper prepared by the Section of Immunotherapy, Polish Society of Allergy.

SLIT (sublingual immunotherapy,) induces allergen-specific immune tolerance by sublingual administration of a gradually increasing dose of an allergen. The mechanism of SLIT is comparable to those during SCIT (subcutaneous immunotherapy), with the exception of local oral dendritic cells, pre-programmed to elicit tolerance. In the SLIT dose, to achieve the same efficacy as in SCIT, it should be 50-100 times higher with better safety profile. The highest quality evidence supporting the efficacy of SLIT lasting 1-3 years has been provided by the large scale double-blind, placebo-controlled (DBPC) trials for grass pollen extracts, both in children and adults with allergic rhinitis. Current indications for SLIT are allergic rhinitis (and conjunctivitis) in both children and adults sensitized to pollen allergens (trees, grass, Parietaria), house dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae), cat fur, as well as mild to moderate controlled atopic asthma in children sensitized to house dust mites. There are positive findings for both asthma and new sensitization prevention. Severe adverse events, including anaphylaxis, are very rare, and no fatalities have been reported. Local adverse reactions develop in up to 70 - 80% of patients. Risk factors for SLIT adverse events have not been clearly identified. Risk factors of non-adherence to treatment might be dependent on the patient, disease treatment, physician-patient relationship, and variables in the health care system organization.

Allergy immunotherapy: what is the evidence for cost saving?

PURPOSE OF REVIEW: 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. RECENT FINDINGS: Examined were 24 publications pertaining to the health economics of AIT. Except for one early study comparing the costs of AIT to symptomatic drug treatment (SDT), the remainder provide compelling evidence for AIT cost savings (whether SCIT or SLIT) over SDT. Furthermore, of the six studies comparing cost outcomes of SLIT to SCIT, four reported cost savings favoring SLIT. SUMMARY: This review, spanning research from Southern Europe, Scandinavia, Northern Europe, North America, and the Czech Republic, encompasses a range of perennial and seasonal allergic conditions, including allergic asthma, allergic rhinitis with or without asthma, and rhinoconjunctivitis with or without allergic rhinitis due to house dust mite, grass or ragweed pollen, or a mixture of various allergens. All but one study compellingly demonstrate cost savings conferred by AIT over SDT.