Major scientific societies, such as the EAACI or the AAAAI, do not express any suggestion on which form of allergen immunotherapy (AIT) is to be preferred (subcutaneous immunotherapy, SCIT, vs. sublingual immunotherapy, SLIT). This choice could depend on their relative pharmacoeconomic value.

To assess the cost-effectiveness of AIT for grass pollen, administered as SCIT or SLIT.

We created a Markovian Model, to evaluate, in a hypothetical cohort of adult patients suffering from moderate-to-severe rhino-conjunctivitis with or without allergic asthma, the cost-effectiveness of SLIT (tablets, Grazax® and Oralair® ) or SCIT (various currently available products, plus indirect non-medical costs, such as travel and productivity costs) in addition to pharmacological therapy, assuming a 9-year horizon to capture AIT long-term effects. The incremental cost-effectiveness ratio (ICER) was calculated assuming pharmacological therapy as the reference comparator.

In the base-case, SCIT was slightly more expensive, but more effective than SLIT, being the most cost-effective option (ICER for SCIT, €11,418; ICER for SLIT, €15,212). ICERs greater than €120,000 for both SCIT and SLIT was demonstrated in a scenario assuming that low treatment persistence rates, which are common in real-life, lead to absence of long-term AIT clinical benefit. Considering indirect non-medical costs SLIT resulted more cost-effective than SCIT (ICER for SCIT, €17,318; ICER for SLIT, €15,212).

In daily practice AIT for grass pollens may be a cost-effective option only in patients with low discontinuation rates. SCIT, which is less affected by this limitation than SLIT, seems the most cost-effective AIT form.

The objective of this study was to analyze the effectiveness of allergen immunotherapy (AIT) with an allergoid in the treatment of house dust mites (HDM)-induced allergic rhinitis and/or asthma based on recent real-life data. The outcomes were measured using asthma incidence and consumption of corresponding medications as the indicator of persisting symptoms.

In this retrospective cohort analysis of a German longitudinal prescription database, patients who received at least two relevant mite AIT prescriptions in two different successive seasonal cycles were compared with non-AIT patients who received at least three symptomatic allergic rhinitis (AR) prescriptions in successive mite seasons. Study endpoints included AR progression, asthma progression, asthma occurrence, and therapy adherence. We used multivariate regression analyses to estimate the effects of AIT, adjusting for relevant variables.

This study included 2,350 patients receiving a mite allergoid and 64,740 control patients. After up to 6 years of follow-up, patients treated with mite allergoid required significantly fewer AR and asthma prescriptions (59.7% versus 10.8%) than the control group, and the probability of asthma development was significantly lower. The adherence of patients receiving allergoid was 63.8% at the end of the second year and 38.6% at the end of the third year.

This real-world evidence confirms the good efficacy of subcutaneous AIT with HDM mite allergoid in the treatment of allergic rhinitis and/or asthma. Up to 6 years of follow-up revealed significant effects in allergic rhinitis by measuring the number of AR medications and demonstrating significant reductions in asthma medications.

Conventional allergen-specific immunotherapy (AIT), based on administrations of allergen extracts, represents up to now the unique protocol for the desensitization of allergic patients. Whereas the effectiveness of AIT was evidenced for the treatment of allergic rhinitis and allergic asthma, such strategy remains experimental for food allergies up to now. However, important issues are commonly associated with AIT as the quality of natural allergen extracts, the long duration and adverse side effects which negatively affect successful desensitization together with the patient compliance. The rapid progression of molecular allergology made possible the quest of safer, shorter and more effective immunotherapeutic approaches. The aim of this review is to provide an update on these different innovative recombinant derivatives including their efficacy but also their limitations. Despite of promising preclinical and early clinical studies, absence of convincing data in large Phase III trials precludes so far the translation of these immunotherapeutic candidates into the clinic.

Subcutaneous immunotherapy (SCIT) is effective for allergic rhinitis and conjunctivitis, asthma, and insect venom hypersensitivity. The risk of severe allergic reactions induced by SCIT remains low, and mild systemic reactions have recently shown a tendency to decline. However, near-fatal and fatal anaphylactic reactions may occur. Clinicians administering allergen-specific immunotherapy should receive specialized training and be aware of risk factors and preventive measures to avoid severe allergic reactions induced by SCIT.

Oral immunotherapy (OIT) is an emerging approach to the treatment of patients with IgE-mediated food allergy and is in the process of transitioning to clinical practice.

To develop patient-oriented clinical practice guidelines on oral immunotherapy based on evidence and ethical imperatives for the provision of safe and efficient food allergy management.

Recommendations were developed using a reflective patient-centered multicriteria approach including 22 criteria organized in five dimensions (clinical, populational, economic, organizational and sociopolitical). Data was obtained from: (1) a review of scientific and ethic literature; (2) consultations of allergists, other healthcare professionals (pediatricians, family physicians, nurses, registered dieticians, psychologists, peer supporters), patients and caregivers; and patient associations through structured consultative panels, interviews and on-line questionnaire; and (3) organizational and economic data from the milieu of care. All data was synthesized by criteria in a multicriteria deliberative guide that served as a platform for structured discussion and development of recommendations for each dimension, based on evidence, ethical imperatives and other considerations.

The deliberative grid included 162 articles from the literature and media reviews and data from consultations involving 85 individuals. Thirty-eight (38) recommendations were made for the practice of oral immunotherapy for the treatment of IgE mediated food allergy, based on evidence and a diversity of ethical imperatives. All recommendations were aimed at fostering a context conducive to achieving objectives identified by patients and caregivers with food allergy. Notably, specific recommendations were developed to promote a culture of shared responsibility between patients and healthcare system, equity in access, patient empowerment, shared decision making and personalization of OIT protocols to reflect patients’ needs. It also provides recommendations to optimize organization of care to generate capacity to meet demand according to patient choice, e.g. OIT or avoidance. These recommendations were made acknowledging the necessity of ensuring sustainability of the clinical offer in light of various economic considerations.

This innovative CPG methodology was guided by patients’ perspectives, clinical evidence as well as ethical and other rationales. This allowed for the creation of a broad set of recommendations that chart optimal clinical practice and define the conditions required to bring about changes to food allergy care that will be sustainable, equitable and conducive to the well-being of all patients in need.

Subcutaneous Allergen Immunotherapy (SCIT) is an effective treatment of respiratory allergy, but injections in children may cause pain, fear, and sometimes systemic adverse events. Needle-free injectors, who generate a “liquid needle” with a sufficient force to pass through the skin and enter the subcutaneous tissue, don’t inject fluids directly into the vein. They have never been used for the delivery of SCIT. In this prospective, double-arm, randomized, patient-blinded, intra-individual multi-center clinical trial, we compared a needleless vs. a traditional administration of SCIT in children and adolescents with grass pollen or House Dust Mite (HDM) allergy.

Intralymphatic immunotherapy (ILIT) for allergic patients requires only a few intralymphatic injections of the allergen. However, the effectiveness and safety for Japanese cedar pollinosis are unclear. The objectives of this study were to clarify whether and how long ILIT is effective for pollinosis, and its safety.

In an open pilot investigation followed by a double-blind, placebo-controlled study, patients with Japanese cedar pollinosis received 3 intralymphatic inguinal injections of the pollen extracts before the first pollen season. The symptom medication score (SMS), nasal provocation testing and scoring visual analogue scale (VAS) were assessed after the first-third seasons.

(1) Although mild adverse events were induced at the injected site, severe adverse events were not noted. (2) During the latter part of the first season, ILIT-treated patients (n=12) tended to show improved SMS compared to placebo-treated (n=6) without statistical significance. When assessed by nasal provocation testing and VAS scoring after the first season, the effectiveness of ILIT was significant. (3) The effects of ILIT continued until the second or third season. (4) Neither allergen-specific antibodies nor Treg/Breg cells changed in the peripheral blood.

ILIT was safe and effective for Japanese cedar pollinosis. The clinical effects remained for 1-2 years.

Shared decision making (SDM) is the process through which patients and their medical provider mutually explore therapy goals, risks/benefits, and treatment options regarding medical care. Decision-aids are tools to help with the values clarification process and assess decisional needs and potential decisional conflicts.

To develop and assess acceptability of a decision-aid for commercial peanut allergy therapies.

The creation of this decision-aid occurred in three stages, including a qualitative study to assess decisional needs, development of a draft decision-aid through multiple iterations in accordance with international guidelines and decision-aid experts, and assessment of decisional acceptability, decisional conflict, and decisional self-efficacy related to using the decision-aid.

The decision-aid went through 9 iterations, resulting in a 4-page aid with 7 parts, explaining the therapies, the key risks and benefits of the therapy choices, the relative importance of key attributes of the therapies, and a self-check assessment regarding informational adequacy and how to take the next steps. Twenty-four subjects assessed the decision-aid, noting it had good acceptability, high decisional self-efficacy (mean score 91.9/100) and low decisional conflict (mean score 20.2/100). Respondents rated the information content as adequate and sufficient, and the information regarding the therapy choices as fair and balanced without a clear bias or presenting a “best choice”.

We have developed this decision-aid as a tool to help caregivers navigate the complexity of decision-making for peanut allergy treatment options. The decisión aid was noted to have good acceptability, with scores reflective of the instrument enhancing decisional self-efficacy and reducing decisional conflict.

IgE-mediated food allergy remains a significant and growing problem across the globe. Of the various treatment modalities, oral immunotherapy (OIT) and epicutaneous immunotherapy (EPIT) have been the best studied. Across various studies of OIT for egg, milk, and peanut allergy, strong levels of desensitization have been shown. With egg and peanut OIT, a limited remission, or sustained unresponsiveness (SU), has further been demonstrated. These advances have been further validated by successful phase 2 and phase 3 studies of peanut OIT. EPIT, using daily administrations of a proprietary patch, demonstrated efficacy as well as safety and tolerability in parallel phase 2 studies; however, its phase 3 study did not meet its primary efficacy outcome. Despite its good track record of desensitization, the safety and tolerability of OIT has remained a question. EPIT, on the other hand, has proven safe and tolerable; however, the adequacy of its desensitization has remained to be determined. As OIT and EPIT continue their march toward regulatory review, optimizations for immunotherapy and novel therapies continue to be developed providing hope for food allergy patients everywhere.

IgE-mediated food allergy (FA) has been emerging as a public health priority, mainly in children. It represents a heavy burden for the entire society and not only for the patients and their families. There is evidence that in children with persistent FA, at least to cow’s milk, hen’s egg, and peanut, oral immunotherapy (OIT) may increase the reaction threshold to food allergen(s), while receiving active therapy (the so-called “desensitization”). Furthermore, OIT protects patients from the occurrence of severe reactions in the event of accidental ingestion of the culprit food during treatment. However, many gaps are still unsolved, including safety issues, identification of predictive biomarkers, and post-desensitization efficacy. This article briefly summarizes the current evidence and the main needs in OIT to stimulate the development of longitudinal, prospective, well-designed studies able to fill the current gaps soon.