Sublingual Allergen Immunotherapy Research Articles

A Meta-Analysis Investigating the Efficacy and Safety of Allergen-Specific Immunotherapy in the Management of Respiratory Allergies

Background: This meta-analysis aimed to evaluate the effectiveness and adverse effects of specific immunotherapy (SIT) in the management of respiratory allergens, including allergic asthma, rhinitis, and related disorders, based on a review of current literature up to November 8, 2022. Methods: We conducted a search of databases, including PubMed, Embase, Cochrane, and Web of Science, to identify relevant randomized controlled trials (RCTs) assessing respiratory allergy-specific immunotherapy. We employed the Consolidated Standards of Reporting Trials (CONSORT) Statement to select RCTs that adhered to rigorous reporting standards. Specifically, we focused on double-blind placebo-controlled (DBPC) trials and open studies involving both adults and children, considering factors such as dosage, inclusion criteria, allergens, and primary outcome measurements. Results: A total of 25 meta-analyses were included in this study. Among them, 14 evaluated sublingual specific allergen immunotherapy (SLIT), 4 assessed subcutaneous allergen immunotherapy (SCIT), 4 explored both sublingual and subcutaneous immunotherapy, and 3 investigated intralymphatic immunotherapy. The outcomes of these meta-analyses indicated a reduction in medication scores in 20 cases and a decrease in symptom scores in 23 cases. Additionally, six studies reported on changes in IgE levels, seven studies focused on IgG4, four studies examined FEV1 (forced expiratory volume in one second), and eight studies reported on symptom and medication scores. Furthermore, eleven studies reported on differences in adverse reactions. Conclusion: The results of our meta-analysis suggest that specific immunotherapy, while associated with some adverse effects, effectively reduces the symptoms of asthma and rhinitis. Therefore, we recommend its use in the treatment of respiratory allergies.

Effectiveness of allergen-specific immunotherapy in children with bronchial asthma sensitized to house dust mites

Background. The only method of treatment that can change the natural course of allergies is allergen-specific immunotherapy, which allows reducing the sensitivity of the child’s body to the causative allergen and decreasing the activity of chronic inflammation. The evidence base for the effectiveness of allergen-specific immunotherapy in the treatment of bronchial asthma (BA) has significantly expanded recently. However, the truly important results remain too limited to make clinically useful conclusions about the efficacy of sublingual allergen-specific immunotherapy (SLIT) in people with BA and further evidence is needed. The purpose of the study is to evaluate the effectiveness of SLIT as an additional treatment for atopic BA of varying severity in children sensitized to house dust mites. Materials and methods. The main group consisted of 80 children with BA aged from 5 to 17 years, they were divided into three groups according to the severity of the disease: group 1 — 20 children with mild intermittent asthma, group 2 — 30 children with mild persistent asthma, group 3 — 30 children with moderately severe persistent asthma. Thirty practically healthy children without BA were also examined as a control group. For SLIT, a sublingual ORALTEK spray produced by Inmunotek (Spain) was used, a mixture of house dust mite allergens Dermatophagoides pteronyssinus 50 %/Dermatophagoides farinae 50 %, 1 ml of the solution contains 30,000 IU of natural allergen extract. To assess the effectiveness of the treatment, we conducted an analysis of the total score of clinical manifestations of asthma and allergic rhinitis and the degree of asthma control according to the Asthma Control Test. We also analyzed the state of cellular and humoral immunity in the dynamics of therapy. These indicators were evaluated within 1 month before the beginning and a month after the end of the one-year course of therapy. To assess the validity and reliability of the obtained results, statistical data processing was carried out using Microsoft Excel 2016 and Statistica for Windows 10 programs. The Student’s t-test was applied to assess the reliability of the results. The difference between the compared values was considered statistically significant at p < 0.05. Results. The results of the statistical analysis confirmed a significant improvement in the control indicators of patients who received SLIT: reduction in the total score of clinical manifestations, the frequency of clinical symptoms and the use of emergency drugs (p < 0.05). By the end of the study, the dynamics of a decrease in these indicators compared to the data before the start of treatment (according to the above list) was as follows: in patients of group 1 — 82.5, 91.8, 94.5 %, in patients of group 2 — 80.5, 88.4, 92.7 %, in patients of group 3 — 76.7, 85.3, 91.2 %. After treatment with the addition of SLIT to the basic therapy, a reliable increase in IgE and sIgA was observed, an increase in the spontaneous proliferative response of T-lymphocytes to the mitogen in all three groups to the level of the controls, a probable decrease in eosinophilic inflammation and an improvement in indicators of the cellular and humoral immunity (p < 0.001). Conclusions. The prescription of SLIT to children with mild intermittent BA, mild persistent BA and perennial allergic rhinitis, moderate persistent BA and perennial allergic rhinitis provides an opportunity to obtain stable control of the disease, reduces the number of visits to the doctor and justifies the wide use of this method in clinical allergy practice.

Sublingual allergen immunotherapy prevents house dust mite inhalant type 2 immunity through dendritic cell-mediated induction of Foxp3+ regulatory T cells

Sublingual allergen immunotherapy (SLIT) is an emerging treatment option for allergic asthma, and a potential disease modifying strategy for asthma prevention. The key cellular events leading to such long term tolerance remains to be fully elucidated. We administered prophylactic SLIT in a mouse model of house dust mite (HDM) driven allergic asthma. HDM extract was sublingually administered over 3 weeks followed by intratracheal sensitization and intranasal challenges with HDM. Prophylactic SLIT prevented allergic airway inflammation and hyperreactivity with a low lab-to-lab variation. The HDM specific Th2 (CD4 T helper) response was shifted by SLIT towards a regulatory and Th17 response in lung and mediastinal lymph node (MLN). By using Der p 1 specific CD4+ T cells (1-DER), we found that SLIT blocked 1-DER T cell recruitment to the MLN and dampened IL-4 secretion following intratracheal HDM sensitization. Sublingually administered Der p 1 protein activated 1-DER T cells in the cervical lymph node (CLN) via CCR7+ migratory dendritic cells (DC). DCs migrating from the oral submucosa to the CLN after SLIT induced Foxp3+ regulatory T cells. When mice were sensitized with HDM, prior prophylactic SLIT increased Der p 1 specific Tregs and lowered Th2 recruitment in the lung. By using Foxp3-DTR mice, Tregs were found to contribute to the immunoregulatory prophylactic effect of SLIT on type 2 immunity. These findings in a mouse model suggest that DC-mediated functional Treg induction in oral mucosa draining LNs is one of the driving mechanisms behind the disease modifying effect of prophylactic SLIT.

Efficacy of 300 IR house dust mite immunotherapy as a function of disease activity: Tertile analysis in clinical trials.

The symptoms of house dust mite (HDM)-induced allergic rhinitis (AR) vary with changes in exposure related to the weather or the domestic environment. In allergen immunotherapy (AIT) studies, a certain level of AR disease activity is necessary to demonstrate treatment efficacy; the latter can be underestimated if a substantial proportion of the patient population is weakly symptomatic. To better estimate the real treatment effect of a HDM sublingual AIT (SLIT) tablet, we analysed the results of natural field studies in detail by applying a tertile approach. We used data from three randomised, controlled trials (RCT) in a total of 2585 patients with AR treated with the 300 index of reactivity (IR) HDM SLIT-tablet or placebo. The study centres were grouped into tertiles according to the level of combined symptom and medication scores in patients in the placebo group. In each tertile, the difference between SLIT and placebo was assessed through an analysis of covariance. In the three RCTs, combined scores were found to be similar in the SLIT and placebo groups in the low tertiles. The treatment effect of the 300 IR HDM tablet increased in the medium and high tertiles, with notably significant differences versus placebo in the highest tertile and greater (ranging from -21% to -39%) than in the entire study population (-13% to -20%). The positive relationship between treatment efficacy and the combined score in each tertile was independent of the RCT and the score used. Application of the tertile approach to AIT studies in a field in which many variables interact strongly might provide more accurate and meaningful measurements of efficacy and benefit for patients, better reflecting their real-life condition.

House dust mite sublingual allergen immunotherapy tablet is safe and well-tolerated in Dutch clinical practice.

Half (49%) of clinically diagnosed allergic rhinitis (AR) patients are sensitized to house dust mite (HDM). If allergen avoidance and symptomatic medication fail, allergen immunotherapy may be indicated. We investigated safety and tolerability of HDM-sublingual immunotherapy by HDM-SLIT tablets in Dutch daily clinical practice. Daily intake of 12 SQ-HDM SLIT-tablet was investigated in a prospective, multicenter, observational study (EUPAS43753). It comprised 4 consultations in 1 year. Data on safety, tolerability, treatment satisfaction, symptomatic medication, compliance, and clinical effectiveness (Control of Allergic Rhinitis and Asthma Test; CARAT) were collected. Descriptive and longitudinal regression data analysis were performed. Adult patients (n = 415), mean (SD) age 36.6 (12.2) years, 61.4% female and 36% asthmatic were included. The preponderance (65.1%) experienced adverse events (AEs). These, mostly mild (67%), AEs comprised: oral allergic reactions (58.6%), respiratory (12.4%) and gastrointestinal symptoms (9.4%). Sixty (14.5%) patients stopped due to AEs and 76 (18.3%) for non-AE reasons. CARAT scores improved clinically significant by 6 points and symptomatic medication use decreased from 96.1% to 77.4%. Most patients (74.5%) tolerated the treatment and were compliant (>86.5%). The majority of patients (62.4%) and investigators (69.4%) were satisfied with treatment. HDM SLIT-tablet is a safe and well-tolerated AR treatment. AEs occur often but are mostly mild and decreasing during the first year. CARAT scores improved and symptomatic medication use decreased suggesting better control of AR with treatment. Compliance, tolerability, and treatment satisfaction are good. However, patient follow-up and compliance remain important points of attention when initiating treatment.

[Allergen-specific immunotherapy : A brief overview in association with allergic conjunctivitis].

Allergen-specific immunotherapy (AIT) is the only causal and disease-modifying treatment for immunoglobulin E (IgE)-mediated typeI allergies. Regular exposure to the causative allergen results in an immunomodulatory effect by which the predominant T‑helper (Th) 2 lymphocyte response is shifted to aTh1 lymphocyte response and more allergen-specific blocking immunoglobulins are produced. The approval of substances for AIT is regulated by the Therapy Allergens Ordinance (TAV). There are subcutaneous and/or sublingual AITs for the following indications: allergic rhinitis, allergic conjunctivitis, allergic asthma and insect venom allergy. In this article the indications for allergic conjunctivitis are discussed in particular. Clinical symptoms and a relevant type 1 sensitization are the prerequisites for the indications for AIT. The assessment of the indications and carrying out an AIT should only be carried out by physicians who have been trained in allergology.

Anafilaktički šok izazvan subkutanom imunoterapijom alergenom Ambrosia elatior - prikaz slučaja

Introduction: Sensitization to ragweed pollen can lead to symptoms of allergic rhinitis, conjunctivitis, and allergic asthma. Allergen immunotherapy (AIT) is an immunomodulatory therapeutic procedure that, in addition to short-term curative effect (reduction of disease symptoms), also has a long-term preventive effect (preventing the progression of allergic rhinitis into allergic asthma and/or preventing the development of a more severe form of the disease). The two main AIT administration modalities used in clinical practice are subcutaneous allergen immunotherapy (SCIT) and sublingual allergen immunotherapy (SLIT). Both modalities are equally effective in reducing disease symptoms, but the use of SCIT is associated with a higher risk of local and systemic adverse reactions. Case report: A patient who developed a clinical picture of anaphylactic shock during the induction phase of SCIT with Ambrosia elatior pollen extract is presented in this article. The clinical course is described as well as the quick and effective therapeutic management of this life-threatening condition. Conclusion: When properly dosed, in a medical facility and under medical supervision, SCIT with Ambrosia elatior is a very safe and well-tolerated treatment option for allergic rhinitis. Local reactions at the site of subcutaneous administration occur more often than systemic adverse reactions. Anaphylactic shock is the most severe form of a systemic allergic reaction that affects multiple organ systems and can end in death, usually due to airway obstruction and cardiovascular collapse. It is necessary to educate the medical staff as well as the patients regarding the proper treatment of this difficult condition. Based on the assessment of risk factors in each patient, severe reactions to SCIT can be predicted and avoided with appropriate precautions and prophylactic measures. Future innovations in AIT are expected to further improve the efficacy and safety of this form of treatment for allergic diseases.

Allergen immunotherapy for allergicasthma.

Remission is the goal of modern asthma treatment. Allergen immunotherapy (AIT) is an essential component in the armamentarium of personalized asthma therapy. Subcutaneous AIT (SCIT) or sublingual AIT (SLIT) offer the possibility to prevent asthma in patients with allergic rhinitis (reduction of the risk of developing asthma) and the possibility to achieve remission in patients with allergic asthma. Accordingly, AIT should always be considered in patients with asthma and a documented, clinically relevant allergy. However, precise phenotyping of the patient is an essential prerequisite for a success of AIT in asthma.

Sublingual versus subcutaneous allergen immunotherapy in bronchial asthma: A randomized controlled trial

Abstract Background Asthma affects 300 million individuals worldwide. It is a serious global health problem affecting all age groups. The significance of eosinophilic inflammation in asthma is well established. Allergen immunotherapy (AIT) acts by increasing tolerance to specific antigens to which individuals demonstrate clinical sensitivity. Objectives Evaluate the efficacy and safety of sublingual immunotherapy (SLIT) versus subcutaneous immunotherapy (SCIT) as regards clinical response, total immunoglobulin E (IgE), and sputum eosinophil as well as adverse effects. Methods This randomized clinical trial included 100 patients with bronchial asthma who were randomly allocated into two groups: the SLIT group (n = 50) and the SCIT group (n = 50). Patients were given a full allergy history, symptoms, and medication scores; a skin prick test; total IgE for allergens, and a sputum eosinophil count. After the end of treatment, the efficacy, as well as side effects of both treatment arms, were evaluated at 6, 12, and 18 months. Results Both SLIT and SCIT were equally effective. Success rates have been demonstrated to be as high as 86–88%. There was a statistically significant decrease in symptom and medication scores, Total IgE levels, and sputum eosinophil results after treatment (P < 0.001). However, no difference was found between groups regarding the efficacy of treatment. SLIT was significantly safer than SCIT (P < 0.001). Conclusion Both treatment modalities were equally effective in treating asthma, but SLIT had a higher safety profile than SCIT.

Quantifying the benefits of early sublingual allergen immunotherapy tablet initiation in children.

Allergic rhinitis (AR) is a chronic inflammatory disease of the upper airway, which progresses into allergic asthma (AA) in up to 45% of children. This analysis aimed to investigate clinical and economic benefits of sublingual allergen immunotherapy (SLIT tablets) initiated early in childhood for the treatment of AR by quantifying the long-term reduction in new cases of AA. A Markov model was developed to estimate the long-term effects of SLIT tablets on the risk of developing asthma. Key parameters were primarily based on data from the GRAZAX® Asthma Prevention trial and included the age- and treatment-dependent risk of developing AA as well as annual probabilities of progression/remission in AR severity. Healthcare costs were estimated using data from the REACT study. In a modelled cohort of children with moderate-to-severe seasonal AR initiated on SLIT tablets at ages 7 and 12, 24% and 29%, respectively, develop AA during a 20-year period. In comparison, when initiated at age 5, 19% develop AA. Additionally, initiation of SLIT tablets at age 5 is associated with a total healthcare cost of EUR 20,429 per patient, whereas initiation at ages 7 and 12 is associated with, respectively, EUR 21,050 and EUR 22,379 per patient 20 years after AR diagnosis. Initiation of SLIT tablets in early childhood is associated with a clinically meaningful and permanent reduction in new cases of AA and lower healthcare costs among children with AR. This finding supports the clinical relevance of initiating SLIT tablets early for children with AR to obtain long-term clinical benefits.

A successful linkage of a named patient products of sublingual immunotherapy-dispensing registry to French healthcare insurance database (SNDS): methodological constitution of the EfficAPSI cohort

ABSTRACT Background The only causal treatment for allergic rhinitis (AR) is allergen immunotherapy (AIT) including personalized liquid sublingual AIT (SLIT). We present the methodology for establishing the EfficAPSI cohort to further evaluate the real-life effectiveness and use of SLIT liquid. Research design and methods The EfficAPSI cohort was constituted by deterministic linkage of Stallergenes Greer dispensing and nationwide French healthcare insurance system (SNDS) databases. Data from 2006 to 2018 were extracted. All patients who initiated Stallergenes Greer SLIT liquid between 2010 and 2013 were considered as exposed and those dispensed with AR symptomatic treatment only as control. To limit the impact of confounding, the models will be weighted using the inverse probability of treatment weighting (IPTW). Results A total of 445,574 patients were included; median age was 38 years; 59.1% were female. Exposed patients (n = 112,492) were significantly younger, more frequently males, and less likely to have comorbidities than controls (n = 333,082). After IPTW, patients’ characteristics from both groups were similar. Conclusions To date, the EfficAPSI cohort has the largest number of person-years of follow-up in the field of AIT. The completeness of the data allows to evaluate SLIT liquid effectiveness with rigorous methodology, leading to important insights on personalized medicine in real-life.

Immunothérapie allergénique aux pollens de graminées : profil de sécurité et d’efficacité

IntroductionRespiratory allergies to grass pollens are very widespread in the general population and the treatment is generally symptomatic which sometimes remains insufficient. Grass pollen allergen immunotherapy is currently the only etiological treatment of seasonal allergic rhinitis apart from allergenic eviction. AimThe aim was to study the effectiveness of sublingual ITA tablets with 5-grasses on allergic disease and describe the adverse effects after one year of treatment. MethodsWe conducted a prospective, descriptive and evaluative study including 40 patients suffering from grass pollen allergic rhinitis. A grass pollen sublingual allergen immunotherapy was received and patients were followed during a one-year treatment to study the efficacy and the safety profile. ResultsThe mean age was 30.9±12.25 years. The sex ratio (M/F) was 0.48. Allergic conjunctivitis was associated in 70% and allergic asthma was associated in 48% of cases. Allergen immunotherapy side effects were mild, consisting of local side effects. No severe side effects were observed. A decrease in allergic rhinitis symptoms was observed in 83% with improvement in medication score in 65%. All patients noted a decrease in conjunctivitis symptoms with a total regression in 54% of cases. A better asthma control was noted in 33%. Among the 19 patients suffering from asthma, we could decrease the drug use in 63% of cases during the first year of treatment. An improvement of the quality of life was observed in 78% of cases. Allergen immunotherapy was significantly more efficient in allergic rhinitis and conjunctivitis with patients under 30years old. ConclusionGrass pollen allergen immunotherapy leads safely to the regression of allergy symptoms and improves the therapeutic load and the quality of life.

Incidence of Food allergy among patients with allergic conjunctivitis

The prevalence of ocular allergy is increasing worldwide. Skin prick test is widely recognized as the most reliable method for diagnosing the incriminating allergen as regards type I hypersensitivity reactions. Food allergy results as immunological response to food protein which leads to occurrence of allergic conjunctivitis (AC), allergic rhinitis, asthma, atopic dermatitis, and eosinophilic esophagitis. There is a scarcity of research investigating the association between food allergy and AC. This retrospective cohort study aimed to determine the incidence of food allergy within AC patients and its linkage to disease intensity and to compare the response to sublingual immunotherapy after 4 months of therapy. The study included 240 individuals diagnosed with AC. Of these patients, only 214 (89.16%) cases exhibited positive skin prick test results and showed incidence of food allergy of 29.6 %. After 4 months of sublingual allergen immunotherapy, the total serum IgE level and the grades of severity decreased significantly (p <0.001 for each). On comparing patients with food allergy on sublingual immunotherapy and patients without food allergy and on sublingual immunotherapy, the change in total serum IgE concentration and the grade of severity did not differ among the two groups (p value was 0.63 and 1.00 respectively). In conclusion, food allergies can contribute to the development of AC. Sublingual allergen immunotherapy can be proposed as a promising therapeutic option for AC patients.

Sublingual Allergen Immunotherapy in a Child Sensitized to Pollens Responder and nonresponder in one – Case Report

Sublingual Allergen Immunotherapy in a Child Sensitized to Pollens Responder and nonresponder in one – Case Report

Présence et caractéristiques des allergies polliniques en France métropolitaine – Étude observationnelle, transversale et multicentrique POLYPOLLEN

ObjectiveThe POLYPOLLEN study provides documentation of the diversity of pollen allergies by describing the pollen allergies requiring sublingual allergen immunotherapy (SLIT) using allergens prepared specially for a named individual (APSI) in France. MethodsThis multicentre, cross-sectional, observational study was conducted in patients consulting between September 2019 and May 2021 and initiating SLIT with pollen APSI. Each investigator was required to include the same number of patients with frequent pollen allergy and patients with less frequent pollen allergy (predetermined list). ResultsThe cohort of 1,018 patients included 52.1% of women, of mean age 30.2±16.5 years, from all regions of metropolitan France. On treatment initiation, 29% of patients had a history of asthma. In all, 40.6% (n=413) of patients presented with a clinically relevant mono-pollen allergy and 59.4% (n=605) presented with a poly-allergy to at least two pollen allergens. The pollen allergies described were (total cohort/mono-allergic patients only): poaceae (grasses) (62.8%/17.3%), betulaceae (birch) (32.5%/7.6%), cupressaceae (cypress) (15.7%/6.0%), olive tree (15.7%/1.7%), ash tree (14.8%/1.3%), ribwort plantain (Plantago lanceolata) (12.0%/1.2%), ragweed (Ambrosia artemisiifolia) (9.3%/2.7%), common mugwort (Artemesia vulgaris) (4.9%/0.6%), wall pellitory (Parietaria officinalis) (4.6%/1.4%) and hybrid plane (3.8%/1.0%). ConclusionThe POLYPOLLEN French study shows there are mainly ten pollens for which it is necessary to have allergen immunotherapy. It highlights the severity of the allergic phenotypes induced by ragweed and cupressaceae and highlights the frequency of co-allergy to oleaceae. It provides new documentation on allergies induced by infrequent pollens and shows the regional disparities of pollen exposure. It testifies to the importance of combining clinical experience and aeropalynology data in order to refine the management of patients allergic to pollens.

Erythrodermic Atopic Dermatitis Associated with Dust Mite and Alternaria alternata in an Eight-Year-Old Child: A Case Report

Atopic Dermatitis (AD) is a chronic inflammatory condition of the skin characterised by itching, recurrent lesions, and lichenification. Erythroderma also known as generalised exfoliative dermatitis, is characterised by erythema that covers more than 90% of the body’s surface. These erythematic lesions are much more prone to infection. In present case, an eight-year-old girl presented with a chief complaint of rashes all over the body with severe itching from two years presented to the Allergy and Asthma Centre. She had positive history of atopy and multiple septicaemia-related hospitalisations since last two years. Skin biopsy leads the diagnosis of Spongiotic Dermatitis consistent with Erythroderma secondary to AD. Multiple allergies, including those to dust mites (DP der p2, p21, DF der f2) and Alternaria alternata (alt 1), were identified by Component-Resolved Diagnosis (CRD). Cyclosporin’s, Omalizumab (a monoclonal antibody against immunoglobulin E), and allergen-specific sublingual immunotherapy were given for the management and all gave excellent results in the patient. AD can be properly diagnosed and treated in its early stages, breaking the cycle that leads to severe erythroderma. To fully comprehend the molecular and immunological genesis of these allergic types, more research is required.

Long-term benefit after allergen immunotherapy to HDM in elderly patients with allergic rhinitis.

Allergen immunotherapy (AIT) is an effective therapy for allergic rhinitis and may have long-term benefits. However, these benefits have not been strictly defined for older people. The evaluation of the effectiveness of AIT in patients over 60 with allergic rhinitis and house dust mites (HDM) allergy over a period of 7 years was performed. Patients after three years of HDM-AIT were observed to assess the sustained clinical effect of treatment. The average adjusted symptom score (AAdSS) and sIgG4 were monitored for 7 years after sublingual (SLIT) and injection AIT (SCIT). After 3 years of HDM-AIT, a significant clinical effect was observed in the group after SLIT and SCIT based on AAdSS compared to the baseline and the placebo group (p < 0.05). After 7 years of follow-up, there was a sustained trend of decrease in clinical symptoms in desensitized patients relative to placebo. Serum sIgG4 was constantly present in all desensitized patients. AIT may be beneficial for treating seniors with allergic rhinitis and allergies to house dust mites.

Nondaily dosing schedule of allergen-specific sublingual immunotherapy: efficacy and safety.

Sublingual immunotherapy is currently promoted by various companies, with administration schedules variable in the different products even though almost all are standardized immunologically. So, this study was planned to examine the efficacy of simple nondaily dosing of sublingual immunotherapy instead of the widely used daily schedule. Fifty-two patients with allergic rhinitis and bronchial asthma were enrolled. Sublingual immunotherapy (manufactured at the allergen immunotherapy preparation unit at Mansoura University) was given in suitable bottles with a dropper mechanism that permits comfortable dosing under the tongue. The physician recommended that the patient put the drops under his/her tongue and leave the drops beneath the tongue for 2 minutes before swallowing. This was repeated every 3 days, with the drop number and concentration gradually rising. After 2 months of follow-up, 65.8% responded partially to the symptom score and 26.3% responded completely to the medication score. There was a significant decline in the symptom and medication scores from the baseline scores (p<0.0001). After 4 months of follow-up, 95.8% responded partially to symptom scores and no one has not responded; 54.2% responded completely to medication scores; and 81% of studied patients had no side effects. However, the most frequent side effect was a sore throat. Our nondaily schedule of sublingual immunotherapy is tolerable, safe, and effective in patients with allergic rhinitis and bronchial asthma.

Real-world evidence for the long-term effect of allergen immunotherapy: Current status on database-derived European studies.

Randomized controlled trials (RCTs) are the gold-standard for benefit-risk assessments during drug approval processes. Real-word data (RWD) and the resulting real-world evidence (RWE) are becoming increasingly important for assessing the effectiveness of drug products after marketing authorization showing how RCT results are transferred into real life care. The effectiveness of allergen immunotherapy (AIT) has been assessed in several RWE studies based on large prescription databases. We performed a literature search for retrospective cohort assessments of prescription databases in Europe to provide an overview on the methodology, long-term effectiveness outcomes, and adherence to AIT. Thirteen respective publications were selected. AIT was more effective in reducing the progression of allergic rhinitis (AR) compared to a non-AIT control group receiving only symptomatic treatment for AR for up to 6 years. The development and progression of asthma were hampered for most endpoints in patients treated with most preparations compared to the non-AIT group, receiving only anti-asthmatic medication. The results for "time to onset" of asthma were inconsistent. Adherence to AIT decreased during the recommended 3-year treatment period, however, in most studies higher adherence to subcutaneous than to sublingual AIT was shown. The analysis of long-term effectiveness outcomes of the RWE studies based on prescription databases confirms the long-term efficacy of AIT demonstrated in RCTs. Progression of rhinitis and asthma symptoms as well as delayed onset of asthma triggered by different allergens, real life adherence to the treatment shows differences in particular application routes.

Impact of COVID-19 in allergen immunotherapy: An Italian survey.

Allergen immunotherapy (AIT) is a common treatment for patients with allergic asthma and allergic rhinoconjunctivitis. There is evidence that the COVID-19 pandemic could have altered the administration of AIT in patients in some countries, as the pandemic caused major limitations to healthcare access and delivery. The objective of this study was to evaluate the impact of the disruption imposed by the pandemic on the perceptions and administration of AIT therapies in Italy. An online survey was carried out among Italian allergists between 22 February 2021 and 12 April 2021. The results show that Italian physicians (N=66) did not consider that the COVID-19 pandemic presented an added risk to patients with allergic asthma or rhinitis receiving AIT. Although most treatments continued, there were reduced rates of AIT therapy initiations and sublingual AIT was favored over subcutaneous AIT.