Safety Of Sublingual Immunotherapy Research Articles

Clinical efficacy of Dermatophagoides farina drops on allergic rhinitis in children sensitized by dust mites combined with different allergens

ObjectiveThis study aimed to investigate the clinical efficacy and safety of sublingual immunotherapy (SLIT) using standardized dermatophagoides farina drops for the treatment of allergic rhinitis (AR) in children sensitized to dust mites combined with different allergens. The findings contribute to establishing a preliminary foundation for future in-depth studies on AR treatment. MethodsA total of 152 AR children undergoing SLIT were categorized into two groups based on serological test results: the inhalation group (dust mite combined with inhalation allergy) and the ingestion group (dust mite combined with ingestion allergy). The clinical efficacy and safety were evaluated by assessing the total nasal symptoms score (TNSS), total medication scores (TMS), visual analog scale scores (VAS scores), and the incidence of adverse reactions before treatment and after two years of treatment. ResultsAfter two years of treatment, TNSS, TMS, and VAS scores significantly improved compared to pre-treatment values in both the inhalation and ingestion groups (p < 0.05). However, there were no significant differences in efficacy between the two groups after two years of treatment (p > 0.05). During the treatment period, only 15 cases (10.9%, 9 cases in the inhalation group and 6 cases in the ingestion group) experienced mild adverse reactions. There was no significant difference in the incidence of adverse reactions between the two groups (p > 0.05). ConclusionSLIT using standardized dermatophagoides farina drops demonstrates long-term efficacy in children with AR, regardless of whether they belong to the inhalation or ingestion group, without significant differences in treatment outcomes.

Safety and Effectiveness of Bypassing Oral Immunotherapy Buildup With an Initial Phase of Sublingual Immunotherapy for Higher-Risk Food Allergy

Because of its favorable safety, sublingual immunotherapy (SLIT) for food allergy has been proposed as an alternative treatment for those in whom oral immunotherapy (OIT) is of higher risk-older children, adolescents, adults, and those with a history of severe reactions. Although safe, SLIT has been shown to be less effective than OIT. To describe the safety of multifood SLIT in pediatric patients aged 4 to 18 years and the effectiveness of bypassing OIT buildup with an initial phase of SLIT. Patients aged 4 to 18 years were offered (multi)food SLIT. Patients built up to 2 mg protein SLIT maintenance over the course of 3 to 5 visits under nurse supervision. After 1 to 2 years of daily SLIT maintenance, patients were offered a low-dose oral food challenge (OFC) (cumulative dose, 300 mg protein) with the goal of bypassing OIT buildup. Between summer 2020 and winter 2023, 188 patients were enrolled in SLIT (median age, 11 years). Four patients (2.10%) received epinephrine during buildup and went to the emergency department, but none experienced grade 4 (severe) reaction. A subset of 20 patients had 50 low-dose OFCs to 300 mg protein and 35 (70%) OFCs were successful, thereby bypassing OIT buildup. In combination with very favorable safety of SLIT, with no life-threatening reactions and few reactions requiring epinephrine, we propose that an initial phase of SLIT to bypass supervised OIT buildup be considered for children in whom OIT is considered to be of higher risk.

Immune Cell Alterations and PI3K-PKB Pathway Suppression in Patients with Allergic Rhinitis Undergoing Sublingual Immunotherapy.

Our prior clinical study assessed the efficacy and safety of sublingual immunotherapy (SLIT) with standardized Dermatophagoides farina drops on patients with allergic rhinitis (AR) while analyzing the characteristics of adverse reactions. This study was conducted to evaluate the immune cell composition alterations in AR patients before and after SLIT, and to comprehensively investigate the role and changes of antigen-specific immune cells associated with treatment efficacy. A total of 68 AR patients who completed 12months of SLIT were included in the study. Before the trial's initiation and after 1year of SLIT, 10ml of venous blood was collected. Peripheral blood mononuclear cells were isolated using the Ficoll gradient method. The mRNA transcriptome was analyzed using an Affymetrix microarray. The proportions of 22 immune cell types were calculated via the CIBERSORTx platform. Correlations between each immune cell type and SLIT were analyzed. PI3K-PKB pathway dysregulation were analyzed using quantitative PCR and Western blot. Flow cytometry was utilized to assess the percentages of Th1 and Th2 cells. Mono-sensitized AR patients exhibited marked increases in plasma cells, activated memory T cells, regulatory T cells, and activated dendritic cells, while experiencing decreased neutrophils and resting dendritic cells. In poly-sensitized AR patients, the most notable change was an increase in regulatory T cells, coupled with decreased T follicular helper cells, resting dendritic cells, and activated mast cells. These findings indicated that SLIT reshaped immune cell profiles in AR patients, and, notably, the specific changes differed between mono-sensitized and poly-sensitized individuals. Furthermore, SLIT appeared to shift the immune response towards a Th2 decrease profile in both groups. Importantly, suppression of the PI3K-PKB pathway was evidenced as inhibition of PKB phosphorylation and the decrease of glycogen synthase kinase 3 β (GSKβ) and mammalian target of rapamycin (mTOR) expression after SLIT. Our study has demonstrated that SLIT treatment led to distinct changes in immune cell profiles between mono-sensitized and poly-sensitized AR patients. Furthermore, SLIT appeared to reduce a Th2 immune response, highlighting its efficacy in AR treatment. Importantly, the study revealed the suppression of the PI3K-PKB pathway, shedding light on the immunological mechanisms underlying SLIT's effectiveness.

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 &lt; 0.001). However, no difference was found between groups regarding the efficacy of treatment. SLIT was significantly safer than SCIT (P &lt; 0.001). Conclusion Both treatment modalities were equally effective in treating asthma, but SLIT had a higher safety profile than SCIT.

Efficacy and Safety of Sublingual Immunotherapy using a Combination of Dermatophagoides Pteronyssinus and Blomia Tropicalis Extracts in Patients with Allergic Rhinitis: A Randomized, Double-Blind, Placebo-Controlled Trial

The aim of this study was to evaluate the safety and efficacy of sublingual immunotherapy (SLIT) with extracts of Dermatophagoides pteronyssinus and Blomia tropicalis in patients with moderate/severe persistent allergic rhinitis (AR). Methods: This was a double-blind, randomized, placebo-controlled trial of SLIT for the treatment of house dust mite-induced AR. A total of 65 patients, aged between 12 and 60 years, were treated for 12 months and randomized into two groups: SLIT and placebo. The SLIT group received a combination of extracts containing Dermatophagoides pteronyssinus and Blomia tropicalis allergens. All had their sensitization confirmed by skin prick test or serum-specific IgE. Total Nasal Symptom Score, RQLQ quality of life questionnaire, current treatment, and need for medication to control symptoms were recorded during the study. Total serum IgE, serum specific IgE, and IgG4 levels to Der p 1 and Blo t were assessed at baseline, 6 and 12 months after treatment. Results: There was no significant difference in the number of adverse events between groups. The SLIT group showed a significant reduction in the consumption of antihistamines to control symptoms (p &lt; 0.0001) when compared to placebo. There was no significant change in serum total IgE, serum specific IgE, and IgG4 to both allergens when comparing the SLIT and placebo groups. Conclusion: After one year, SLIT using a dose of 1 mcg of Der p 1/day and 753 UBE of Blo t/day proved to be effective and safe in controlling AR exacerbations.

Safety of Sublingual Immunotherapy: A Secondary Analysis of Post-marketing Adverse Events Reports Using a Japanese Public Database.

Purpose Allergic rhinitisimpacts a significant portion of the Japanese population, leading to the rise of sublingual immunotherapy (SLIT) as an alternative treatment. Despite its growing popularity, there is limited safety information. Therefore, this study aimed to consolidate data on its adverse effects in an academic context. Methods We conducted a secondary analysis of adverse events reported in the Pharmaceutical Adverse Events Information Database for three SLIT drugs (Actair®, Cedarcure®, and Miticure®) approved in Japan. A descriptive analysis concerning age, gender, underlying diseases, symptoms, time of onset, and outcomes was performed. Results We identified 98 cases of adverse reactions reported for the SLIT drugs. These cases were mainly from the pediatric to adolescent group (73.7%). Males made up 59.5% of reports. Recovery or improvement was noted in 97.7% of reports. Anaphylactic reactions were the most common adverse event (42.6%), followed by respiratory distress (12.2%). Reactions typically occurred within one week of starting treatment (54.1%). Conclusions Our research illuminated the safety of SLIT drugs in Japan, revealing a favorable profile. It underscores the need for vigilance, particularly among younger patients and during initial doses, emphasizing the importance of proper patient selection and further research to enhance the treatment's efficacy.

Tolerability and Safety of Sublingual Immunotherapy in Patients with Tree Pollen Allergy in Daily Practice-An Open, Prospective, Non-Interventional Study.

To investigate the tolerability and safety of two sublingual tree pollen extracts approved in 2018, a non-interventional study (NIS) was performed. This NIS was an 8-month observational study conducted at 84 sites throughout Germany. Study participants received either a sublingual liquid allergen extract of birch pollen (SBPE) or a liquid allergen extract consisting of a mixture of birch, hazel, and alder tree pollen (STPE). Data from 432 patients were analyzed for the occurrence of adverse events and patient compliance. At least one local reaction occurred in 69 (22.2%) patients, whereas systemic reactions were only observed in 27 (6.3%) patients. STPE-treated patients developed systemic reactions more frequently than SBPE-treated patients (SBPE: 9 (4.3%) vs. STPE: 18 (8.0%)). Only one patient developed a systemic grade III reaction. Severe systemic grade IV reactions were not observed. A total of 348 (98.6%) of the patients who completed all visits were satisfied or very satisfied with the sublingual immunotherapy (SLIT), and 322 (71%) patients completed all visits. Both investigated products were well tolerated by the patients and demonstrated a good safety profile. AEs were observed less frequently than in the preceding clinical phase III trial, and no new safety concerns were identified.

Efficacy and safety of Artemisia annua sublingual immunotherapy in patients with seasonal allergic rhinoconjunctivitis over two pollen seasons.

This study investigates the efficacy and safety of sublingual immunotherapy (SLIT) with A. annua allergens in patients with seasonal allergic rhinoconjunctivitis over two pollen seasons. Seventy patients with moderate-severe seasonal allergic rhinoconjunctivitis were divided evenly into the SLIT and control groups. The SLIT last from 3months before the summer-autumn pollen season in 2021 till the end of the summer-autumn pollen season in 2022. The daily individual symptom score, total rhinoconjunctivitis symptom score (dTRSS), total medication score (dTMS), combined score of medication and rhinoconjunctivitis symptom (dCSMRS), visual analog scale (VAS) score, and adverse events (AEs) were evaluated. The average pollen concentration in 2022 was twice that previous two-year during the pollen season. Fifty-six patients completed treatments (SLIT group: 29, control group: 27). Compared with baseline, the individual symptoms, dTRSS, dTMS, dCSMRS, and VAS scores of SLIT group declined in 2021. After 16months of SLIT, all efficacy indexes in 2022 were still lower than baseline and equivalent to those in 2021. In control group, the efficacy indexes in 2022 were higher than that in 2020 and 2021. The efficacy indexes of SLIT group were lower than those of control group in 2021 and 2022. SLIT is effective for both mono- and poly-sensitized patients. AEs incidence in SLIT group was 82.7% without severe AEs. The A. annua-SLIT can obtain efficacy and safety over two pollen seasons for patients with moderate-severe seasonal allergic rhinoconjunctivitis.

Sublingual immunotherapy with Dermatophagoides farinae drops for pediatric atopic dermatitis.

We evaluated the clinical effect and safety of sublingual immunotherapy (SLIT) with Dermatophagoides farinae drops for pediatric atopic dermatitis (AD). We enrolled children aged 4-13 years with AD and grouped them into the SLIT and control groups using the random number table method. We subdivided each group based on treatment duration (1-, 2-, and 3-year subgroups). The SLIT group received Dermatophagoides farinae drops, and both groups received conventional treatment (topical glucocorticoids, skin moisturizers, oral antihistamines, and allergen avoidance). Effective rate and effect were compared between groups after 1, 2, and 3 years of treatment. We assessed 309 SLIT cases (male, 192; age, 4-13 years) and 131 controls (male, 79; age 4-13 years). The effective rate and curative effect after 2 and 3 years of treatment were significantly different between the groups (P < 0.05). The effect and effective rates between corresponding SLIT and control group treatment duration subgroups were significantly different (P < 0.05). SLIT group duration subgroups showed significant differences in the effect and effective rates (P < 0.05). Posttreatment Scoring Atopic Dermatitis (SCORAD) scores in the SLIT group duration subgroups were significantly lower than those of the corresponding control subgroups (P < 0.05). Upon follow-up at 1 year post treatment completion, the SLIT group's SCORAD score was significantly lower than its baseline score and the control group's follow-up score (P < 0.05). SLIT with Dermatophagoides farinae drops for pediatric AD is safe and effective; effectiveness is maintained after treatment cessation, and prolonged treatment improves efficacy.

EFFICACY AND SAFETY OF SUBLINGUAL IMMUNOTHERAPY IN ALLERGIC ASTHMA AMONG CHILDREN AND ADOLESCENTS INTERVENTIONAL STUDY

Background: bronchial asthma is a chronic inflam­matory disorder with bronchial hyper-responsiveness. Environmental exposure in sensitized individuals is a major inducer of Allergy-associated asthma in children and adults, sublingual immunotherapy (SLIT) leads to improvement in their pulmonary functions and asthma control. Objectives: To Evaluate the Efficacy and Safety of Sublingual Immunotherapy in Allergic Asthma among Children and Adolescents. Methods: A 12 months prospective, open, low Interventional, Randomized, Controlled, single-site Study (Egyptian company for production of vaccines, sera and drugs VACSERA, allergy, and immunology clinic) was conducted between March 29, 2016, and December 27, 2018. Four groups including 62 allergic asthmatics patients both children (n = 30), and adults (n = 32), evaluating SLIT for a single-allergen (i.e. house dust mite) for 12 months, Adults received either SLIT with the pharmacotherapy (n = 17), or pharmacotherapy alone (n = 15).Children received either SLIT with the pharmacotherapy (n = 14), or pharmacotherapy alone (n = 16). Physiological parameters (Spirometry), Asthma control Questionnaires, A complete blood picture including peripheral blood Eosinophilic count, and the environmental preventive therapy were done to all patients. Results: After 1-year treatment of patients treated with SLIT and pharmacotherapy, were compared with those who received pharmacotherapy alone. There was a significant improvement in asthma control score, a significant increase in actual FEV1, FVC in SLIT with the pharmacotherapy groups in adults and children when compared with pharmacotherapy alone. There was a significant decrease in the eosinophilic count when compared with patients treated with the pharmacotherapy alone. There is a significant difference between children and adults regarding the occurrence of adverse effects in the form of Local reaction not requiring treatment (mouth, throat, and skin; irritation/swelling/pain) reported in SLIT with the pharmacotherapy groups. Conclusion: patients treated with SLIT demonstrated clinical improvement compared with those who received pharmacotherapy in adult asthmatics and children sensitized to HDM.

A Retrospective Cohort Study of Sublingual Immunotherapy with Standardized Dermatophagoides farinae Drops for Allergic Rhinitis.

To evaluate the efficacy and safety of sublingual immunotherapy (SLIT) with standardized Dermatophagoides farinae (Df) drops in monosensitized and polysensitized patients with allergic rhinitis (AR) and to analyze the adverse events (AEs). A retrospective analysis was performed using data for 68 patients with AR who received SLIT. The patients were divided into a monosensitized group (36 cases) and a polysensitized group (32 cases) based on serum-specific IgE test results. In the two groups of patients, total nasal symptoms score (TNSS), total medication score (TMS), visual analog scale (VAS) score, and AEs before treatment and at 1, 3, 6, and 12months of treatment were evaluated. Compared with that before treatment, the TNSS, TMS, and VAS score in the monosensitized and polysensitized groups all decreased significantly at 3, 6, and 12months of SLIT (all P < 0.05). There were no significant differences in treatment efficacy indicators between the two groups at all treatment time points (all P > 0.05). In terms of safety, compared with 1month after initiating SLIT, the incidence of AEs in the monosensitized and polysensitized groups at 6 and 12months of treatment significantly decreased (all P < 0.05). There was a statistically significant decrease in the incidence of AEs in both groups at 6months compared with 3months of treatment (χ2 = 1.92 and 5.85, respectively, all P < 0.05). The difference in incidence of AEs between the monosensitized and polysensitized groups was not statistically significant at any treatment time point (all P > 0.05). AEs in all patients were local mild reactions; no serious AEs were found. SLIT with standardized Df drops has similar efficacy and safety for monosensitized and polysensitized patients with AR. AEs mostly occurred during the first 3months of SLIT in both the monosensitized and polysensitized groups, and the incidence of AEs gradually decreased as the course of treatment extended.

The safety of sublingual immunotherapy, can the rare systemic reactions be prevented?

ABSTRACT Introduction: The safety of subcutaneous immunotherapy (SCIT), and particularly the dramatic issue of fatal reactions, has been an obstacle that limited the implementation of a therapy with unique characteristics of action on the causes of allergy. The introduction of sublingual immunotherapy (SLIT) was aimed at solving safety problems while maintaining clinical efficacy. Areas covered: For more than 20 years, SLIT has been based on allergen extracts in drops at low average doses. As evidenced by meta-analyses, the typical adverse events (AE) have consisted of local reactions in the mouth and throat. Unlike the injection route, no correlation was observed between the administered dose and AEs. The development of SLIT products in tablets, based on higher doses than drops, has somewhat changed the concept of SLIT safety. Although large trials, performed to obtain regulatory agency approval, have shown overall high safety, rare anaphylactic reactions have been described. Expert opinion: SLIT is globally safe, and no fatal reactions have ever been reported, but with currently available high biological potency products it is necessary to follow prudential rules, such as the administration of the first dose under medical supervision and the thorough education of patients to avoid taking of higher doses than recommended.

Successful sublingual immunotherapy for severe egg allergy in children: a case report

BackgroundEgg allergy is one of the most common food allergies in children. To date, oral immunotherapy (OIT) has been considered as a promising treatment option for egg allergy. However, safety issues remain concerning severe adverse events requiring epinephrine injection. Hence, establishing a safer method to treat egg allergy would be beneficial. We report here two children with egg allergy who were safely treated with sublingual immunotherapy (SLIT) before transitioning to OIT.Case presentationPatient 1 was a 7-year-old girl and Patient 2 was a 5-year-old girl. Although OIT for egg had been attempted in both patients, severe anaphylactic symptoms were induced by ingesting only 0.1 g of heated whole egg. Therefore, SLIT was conducted with aqueous suspensions consisting of water and heated whole egg powder. Suspensions were administered sublingually, kept in the mouth for 2 min, and spat out immediately thereafter. SLIT was continued for 7 months for Patient 1 and 8 months for Patient 2 due to the exploratory character of the study. Afterwards, the patients successfully transferred to low-dose OIT with 1 g of heated whole egg (≒170 mg of egg protein) daily, and are continuing the therapy as of June 2020. As for adverse reactions, Patient 1 expressed oral cavity itchiness once at the beginning of SLIT. Patient 2 had no adverse reaction. The levels of antigen-specific IgE decreased in both patients after SLIT, and further decreased after switching to OIT.ConclusionsFew clinical studies have evaluated the efficacy and safety of SLIT for egg allergy. Although the treatment was conducted in only two patients, our results have shown that SLIT is a promising treatment procedure for egg allergy. Further clinical trials will be needed to additionally assess the efficacy and safety of SLIT in children with food allergy.

Efficacy of sublingual immunotherapy tablets in dust mite and pollen allergy.

The latest evidence on the mechanisms, efficacy, and safety of sublingual immunotherapy (SLIT) was reviewed. Interleukin (IL) 35 and IL-35-producing regulatory T cells were assessed as new biomarkers for SLIT responsiveness. A detailed analysis of clinical studies, including timothy grass pollen, 5-grass pollen, ragweed, and house-dust mite SLIT tablets, was provided, including a comparative analysis of efficacy and safety of SLIT versus subcutaneous immunotherapy.

Evaluation of the Efficacy and Safety of Sublingual Immunotherapy (Traditional Coca’s extract) in Allergic Rhinoconjunctivitis

Background: Allergic rhinoconjunctivitis is a common allergic disorder that significantly affects the patient’s Quality of life (QoL). In countries with low socioeconomic levels, traditional Coca’s extracts is an economical choice for Sublingual immunotherapy (SLIT).Objectives: This study aimed to evaluate the efficacy, safety, and effect on medication score of homemade Coca’s extracts SLIT in improving the QoL of patients with allergic rhinoconjunctivitis. Methodology: 120 allergic rhinoconjunctivitis patients were randomly classified into two similar groups of 60 patients each. Group I received pharmacological therapy regularly, while group II received SLIT and pharmacological treatment. Both groups were followed up for one year. Results: During the period of study, one patient dropped out from group I, while, 9 (15%) patients dropped out from group II. Initially, there were no statistically significant differences in the scores of mini rhinoconjunctivitis quality of life questionnaire (miniRQLQ) or medication scores between the two groups. After one year, both groups showed statistically highly significant improvement in QoL (p&lt;0.001); however, improvement in group 2 was statistically significantly higher than group I (p&lt;0.001). Medication score of group I showed a mild non-significant decrease from 2.97±0.18 to 2.70±0.723, while, Group II medication score significantly decrease from 3.00±0.000 to 0.38±0.495. There were no severe adverse effects in any of the two groups. No statistical difference was found in the incidence of mild adverse reaction between both groups. Conclusion: Home made Coca’s extracts used in SLIT are a safe treatment that improve both qualities of life and medication score in patients suffering from severe allergic rhinoconjunctivitis.

Risk Factors for Safety of Allergen-Specific Sublingual Immunotherapy in Children with Allergic Rhinitis

A good compliance often attributes to good efficacy and safety of sublingual immunotherapy (SLIT). However, few studies have been conducted on the safety of SLIT treatment in children. We aimed to confirm the pretreatment parameters to predict the safety in children who underwent SLIT. 601 children with allergic rhinitis (AR) treated with SLIT were enrolled in this study. Baseline clinical information and laboratory parameters were collected. The clinical response and adverse events (AEs) were recorded and evaluated. A multivariate logistic regression model was established to confirm the predictors for AEs. The AEs were reported in 75 children (13.8%). The serum-specific IgE (s-IgE) level was significantly correlated with the occurrence of AEs by multivariate logistic regression analysis. Our receiver operating characteristic (ROC) analysis of the serum s-IgE levels >21.6 IU/mL had the best sensitivity (83.7%) and specificity (76.7%) to predict safety. The serum s-IgE level was significantly correlated with safety of SLIT in children, which may be helpful for patient selection before SLIT.

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

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

COMPARATIVE CHARACTERISTICS OF SAFETY OF SUBLINGUAL AND PARENTERAL IMMUNOTHERAPY METHODS

Among a significant number of allergies, the most common among children and adults is pollen allergy. Pollen allergies primarily lead to irritation of the nose and eyes, but can also cause headaches, weakness, fatigue, and decreased attention span. In an acute allergic reaction, anaphylactic shock can occur, that is, a lifethreatening sharp drop in blood pressure. These and many other consequences of allergic reactions imply the need to create drugs that could cure a person of allergies or stop the manifestation of allergen reactions. The aim of the article was to study the safety of allergen-specific immunotherapy. The research methods included an analysis of the comparison of the effectiveness of two immunotherapy methods, a comparison of the safety of sublingual and parenteral methods of administering allergic vaccines, a comparative assessment of the safety of types of allergen-specific immunotherapy. The study involved 228 patients with varying severity of hay fever, among whom were children from 5 to 18 years old and an adult population (113 patients were men, 115 were women). The study revealed that sublingual immunotherapy increases the safety of treatment and is a good substitute for parenteral immunotherapy, especially in children. The studies have also confirmed well-known scientific evidence on the safety of sublingual immunotherapy in patients with hay fever. It was concluded that sublingual immunotherapy increases the safety of treatment and is a good substitute for the parenteral allergenspecific immunotherapy method, especially in pediatric patients, while having several advantages, such as a significant reduction in adverse reactions, high potency, and a convenient mode of administration, greater patient commitment and trust in treatment, and the elimination of infection transmission.

Evidence and Practicalities of Aqueous Sublingual Immunotherapy, Tablet Sublingual Immunotherapy, and Oral Mucosal Immunotherapy for Allergic Rhinitis and Allergic Asthma

Allergen immunotherapy (AIT) is the only disease-modifying treatment for allergic rhinitis (AR). Multiple modalities of AIT dosed via sublingual or oral routes are becoming available. This review discusses current evidence and practicalities of aqueous and tablet sublingual immunotherapy (SLIT) and oral mucosal immunotherapy (OMIT) in the treatment of AR and allergic asthma. Several large-scale studies demonstrate the efficacy and safety of SLIT. These studies have led to the United States Food and Drug Administration (USFDA) approval of tablet SLIT against grass, ragweed, and house dust mites (HDM). However, off-label use of aqueous SLIT is still practiced as a safe and effective alternative in polysensitized patients. Growing evidence suggests a role for SLIT in patients with allergic asthma. The literature supports the efficacy and safety of aqueous and tablet SLIT for AR, while some controversy remains over the utility of SLIT for allergic asthma. OMIT is currently in the early stages of development.

Sublingual immunotherapy of atopic dermatitis in mite-sensitized patients: a multi-centre, randomized, double-blind, placebo-controlled study

Allergen-specific immunotherapy is widely used for allergic rhinitis and asthma treatment worldwide. This study explored the efficacy and safety of sublingual immunotherapy (SLIT) with the extracts of Dermatophagoides Farinae (D. farinae Drops) on house dust mites (HDM)-induced atopic dermatitis (AD). 239 patients with HDM-induced AD were recruited and exposure to a multi-centre, randomized, double-blind, and placebo-controlled clinical trials for 36 weeks, which were randomly divided into placebo and sublingual D. farinae Drops groups (high-dose, medium-dose and low-dose), respectively. Statistical analysis was performed in three groups: Full Analysis Set, Per Protocol Set and Safety Set. 48 cases have withdrawn from the study before the end of study. As primary outcomes, significant decreases in scoring atopic dermatitis and total medication score were showed in medium-dose and high-dose D. farinae Drops groups. In the sixth visit, the skin lesion area showed a statistically significant difference between high-dose/medium-dose D. farinae Drops group and placebo group (p < .05). Most adverse events are slight, and no life-threatening adverse drug reaction happened. Our research demonstrates the beneficial effect of SLIT with high or medium dose D. farinae Drops on AD, and the treatment was well tolerated.