Sublingual Tablet Immunotherapy Improves Quality of Life in Adults With Allergic Rhinoconjunctivitis.

BACKGROUND: Allergic rhinitis with or without conjunctivitis can negatively impact many aspects of quality of life (QoL). The efficacy and safety of standardized quality (SQ) sublingual immunotherapy (SLIT) tablets have been confirmed across large clinical trials in adults with grass, tree, ragweed, and house dust mite (HDM) allergic rhinitis with or without conjunctivitis. OBJECTIVE: This pooled analysis investigates whether the reduction in symptom burden found across the clinical trials is supported by improvements in QoL. METHODS: A total of 11 phase II/III randomized placebo-controlled trials across the SQ grass, tree, ragweed, and HDM SLIT tablets (grass: N = 3179; ragweed: N = 767; tree: N = 634; HDM: N = 2221) were included. QoL was assessed using the standardized Rhinitis Quality of Life Questionnaire (RQLQ), with the exception of 3 grass trials, which used the nonstandardized version. The overall RQLQ scores were expressed as a mean of 7 domains. In the pooled analysis, treatment was used as fixed effect; and the trial, and the interaction between region/country and trial as random effects. RESULTS: The pooled analysis showed consistent and statistically significant improvements in overall RQLQ scores across all 4 SQ SLIT tablets versus placebo (pooled estimate [95% CI], P value-grass: -0.20 [-0.28 to -0.12], P < .001; tree: -0.42 [-0.58 to -0.26], P < .001; ragweed: -0.36 [-0.55 to -0.17], P < .001; HDM: -0.28 [-0.39 to -0.17], P < .001). Furthermore, significant improvements versus placebo for all 4 SQ SLIT tablets were seen across the 7 individual domains. CONCLUSIONS: The proven efficacy of SQ SLIT tablets to reduce symptoms across 4 of the most common respiratory allergens is supported by concurrent significant improvements in RQLQ scores overall and for all 7 domains.

Innovations in the treatment of anaphylaxis: A review of recent data.

PURPOSE OF REVIEW: The current standard of first-line emergency treatment of anaphylaxis is intramuscular (IM) epinephrine, mostly administered through epinephrine autoinjector (EAI) in the outpatient setting. However, undercarriage and underuse of EAIs are common, and delayed epinephrine use is associated with increased morbidity and mortality. Patients, caregivers, and healthcare professionals have expressed a strong desire for small, needle-free devices and products that would offer improved carriage, ease of use, and more convenient, less invasive routes of epinephrine administration. Novel mechanisms of epinephrine administration are under investigation to help address several recognized EAI limitations. This review explores innovative nasal and oral products under investigation for the outpatient emergency treatment of anaphylaxis. FINDINGS: Human studies of epinephrine administered through nasal epinephrine spray, a nasal powder spray, and a sublingual film have been conducted. Data from these studies indicate promising pharmacokinetic results comparable to those of the standard of outpatient emergency care (0.3-mg EAI) and syringe and needle IM epinephrine administration. Several products have shown maximum plasma concentration values higher than those of the 0.3-mg EAI and manual IM injection, although it remains unclear whether this has clinical relevancy in patient outcomes. Generally, these modalities show comparable time to maximum concentrations. Pharmacodynamic changes observed with these products are comparable to or more robust than those seen with EAI and manual IM injection. SUMMARY: Given comparable or superior pharmacokinetic and pharmacodynamic results and safety of innovative epinephrine therapies to those of current standards of care, US Food and Drug Administration approval of these products may help address numerous barriers that EAIs present. The ease of use and carriage and favorable safety profiles of needle-free treatments may make them an attractive alternative to patients and caregivers, potentially addressing injection fears, needle-based safety risks, and other reasons for lack of or delayed use.

Proposed solutions by the American College of Allergy, Asthma, and Immunology and advocacy experts to address racial disparities in atopic dermatitis and food allergy.

Atopic dermatitis (AD) and food allergies are more prevalent and more severe in people with skin of color than White individuals. The American College of Allergy, Asthma, and Immunology (ACAAI) sought to understand the effects of racial disparities among patients with skin of color with AD and food allergies. The ACAAI surveyed its members (N = 200 completed), conducted interviews with health care providers and advocacy leaders, and hosted a roundtable to explore the challenges of diagnosis and management of AD and food allergies in people with skin of color and to discuss potential solutions. Most of the survey respondents (68%) agreed that racial disparities make it difficult for people with skin of color to receive adequate treatment for AD and food allergies. The interviews and roundtable identified access to care, burden of costs, policies and infrastructure that limit access to safe foods and patient education, and inadequate research involving people with skin of color as obstacles to care. Proposed solutions included identifying ways to recruit more people with skin of color into clinical trials and medical school, educating health care providers about diagnosis and treating AD and food allergy in people with skin of color, improving access to safe foods, creating and disseminating culturally appropriate materials for patients, and working toward longer appointment times for patients who need them. Challenges in AD and food allergy in persons with skin of color were identified by the ACAAI members. Solutions to these challenges were proposed to inspire actions to mitigate racial disparities in AD and food allergy.

Pediatric sublingual allergen immunotherapy.

Sublingual immunotherapy (SLIT) offers an important therapeutic modality in the management of children with respiratory allergies. Along with subcutaneous immunotherapy, these modalities are the only selections that have shown not merely relief of symptoms but also disease-modifying activity. SLIT can be given as either a dissolvable tablet (SLIT-T) or liquid drops (SLIT-D). In studies that examined the efficacy and safety in allergic rhinitis and asthma, SLIT-T and SLIT-D both show efficacy in reducing symptoms and the need for medication, although it seems that SLIT-T may show a better response. Almost all SLIT-D efficacy studies are with single allergens. There are virtually no data on the efficacy of mixing unrelated allergens in the same prescription. Both SLIT-T and SLIT-D treatments are safe, with the most common adverse effects being local ones, such as oral pruritus and mouth irritation, which tend to be mild and short lived. Studies that assess the role of SLIT in the prevention of new sensitizations and asthma in the pediatric population are insufficient and of mixed results; therefore, no conclusions can be made. In the treatment of other pediatric conditions, such as food allergy and atopic dermatitis, there are few studies that assessed if, and the degree of, the benefit with SLIT. In determining if SLIT should be prescribed for the pediatric patient, there is a need for shared decision-making to allow the older child and parents or caregivers to understand the pros and cons, and the costs of all the options and relate their values and preferences to the physician.

Rapid and Continuing Improvements in Nasal Symptoms with Dupilumab in Patients with Severe CRSwNP.

Purpose: In the phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) studies in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), dupilumab significantly improved the co-primary endpoints of change from baseline to Week 24 in nasal polyp score (NPS) and nasal congestion/obstruction (NC) vs placebo on background intranasal corticosteroids (standard of care [SOC]). This post hoc analysis of SINUS-24/-52 investigated the direction and magnitude of within-patient change in these endpoints over time. Methods: NPS (scale 0-8) was assessed at Weeks 4, 8, 16, 24, 40, and 52 in SINUS-52 and Weeks 8, 16, and 24 in SINUS-24. Daily patient-reported NC scores (0 [no symptoms]-3 [severe symptoms]) were averaged over 28 days. Within-patient changes from baseline were assessed through Week 24 in pooled SINUS-24/-52 (n = 438/286 dupilumab/SOC) and through Week 52 in SINUS-52 (n = 150/153). Results: In SINUS-52, NPS improved in 70.0% of dupilumab-treated patients at Week 4 vs 31.8% with SOC (odds ratio [OR] 5.2 [95% confidence interval 3.1-8.8]) and 78.7% vs 28.2% at Week 52 (OR 10.6 [6.0-18.7]) (all p < 0.0001). NC improved in 73.3% of dupilumab-treated patients at Week 4 vs 46.7% with SOC (OR 3.2 [2.0-5.3]) and 86.9% vs 50.7% at Week 52 (OR 6.4 [3.5-11.5]) (all p < 0.0001). Clinically meaningful (≥1 point) improvements in NPS occurred in 55.7% and 72.3% of dupilumab-treated patients at Weeks 4 and 52, respectively, vs 16.9% and 16.2% with SOC. Clinically meaningful (≥1 point) improvements in NC occurred in 16.7% and 67.6% of dupilumab-treated patients at Weeks 4 and 52, respectively, vs 3.9% and 20.8% with SOC. At Week 52, NPS worsening from baseline was observed in 5.7% of dupilumab-treated patients vs 40.1% with SOC and NC worsening in 2.1% vs 20.8%, respectively. Conclusion: Dupilumab provided rapid, continuing, and clinically relevant improvements over time in NPS and NC in most patients with severe CRSwNP in the SINUS studies.

Determining the minimal important differences in the RQLQ score with grass and tree allergy immunotherapy versus placebo in adults with moderate-to-severe allergy.

BACKGROUND: Pollen from grasses and trees can trigger allergic rhinitis (AR), where the symptoms and associated consequences can negatively affect quality of life (QoL). The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is frequently used in clinical trials of AR to assess QoL. To help interpret RQLQ data, the minimal important difference (MID) can be used to assess whether a mean difference in QoL between treatment groups is clinically meaningful. In seasonal allergy, an MID differs according to the allergen, pollen exposure, symptom severity, patient age and treatment; the same MID cannot be applied to all scenarios. METHODS: Using data from four Phase III clinical trials of SQ sublingual immunotherapy-tablets in adults with moderate-to-severe allergy, between-group MIDs were derived for the RQLQ in grass pollen allergy (during the peak [n = 501] and entire [n = 514] pollen seasons), and in tree pollen allergy (during the birch [n = 516] and tree [n = 518] pollen seasons), using anchor-based methodology, supported by distribution-based methods. RESULTS: For grass pollen allergy, anchor-based derived between-group MIDs were 0.22 for the entire pollen season (n = 343) and 0.10 for the peak pollen season (n = 335). For tree pollen allergy, anchor-based derived between-group MIDs were 0.26 for the tree pollen season (n = 306) and 0.16 for the birch pollen season (n = 305) (representative of peak season). Distribution-based derived MIDs were supportive of the anchor-based values. CONCLUSIONS: This analysis has derived between-group MIDs specific to the trial populations evaluated and to the conditions under which the data were obtained, and highlights the need for a range of MIDs to reflect the unique nature of seasonal allergic disease.

Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial.

Importance: Systemic corticosteroids are commonly used in treating severe COVID-19. However, the role of inhaled corticosteroids in the treatment of patients with mild to moderate disease is less clear. Objective: To determine the efficacy of the inhaled steroid ciclesonide in reducing the time to alleviation of all COVID-19-related symptoms among nonhospitalized participants with symptomatic COVID-19 infection. Design, Setting, and Participants: This phase 3, multicenter, double-blind, randomized clinical trial was conducted at 10 centers throughout the US and assessed the safety and efficacy of a ciclesonide metered-dose inhaler (MDI) for treating nonhospitalized participants with symptomatic COVID-19 infection who were screened from June 11, 2020, to November 3, 2020. Interventions: Participants were randomly assigned to receive ciclesonide MDI, 160 µg per actuation, for a total of 2 actuations twice a day (total daily dose, 640 µg) or placebo for 30 days. Main Outcomes and Measures: The primary end point was time to alleviation of all COVID-19-related symptoms (cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell) by day 30. Secondary end points included subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19. Results: A total of 413 participants were screened and 400 (96.9%) were enrolled and randomized (197 [49.3%] in the ciclesonide arm and 203 [50.7%] in the placebo arm; mean [SD] age, 43.3 [16.9] years; 221 [55.3%] female; 2 [0.5%] Asian, 47 [11.8%] Black or African American, 3 [0.8%] Native Hawaiian or other Pacific Islander, 345 [86.3%] White, and 1 multiracial individuals [0.3%]; 172 Hispanic or Latino individuals [43.0%]). The median time to alleviation of all COVID-19-related symptoms was 19.0 days (95% CI, 14.0-21.0) in the ciclesonide arm and 19.0 days (95% CI, 16.0-23.0) in the placebo arm. There was no difference in resolution of all symptoms by day 30 (odds ratio, 1.28; 95% CI, 0.84-1.97). Participants who were treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions for reasons related to COVID-19 (odds ratio, 0.18; 95% CI, 0.04-0.85). No participants died during the study. Conclusions and Relevance: The results of this randomized clinical trial demonstrated that ciclesonide did not achieve the primary efficacy end point of reduced time to alleviation of all COVID-19-related symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT04377711.

The Role of Cetirizine in the Changing Landscape of IV Antihistamines: A Narrative Review.

Since 1955, the only available H1 antihistamines for intravenous administration have been first-generation formulations and, of those, only intravenously administered (IV) diphenhydramine is still approved in the USA. Orally administered cetirizine hydrochloride, a second-generation H1 antihistamine, has been safely used over-the-counter for many years. In 2019, IV cetirizine was approved for the treatment of acute urticaria. In light of this approval, this narrative review discusses the changing landscape of IV antihistamines for the treatment of histamine-mediated conditions. Specifically, IV antihistamines will be discussed as a treatment option for acute urticaria and angioedema, as premedication to prevent infusion reactions related to anticancer agents and other biologics, and as an adjunct treatment for anaphylaxis and other allergic reactions. Before the development of IV cetirizine, randomized controlled trials of IV antihistamines for these indications were lacking. Three randomized controlled trials have been conducted with IV cetirizine versus IV diphenhydramine in the ambulatory care setting. A phase 3 trial of IV cetirizine 10 mg versus IV diphenhydramine 50 mg was conducted in 262 adults who presented to the urgent care/emergency department with acute urticaria requiring antihistamines. For the primary efficacy endpoint, defined as change from baseline in a 2-h patient-rated pruritus score, non-inferiority of IV cetirizine to IV diphenhydramine was demonstrated (score - 1.6 vs - 1.5, respectively; 95% CI - 0.1, 0.3). Compared with IV diphenhydramine, IV cetirizine demonstrated fewer adverse effects including less sedation, a significantly shorter length of stay in the treatment center, and fewer returns to the treatment center at 24 and 48 h. Similar findings were demonstrated in another phase 2 acute urticaria trial and in a phase 2 trial assessing IV cetirizine for pretreatment for infusion reactions in the oncology/immunology setting. IV cetirizine is associated with similar patient outcomes, fewer adverse effects, and increased treatment center efficiency than IV diphenhydramine.

Efficacy and safety of crisaborole in patients with mild-to-moderate atopic dermatitis and other atopic comorbidities.

Background: Crisaborole is a nonsteroidal anti-inflammatory phosphodiesterase 4 inhibitor that is approved for the treatment of patients with mild-to-moderate atopic dermatitis (AD); however, the efficacy and safety of crisaborole in patients with AD and other atopic comorbidities have not been investigated. Objective: This post hoc pooled analysis of the pivotal phase III studies (CrisADe CORE 1 and CORE 2) assessed the efficacy and safety of crisaborole versus vehicle in patients aged ≥ 2 years with mild-to-moderate AD and other atopic comorbidities. Methods: Patients with mild-to-moderate AD and a medical history of asthma, allergic rhinitis, or food allergies were identified. Efficacy assessments included the proportion of patients who achieved Investigator's Static Global Assessment (ISGA) success at day 29, ISGA clear or almost clear at day 29, and improvement in the Severity of Pruritus Scale score at week 4. Safety was assessed via treatment-emergent adverse events (TEAEs). Results: This analysis included 1522 patients (crisaborole, 1016; vehicle, 506); 26.2, 15.9, and 16.5% had a medical history of asthma, allergic rhinitis, and food allergies, respectively. The mean age was 12.2 years. A significantly greater proportion of patients treated with crisaborole achieved ISGA success at day 29 compared with patients treated with vehicle for most subgroups analyzed. Furthermore, a significantly greater proportion of patients treated with crisaborole achieved ISGA clear or almost clear at day 29 across all subgroups and demonstrated improvement in the Severity of Pruritus Scale score at week 4 versus patients treated with vehicle in most of the subgroups. Overall, most TEAEs were mild or moderate in severity; the most common treatment-related TEAE in patients with atopic comorbidities was application-site pain (crisaborole, 5.1%; vehicle, 1.7%). Conclusion: Crisaborole was efficacious and well tolerated in patients with mild-to-moderate AD and other atopic comorbidities, which suggested that crisaborole should be considered for the management of AD in this population. Clinical Trials NCT02118766 (CrisADe CORE 1) and NCT02118792 (CrisADe CORE 2), www.clinicaltrials.gov.

Economic burden of peanut allergy in pediatric patients with evidence of reactions to peanuts in the United States.

BACKGROUND: The economic burden of food allergy is large; however, costs specific to individuals with peanut allergy experiencing reactions to peanuts remain to be evaluated. As the prevalence of peanut allergy continues to increase in children, a better understanding of the cost of care is warranted. OBJECTIVE: To assess the cost of care of peanut allergy among privately insured and Medicaid-insured pediatric patients in the United States. METHODS: This retrospective matched-cohort study included patients aged 4-17 years from the Optum Health Care Solutions and Medicaid Claims databases (January 1, 2007-March 31, 2017). Patients were classified into 2 cohorts: peanut allergy (with peanut allergy diagnosis codes and reactions triggering health care resource utilization [HRU]) and peanut allergy-free (no peanut allergy diagnosis codes in claims). Peanut allergy patients were matched 1:10 to peanut allergy-free patients based on baseline covariates. Comorbidities including anxiety and depression, HRU, and direct health care costs were compared between cohorts and reported for both perspectives separately. RESULTS: Compared with peanut allergy-free patients (n = 30,840 privately insured; n = 12,450 Medicaid), peanut allergy patients (n = 3,084 privately insured; n = 1,245 Medicaid) had higher prevalence of asthma, atopic dermatitis/eczema, other food allergies, allergic rhinitis, depression, and anxiety (all P < 0.01). Peanut allergy patients had higher HRU per patient per year (PPPY), including 90% more emergency department visits among both privately insured and Medicaid patients (P < 0.01) and higher direct health care costs PPPY, with incremental costs of $2,247 total or $1,712 excluding asthma-related costs for privately insured patients and $2,845 total or $1,844 excluding asthma-related costs for Medicaid patients (all P < 0.01). CONCLUSIONS: Pediatric patients in the United States with peanut allergy and reactions triggering HRU had significantly higher comorbidity burdens, HRU, and direct health care costs, regardless of asthma-related costs, versus those without peanut allergy. DISCLOSURES: This study was funded by Aimmune Therapeutics, a Nestlé Health Science company. The study sponsor was involved in several aspects of the research including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication. Yu and Tilles are employees of Aimmune Therapeutics, a Nestlé Health Science company. Robison and Norrett were employees of Aimmune Therapeutics at the time this study was conducted. Blaiss, Meadows, and Hass provided paid consulting services to Aimmune Therapeutics. Guerin and Latremouille-Viau are employees of Analysis Group, a consulting company that provided paid consulting services to Aimmune Therapeutics. Parts of the results were presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting held March 25-28, 2019, in San Diego, CA, and at the ISPOR Annual Meeting held May 18-22, 2019, in New Orleans, LA.

Allergy to oak pollen in North America.

Background: Oak pollen is an important allergen in North America. The genus Quercus (oak) belongs to the family Fagaceae under the order Fagales. Objective: The objective of this article was to narratively review the oak pollen season, clinical and epidemiologic aspects of allergy to oak pollen, oak taxonomy, and oak allergen cross-reactivity, with a focus on the North American perspective. Methods: A PubMed literature review (no limits) was conducted. Publications related to oak pollen, oak-related allergic rhinitis with or without conjunctivitis, and oak-related allergic asthma were selected for review. Results: Oak species are common throughout the United States and contribute up to 50% to overall atmospheric pollen loads. Mean peak oak pollen counts can reach >2000 grains/m³. The start of the oak pollen season generally corresponds to the seasonal shift from winter to spring based on latitude and elevation, and may begin as early as mid February. The duration of the season can last > 100 days and, in general, is longer at lower latitudes. In the United States, ∼30% of individuals with allergy are sensitized to oak. The oak pollen season correlates with increased allergic rhinitis symptom-relieving medication use and asthma-related emergency department visits or hospitalizations. Oak falls within the birch homologous group. Extensive immunologic cross-reactivity has been demonstrated between oak pollen and birch pollen allergens, and, more specifically, their major allergens Que a 1 and Bet v 1. The cross-reactivity between oak and birch has implications for allergy immunotherapy (AIT) because guidelines suggest selecting one representative allergen within a homologous group for AIT, a principle that would apply to oak. Conclusion: Allergy to oak pollen is common in North America and has a substantial clinical impact. Oak pollen allergens are cross-reactive with birch pollen allergens, which may have implications for AIT.

Chronic rhinosinusitis with nasal polyps management in the age of biologics.

Background: Chronic rhinosinusitis is one of the most common medical conditions seen in the U.S. population. Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults has predominately a type 2 inflammatory endotype that usually is treated with medical management that consists of inhaled corticosteroids, saline solution irrigation, oral corticosteroid bursts, and, at times, leukotriene antagonists and antibiotics. If medical management fails, then surgical intervention is usually recommended. Various biologics that target type 2 inflammation are now available, which have been or will be approved for use in these patients. Objective: To determine where biologics that affect the type 2 pathway fit into the algorithm of treatment for CRSwNP. Methods: A review of the literature on standard-of-care measures and surgical interventions in CRSwNP and an analysis of recent studies on the efficacy and safety of biologics in this condition. Results: Standard of care with medication and surgical interventions fail in some patients with CRSwNP. Biologics that affect the type 2 inflammatory pathway led to a decrease in nasal polyp size, improved nasal congestion, and improved quality of life both in patients who had surgery and those who had not had surgery for CRSwNP. Also, they showed efficacy and safety in patients whether or not they had comorbid asthma. These agents do not cure the patient with CRSwNP, and will be required chronically for control. Conclusion: Shared decision-making should be used in determining the use of certain medications, surgical management, and biologics in patients with CRSwNP. In patients for whom surgery has already failed and in patients with moderate-to-severe CRSwNP who have other type 2 comorbidities, e.g., asthma, a trial of biologics is a rational course.

Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial.

STUDY OBJECTIVE: Acute urticaria is a frequent presentation in emergency departments (EDs), urgent care centers, and other clinical arenas. Treatment options are limited if diphenhydramine is the only intravenous antihistamine offered because of its short duration of action and well-known adverse effects. We evaluate cetirizine injection, the first second-generation injectable antihistamine, for acute urticaria in this multicenter, randomized, noninferiority, phase 3 clinical trial. METHODS: Adult patients presenting to EDs and urgent care centers with acute urticaria requiring an intravenous antihistamine were randomized to either intravenous cetirizine 10 mg or intravenous diphenhydramine 50 mg. The primary endpoint was the 2-hour pruritus score change from baseline, with time spent in treatment center and rate of return to treatment centers as key secondary endpoints. Frequency of sedation and anticholinergic adverse effects were also recorded. RESULTS: Among 262 enrolled patients, the 2-hour pruritus score change from baseline for intravenous cetirizine was statistically noninferior to that for intravenous diphenhydramine (-1.6 versus -1.5; 95% confidence interval -0.1 to 0.3), and in favor of cetirizine. Treatment differences also favored cetirizine for mean time spent in treatment center (1.7 versus 2.1 hours; P=.005), return to treatment center (5.5% versus 14.1%; P=.02), lower change from baseline sedation score at 2 hours (0.1 versus 0.5; P=.03), and adverse event rate (3.9% versus 13.3%). CONCLUSION: Intravenous cetirizine is an effective alternative to intravenous diphenhydramine for treating acute urticaria, with benefits of less sedation, fewer adverse events, shorter time spent in treatment center, and lower rates of revisit to treatment center.

Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations?

PURPOSE OF REVIEW: Allergen immunotherapy has been used for over 100 years in the treatment of allergic rhinitis. With two major options for administering this disease-modifying therapy, SCIT, and SLIT, what is our current understanding of the efficacy and safety of each one? How do we determine who is the appropriate candidate for each one in the real world? RECENT FINDINGS: SCIT and SLIT show significant improvement in clinical symptoms and need for medication in the treatment of allergic rhinitis. In recent meta-analyses, there is no significant difference in the efficacy between the two treatments, but SLIT has more local side effects though less systemic ones. Shared decision-making should be instituted to determine which treatment should be started in a patient with allergic rhinitis. This review provides up-to-date information on the efficacy and safety of SCIT vs SLIT in the care of children and adults with allergic rhinitis in the real world and the role of shared decision-making in the use of these modalities. TRIAL REGISTRATIONS: Clinicaltrials.gov: NCT04145219 and NCT02478398.

Monoclonal Antibody Therapy in Childhood Asthma.

PURPOSE OF REVIEW: There has been an explosion of monoclonal antibodies in the treatment of severe uncontrolled adult asthma. Studies have now been published in severe pediatric asthma. There are numerous questions that need to be answered in determining whether these modalities are appropriate and safe in children. RECENT FINDINGS: This is a narrative review examining the latest pediatric literature on monoclonal antibodies, both approved and in the pipeline, for uncontrolled asthma. Presently, all of the biologics are positioned to treat patients with underlying type 2 high disease. Two monoclonal antibodies are approved for children 6 years of age and older, omalizumab and mepolizumab, with more likely approved in the near future. The effect of these agents in controlling severe pediatric asthma is promising. Data is limited to long-term efficacy and safety, and whether any agent has an effect on the natural history of asthma.

Safety of Timothy Grass Sublingual Immunotherapy Tablet in Children: Pooled Analyses of Clinical Trials.

BACKGROUND: Timothy grass sublingual immunotherapy (SLIT) tablets are indicated for children with allergic rhinitis with or without conjunctivitis. OBJECTIVE: To use pooled analyses to assess the short- and long-term tolerability and safety of timothy grass SLIT-tablet in children. METHODS: Data from 9 double-blinded, randomized European or North American trials that included children with allergic rhinitis with or without conjunctivitis treated up to 3 years with once-daily timothy grass SLIT-tablet or placebo were pooled. RESULTS: In all, 1818 (timothy grass SLIT-tablet, n = 923; placebo, n = 895) subjects were included in the analysis. The frequency of treatment-emergent adverse events (AEs) was 86% in the SLIT-tablet group and 83% in the placebo group, and the frequency of treatment-related AEs (TRAEs) was 59% and 23%, respectively. Most (98%) TRAEs were mild to moderate in severity. The 2 most common TRAEs with SLIT-tablet were oral pruritus (33%) and throat irritation (19%), which had a median onset of 1 day and recurrence of 14.5 and 5 days, respectively. In all, 8% of subjects in the SLIT-tablet group and 2% in the placebo group discontinued because of AEs. There were 7 serious AEs assessed as related to SLIT-tablet, 1 systemic allergic reaction (severe with a drop in blood pressure), 3 epinephrine administrations, no eosinophilic esophagitis events, and no serious airway obstructions. The safety profile was similar in subjects across geographic regions and with and without asthma. CONCLUSIONS: Pooled data indicate that short- and long-term timothy grass SLIT-tablet is well tolerated in children, regardless of geographic region. AEs were generally local, mild, and transient allergic reactions.

The role of mobile health technologies in allergy care: An EAACI position paper.

Mobile health (mHealth) uses mobile communication devices such as smartphones and tablet computers to support and improve health-related services, data and information flow, patient self-management, surveillance, and disease management from the moment of first diagnosis to an optimized treatment. The European Academy of Allergy and Clinical Immunology created a task force to assess the state of the art and future potential of mHealth in allergology. The task force endorsed the "Be He@lthy, Be Mobile" WHO initiative and debated the quality, usability, efficiency, advantages, limitations, and risks of mobile solutions for allergic diseases. The results are summarized in this position paper, analyzing also the regulatory background with regard to the "General Data Protection Regulation" and Medical Directives of the European Community. The task force assessed the design, user engagement, content, potential of inducing behavioral change, credibility/accountability, and privacy policies of mHealth products. The perspectives of healthcare professionals and allergic patients are discussed, underlining the need of thorough investigation for an effective design of mHealth technologies as auxiliary tools to improve quality of care. Within the context of precision medicine, these could facilitate the change in perspective from clinician- to patient-centered care. The current and future potential of mHealth is then examined for specific areas of allergology, including allergic rhinitis, aerobiology, allergen immunotherapy, asthma, dermatological diseases, food allergies, anaphylaxis, insect venom, and drug allergy. The impact of mobile technologies and associated big data sets are outlined. Facts and recommendations for future mHealth initiatives within EAACI are listed.