Allergy Medication Use Research Articles

History of Multiple Allergies and Gradual Onset Running-Related Injuries in Distance Runners: SAFER XXXV.

To determine if any gradual onset running-related injury (GORRI) was associated with any allergies, multiple allergies (allergies to animals, plants, medication), and allergy medication use. Cross-sectional descriptive study. Two Oceans Marathons (56 km, 21.1 km), South Africa. A total of 76 654 race entrants (2012-2015). The prevalence (%) and prevalence ratios (PR; 95% confidence intervals) for history of (1) any allergies, (2) multiple allergies to broad categories of allergens (animal material, plant material, allergies to medication, and other allergies), and (3) allergy medication use. Using a compulsory online screening questionnaire, the outcome was a history of any GORRIs, and subcategories of GORRIs (muscle, tendon) in the past 12 months and history of GORRIs (and subtypes of GORRIs) were reported. In 68 258 records with injury and allergy data, the following were significantly associated with reporting any GORRIs: a history of any allergy (PR = 2.2; P < 0.0001), a history of allergies to broad categories of allergens (animal, plant, medication allergy, other) (P < 0.0001), and the use of allergy medication (P < 0.0001). A history of any allergies (PR = 2.4; P < 0.0001), all broad categories of allergies, and allergy medication use were significantly associated with muscle (P < 0.0001) and tendon injuries (P < 0.0001). The risk of reporting a GORRI increased as the number of reported categories of allergies increased (P < 0.0001). A novel finding was the cumulative risk effect with a history of multiple allergies. Further studies should aim to determine the underlying mechanism relating allergies and GORRIs.

Depression Screening Scores and Allergy and Gastrointestinal Medication Use in Adolescents.

Between 2005 and 2014, the 12-month prevalence of major depressive episodes among adolescents aged 12 to 17 years increased from 8.5% to 11.3%. Adolescent-onset depression is related to increased risk for depression and suicidal attempts in adulthood. It is known that depression is an adverse effect among adults taking OAM; however, the effect of OAM on adolescents is unknown. The aim of this study was to describe the relationship between Patient Health Questionnaire 9- Modified (PHQ9-M) scores and OAM use among adolescents. This study included data abstracted from charts of adolescents aged 12 to 21 years who completed a Kansas Be Healthy wellness appointment at the KUSM-W Peds Clinic in 2017. Odds ratios were used to calculate the relationship between oral allergy medication and gastrointestinal medication use among adolescents and PHQ9-M scores. Of the 425 adolescent charts analyzed, 22% (n=96) had positive PHQ9-M screens (a score of 10 or greater), and 13% (n=56) reported current use of allergy medication and/or GI medications. Adolescents taking oral allergy medication were 1.77 times more likely to have a positive PHQ9-M screen than those not taking oral allergy medication. Among adolescents on allergy medication, there was no difference in PHQ9- M scores based on the drug class (1^st or 2<up>nd</sup> generation antihistamine or Montelukast). Healthcare providers must diligently explore OAM/GI use with adolescents during clinical encounters and discuss possible adverse effects of OAM on mood.

Factors associated with medication adherence among adults with asthma

Objective Asthma medication adherence is of crucial importance for successful disease management. The aim of this study was to identify and rank factors associated with medication adherence among adults with asthma in the general population. Methods We used data on physician-diagnosed asthma, medication adherence, and factors associated with asthma medication adherence from the Danish General Suburban Population Study using a cross-sectional study design. We ranked factors associated with asthma medication adherence based on the magnitude of odds ratios, and the population attributable fractions. Results Among 20,032 individuals from the general population, 1,128 (6%) suffered from asthma and 822 (73%) of these were adherent to asthma medications. Based on odds ratios, the three top-ranked factors associated with asthma medication adherence were asthma attacks within the past year (4.0; 95% CI: 2.9–5.5), allergy medication use (3.8; 2.6–5.6), and age above median (3.4; 2.4–4.7), followed by asthma severity markers like airway obstruction, and coughing with mucus. Based on population attributable fractions, the three top-ranked factors associated with adherence to asthma medications were asthma attacks within the past year (70%), age above median (57%), and use of allergy medication (49%). Conclusions The study showed that in the general population recent asthma attacks, higher age, and taking allergy medication were the three most important factors associated with asthma medication adherence. The importance of maintaining adherence to asthma medications even in the absence of severe disease or expressed asthma symptoms should be better communicated to the general population.

Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making

The Food and Drug Administration is tasked with evaluating the efficacy and safety of a drug. Despite having a regimented appraisal process in place, safety evidence can emerge during clinical trials as well as from observations and studies conducted after the drug has been on the market, which might require a boxed warning. The boxed warning is the most severe warning that the Food and Drug Administration can give to an approved drug. It is commonly referred to as a Black Box Warning because it is outlined in the package insert by a thick black box to garner the attention of prescribers and patients. There are currently more than 400 medications that have boxed warnings, and the information addressing major risks associated with a particular drug may, appropriately or inappropriately, influence patient and clinician decision making. Health care professionals must use the best evidence and clinical judgment in determining whether to prescribe medications with these warnings. Use of an approved drug at dosages or for indications other than what it was originally licensed for is referred to as "off-label" and is legal, commonplace, and may be evidence-based. All drugs may expose patients to possible harm, so prescribers have an obligation to discuss the best available evidence regarding benefits and harms so that patients can participate in shared decision making.

Allergic rhinitis co-morbidity on asthma outcomes in city school children

Background School based asthma programs have demonstrated that preventive asthma therapy administered in school reduces asthma morbidity. The burden of co-morbid allergic disease on asthma outcomes in a large school based asthma cohort has been unexplored. Objective Evaluate the prevalence of allergic rhinitis (AR) in historically minoritized school children with persistent asthma, and determine if AR is an independent risk factor for asthma morbidity. Methods We evaluated the prevalence of AR in children enrolled in 3 NIH funded school based asthma programs in Rochester, NY. We used linear regression and multivariate analyses to compare asthma outcomes for children whose caregivers did and did not report AR. Results We used data from 1,029 children with asthma (mean age 7.4, 60.4% Black, 29.5% Hispanic, 72.8% insured with Medicaid). 63% of children reported AR. Children with AR had significantly fewer symptom free days over 2 weeks compared to children without AR (7.2 vs. 8.3, p < 0.001). Children with AR also had more daytime symptoms, (4.7 vs. 3.7, p < 0.001), more rescue medication use (4.5 vs. 3.4, p < 0.01), and more activity limitation due to asthma (3.6 vs. 2.5, p < 0.001). Only 44% of children with AR reported allergy medication use. Conclusions Among a large school-based cohort of minoritized children with asthma, we found that the majority of children have comorbid allergic rhinitis, which was associated with increased asthma morbidity. Inadequate recognition and treatment for allergic rhinitis likely represents substantial preventable morbidity for this group.

Ecological momentary assessment of outcomes in allergic rhinitis and chronic rhinosinusitis: A review

Allergic rhinitis (AR) and chronic rhinosinusitis (CRS) rely on patient-reported symptoms and quality-of-life measures, which are subject to bias. Ecological momentary assessment (EMA) captures data in real time through repeated short surveys, thus reducing errors/biases. EMA's use in sinonasal conditions has not been well described, and the goal of this study was to examine the literature on EMA and AR/CRS. METHODS: A literature review was performed using the following search terms: AR, CRS, and EMA. Inclusion criteria were the use of EMA reporting of sinonasal symptoms at more than one time point. Systematic reviews and non-full text articles were excluded. Population demographics, sinonasal disease, type of EMA platform used, type and severity of symptoms reported, medication use and symptom correlation with location/pollen/pollution were collected. Eight studies met the inclusion criteria, and all focused on AR. All studies were conducted outside the United States in both children and adults. Seven studies used a smartphone application for reporting symptoms, and one used WeChat surveys. EMA data collection varied, with repetitive survey intervals determined either by patients (n=6) or research team (n=2). All studies reported sinonasal severity scores, while six reported additional symptoms (e.g., ocular, pulmonary, sleep, general health). Five collected self-reported allergy medication use. Seven studies correlated symptoms with location, pollen, or pollution. Few studies in AR and no studies in CRS assessed the use of EMA. EMA may provide a better understanding of the real-time relationship of environmental triggers with symptoms, in turn guiding treatment decisions.

The influence of selection bias on identifying an association between allergy medication use and SARS-CoV-2 infection.

BackgroundMedications to prevent and treat SARS-CoV-2 infection are needed to complement emerging vaccinations. Recent in vitro and electronic health record (EHR) studies suggested that certain allergy medications could prevent SARS-CoV-2 infection. We sought to carefully examine the potential selection bias associated with utilizing EHRs in these settings.MethodsWe analyzed associations of three allergy medications (cetirizine, diphenhydramine or hydroxyzine) with testing negative for SARS-CoV-2, measuring the potential effect of selection bias on these associations. We used a retrospective cohort of EHR data from 230,376 patients (18 years+) who visited outpatient clinicians in a single, large academic center at least once but were never hospitalized (10/1/2019–6/1/2020). Main exposures included EHR documentation of three allergy medications and allergy, with an intermediate outcome of receipt of a SARS-CoV-2 test, and the primary outcome as testing negative.FindingsSARS-CoV-2 testing rates varied by sex, age, race/ethnicity and insurance. Increasing age and public insurance were associated with a higher adjusted odds of test negativity, while being Black or Hispanic was significantly associated with test positivity. Allergy diagnosis and use of any of three allergy medications were each associated with a higher likelihood of receiving a test (e.g. diphenhydramine - Odds Ratio (OR) 2.99, 95% Confidence Interval (CI) 2.73, 3.28; cetirizine 1.75 (95% CI 1.60, 1.92)). Among those tested, only use of diphenhydramine was associated with a negative SARS-CoV-2 test (adjusted OR = 2.23, 95% CI 1.10, 4.55). However, analyses revealed that selection bias may be responsible for the apparent protective effect of diphenhydramine.InterpretationDiphenhydramine use was associated with more SARS-CoV-2 testing and subsequent higher odds for negative tests. While EHR-based observational studies can inform a need for interventional trials, this study revealed limitations of EHR data. The finding that diphenhydramine documentation conferred a higher odds of testing negative for SARS-CoV-2 must be interpreted with caution due to probable selection bias.Abbreviations: SARS-CoV-2, ACE2, COVID-19, EHR

\u201cEnvironmental risk factors associated with juvenile idiopathic arthritis associated uveitis: a systematic review of the literature\u201d

BackgroundJuvenile idiopathic arthritis associated uveitis (JIA-U) is the most common extra-articular manifestation of juvenile idiopathic arthritis (JIA) and carries considerable risk to vision. The aim of this systematic review was to synthesise evidence of environmental risk factors for JIA-U and identify risk factors which may be modifiable or used to stratify JIA patients.MethodsThis systematic review was carried out in accordance with PRISMA guidelines. Four online databases - Cumulative Index of Nursing and Allied Health Literature, Web of Science, MEDLINE and Embase - were searched from database inception to 12th August 2020. Identified studies were screened by two independent reviewers against pre-defined inclusion and exclusion criteria. Data was extracted from all primary studies meeting inclusion criteria and independently checked.ResultsWe identified three studies from 895 unique records which met the inclusion criteria, each examining a different environmental risk factor. This systematic review includes 973, predominantly female, participants with JIA across these three studies. The use of allergy medication or documentation of “allergy”/“allergic” in the medical records was associated with an increased risk of JIA-U in all models presented. Vitamin D sufficiency was associated with reduced risk of JIA-U. There was insufficient evidence to support an association between seasonality and JIA-U.ConclusionsThis review identifies a potential role for allergy and vitamin D in JIA-U. It also illustrates the paucity of data regarding environmental risk factors for JIA-U and highlights the need for further research to both identify additional risk factors and replicate existing findings.

The Influence of Selection Bias on Identifying an Association between Allergy Medication Use and SARS-CoV-2 Infection

Background: Medications to prevent and treat SARS-CoV-2 infection are needed to complement emerging vaccinations. Recent in vitro studies suggested that certain allergy medications could prevent SARS-CoV-2 infection so we sought to characterize this relationship using existing electronic health record (EHR) data.Methods: We analyzed associations of three allergy medications (cetirizine, diphenhydramine or hydroxyzine) with testing negative for SARS-CoV-2 infection, and measuring also the potential effect of selection bias on these associations. We used EHR data from 230,376 patients (18 years+) who visited outpatient clinicians in a single, large academic center at least once but were never hospitalized (10/1/2020-6/1/2020). Main exposures included EHR documentation of three allergy medications and allergy, with intermediate outcome of receipt of a SARS-CoV-2 test, and the primary outcome as testing negative. Findings: Testing rates varied by sex, age, race/ethnicity and insurance type. Higher age categories and public insurance were associated with a higher adjusted odds of a negative test, while being Black or Hispanic was significantly associated with test positivity. Allergy diagnosis and use of any of three allergy medications were each associated with a higher likelihood of receiving a test (e.g. diphenhydramine - Odds Ratio (OR) 2.99, 95% Confidence Interval (CI) 2.73, 3.28; cetirizine 1.75 (95% CI 1.60, 1.92)). Among those who were tested, only use of diphenhydramine was associated with a negative SARS-CoV-2 test (adjusted OR = 2.23, 95% CI 1.10, 4.55). However, further analyses revealed that selection bias was likely responsible for the apparent protective effect of diphenhydramine.Interpretation: While EHR-based observational studies can inform a need for interventional trials, this study highlights their limitations. The finding that diphenhydramine was associated with a higher odds of testing negative for SARS-CoV-2 must be interpreted with caution due to selection bias.Funding: The Children’s Miracle Network of the University of Florida partially funded this study.Declaration of Interests: Dr. Rasmussen has served on advisory committees for the Teva Pregnancy Registry and Solriamfetol Pregnancy Registry and has consulted for F. Hoffmann-La Roche AG as a litigation expert. Dr. Ostrov has a patent pending for compounds to prevent and treat COVID-19 and methods of using the same. All other authors have nothing to declare. Ethics Approval Statement: We received human subjects approval from the University of Florida Institutional Review Board.

A randomized trial of subcutaneous allergy immunotherapy in inner-city children with asthma less than 4 years of age

BackgroundAllergic sensitization to environmental allergens in the first years of life is a strong predictor of asthma morbidity in children. Allergy immunotherapy can improve asthma and allergy outcomes, but its efficacy in inner-city, atopic children of less than 4 years of age with recurrent wheezing has not yet been established. ObjectiveTo determine whether subcutaneous allergy immunotherapy improves asthma in a population of US inner-city children when started at less than 4 years of age. MethodsIn a randomized controlled, open-label phase I-II single-center trial in the Bronx, New York, 58 children with recurrent wheezing or physician-diagnosed asthma were randomized to receive asthma standard of care treatment with or without a 3-year course of multiple allergen subcutaneous immunotherapy. ResultsA total of 23 children in the control group and 27 children in the immunotherapy group began the study. A total of 20 of 27 children commencing immunotherapy completed at least 2 years of immunotherapy. There was no difference in asthma medication and symptom scores between the treatment or control groups over time. Similarly, naso-ocular symptoms and allergy medication use were similar in both groups over time. Nevertheless, asthma-related quality of life improved in the immunotherapy group compared with the control group (P = .03). ConclusionWith the exception of asthma-related quality of life, allergy immunotherapy was ineffective in improving asthma outcomes in this population of inner-city children of less than 4 years of age. These findings suggest that the effects of allergy immunotherapy depend on population-specific factors and highlight the importance of precise predictors of immunotherapy efficacy. Trial RegistrationClinicalTrials.gov Identifier: NCT01028560.

Residential green space and seasonal distress in a cohort of tree pollen allergy patients.

Residential green space may improve human health, for example by promoting physical activity and by reducing stress. Conversely, residential green space may increase stress by emitting aeroallergens and exacerbating allergic disease. Here we examine impacts of exposure to residential green space on distress in the susceptible subpopulation of adults sensitized to tree pollen allergens. In a panel study of 88 tree pollen allergy patients we analyzed self-reported mental health (GHQ-12), perceived presence of allergenic trees (hazel, alder, birch) near the residence and residential green space area within 1 km distance [high (≥3 m) and low (<3 m) green]. Results were adjusted for patients' background data (gender, age, BMI, smoking status, physical activity, commuting distance, education level, allergy medication use and chronic respiratory problems) and compared with distress in the general population (N = 2467). Short-term distress [mean GHQ-12 score 2.1 (95% confidence interval 1.5-2.7)] was higher in the study population than in the general population [1.5 (1.4-1.7)]. Residential green space had protective effects against short-term distress [high green, per combined surface area of 10 ha: adjusted odds ratio OR = 0.94 (95% confidence interval 0.90-0.99); low green, per 10 ha: OR = 0.85 (0.78-0.93)]. However, distress was higher in patients who reported perceived presence of allergenic trees near their residence [present vs. absent: OR = 2.04 (1.36-3.07)]. Perceived presence of allergenic tree species in the neighbourhood of the residence of tree pollen allergy patients modulates the protective effect of residential green space against distress during the airborne tree pollen season.

SYMPTOM RELIEF AND IMPROVED QUALITY OF LIFE IN ALLERGIC RHINITIS PATIENTS AFTER TRANSDERMAL ALLERGY IMMUNOTHERAPY

Introduction Patients with allergic rhinitis (AR) experience side effects from pharmacotherapies and subcutaneous immunotherapy (SCIT). This prospective, observational study (IRB-approved, informed consent) assessed changes in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) scores and symptoms from baseline to 3 months for patients with AR using a transdermal allergy immunotherapy (TdIT) formulation. Methods In this observational study, patients 12-64 years old with seasonal/perennial AR who tried/failed SCIT, applied a TdIT with selected allergens compounded in a liposomal base cream over three months. Patients completed a survey at baseline, ∼1.5 months and ∼3 months to assess symptoms, quality of life, and side effects. This interim analysis compares baseline (S1) to 3-month (S3) results. Results Paired data from 43 patients (30 female, 13 male, mean age 43.4±14.6 years) were collected from eight physicians across 6 US states. Mean number of days between S1 and S3 = 93.9±32.8 days. MiniRQLQ scores (scale: 0=not troubled, to 6=extremely troubled during the last week) decreased statistically significantly from 2.51/6 at S1 to 1.94/6 at S3 (P=.004, Wilcoxon test). At S3: side effects of TdIT were reported by 9 patients (none serious: 3 rash/redness, 1 rash/redness just once, 1 slight itching at application, and 4 not specified), 40% had noticed allergy symptom reduction, and 21% had stopped/reduced other allergy medication use. Conclusions TdIT may provide an alternative route of administration for allergy immunotherapy. Interim results demonstrated that patients with AR receiving TdIT had improved quality of life and reduced AR symptoms with minimal or no side effects.

Single vs multiallergen sublingual immunotherapy in the polysensitized patient: a pilot study.

Sublingual immunotherapy (SLIT) has emerged as an effective and exceptionally safe method of treatment of the atopic patient. However, the optimal number of allergens that should be included in the SLIT treatment regimen for the polysensitized patient is not known and practices vary widely. This study aims to compare the efficacy of single-allergen SLIT with pauci-allergen vs multiallergen aqueous SLIT in polysensitized patients. Sixteen subjects sensitized to 6+ allergens were enrolled in the study. Subjects were blinded and randomized to SLIT treatment groups that included 1 (single), 3 (pauci), or all sensitized allergens (multi). Allergens selected were those to which the patient was most sensitized and correlated with history. Primary outcomes included daily allergy medication use, weekly Rhinoconjunctivitis Symptom Score (RCSS), and the mini-Rhinoconjuncitivitis Quality of Life Questionnaire (m-RQLQ). All metrics were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months. There were significant decreases from baseline in RCSS and m-RQLQ scores in all study groups at each interval after beginning SLIT (p < 0.05). There was no significant decrease in number of daily allergy medications used regardless of number of allergens in patient's treatment vial (p = 0.50). No significant differences emerged based on number of allergens used. Single-antigen, pauci-antigen, and multiantigen aqueous SLIT significantly improved allergy symptoms. There was no significant difference observed in efficacy of single-allergen SLIT vs pauci-allergen or multi-allergen SLIT in polysensitized patients.

Allergy and asthma medication use in home-dwelling U.S. older adults.

Little is known about the use of allergy and asthma medications in older adults. This study aimed to assess the prevalence of use of these medications in older adults and evaluate predictors of their use. Cross-sectional study using data from the National Social Life, Health, and Aging Project (NSHAP), a nationally representative sample of community-dwelling, U.S. adults 57 to 85 years (n = 2976) collected in 2005-2006. We determined prevalence of medication use and used logistic regression to evaluate sociodemographic and health factors associated with their use. Overall prevalence of allergy medication usage was 8.4% (most commonly antihistamines), and prevalence of asthma medication usage was 8.0% (most commonly bronchodilators). Allergy medication use was significantly associated with history of asthma (odds ratio [OR] 2.37; 95% confidence interval [CI], 1.52 to 3.69), chronic obstructive pulmonary disease (COPD) (OR 2.35; 95% CI, 1.58 to 3.51), or nasal surgery (OR 1.97; 95% CI, 1.00 to 3.86). Older age was associated with decreased allergy medication use (per decade, OR 0.80; 95% CI, 0.66 to 0.98). Although increased education was associated with increased overall allergy medication use, it was associated with decreased use of allergy medications generally contraindicated in the elderly. In contrast, the only significant predictors of asthma medication use were history of asthma (OR 19.66; 95% CI, 3.18 to 121.70) or COPD (OR 4.25; 95% CI, 0.88 to 20.44). Allergy and asthma medication use is prevalent among older adults and driven mostly by history of asthma or COPD. Additional sociodemographic factors predict allergy (but not asthma) medication use. Further studies are needed to evaluate efficacy of these drugs in the elderly.

Health care resource use and associated costs among patients with seasonal versus perennial allergic rhinitis.

Health care resource use (HRU) and costs among patients with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) have not been widely studied. To develop an algorithm to classify patients with SAR and patients with PAR, and to evaluate treatment patterns, HRU, and costs among these patients. Patients with allergic rhinitis (AR) were identified retrospectively by using electronic medical records and administrative claims data, with an index date as the earlier of the date of AR diagnosis or allergy medication use. Patients with AR were followed-up from 12 months before the index date through 12 months after the index date (follow-up) and were classified as SAR or PAR based on medication patterns during follow-up. AR-related HRU, allergy immunotherapy administration, and costs per patient per year during follow-up were compared between patients with SAR and those with PAR, with analyses stratified by asthma diagnosis before the index date and by physician specialty (primary care physician versus specialist). Approximately 23% of patients with AR were classified as having PAR and 77% as having SAR. During follow-up, the patients with PAR had more allergy medication prescriptions versus the patients with SAR (8.0 versus 2.4 prescriptions), higher prescription medication costs ($1551 versus $313), higher allergy immunotherapy cost ($180 versus. $118), and higher total AR-related costs ($1944 versus $643); all with p < 0.001. Patients with asthma had higher costs than those without asthma. Patients seen by a specialist has higher costs than those treated by a primary care physician. Patients with PAR experienced more AR-related prescription drug use and higher health care costs than patients with SAR, with prescription drug costs being the main cost driver. Treatments that reduce the need for ongoing prescription medication use have the potential to be cost saving.

Investigating dynamic sources of pharmaceuticals: Demographic and seasonal use are more important than down-the-drain disposal in wastewater effluent in a University City setting

Pharmaceutical pollution in surface waters poses risks to human and ecosystem health. Wastewater treatment facilities are primary sources of pharmaceutical pollutants, but little is known about the factors that affect drugs entering the wastewater stream. This paper investigates the effects of student pharmaceutical use and disposal behaviors and an annual demographic shift on pharmaceutical pollution in a university town. We sampled wastewater effluent during a ten-day annual spring student move-out period at the University of Vermont. We then interpreted these data in light of survey results that investigated pharmaceutical purchasing, use, and disposal practices among the university student population. Surveys indicated that the majority of student respondents purchased pharmaceuticals in the previous year. Many students reported having leftover drugs, though only a small portion disposed of them, mainly in the trash.We detected 51 pharmaceuticals in 80% or more of the wastewater effluent samples collected over the ten-day sampling period. Several increased in concentration after students left the area. Concentrations of caffeine and nicotine decreased weakly. Drug disposal among this university student population does not appear to be a major source of pharmaceuticals in wastewater. Increases in pharmaceutical concentration after the students left campus can be tied to an increase in the seasonal use of allergy medications directly related to pollen, as well as a demographic shift to a year-round older population, which supports national data that older people use larger volumes and different types of pharmaceuticals than the younger student population.

Safety evaluation of MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) for allergic rhinitis

Introduction: As a chronic disease, allergic rhinitis (AR) requires regular use of allergy medications for the effective management of symptoms. It is therefore imperative that AR treatments not only provide adequate symptom control but are also well tolerated.Areas covered: MP29-02 (Dymista, Meda, Solna, Sweden) is the first new class of AR medication (WHO ATC R01AD58) since the introduction of intranasal corticosteroids (INS) almost 50 years ago. It is a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate delivered in a single spray. Here we review all the safety information relevant to MP29-02, from the initial phase I bioavailability and disposition data, to the phase III 14-day and 52-week data and finally to phase IV safety data collected during MP29-02 use in routine clinical practice.Expert opinion: MP29-02 is the first real therapeutic advance in AR since the introduction of INS and has the potential to change the way this disease is managed, simplifying AR treatment regimens to a single puff in each nostril twice a day. Patients will benefit from superior symptom relief MP29-02 compared to INS with the added assurance that the safety of MP29-02 has been confirmed in the short term and long term as well as in real life.

Beneficial role for supplemental vitamin D3 treatment in chronic urticaria: a randomized study

BackgroundObservational reports have linked vitamin D with chronic urticaria, yet no randomized controlled trial has been conducted. ObjectiveTo determine whether high-dose vitamin D supplementation would decrease Urticaria Symptom Severity (USS) scores and medication burden in patients with chronic urticaria. MethodsIn a prospective, double-blinded, single-center study, 42 subjects with chronic urticaria were randomized to high (4,000 IU/d) or low (600 IU/d) vitamin D3 supplementation for 12 weeks. All subjects were provided with a standardized triple-drug therapy (cetirizine, ranitidine, and montelukast) and a written action plan. Data on USS scores, medication use, blood for 25-hydroxyvitamin D, and safety measurements were collected. ResultsTriple-drug therapy decreased total USS scores by 33% in the first week. There was a further significant decrease (40%) in total USS scores in the high, but not low, vitamin D3 treatment group by week 12. Compared with low treatment, the high treatment group demonstrated a trend (P = .052) toward lower total USS scores at week 12, which was driven by significant decreases in body distribution and number of days with hives. Beneficial trends for sleep quality and pruritus scores were observed with high vitamin D3. Serum 25-hydroxyvitamin D levels increased with high vitamin D3 supplementation, but there was no correlation between 25-hydroxyvitamin D levels and USS scores. There was no difference in allergy medication use between groups. No adverse events occurred. ConclusionAdd-on therapy with high-dose vitamin D3 (4,000 IU/d) could be considered a safe and potentially beneficial immunomodulator in patients with chronic urticaria. Trial Registrationclinicaltrials.gov Identifier: NCT01371877.

Profiling risk factors for chronic uveitis in juvenile idiopathic arthritis: a new model for EHR-based research

BackgroundJuvenile idiopathic arthritis is the most common rheumatic disease in children. Chronic uveitis is a common and serious comorbid condition of juvenile idiopathic arthritis, with insidious presentation and potential to cause blindness. Knowledge of clinical associations will improve risk stratification. Based on clinical observation, we hypothesized that allergic conditions are associated with chronic uveitis in juvenile idiopathic arthritis patients.MethodsThis study is a retrospective cohort study using Stanford’s clinical data warehouse containing data from Lucile Packard Children’s Hospital from 2000–2011 to analyze patient characteristics associated with chronic uveitis in a large juvenile idiopathic arthritis cohort. Clinical notes in patients under 16 years of age were processed via a validated text analytics pipeline. Bivariate-associated variables were used in a multivariate logistic regression adjusted for age, gender, and race. Previously reported associations were evaluated to validate our methods. The main outcome measure was presence of terms indicating allergy or allergy medications use overrepresented in juvenile idiopathic arthritis patients with chronic uveitis. Residual text features were then used in unsupervised hierarchical clustering to compare clinical text similarity between patients with and without uveitis.ResultsPreviously reported associations with uveitis in juvenile idiopathic arthritis patients (earlier age at arthritis diagnosis, oligoarticular-onset disease, antinuclear antibody status, history of psoriasis) were reproduced in our study. Use of allergy medications and terms describing allergic conditions were independently associated with chronic uveitis. The association with allergy drugs when adjusted for known associations remained significant (OR 2.54, 95% CI 1.22–5.4).ConclusionsThis study shows the potential of using a validated text analytics pipeline on clinical data warehouses to examine practice-based evidence for evaluating hypotheses formed during patient care. Our study reproduces four known associations with uveitis development in juvenile idiopathic arthritis patients, and reports a new association between allergic conditions and chronic uveitis in juvenile idiopathic arthritis patients.

Sublingual immunotherapy and quality of life

Sublingual immunotherapy (SLIT) has been shown to be a new and promising treatment for people with various allergic syndromes. Several studies have examined its efficacy. However, significantly fewer investigations have explored its specific impact on the patient's quality of life (QOL). SLIT has an excellent safety profile, superior in many ways to subcutaneous immunotherapy (SCIT). Additionally, SLIT significantly decreases the use of allergy medications, as well as decreasing the money spent on allergy symptom control. Finally, SLIT has been shown to improve the patient's QOL when compared to placebo or even second-generation antihistamines. Increasing data support the use of SLIT as a well tolerated, cost-effective, and time-efficient modality for the treatment of multiple allergic syndromes. However, additional studies are needed, particularly QOL studies which compare SLIT to the FDA-approved SCIT.