Improving Clinical Practice Through Patient Registries in Allergy and Immunology.

Patient registries are a mechanism for collecting data on allergic and immunologic diseases that provide important information on epidemiology and outcomes that can ultimately improve patient care. Key criteria for establishing effective registries include the use of a clearly defined purpose, identifying the target population and ensuring consistent data collection. Registries in allergic diseases include those for diseases such as inborn errors of immunity (IEI), food allergy, asthma and anaphylaxis, pharmacological interventions in vulnerable populations, and adverse effects of pharmacologic interventions including hypersensitivity reactions to drugs and vaccines. Important insights gained from patient registries in our field include contributions in phenotype and outcomes in IEI, the risk for adverse reactions in food-allergic patients in multiple settings, the benefits and risk of biologic medications for asthma during pregnancy, vaccine safety, and the categorization and genetic determination of risk for severe cutaneous adverse reactions to medications. Impediments to the development of clinically meaningful patient registries include the lack of funding resources for registry establishment and the quality, quantity, and consistency of available data. Despite these drawbacks, high-quality and successful registries are invaluable in informing clinical practice and improving outcomes in patients with allergic and immunological diseases.

Asthma in pregnancy: a review of recent literature.

PURPOSE OF REVIEW: Asthma remains the most common respiratory disease in pregnancy. Identifying risk factors for asthma exacerbations during pregnancy is critical, as uncontrolled asthma can have detrimental effects for both mother and baby. In this review, we discuss recent literature exploring risk factors, fetal and maternal effects, and treatment options for asthma during pregnancy. RECENT FINDINGS: Recent literature suggests that optimizing asthma during pregnancy improves outcomes for both mother and baby, as well as later in childhood. Current research affirms that the benefit of asthma medication use outweighs any potential risks related to the medications themselves. Limited information is available regarding the use of newer therapies such as biologics during pregnancy. SUMMARY: Identifying risk factors for asthma exacerbations during pregnancy is critical to prevent adverse outcomes for both mother and baby. Recent evidence continues to affirm the safety of asthma medication use; more studies are needed regarding the use of new therapies during pregnancy.

Adverse neonatal outcomes in pregnant women with asthma: An updated systematic review and meta-analysis.

BACKGROUND: A systematic review and meta-analysis from 2013 reported increased risks of congenital malformations, neonatal death and neonatal hospitalization amongst infants born to women with asthma compared to infants born to mothers without asthma. OBJECTIVE: Our objective was to update the evidence on the associations between maternal asthma and adverse neonatal outcomes. SEARCH STRATEGY: We performed an English-language MEDLINE, Embase, CINAHL, and COCHRANE search with the terms (asthma or wheeze) and (pregnan* or perinat* or obstet*). SELECTION CRITERIA: Studies published from March 2012 until September 2023 reporting at least one outcome of interest (congenital malformations, stillbirth, neonatal death, perinatal mortality, neonatal hospitalization, transient tachypnea of the newborn, respiratory distress syndrome and neonatal sepsis) in a population of women with and without asthma. DATA COLLECTION AND ANALYSIS: The study was reported following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) and the Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. Quality of individual studies was assessed by two reviewers independently using the Newcastle-Ottawa Scale. Random effects models (≥3 studies) or fixed effect models (≤2 studies) were used with restricted maximum likelihood to calculate relative risk (RR) from prevalence data and the inverse generic variance method where adjusted odds ratios (aORs) from individual studies were combined. MAIN RESULTS: A total of 18 new studies were included, along with the 22 studies from the 2013 review. Previously observed increased risks remained for perinatal mortality (relative risk [RR] 1.14, 95% confidence interval [CI]: 1.05, 1.23 n = 16 studies; aOR 1.07, 95% CI: 0.98-1.17 n = 6), congenital malformations (RR 1.36, 95% CI: 1.32-1.40 n = 17; aOR 1.42, 95% CI: 1.38-1.47 n = 6), and neonatal hospitalization (RR 1.27, 95% CI: 1.25-1.30 n = 12; aOR 1.1, 95% CI: 1.07-1.16 n = 3) amongst infants born to mothers with asthma, while the risk for neonatal death was no longer significant (RR 1.33, 95% CI: 0.95-1.84 n = 8). Previously reported non-significant risks for major congenital malformations (RR1.18, 95% CI: 1.15-1.21; aOR 1.20, 95% CI: 1.15-1.26 n = 3) and respiratory distress syndrome (RR 1.25, 95% CI: 1.17-1.34 n = 4; aOR 1.09, 95% CI: 1.01-1.18 n = 2) reached statistical significance. CONCLUSIONS: Healthcare professionals should remain aware of the increased risks to neonates being born to mothers with asthma.

COVID-19 and Pregnancy: Interrelationships With Asthma and Allergy.

Pregnant individuals are at higher risk of complications from respiratory viruses such as coronavirus-19 disease (COVID-19). Altered lung function, vaccine hesitancy, and resistance to taking necessary medications because of a lack of safety data in pregnancy make this population especially vulnerable to the effects of COVID-19. Like many medical conditions, the treatment of allergic conditions, including asthma and allergic rhinitis, were affected during the pandemic, with decreased numbers of in-person visits and interruptions in medical treatment. There were initially no data to allow pregnant women with asthma know whether the condition put them at higher risk of complications from COVID-19. There are now increasing data for the efficacy and safety of vaccines for COVID-19 in at-risk populations, including pregnant women. Vaccine studies show no increased risk for spontaneous abortion, congenital anomalies, or pregnancy complications. Furthermore, infants of individuals vaccinated during pregnancy have been shown to obtain protective antibodies via the placenta, providing protection against COVID-19 after birth. Although overall risks are low, pregnant women who become infected with COVID-19 are at higher risk for maternal and pregnancy complications. Antiviral treatment is available for pregnant women with mild to moderate symptoms of COVID-19, with reassuring safety data to date. Dexamethasone is the mainstay of inpatient therapy.

Asthma in Pregnancy.

This JAMA Insights in the Women's Health series examines the management of asthma during pregnancy, including diagnosis, treatment, and the handling of exacerbations.

Monoclonal Antibodies (Biologics) for Allergic Rhinitis, Asthma, and Atopic Dermatitis During Pregnancy and Lactation.

Asthma, allergic rhinitis, chronic urticaria, and atopic dermatitis are common diseases that affect hundreds of thousands of pregnant women each year. The authors discuss the use of biologics in women who are pregnant or lactating, indications, available safety information, and knowledge gaps. There are pregnant patients for which standard treatment is either inadequate or contraindicated; in those cases, monoclonal antibodies (biologics) should be considered despite the unknown risk to the fetus. In severe asthma, omalizumab is the best studied with reassuring available safety data. Insufficient safety data exist on mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab use during pregnancy and lactation.

Chronic Management of Asthma During Pregnancy.

Asthma is one of the most common potentially serious medical problems to complicate pregnancy. Optimal management of asthma during pregnancy is thus important for both mother and baby. Treating asthmatic women requires understanding the effects of pregnancy on the course of asthma, and, conversely, the effects of asthma on pregnancy outcomes. Successful management also requires an understanding the barriers to asthma control in this population of patients. Evidence has shown that it is essential that the allergist-immunologist, obstetrician, and patient work as a team during pregnancy to achieve optimal maternal and neonatal outcomes.

Extrapolating Evidence-Based Medicine of AIT Into Clinical Practice in the United States.

Allergy/immunology specialists in the United States prescribing allergy immunotherapy (AIT) have placed a heavy value on practical experience and anecdotal evidence rather than research-based evidence. With the extensive research on AIT conducted in the last few decades, the time has come to better implement evidence-based medicine (EBM) for AIT. The goal of this review was to critically assess EBM for debated concepts in US AIT practice for respiratory allergies in the context and quality of today's regulatory standards. Debated topics reviewed were the efficacy and safety of AIT in various subgroups (eg, polyallergic patients, older patients, patients with asthma, and pregnant women), diagnosis topics (eg, skin prick test vs allergen-specific serum IgE, factors affecting skin prick tests, use of nasal or conjunctival allergen challenges, and telemedicine for diagnosis), and dosing topics (eg, optimal dosing for subcutaneous immunotherapy and sublingual immunotherapy tablets, US liquid allergen extract history, duration of treatment, and biomarkers of efficacy). In addition, EBM for patient-centered AIT issues (eg, adherence, use of practice guidelines, and pharmacoeconomics) and the approach to implementation of AIT EBM in future clinical practice were addressed. The EBM for each concept was briefly summarized, and when possible, a practical, concise recommendation was given.

Contemporary management and treatment strategies for asthma during pregnancy.

Introduction: Asthma is one of the most common conditions that afflict pregnant women. Because uncontrolled asthma in pregnancy affects both maternal and offspring outcomes, careful attention to maintaining control of asthma symptoms throughout pregnancy is of critical importance.Areas Covered: Using a search of PUBMED/MEDLINE for 'asthma and pregnancy,' this article will review the current literature regarding epidemiology and course of asthma in pregnancy, the effects of uncontrolled asthma on both the mother and offspring, and provide an overview of the management, both non-pharmacologic and pharmacologic, of asthma in pregnancy.Expert Opinion: There is a lack of adequate safety information for most medications taken during pregnancy. Future research might allow better methods to predict which women will experience worsening during pregnancy. For now, surveillance systems like pregnancy registries or observational cohort studies can provide safety information for medications used during pregnancy.

The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities.

Asthma is one of the most common underlying diseases in women of reproductive age that can lead to potentially serious medical problems during pregnancy and lactation. A group of key stakeholders across multiple relevant disciplines was invited to take part in an effort to prioritize, strategize, and mobilize action steps to fill important gaps in knowledge regarding asthma medication safety in pregnancy and lactation. The stakeholders identified substantial gaps in the literature on the safety of asthma medications used during pregnancy and lactation and prioritized strategies to fill those gaps. Short-term action steps included linking data from existing complementary study designs (US and international claims data, single drug pregnancy registries, case-control studies, and coordinated systematic data systems). Long-term action steps included creating an asthma disease registry, incorporating the disease registry into electronic health record systems, and coordinating care across disciplines. The stakeholders also prioritized establishing new infrastructures/collaborations to perform research in pregnant and lactating women and to include patient perspectives throughout the process. To address the evidence gaps, and aid in populating product labels with data that inform clinical decision making, the consortium developed a plan to systematically obtain necessary data in the most efficient and timely manner.

Clinicians' Perspective of the New Pregnancy and Lactation Labeling Rule (PLLR): Results from an AAAAI/FDA Survey.

BACKGROUND: On June 30, 2015, the US Food and Drug Administration (FDA) began implementation of the Pregnancy and Lactation Labeling Rule (PLLR), which replaced the pregnancy letter category system (A, B, C, D, and X) with integrated narrative summaries of the risks of using a drug or biological product during pregnancy and lactation. The letter category system, first established in 1979, was regarded as overly simplistic and misinterpreted as a grading system. The PLLR labeling format was created to improve the presentation of available data on use of the drug during pregnancy and/or lactation. OBJECTIVE: To survey clinician awareness, assessment, and use of this new labeling format. METHODS: In January 2018, an online survey, developed in collaboration between the American Academy of Allergy, Asthma & Immunology and the FDA, was sent to a random sample of the US membership of the American Academy of Allergy, Asthma & Immunology. The survey content consisted of questions addressing the following: demographic characteristics, awareness and use of the PLLR, and value and understanding of the PLLR format on the basis of an example of the "Pregnancy" subsection of labeling. RESULTS: Of the 1500 members who received the survey via an email, 184 (12%) completed the survey. Respondents had a mean age of 56 years and treated on average 2 pregnant women per month. Less than half (46%) of the respondents were aware that the pregnancy letter category system was replaced with a narrative summary. After reading the example, most of the respondents (68%) did not feel that the narrative summary was concise. However, 71% of the respondents found the background risk and disease-associated risk information helpful. Most of the respondents (95%) continued to use the pregnancy letter category system to make prescribing decisions. CONCLUSIONS: These survey results suggest that the PLLR format was not known by most prescribers and that the pregnancy letter category format is continuing to be used despite significant flaws in the old system. However, the survey did not address why prescribers were continuing to rely on the pregnancy letter category system. Whether this is due to the PLLR format itself or the lack of quality data to inform the safe use of medications in pregnancy cannot be determined from these survey results. The FDA will use these survey results to refine the communication of pregnancy safety information in labeling and will expand outreach efforts to educate health care providers in the new labeling system.

Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort.

BACKGROUND: The Observational Study of the Use and Safety of Xolair (omalizumab) during Pregnancy (EXPECT) pregnancy registry was a prospective observational study established in 2006 to evaluate perinatal outcomes in pregnant women exposed to omalizumab and their infants. OBJECTIVE: This analysis compares EXPECT outcomes with those from a disease-matched population of pregnant women not treated with omalizumab. Data from a substudy of platelet counts among newborns are also presented. METHODS: The EXPECT study enrolled 250 women with asthma exposed to omalizumab during pregnancy. The disease-matched external comparator cohort of women with moderate-to-severe asthma (n = 1153), termed the Quebec External Comparator Cohort (QECC), was created by using data from health care databases in Quebec, Canada. Outcome estimates were age adjusted based on the maternal age distribution of the EXPECT study. RESULTS: Among singleton infants in the EXPECT study, the prevalence of major congenital anomalies was 8.1%, which was similar to the 8.9% seen in the QECC. In the EXPECT study 99.1% of pregnancies resulted in live births, which was similar to 99.3% in the QECC. Premature birth was identified in 15.0% of EXPECT infants and 11.3% in the QECC. Small for gestational age was identified in 9.7% of EXPECT infants and 15.8% in the QECC. CONCLUSION: There was no evidence of an increased risk of major congenital anomalies among pregnant women exposed to omalizumab compared with a disease-matched unexposed cohort. Given the observational nature of this registry, however, an absence of increased risk with omalizumab cannot be definitively established.

Clinical Updates in Women's Health Care Summary: Asthma.

Asthma is a common and potentially life-threatening lung disease. The prevalence of asthma is higher in women than in men. This monograph provides an overview of the pathophysiology, evaluation, and management of asthma in women. Management approaches in reproductive-aged, pregnant, and postmenopausal patients are addressed.

Management of Asthma during Pregnancy: Optimizing Outcomes and Minimizing Risk.

Pregnancy may be complicated by new onset or preexisting asthma. This article reviews diagnosis and management of asthma in the pregnant patient. Special attention is paid to the challenges in diagnosis and management of this condition during pregnancy. Asthma is one of the most common potentially serious medical problems to complicate pregnancy, and asthma may adversely affect both maternal quality of life and perinatal outcomes. Asthma may adversely affect both maternal quality of life and, perinatal outcomes. Pregnant asthmatics have been shown to be at an increased risk of adverse perinatal outcomes. Optimal management of asthma during pregnancy is thus important for both mother and baby. This article provides an update on the available literature regarding the safety of commonly used asthma medications during pregnancy.