Allergy And Asthma Proceedings[JOURNAL]
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200 papers
Diagnosis of ciprofloxacin hypersensitivity improves by incorporating MRGPRX2 in basophil activation test.
Yegit OO, Gelmez MY, Demir S … +7 more , Akdeniz N, Toprak ID, Karadag P, Can A, Unal D, Deniz G, Gelincik A
Allergy Asthma Proc · 2025 May · PMID 40380368 · Publisher ↗
Immediate hypersensitivity reactions (IHR) to ciprofloxacin can be caused by Mas-related G-protein coupled receptor X2 (MRGPRX2) as well as immunoglobulin E (IgE)-dependent mechanisms. When considering the complexity of...
Immediate hypersensitivity reactions (IHR) to ciprofloxacin can be caused by Mas-related G-protein coupled receptor X2 (MRGPRX2) as well as immunoglobulin E (IgE)-dependent mechanisms. When considering the complexity of the Patho mechanism, there are doubts with regard to the adequacy of conventional basophil activation test (BAT) in diagnosing fluoroquinolone-induced IHR. Our aim was to present a BAT method that relies on specifically evaluating the basophils expressing MRGPRX2 to increase the diagnosis rate of ciprofloxacin-induced MRGPRX2-mediated IHR. CD63 and MRGPRX2 expressions were analyzed with and without ciprofloxacin stimulation on basophils from patients and healthy controls by using flow cytometry. The net percentage of upregulation (net%) of MRGPRX2 and CD63 on basophils were statistically analyzed. Fourteen patients with confirmed IHR to ciprofloxacin and age- and gender-matched 12 healthy controls were analyzed. The median (interquartile range) age of the patients was 39.5 years (33.5-51.5 years) and 92.9% were women. The median (interquartile range) net% expression of CD63 on basophils, MRGPRX2 on basophils, and CD63 on MRGPRX2 basophils after ciprofloxacin stimulation was all higher in patients (18.1 [5.8-25.3], 3.7 [3.0-5.4], and 13.9 [7.8-28.8], respectively) compared with healthy controls (6.6 [3.8-11.4], 2.4 [0.6-3.7], and 1.3 [0.4-8.9], respectively) (p = 0.027, p = 0.042, and p = 0.001, respectively). Receiver operating characteristic analysis showed that the net% of CD63 expression on MRGPRX2 basophils had a greater area under the curve to predict ciprofloxacin IHR than did the net% of CD63 expression on basophils. A net% > 10.3% of CD63 expression on basophils showed a sensitivity of 71.4% and a specificity of 75.0%, whereas a net% > 3.9% of theCD63 expression on MRGPRX2 basophils showed a sensitivity of 100% and a specificity of 75.0%. The proposed method diagnosed four more patients compared with the conventional BAT. Analysis of our data indicated that the determination of MRGPRX2 together with CD63 in basophils improves the diagnosis of ciprofloxacin IHR with a better sensitivity compared with conventional BAT.
Angioedema without urticaria: Diagnosis and management.
Young MC, Banerji A
Allergy Asthma Proc · 2025 May · PMID 40380367 · Publisher ↗
Angioedema is nonpitting swelling that involves the deeper subcutaneous and submucosal layers of tissue. Angioedema can be classified as histaminergic, bradykinin mediated, or idiopathic in etiology. Bradykinin-mediated...
Angioedema is nonpitting swelling that involves the deeper subcutaneous and submucosal layers of tissue. Angioedema can be classified as histaminergic, bradykinin mediated, or idiopathic in etiology. Bradykinin-mediated angioedema presents without urticaria, whereas histaminergic angioedema is usually associated with urticaria (i.e., chronic spontaneous urticaria and angioedema) but manifests with isolated angioedema in ∼20% of patients and clinically overlaps with idiopathic angioedema. Bradykinin-mediated angioedema most commonly occurs in hereditary angioedema (HAE) with or without C1-esterase inhibitor (C1-INH) (HAE-C1INH) deficiency, acquired C1-INH deficiency, and angiotensin-converting enzyme (ACE) inhibitor angioedema. HAE is a life-threatening genetic autosomal dominant disorder most commonly due to a mutation in the serpin family G member 1 (SERPING1) gene, which leads to a deficiency in C1-INH, although multiple new genetic mutations have also been described in HAE with normal C1-INH (HAE-nl-C1INH) level. Clinically, patients have edema that can lead to life-threatening laryngeal edema and asphyxiation. HAE-nl-C1INH describes patients with similar symptoms to those with HAE-C1INH deficiency but have normal C1-INH function and are distinguished by various genetic mutations and a family history of angioedema. Acquired C1-INH deficiency also mimics HAE with symptoms but is due to circulating anti-idiotypic antibodies, leading to either C1-INH consumption or inactivation. Patients are often diagnosed with underlying malignant, lymphoproliferative, or autoimmune disorders. ACE-inhibitor angioedema classically presents with facial, tongue, and oral cavity swelling not associated with pruritus accompanied by normal laboratory studies. Treatment involves stopping the ACE inhibitor though recurrence can occur for a few weeks to months after discontinuation. Idiopathic angioedema is the largest category and is diagnosed when patients experience angioedema without an identifiable etiology with nl-C1INH function and no family history of angioedema. Idiopathic angioedema is further characterized into histaminergic or nonhistaminergic angioedema, depending on the response to high-dose antihistamines. Given the considerable impact of angioedema, physicians and patients must collaborate to craft personalized management strategies. For those with HAE, short- and long-term prophylaxis and on-demand therapy must be considered.
Selective immunoglobulin E deficiency and its association with autoimmune and autoinflammatory diseases.
Gerek ME, Colkesen F, Onalan T … +5 more , Akkus FA, Kilinc M, Evcen R, Kahraman S, Arslan S
Allergy Asthma Proc · 2025 May · PMID 40380366 · Publisher ↗
Selective immunoglobulin E deficiency (sIgED) is a rare condition characterized by low serum IgE levels with normal levels of other immunoglobulin classes. The prevalence of sIgED varies considerably across populations,...
Selective immunoglobulin E deficiency (sIgED) is a rare condition characterized by low serum IgE levels with normal levels of other immunoglobulin classes. The prevalence of sIgED varies considerably across populations, with a higher prevalence observed in clinical settings. Studies report sIgED prevalence that ranges up to 9.7% in patients attending rheumatology clinics, 8.1% in allergy/immunology clinics, and 2.6% in healthy blood donors. Its role in immune regulation and association with autoimmune and autoinflammatory disorders remains poorly understood. This study aimed to investigate the relationship between sIgED and immune-mediated diseases by hypothesizing that sIgED may predispose individuals to an increased prevalence of these conditions. This retrospective cohort study analyzed data from 3692 patients at a tertiary care center between November 2018 and December 2023. Patients with IgE levels ≤2.5 IU/mL and normal levels of other immunoglobulin classes were classified as having sIgED, whereas those with IgE levels >2.5 IU/mL served as controls. Autoimmune and autoinflammatory diseases were identified by using medical records and International Classification of Diseases codes. Statistical analyses were performed to compare the prevalence of these conditions between the groups. The prevalence of autoimmune and autoinflammatory diseases was significantly higher in the sIgED group versus controls (25.2% versus 15.6%; p < 0.001). Conditions such as Hashimoto thyroiditis, vitiligo, familial Mediterranean fever, and Behçet disease were disproportionately observed in patients with sIgED. Demographic characteristics, including age and gender, were not significantly different between the groups (p = 0.171 and p = 0.257, respectively). The sIgED is associated with a higher prevalence of autoimmune and autoinflammatory diseases, which underscores its potential role in immune dysregulation. This finding highlights the need for further prospective, multicenter studies to validate these associations, elucidate underlying mechanisms, and explore potential clinical implications of IgE deficiency in immune-mediated pathologies.
Evaluation of the frequency of allergic diseases in pediatric patients with juvenile idiopathic arthritis.
Yilmaz Topal O, Tekgoz N, Kaplan MM … +6 more , Yigit M, Metbulut AP, Celikel E, Kulhas Celik I, Celikel Acar B, Dibek Misirlioglu E
Allergy Asthma Proc · 2025 May · PMID 40380365 · Publisher ↗
Allergic diseases are characterized by a T-helper type 2 (Th2) dominant immune response, whereas juvenile idiopathic arthritis (JIA) is an autoimmune condition attributed to the Th1 pathway of CD4 T cells. Reciprocal inh...
Allergic diseases are characterized by a T-helper type 2 (Th2) dominant immune response, whereas juvenile idiopathic arthritis (JIA) is an autoimmune condition attributed to the Th1 pathway of CD4 T cells. Reciprocal inhibition between the Th1 and Th2 responses is proposed to result in mutual exclusion of their polarized immune responses and associated diseases. This study aimed to ascertain the frequency of allergic diseases among children with JIA. The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire was used to assess symptoms of allergic diseases in children with JIA and a control group of children with no known autoimmune diseases. The presence of current wheezing, allergic rhinitis and/or rhinoconjunctivitis symptoms, eczema symptoms, and food allergy symptoms were assessed based on affirmative answers. The ISAAC questionnaire was administered to 101 children with JIA and 99 healthy controls. The median (interquartile range [IQR]) age was 12.64 years (8.83-15.83 years) in the JIA group and 11.99 years (6.65-14.90 years) in the control group. Children with JIA had lower rates of current wheezing (p = 0.003), current allergic rhinitis (p < 0.001), current rhinoconjunctivitis (p = 0.006), current atopic dermatitis (p < 0.001), and current food allergy (p = 0.005) symptoms. In addition, ever having had allergic rhinitis, wheezing, and atopic dermatitis were less common in the JIA group. In the multivariate logistic regression model, the absence of autoimmune disease in the patient and the presence of any allergic disease in the mother emerged as independent risk factors for current wheezing symptoms and current rhinoconjunctivitis and/or rhinitis. The results of this study demonstrated that the frequency of allergic diseases was lower in the presence of JIA, an autoimmune disease. This offers further evidence of mutual opposition between diseases that involve the Th1 and Th2 pathways, but there remains no consensus on this matter. More comprehensive studies that delve into the molecular foundations of these diseases are still needed to reach more definitive conclusions.
Interaction between asthma and overweight/obesity on cancer results from the National Health and Nutrition Examination Survey 2005-2018.
Zhang W, Cao L, Sun J … +1 more , Zhang C
Allergy Asthma Proc · 2025 May · PMID 40380364 · Publisher ↗
Asthma, overweight/obesity, and cancer are closely related major public health problems. This study aimed to investigate the interaction between asthma and overweight/obesity on the cancer risk. We analyzed data from th...
Asthma, overweight/obesity, and cancer are closely related major public health problems. This study aimed to investigate the interaction between asthma and overweight/obesity on the cancer risk. We analyzed data from the National Health and Nutrition Examination Survey 2005-2018. Participants ages ≥ 20 years with information on asthma status, body mass index (BMI), and cancer diagnosis were included. Multivariate logistic regression models adjusted for relevant covariates were used to examine the associations among asthma, overweight/obesity, and cancer risk. In addition, we assessed the additive interaction between asthma and overweight/obesity on the cancer risk by using measures, including the relative excess risk due to interaction (RERI), attributable proportion of interaction (AP), and synergy index (S). In total, 26,320 participants met the inclusion criteria. Asthma was associated with an increased risk of cancer (odds ratio [OR] 1.37 [95% confidence interval {CI}, 1.17-1.59]), whereas overweight/obesity (BMI ≥ 25 kg/m²) was also significantly associated with an elevated cancer risk (OR 1.97 [95% CI, 1.32-2.94]). Notably, a significant interaction between asthma and overweight/obesity was observed in relation to the cancer risk (RERI 0.49 [95% CI, 0.02-0.96]; AP 0.20 [95% CI, 0.04, 0.37]; S 1.53 [95% CI, 1.01-2.32]). Our findings demonstrated a synergistic interaction between asthma and overweight/obesity on the cancer risk. The combined effect of asthma and overweight/obesity on the cancer risk exceeded the sum of their individual effects.
Garadacimab improves long-term health-related quality of life in patients with hereditary angioedema.
Guilarte M, Lumry WR, Magerl M … +8 more , Martinez Saguer I, Reshef A, Sobotkova M, Braverman J, Lawo JP, Wieman L, Nenci C, Katelaris CH
Allergy Asthma Proc · 2025 May · PMID 40380363 · Publisher ↗
Hereditary angioedema (HAE) attacks substantially impair health-related quality of life (HRQoL). Current World Allergy Organization and the European Academy of Allergy and Clinical Immunology guidelines goals include com...
Hereditary angioedema (HAE) attacks substantially impair health-related quality of life (HRQoL). Current World Allergy Organization and the European Academy of Allergy and Clinical Immunology guidelines goals include complete control and normalization of patients' lives. Garadacimab (anti-activated factor XII monoclonal antibody) reduced the mean attack rate after first administration in the pivotal phase III (VANGUARD; NCT04656418) and ongoing long-term phase III open-label extension (OLE) (NCT04739059) studies. To report exploratory HRQoL data from the interim analysis of the phase III OLE study (data cutoff February 13, 2023). Patients ages ≥12 years and with HAE received garadacimab 200 mg subcutaneously once monthly in the OLE study. The patient population comprised patients who were garadacimab naive (received placebo in the previous phase III study and newly enrolled patients) and patients who received garadacimab in previous phase II/III studies. The Angioedema Quality of Life (AE-QoL) questionnaire, Treatment Satisfaction Questionnaire for Medication version II (TSQM II), and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire were administered at baseline and every 3 months during the OLE study. AE-QoL and TSQM II scores were evaluated in comparison with minimal clinically important differences (MCID). Overall, 90 patients who were garadacimab naive and 71 patients with previous garadacimab exposure received garadacimab in the phase III OLE study. The mean ± standard deviation AE-QoL total score improved by 34.2 ± 18.8 points in patients who were garadacimab naive and by 2.3 ± 13.1 points further to the reduction experienced in patients with previous garadacimab exposure. The AE-QoL MCID was met by 92.1% of patients who were garadacimab naive; 81.6% of patients with previous garadacimab exposure experienced stable AE-QoL scores or further improvements per MCID. TSQM II scores were improved from day 1 with garadacimab and sustained to month 12. Improvements in WPAI:GH scores were consistent with AE-QoL and TSQM II. Garadacimab elicited clinically meaningful long-term improvements in HRQoL, work productivity, and treatment satisfaction in patients with HAE, which brought them closer to complete disease control and normalization of life.Clinical trial NCT04739059, <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">clinicaltrials.gov</ext-link>.
Single-bag rapid drug desensitization for chemotherapeutic hypersensitivity reactions: A single-center experience.
Gul O, Bayrak Durmaz MS, Yıldız R … +4 more , Aytekin F, Beyhan N, Efe O, Bavbek S
Allergy Asthma Proc · 2025 May · PMID 40380362 · Publisher ↗
Rapid drug desensitization (RDD) is a procedure that provides temporary tolerance to chemotherapeutics for appropriate patients who experience hypersensitivity reactions (HSR), which allow them to continue their treatmen...
Rapid drug desensitization (RDD) is a procedure that provides temporary tolerance to chemotherapeutics for appropriate patients who experience hypersensitivity reactions (HSR), which allow them to continue their treatments. Due to the labor-intensive and time-consuming nature of the commonly used multiple-bag RDD procedure, there is a need to develop an alternative protocol. We aimed to share our experiences with single-bag RDD in patients experiencing HSRs with chemotherapeutics. The study was conducted by retrospectively reviewing the files of patients who experienced immediate-type HSRs to chemotherapeutics and underwent single-bag RDD. The severity of HSRs was classified according to the Brown grading system. Prick and/or intradermal skin tests were performed with the relevant agents. The protocols were applied as a single-bag, 12-step process. The study comprised 46 patients (women/men, 35/11; mean ± standard deviation age, 55.9 ± 11.9 years; 27 HSRs to platinums; 16 HSRs to taxanes; and 3 HSRs to biologic agents). Nine patients (19.6%) had an initial HSR of grade 1, 26 patients (56.5%) had an initial HSR of grade 2, and 11 patients (23.9%) had an initial HSR of grade 3. The skin testing result with the responsible drug was positive in 15 of 42 (35.7%), and the rate of positive responses in patients with grade 1, 2, and 3 initial HSRs was 37.5%, 33.3%, and 40%, respectively. A total of 163 single-bag RDDs procedures were performed, and 17 breakthrough reactions (BTR) occurred during the procedure (five of these reactions [29.5%] were grade 1; nine [53.9%] were grade 2; three [17.6%] were grade 3). Of these BTRs, 16 occurred with platinums and one with rituximab; no BTRs were observed with taxanes. In conclusion, 99.3% of the total 163 single-bag RDD procedures were successfully completed. Our experience indicates that single-bag RDD can be a safe and effective alternative that saves time and labor in appropriate patients.
Value-based care in allergy-immunology: Beyond the quality-adjusted life year.
Sanders J, Greenhawt M, Oppenheimer J … +2 more , Anagnostou A, Shaker MS
Allergy Asthma Proc · 2025 May · PMID 40380361 · Publisher ↗
Value-based health care in the field of allergy/immunology must be informed by multiple factors, including costs (direct and indirect), outcomes, and the patient experience. We review features that define value-based he...
Value-based health care in the field of allergy/immunology must be informed by multiple factors, including costs (direct and indirect), outcomes, and the patient experience. We review features that define value-based health care and discuss a perspective that considers cost-effective care beyond the quality-adjusted life year (QALY). A narrative review and synthesis of the literature was leveraged to advance an understanding of health-care delivery that considers shared decision-making, health-economic outcomes, and the patient experience. The patient and family experience of health and wellness must be considered carefully when interpreting health-economic evaluations. Health-state utilities consider trade-offs for wellness under conditions of risk and are used to inform QALYs for a myriad of disease states. Cost-effectiveness of medical therapies relates to trade-offs that are considered for populations, but these metrics can be translated holistically to inform health-care decisions for patients if considered contextually. In the case of food allergy, omalizumab would likely not be cost-effective on an individual level (incremental cost-effectiveness ratio, $573,698/QALY), but for those individuals with a high utility impairment, or, if considered from the perspective of a family unit, may be a more attractive therapy from a health-economic point of view. The balance between health and disease is such that there is always more disease than can be treated at any given moment, and both money and time can only be spent once. Because choice is inevitable, health-economic analysis can help inform clinical care. Still, translating population-level cost-effectiveness to individuals is challenging and decisions must be tailored to each patient and context.
Early-life risk factors for recurrent wheezing in preschool children: A meta-analysis of 15 cohort studies.
Zheng K, Wang X
Allergy Asthma Proc · 2025 May · PMID 40380360 · Publisher ↗
Recurrent wheezing (RW) is particularly prevalent in preschool-age children and is strongly associated with the future development of asthma. Because no meta-analysis of risk factors for RW comprehensively assess is nee...
Recurrent wheezing (RW) is particularly prevalent in preschool-age children and is strongly associated with the future development of asthma. Because no meta-analysis of risk factors for RW comprehensively assess is needful. The research was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search of English-language studies was performed across four medical literature data bases. Subgroup analyses, sensitivity analyses, and evaluations of publication bias were carried out. Multiple cohort studies were included. Stata software and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) were used for data analysis; risk factors associated with positive results were discussed qualitatively. A total of 15 cohort studies that covered 128,065 children were included. Some risk factors, including allergic rhinitis (odds ratio [OR] 4.16 [95% confidence interval {CI}, 1.06-16.33]), family history of asthma (OR 2.14 [95% CI, 1.24-3.69]), food allergy (OR 2.25 [95% CI, 1.73-2.93]), preterm (OR 1.87 [95% CI, 1.36-2.58]), male (OR 1.47 [95% CI, 1.17-1.84]), cesarean section (OR 1.36 [95% CI, 1.08-1.71]), environmental tobacco smoke (OR 2.15 [95% CI, 1.55-2.99]), got positive results. Risk factors for RW in preschool children were sought. This meta-analysis provides a new perspective theoretical basis for preventing childhood asthma.
Evaluation of direct oral provocation test results in mild cutaneous reactions to cephalosporins in children.
Kuzucu FN, Genis C, Selmanoglu A … +3 more , Ipek Demir K, Sengul Emeksiz Z, Dibek Misirlioglu E
Allergy Asthma Proc · 2025 May · PMID 40380359 · Publisher ↗
Cephalosporins are beta-lactam antibiotics commonly used in children and are the second most common cause of drug hypersensitivity reactions after penicillins. Antibiotic allergy is diagnosed by tests such as prick and i...
Cephalosporins are beta-lactam antibiotics commonly used in children and are the second most common cause of drug hypersensitivity reactions after penicillins. Antibiotic allergy is diagnosed by tests such as prick and intradermal skin tests and the drug provocation test (DPT). Skin tests can be challenging for both patients and clinicians. In appropriate cases, omitting these tests in favour of direct DPT may help to avoid diagnostic delays. Our study aimed to evaluate the results of direct DPT in children with a history of mild cutaneous reactions to cephalosporins. Between 2019 and 2024, pediatric patients with a documented history of mild cutaneous reactions to cephalosporins who underwent direct DPT without prior prick or intradermal skin testing were included in this study conducted at our clinic. Patients with systemic manifestations beyond cutaneous reactions at the time of the index reaction were excluded from the study. The study included 128 patients who underwent direct DPT with cephalosporins. The most commonly suspected drugs were cefixime (45.3%), cefdinir (25.8%) and cefuroxime (18%). While 96.1% did not react, cephalosporin allergy was confirmed in 3.9% but all reactions were limited to skin involvement and none more severe than the index reaction. In our study, direct DPT ruled out suspected allergy in 96.1% of patients with a history of mild skin reactions to cephalosporins. In conclusion, direct oral DPT was found to be a safe and feasible approach for patients with isolated mild skin reactions, effectively bypassing the need for skin testing.
From burden to breakthrough: Advances in hereditary angioedema, drug allergy, and allergic disease prevention.
Bellanti JA, Settipane RA
Allergy Asthma Proc · 2025 May · PMID 40380358 · Full text
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Risk factors predisposing children to transient hypogammaglobulinemia of infancy.
Celiksoy MH, Yildirim I, Yirgin K … +1 more , Haziroglu Okmen Z
Allergy Asthma Proc · 2025 May · PMID 40380357 · Publisher ↗
Transient hypogammaglobulinemia of infancy (THI) is a heterogeneous disorder characterized by reduced serum immunoglobulin G (IgG) levels in early infancy. This study aimed to identify potential risk factors associated...
Transient hypogammaglobulinemia of infancy (THI) is a heterogeneous disorder characterized by reduced serum immunoglobulin G (IgG) levels in early infancy. This study aimed to identify potential risk factors associated with THI. Children with THI and normoglobulinemic healthy children were compared by using a questionnaire that addressed possible risk factors. In total, 108 participants were enrolled, 54 patients with THI and 54 healthy controls. The median age at diagnosis of the patients with THI was 17 months (range, 4-38 months), and 40 (74.1%) were boys. In the control group, the median age was 22 months (range, 16-61 months), and 27 (50.0%) were boys. Male sex (p = 0.004), cesarean section birth (p = 0.003), low maternal education (p = 0.001), low paternal education (p = 0.004), analgesic use during pregnancy (p = 0.001), antibiotic use during pregnancy (p = 0.001), multivitamin use during pregnancy (p = 0.001), gestational diabetes or preeclampsia (p = 0.039), smoking exposure (p = 0.001), atopic disease (p = 0.001), and familial atopy (p = 0.001) were associated with THI, whereas low socioeconomic level (p = 0.001) and breast-feeding for > 6 months (p = 0.032) were less likely in the THI group. There are several features of pregnancy history and family demographics that are associated with THI.
Becoming attack-free further improves health-related quality of life in patients with hereditary angioedema receiving garadacimab.
Staubach P, Craig TJ, Fukuda T … +8 more , Aygoren-Pursun E, Hakl R, Braverman J, Lawo JP, Pollen M, Nenci C, Li PH, Farkas H
Allergy Asthma Proc · 2025 May · PMID 40380356 · Publisher ↗
Hereditary angioedema (HAE) is associated with substantial health-related quality of life (HRQoL) impairments. Complete disease control and life normalization are key treatment goals. In previous studies, garadacimab pre...
Hereditary angioedema (HAE) is associated with substantial health-related quality of life (HRQoL) impairments. Complete disease control and life normalization are key treatment goals. In previous studies, garadacimab prevented HAE attacks with a favorable safety profile and HRQoL improvements. HRQoL was evaluated in patients with HAE receiving garadacimab stratified by attack-free status. In the pivotal phase III study (NCT04656418), 39 patients received garadacimab 200 mg subcutaneously once monthly and 25 volume-matched placebo. In the phase III open-label extension (OLE), 90 patients in the garadacimab-naive group (received placebo in previous studies or newly enrolled) and 71 patients in the previous garadacimab exposure group (received garadacimab in previous studies) received garadacimab (NCT04739059). Patients ages ≥ 18 years completed the Angioedema Quality of Life (AE-QoL) questionnaire in both studies; scores were evaluated post hoc by attack-free status. In the pivotal phase III and phase III OLE studies, 62% and 60% of patients, respectively, were attack-free. In the pivotal phase III study, the mean AE-QoL total score improved with garadacimab, from 38.8 (day 1) to 6.6 (month 6) for attack-free patients (n = 19) and to 18.4 for patients with one or more attacks (n = 14) versus a change in mean AE-QoL total score from 43.7 to 40.5 with placebo (n = 20). In the phase III OLE study, the mean AE-QoL total score for patients who were garadacimab naive decreased from 46.2 (day 1) to 8.6 (month 12) for attack-free patients (n = 34) and from 54.5 to 23.5 for patients with one or more attacks (n = 30). For the previous garadacimab exposure group, AE-QoL improvements were maintained from previous studies, regardless of attack-free status. Garadacimab was associated with HRQoL improvement versus run-in in all groups. After garadacimab exposure in previous studies, improvements were maintained in the phase III OLE study. Attack-free patients had the greatest HRQoL improvements, bringing them closer to complete disease control and life normalization.Clinical trials NCT04656418, NCT04739059, <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>.
Antibiotic allergy in children: Can the severity and characteristics of the index reaction predict drug provocation test results?
Genis C, Kuzucu FN, Selmanoglu A … +3 more , Ipek Demir K, Sengul Emeksiz Z, Dibek Misirlioglu E
Allergy Asthma Proc · 2025 May · PMID 40380355 · Publisher ↗
Antibiotic allergy in children is often misdiagnosed. The criterion standard for confirming drug allergy is the drug provocation test (DPT) based on the patient's history and clinical findings. This study aimed to asses...
Antibiotic allergy in children is often misdiagnosed. The criterion standard for confirming drug allergy is the drug provocation test (DPT) based on the patient's history and clinical findings. This study aimed to assess whether the characteristics and the severity grades of the index reaction can accurately predict DPT outcomes in children with suspected antibiotic allergy. A retrospective study was conducted from 2014 to 2024, which included children with immediate-type index and provocation reactions. Data included age, type, duration, severity grades of reactions, and suspected antibiotic. Reactions were graded by using the Brown scoring system. Statistical analyses included the Spearman correlation and kappa coefficient. Seventy-three children with negative skin test results underwent DPT in this study. Urticaria was the most common reaction, which occurred in 46.6% of index and 57.5% of provocation reactions. Brown's grading showed 64 grade 1, 5 grade 2, 3 grade 3, and 1 ungraded index reactions. The Brown grading showed 64 grade 1, 5 grade 2, and 3 grade 3 reactions, and 1 ungraded index reaction. For provocation, 64 grade 1, 6 grade 2, 1 grade 3, and 2 were ungraded. There was moderate agreement between the index and provocation reaction types (kappa = 0.348; p < 0.001). A significant agreement was found between urticaria in the index reaction and anaphylaxis during the DPT (kappa = 0.173; p = 0.009). Moderate agreement was also observed for index and provocation anaphylaxis (kappa = 0.480; p < 0.001). In addition, a positive correlation was noted between the severity of the index and provocation reactions (Spearman = 0.460; p < 0.001). The severity and characteristics of index reactions provide valuable insight into the outcome of DPT. The Brown grading system is a valuable tool for predicting DPT outcomes, including severe reactions. Urticaria and anaphylaxis during the index reaction may be predictors of severe outcomes in DPT and should be closely monitored. Understanding the characteristics and severity of the index reaction and incorporating them into clinical practice may facilitate the prediction of DPT outcomes, guide clinical decision-making, improve diagnostic accuracy, and enhance patient safety.
Cost-effectiveness of school integrated pest management and air filtration in students with asthma.
Socolovsky C, Louisias M, Alsulami S … +19 more , Petty CR, Trivedi M, Lai PS, Cunningham A, Gaffin J, Thorne P, Coull B, Koutrakis P, Baccarelli A, Gold DR, Adamkiewicz G, Permaul P, Banzon T, Hauptman M, Bartnikas LM, Baxi S, Sheehan WJ, Phipatanakul W, Samnaliev M
Allergy Asthma Proc · 2025 May · PMID 40380354 · Full text
The cost-effectiveness of school environmental remediation in asthma is not known. The School Inner City Asthma Intervention Study (SICAS2) was a randomized controlled trial that assessed school integrated pest managemen...
The cost-effectiveness of school environmental remediation in asthma is not known. The School Inner City Asthma Intervention Study (SICAS2) was a randomized controlled trial that assessed school integrated pest management (IPM) and classroom high efficiency particulate air (HEPA) filtration on asthma morbidity in urban schools. The objective was to evaluate the cost-effectiveness of SICAS2. We conducted a cost-effectiveness analysis from a societal perspective that compared four interventions: IPM, HEPA, IPM + HEPA, and no intervention. Quality-adjusted life years (QALY) were derived from the EuroQol-5 Dimension-Youth and EuroQol-5 Dimension-3 levels instruments. Total costs (2021 U.S. dollars) included intervention cost, cost of caregiver productivity impacted by child school absenteeism, and health-care utilization costs (e.g., emergency department visits). The evaluation period was based on a mean follow-up time of 166 days. Sensitivity analyses were performed by using cost estimates 50% above and below initial cost benchmarks. A total of 154 SICAS2 participants were included. Intervention costs per student were $12.21 (IPM + HEPA), $7.27 (IPM), and $4.94 (HEPA). Sequential analyses revealed that IPM + HEPA was the most cost-effective option, with an incremental cost-effectiveness ratio of $19,667 per QALY. Sensitivity analyses demonstrated stability, with variability in probability estimates not exceeding 10%. IPM + HEPA demonstrated good value to society, which reflected the low cost and the economic impact of missed school days. This intervention may have a pronounced benefit for historically minoritized and marginalized children in urban schools who are disproportionately exposed to air pollution and indoor allergens. The SICAS2 intervention may offer a cost-effective tool to target proximal causes of disparities even in the most resource-limited schools.
Adherence and persistence among patients with hereditary angioedema receiving long-term prophylaxis in the United States.
Zuraw BL, Lopez-Gonzalez L, Manjelievskaia J … +7 more , Winer I, Dean A, Wall S, Nelson J, Nestler-Parr S, Gillard P, Christiansen SC
Allergy Asthma Proc · 2025 May · PMID 40300843 · Publisher ↗
Real-world evidence that compares the treatment patterns of targeted long-term prophylaxis (LTP) for hereditary angioedema (HAE), including berotralstat, lanadelumab, and subcutaneous (SC) plasma-derived C1 inhibitor (pd...
Real-world evidence that compares the treatment patterns of targeted long-term prophylaxis (LTP) for hereditary angioedema (HAE), including berotralstat, lanadelumab, and subcutaneous (SC) plasma-derived C1 inhibitor (pdC1-INH) is limited. The study aimed to assess adherence and persistence after initiation of berotralstat, lanadelumab, or SC-pdC1-INH. Electronic health records linked to claims data was used to select patients ages ≥ 12 years, initiating one of three LTPs between June 22, 2017, and September 12, 2023, with mutually exclusive cohorts assigned hierarchically in reverse order of their U.S. Food and Drug Administration approval date. Patients were required to have ≥ 12 months of continuous enrollment before and after the LTP initiation date. Demographics and baseline clinical characteristics were captured. Primary study measures were adherence, defined as the mean proportion of days covered (PDC), and persistence, defined as having no gap in treatment ≥ 45 days after the LTP initiation date. A subgroup analysis was conducted among patients with two or more claims for their index LTP. A sensitivity analysis was performed by reassigning cohorts based on the first claim for qualifying LTP after June 22, 2017. The main analysis included 357 patients (90 on berotralstat, 189 lanadelumab, and 78 SC-pdC1-INH). Overall, 46% to 51% of the patients had LTP experience. Adherence (mean PDC) was similar between treatments at 0.73, 0.78, and 0.74 for berotralstat, lanadelumab, and SC-pdC1-INH, respectively. Proportions of patients persistent on index LTP after 12 months were similar across LTPs: 61%, 58%, and 53% for berotralstat, lanadelumab, and SC-pdC1-INH, respectively. The findings of the subgroup and sensitivity analyses supported the main analysis. Adherence and persistence rates for all three LTP treatments were uniformly high. Berotralstat adherence and persistence were comparable with those observed after lanadelumab or SC-pdC1-INH initiation in the main analysis, among patients with two or more claims for their index LTP, and among cohorts assigned based on the first claim for qualifying LTP.
Analyzing social media conversations to gain insights into the experiences of patients with hereditary angioedema.
Braverman J, Ellis D, Gavata-Steiger S … +3 more , Dhas AB, Muthu R, Ataher QS
Allergy Asthma Proc · 2025 May · PMID 40295108 · Publisher ↗
Hereditary angioedema (HAE) is a rare genetic disease characterized by recurrent, unpredictable, painful, and potentially life-threatening angioedema attacks, which substantially impair patients' quality of life. Gatheri...
Hereditary angioedema (HAE) is a rare genetic disease characterized by recurrent, unpredictable, painful, and potentially life-threatening angioedema attacks, which substantially impair patients' quality of life. Gathering patients' perspectives is important to understand lived experiences, the patient journey, and preferences to determine optimal HAE management. Social media platforms have become important mediums through which patient and carer groups share experiences and advice. We conducted the first social media listening (SML) study in an HAE setting to identify and characterize the experiences of patients with HAE to better understand disease and treatment burden and their unmet needs. This was a retrospective analysis of social media content that relates to the experience of individuals with HAE from January 2018 to October 2023. We used keyword-based searches of social media platforms to identify posts that relate to burdens, unmet needs, and other themes shared by patients, caregivers, or health-care professionals. After anonymization and removal of duplicates, content was extracted and categorized by subject matter experts for qualitative and quantitative analysis according to themes. Of 6,012 posts collected, 892 were identified as relevant patient-mentioned posts. Of these, 459 posts related to burden; the most common topic was disease burden and discussed symptoms such as persistent swelling, painful attacks, and frequent attacks. Other burden-related topics included health service, medication, and injections. Unmet needs were discussed in 270 posts; the most common were treatment-related needs such as insurance denials, inadequate medication availability, and treatment costs. Other unmet needs related to education, health service, and diagnosis. Evaluation of the lived experience of patients with HAE and their caregivers SML can be a valuable tool to aid optimizing HAE management. Our findings add to existing evidence that the disease burden is still a considerable issue for patients with HAE, who continue to have unmet treatment needs.
Dose-response studies of methylated and nonmethylated CpG ODNs from longum subsp. for optimizing Treg cell stimulation.
Li D, Cruz I, Sorkhabi S … +3 more , Foley PL, Wagner J, Bellanti JA
Allergy Asthma Proc · 2025 Mar · PMID 40011992 · Publisher ↗
Allergen immunotherapy (AIT) is the most effective treatment for atopic allergic diseases, aiming to induce regulatory T cells (Treg) that modify the immune response to specific allergens, which leads to long-term tolera...
Allergen immunotherapy (AIT) is the most effective treatment for atopic allergic diseases, aiming to induce regulatory T cells (Treg) that modify the immune response to specific allergens, which leads to long-term tolerance and reduced symptoms. Enhancing Treg activity is crucial for improving immunotherapy outcomes. In a previous murine model study, we examined the effects of a synthetic methylated DNA oligodeoxynucleotide (ODN) from the Bl-T2 m5C motif of subsp. . The ODN that contains the methylated BI-T2 m5C motif (methylated ODNA) sequence conjugated with ovalbumin induced Treg production, whereas ODN that contains the unmethylated BI-T2 m5C motif (unmethylated ODNB) induced proinflammatory responses, which demonstrated the potential of methylated ODNs for AIT. In building on these results, this study explored the effects of methylated and nonmethylated DNA motifs from subsp. on inflammation and Treg induction, while investigating the dose-response relationships of methylated Cytosine-phosphate-Guanine (CpG) ODNs for optimal Treg stimulation in clinical applications. Serum levels of IL-17A, IL-4, IL-10, and transforming growth factor beta (TGF-β) were measured by enzyme linked immunosorbent assay (ELISA), and flow cytometry assessed splenic Treg populations in BALB/c mice receiving graded doses of methylated or unmethylated ODNs. Mice were immunized intraperitoneally with a single 100-μg dose (plan A) or multiple 25 μg (plan B) or 100 μg (plan C) doses. Calf thymic DNA served as a positive control, with phosphate-buffered saline solution and alum as negative controls. Methylated ODNs significantly increased CD25FOXP3 Tregs compared with unmethylated ODNs and controls. Plan A (100 μg) elevated serum IL-10, which indicated effective Treg induction, whereas plan B (four 25 μg doses) did not activate Tregs. Plan C (multiple 100 μg doses) reduced Treg responses, which highlighted a critical dosing threshold for optimal Treg induction. This study demonstrated the potential of methylated DNA motifs as therapeutic agents in AIT. The dose-response relationships of methylated CpG ODNs from pave the way for clinical applications that target Treg activity in allergic diseases.
Efficacy of anti-interleukin 5 therapy in hypereosinophilic syndrome: An updated systematic review and meta-analysis.
Masood S, Paracha MR, Ahmed S … +8 more , Malik M, Khalid AR, Khalid MH, Fatima L, Nasir BM, Rahman SU, Khan K, Ahmad F
Allergy Asthma Proc · 2025 Mar · PMID 40011991 · Publisher ↗
Hypereosinophilic syndromes (HES) are marked by persistent eosinophilia, absence of a primary cause, and evidence of eosinophil-mediated organ damage. HES presents a spectrum of clinical manifestations, with prognosis an...
Hypereosinophilic syndromes (HES) are marked by persistent eosinophilia, absence of a primary cause, and evidence of eosinophil-mediated organ damage. HES presents a spectrum of clinical manifestations, with prognosis and treatment varying based on the subtype, including myeloid/lymphoid neoplasms and chronic eosinophilic leukemia, not otherwise specified. The primary treatment goal is to reduce eosinophil levels to prevent organ damage, typically by using glucocorticoids and immunosuppressive agents. However, these treatments often have limited efficacy and considerable adverse effects. Given the central role of interleukin (IL) 5 in eosinophil development and survival, this study aimed to assess the efficacy and safety of anti-IL-5 therapies in patients with HES. A systematic literature search was conducted on two data bases. The primary outcome was the reduction in absolute eosinophil count, and secondary outcomes included the incidence of flares and adverse events. Data Analysis was conducted, and forest plots were made for each outcome. Four trials were included in the analysis. Ninety-five percent of the patients in the anti-IL-5 group showed a reduction in the absolute eosinophil count compared with 41% in the placebo group (risk ratio [RR] 2.32 [95% confidence interval {CI}, 1.67-3.22]; p = <0.00001; tau statistic (I²) = 0%). Anti-IL-5 therapy was associated with a lower incidence of disease flares, with 15% of the patients in the anti-IL-5 group who experienced flares compared with 30% in the placebo group (RR 0.50 [95% CI, 0.31-0.86]; p = 0.01; I² = 0%). The incidence of adverse events was similar between the two groups (RR 0.99 [95% CI, 0.91-1.07]; p = 0.81; I² = 0%). Anti-IL-5 therapies are effective in reducing eosinophil count and preventing disease flares in patients with HES.
Early clinical improvement of anosmia and sinus nitric oxide in chronic rhinosinusitis with nasal polyps subjects treated with dupilumab.
Lanz MJ, Eisenlohr CP, Cepeda LH
Allergy Asthma Proc · 2025 Mar · PMID 40011990 · Publisher ↗
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) have a high morbidity of anosmia, yet there are few noninvasive biomarkers to measure treatment response. Nitric oxide (NO) is found in the paranasal sinuse...
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) have a high morbidity of anosmia, yet there are few noninvasive biomarkers to measure treatment response. Nitric oxide (NO) is found in the paranasal sinuses at 100 times higher levels than in the lungs and is vital for antimicrobial and/or mucociliary activities and vasodilatory properties. Dupilumab has been shown to improve anosmia in 2 weeks as measured by the University of Pennsylvania Smell Identification Test (UPSIT), 22-item Sinonasal Outcome Test (SNOT-22), and Loss of Smell (LoS) scoring. We examined the use of NO in various collection methods to monitor anosmia improvement with dupilumab treatment. Adults with CRSwNP confirmed by computer tomography or endoscopy consented to receive dupilumab 300 mg every two weeks for 16 weeks. Subjects with polyposis despite treatment with steroids and/or a history of sinus surgery were recruited. Measurements of sinus NO (sNO) from the nostril while humming, nasal NO (nNO) while breath-holding, and fractional exhaled nitric oxide (FeNO) while exhaling were collected at baseline and at 1, 2, 4, 8, 12, 16 weeks. Olfactory impairment was measured by using the UPSIT, SNOT-22, and LoS scoring at every visit. Sixteen adults, with a mean (range) age of 43 years (25-53 years) were predominantly women (12/16). Baseline mean (range) sNO values of 434 ppb (203-665 ppb) significantly increased at 2 weeks to a mean (range) of 1150 ppb (684-1616 ppb) (p < 0.05). Significant improvements in the UPSIT, SNOT-22, and LoS scores were found at 2 weeks; a weak correlation of the sNO level with the UPSIT and SNOT-22 scores was noted. No significant changes in the FeNO or nNO values were found. Significant improvement was found specifically with anosmia by the end of 2 weeks. Our small pilot study revealed increased sNO levels in the sinuses as early as 2 weeks after the initial dupilumab administration. Thus, in patients with CRSwNP without asthma, the sNO value has the potential to be used as a noninvasive, objective biomarker for early treatment improvement in anosmia.
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