Background: Omalizumab has been a valuable option for patients with severe asthma, with increasing data with regard to the effectiveness of omalizumab in patients with allergic bronchopulmonary aspergillosis (ABPA). Objective: The objective was to evaluate the long-term clinical and functional effectiveness of omalizumab in patients with ABPA. Methods: Patients who received omalizumab for ABPA in our clinic between December 2008 and September 2023 were retrospectively evaluated. Data were assessed before the initiation of omalizumab, at the first year of treatment, and at the last visits of the patients. Patients with Asthma Control Test (ACT) scores of ≥20, no hospitalization/emergency admissions due to asthma, a reduced daily oral corticosteroid (OCS) dose, and an increase in forced expiratory volume in 1 second (FEV1) level were considered as complete responders. Results: A total of 22 patients (no. men/women: 11/11) with ABPA and with a mean age of 53 ± 14.94 years (minimum 27 years, maximum 77 years) were included in the study. Significant increases were observed in FEV1 measured at the first year and last visit compared with pretreatment (p = 0.007). In patients who received a mean ± standard deviation (SD) of 12.73 ± 8.87 mg of methylprednisolone before treatment, the OCS dose decreased to a mean ± SD of 2.45 ± 3.08 mg of methylprednisolone in the first year and a mean ± SD of 0.36 ± 1 mg of methylprednisolone at the last visit (p < 0.001). Of 22 patients, 21 were treated with OCS, whereas 1 patient refused to use OCS due to corticophobia. The mean ± SD ACT score was 17.50 ± 4.77 (minimum 7, maximum 24) at baseline, increased to 22.23 ± 2.44 (minimum 18, maximum 25) at the first year (p < 0.001), and 23.73 ± 1.88 (minimum 19, maximum 25) at the last visit. A significant decrease in asthma attacks and hospitalizations at the first year and last visit after omalizumab treatment was observed (p < 0.001). Nineteen patients (86.3%) responded completely, and three (13.7%) responded partially to omalizumab treatment. Conclusion: Omalizumab treatment in patients with ABPA resulted in a significant reduction in asthma attacks, hospitalizations, and OCS doses, and in significant increases in FEV1 and ACT scores.
{"title":"Long-term omalizumab treatment outcomes in patients with allergic bronchopulmonary aspergillosis.","authors":"Fuat Aytekin, Orhun Efe, Nazan Beyhan, Erman Gidik, Ozcan Gul, Bekir Tunca, Zeynep Celebi Sozener, Betul Ayse Sin, Vesile Dilsad Mungan, Sevim Bavbek, Omur Aydin","doi":"10.2500/aap.2025.46.250012","DOIUrl":"10.2500/aap.2025.46.250012","url":null,"abstract":"<p><p><b>Background:</b> Omalizumab has been a valuable option for patients with severe asthma, with increasing data with regard to the effectiveness of omalizumab in patients with allergic bronchopulmonary aspergillosis (ABPA). <b>Objective:</b> The objective was to evaluate the long-term clinical and functional effectiveness of omalizumab in patients with ABPA. <b>Methods:</b> Patients who received omalizumab for ABPA in our clinic between December 2008 and September 2023 were retrospectively evaluated. Data were assessed before the initiation of omalizumab, at the first year of treatment, and at the last visits of the patients. Patients with Asthma Control Test (ACT) scores of ≥20, no hospitalization/emergency admissions due to asthma, a reduced daily oral corticosteroid (OCS) dose, and an increase in forced expiratory volume in 1 second (FEV<sub>1</sub>) level were considered as complete responders. <b>Results:</b> A total of 22 patients (no. men/women: 11/11) with ABPA and with a mean age of 53 ± 14.94 years (minimum 27 years, maximum 77 years) were included in the study. Significant increases were observed in FEV<sub>1</sub> measured at the first year and last visit compared with pretreatment (p = 0.007). In patients who received a mean ± standard deviation (SD) of 12.73 ± 8.87 mg of methylprednisolone before treatment, the OCS dose decreased to a mean ± SD of 2.45 ± 3.08 mg of methylprednisolone in the first year and a mean ± SD of 0.36 ± 1 mg of methylprednisolone at the last visit (p < 0.001). Of 22 patients, 21 were treated with OCS, whereas 1 patient refused to use OCS due to corticophobia. The mean ± SD ACT score was 17.50 ± 4.77 (minimum 7, maximum 24) at baseline, increased to 22.23 ± 2.44 (minimum 18, maximum 25) at the first year (p < 0.001), and 23.73 ± 1.88 (minimum 19, maximum 25) at the last visit. A significant decrease in asthma attacks and hospitalizations at the first year and last visit after omalizumab treatment was observed (p < 0.001). Nineteen patients (86.3%) responded completely, and three (13.7%) responded partially to omalizumab treatment. <b>Conclusion:</b> Omalizumab treatment in patients with ABPA resulted in a significant reduction in asthma attacks, hospitalizations, and OCS doses, and in significant increases in FEV<sub>1</sub> and ACT scores.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 4","pages":"280-286"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144582861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.2500/aap.2025.46.250037
C Dustin Waters, Abbey Cruzan, Robert Silge
Background: Patients with penicillin allergy have been shown to have suboptimal antibiotics prescribed for infections as well as an increased risk of adverse effects. However, it is currently unknown at what rate patients with penicillin allergy are prescribed antibiotics after hospitalization. Objective: The purpose of this study was to determine the rate at which patients with penicillin allergy are prescribed antibiotics after hospitalization and if this rate differs from that of patients without penicillin allergy. Methods: This was a retrospective case-control study that evaluated subsequent courses of antibiotics after hospitalization in patients with and those without penicillin allergies. Subsequent courses of antibiotics were compared between patients who with penicillin allergy and patients who were not allergic to penicillin for the 15 months after hospitalization by using the incidence rate ratio of new antibiotics prescribed. Results: Patients in the penicillin allergy group received significantly more outpatient antibiotics in the 15 months after hospitalization compared with patients with no penicillin allergy. The incidence rate ratio between the two groups was 1.27 (95% confidence interval, 1.10-1.48); p = 0.0014. There was no difference between the subsequent courses of inpatient antibiotic courses during the same time period. Conclusion: Patients with a penicillin allergy in the current evaluation received significantly more outpatient courses of antibiotics than did the patients without a penicillin allergy. These data provide more evidence for the importance of penicillin allergy de-labeling to provide patients with the most appropriate antibiotics for their respective infections.
{"title":"Penicillin allergy labels are associated with a greater number of courses of antibiotics after hospitalization.","authors":"C Dustin Waters, Abbey Cruzan, Robert Silge","doi":"10.2500/aap.2025.46.250037","DOIUrl":"10.2500/aap.2025.46.250037","url":null,"abstract":"<p><p><b>Background:</b> Patients with penicillin allergy have been shown to have suboptimal antibiotics prescribed for infections as well as an increased risk of adverse effects. However, it is currently unknown at what rate patients with penicillin allergy are prescribed antibiotics after hospitalization. <b>Objective:</b> The purpose of this study was to determine the rate at which patients with penicillin allergy are prescribed antibiotics after hospitalization and if this rate differs from that of patients without penicillin allergy. <b>Methods:</b> This was a retrospective case-control study that evaluated subsequent courses of antibiotics after hospitalization in patients with and those without penicillin allergies. Subsequent courses of antibiotics were compared between patients who with penicillin allergy and patients who were not allergic to penicillin for the 15 months after hospitalization by using the incidence rate ratio of new antibiotics prescribed. <b>Results:</b> Patients in the penicillin allergy group received significantly more outpatient antibiotics in the 15 months after hospitalization compared with patients with no penicillin allergy. The incidence rate ratio between the two groups was 1.27 (95% confidence interval, 1.10-1.48); p = 0.0014. There was no difference between the subsequent courses of inpatient antibiotic courses during the same time period. <b>Conclusion:</b> Patients with a penicillin allergy in the current evaluation received significantly more outpatient courses of antibiotics than did the patients without a penicillin allergy. These data provide more evidence for the importance of penicillin allergy de-labeling to provide patients with the most appropriate antibiotics for their respective infections.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 4","pages":"335-338"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144582863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.2500/aap.2025.46.250043a
{"title":"Abstract Presented at the WSAAI 2025 62nd Annual Scientific Session, February 9-13, 2025, Waimea, HI.","authors":"","doi":"10.2500/aap.2025.46.250043a","DOIUrl":"10.2500/aap.2025.46.250043a","url":null,"abstract":"","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 4","pages":"348"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144582840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.2500/aap.2025.46.250041
Monique Olivia Burch, Daniel Gimenez Rocha, Leticia Belleze, Marcos Jose Oliveira Da Silva, Renata Pletsch Assuncao, Daniel Antunes, Ronei Luciano Mamoni, Eduardo Vieira Ponte
Background: It is unclear whether the continuous use of a high dose of inhaled corticosteroids (ICS) could contribute to an unfavorable trajectory in body weight. Objectives: The objective was to evaluate whether a high dose of ICS used continuously for maintenance therapy increases the risk of an unfavorable body weight trajectory in individuals with asthma and who are not obese. Methods: We screened consecutive individuals with chronic respiratory symptoms suggestive of asthma who underwent a medical consultation in any of the 42 public health facilities in the municipality of Jundiaí, Brazil. We included individuals with proven asthma who were ≥ 20 years of age and who had a body mass index (BMI) < 30 kg/m² on the day of screening for the study. Individuals participated in two study visits 12 months apart, named V1 and V₂. Between study visits, individuals had one intermediate consultation with their referring physician. Results: Ninety-nine individuals used a high dose of ICS during the study and 294 used a low-medium dose. The individual with asthma and no obesity and who used a high dose of ICS had a similar risk of having obesity at V₂ compared with those who used a low-medium dose (adjusted odds ratio 1.18 [95% confidence interval, 0.46-3.04]). The probability of gaining weight was similar between the two groups. Conclusion: The use of a high dose of ICS for 1 year does not increase the risk of obesity among individuals with asthma and who are not obese, nor is it associated with an unfavorable body weight trajectory compared with individuals with asthma who were using a low-medium dose of ICS. This information may help reduce fears about using ICS.
{"title":"Body weight trajectory of non-obese asthmatics: Relationship with inhaled corticosteroids maintenance therapy.","authors":"Monique Olivia Burch, Daniel Gimenez Rocha, Leticia Belleze, Marcos Jose Oliveira Da Silva, Renata Pletsch Assuncao, Daniel Antunes, Ronei Luciano Mamoni, Eduardo Vieira Ponte","doi":"10.2500/aap.2025.46.250041","DOIUrl":"10.2500/aap.2025.46.250041","url":null,"abstract":"<p><p><b>Background:</b> It is unclear whether the continuous use of a high dose of inhaled corticosteroids (ICS) could contribute to an unfavorable trajectory in body weight. <b>Objectives:</b> The objective was to evaluate whether a high dose of ICS used continuously for maintenance therapy increases the risk of an unfavorable body weight trajectory in individuals with asthma and who are not obese. <b>Methods:</b> We screened consecutive individuals with chronic respiratory symptoms suggestive of asthma who underwent a medical consultation in any of the 42 public health facilities in the municipality of Jundiaí, Brazil. We included individuals with proven asthma who were ≥ 20 years of age and who had a body mass index (BMI) < 30 kg/m² on the day of screening for the study. Individuals participated in two study visits 12 months apart, named V<sub>1</sub> and V₂. Between study visits, individuals had one intermediate consultation with their referring physician. <b>Results:</b> Ninety-nine individuals used a high dose of ICS during the study and 294 used a low-medium dose. The individual with asthma and no obesity and who used a high dose of ICS had a similar risk of having obesity at V₂ compared with those who used a low-medium dose (adjusted odds ratio 1.18 [95% confidence interval, 0.46-3.04]). The probability of gaining weight was similar between the two groups. <b>Conclusion:</b> The use of a high dose of ICS for 1 year does not increase the risk of obesity among individuals with asthma and who are not obese, nor is it associated with an unfavorable body weight trajectory compared with individuals with asthma who were using a low-medium dose of ICS. This information may help reduce fears about using ICS.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 4","pages":"296-303"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144582855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.2500/aap.2025.46.250031
Mehmet Erdem Cakmak, Nida Oztop
Background: Delayed pressure urticaria (DpU) is a subtype of inducible urticaria characterized by painful erythematous swellings that appear after pressure is applied to the skin. Objectives: The aim of this study was to evaluate the efficacy of omalizumab treatment in patients with DpU and the effect of omalizumab treatment on disease control. Methods: This retrospective observational study included a total of 78 patients with chronic spontaneous urticaria (CSU) or DpU who received omalizumab treatment. At 6 months after the initiation of omalizumab treatment, the effects of the treatment on the the urticaria control test (UCT) and the Dermatology Quality of Life questionnaire (DLQI) score and the effects on pressure urticaria were evaluated. The effect of omalizumab on pressure urticaria was determined by performing a pressure provocation test. Results: At the end of the 6th month of omalizumab treatment, the increase in UCT scores was statistically significant in all the patients, in the patients with CSU, and in the patients with CSU plus DpU (p < 0.001, p = 0.025, and p < 0.001, respectively). At the end of the 6th month of omalizumab treatment, the improvement in DLQI scores was statistically significant in all the patients, in patients with CSU, and in patients with CSU plus DpU (p < 0.001, p = 0.002, and p < 0.001, respectively). After the pressure provocation test, no urticarial wheals were observed in the area where pressure had been applied in any patient within 6 hours. Conclusion: The findings of the current study provide evidence that omalizumab treatment may be effective in patients with DpU.
{"title":"Delayed pressure urticaria successfully treated with omalizumab: A tertiary-level health-care center experience.","authors":"Mehmet Erdem Cakmak, Nida Oztop","doi":"10.2500/aap.2025.46.250031","DOIUrl":"10.2500/aap.2025.46.250031","url":null,"abstract":"<p><p><b>Background:</b> Delayed pressure urticaria (DpU) is a subtype of inducible urticaria characterized by painful erythematous swellings that appear after pressure is applied to the skin. <b>Objectives:</b> The aim of this study was to evaluate the efficacy of omalizumab treatment in patients with DpU and the effect of omalizumab treatment on disease control. <b>Methods:</b> This retrospective observational study included a total of 78 patients with chronic spontaneous urticaria (CSU) or DpU who received omalizumab treatment. At 6 months after the initiation of omalizumab treatment, the effects of the treatment on the the urticaria control test (UCT) and the Dermatology Quality of Life questionnaire (DLQI) score and the effects on pressure urticaria were evaluated. The effect of omalizumab on pressure urticaria was determined by performing a pressure provocation test. <b>Results:</b> At the end of the 6th month of omalizumab treatment, the increase in UCT scores was statistically significant in all the patients, in the patients with CSU, and in the patients with CSU plus DpU (p < 0.001, p = 0.025, and p < 0.001, respectively). At the end of the 6th month of omalizumab treatment, the improvement in DLQI scores was statistically significant in all the patients, in patients with CSU, and in patients with CSU plus DpU (p < 0.001, p = 0.002, and p < 0.001, respectively). After the pressure provocation test, no urticarial wheals were observed in the area where pressure had been applied in any patient within 6 hours. <b>Conclusion:</b> The findings of the current study provide evidence that omalizumab treatment may be effective in patients with DpU.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 4","pages":"323-327"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144582857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-01DOI: 10.2500/aap.2025.46.250042
Joseph A Bellanti, Russell A Settipane
{"title":"Expanding horizons of omalizumab: New frontiers in asthma and beyond.","authors":"Joseph A Bellanti, Russell A Settipane","doi":"10.2500/aap.2025.46.250042","DOIUrl":"10.2500/aap.2025.46.250042","url":null,"abstract":"","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 4","pages":"271-273"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12236462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144582858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01DOI: 10.2500/aap.2025.46.250011
Fatma Nur Kuzucu, Cankat Genis, Ahmet Selmanoglu, Kezban Ipek Demir, Zeynep Sengul Emeksiz, Emine Dibek Misirlioglu
Background: 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. Objective: Our study aimed to evaluate the results of direct DPT in children with a history of mild cutaneous reactions to cephalosporins. Methods: 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. Results: 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. Conclusion: 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.
{"title":"Evaluation of direct oral provocation test results in mild cutaneous reactions to cephalosporins in children.","authors":"Fatma Nur Kuzucu, Cankat Genis, Ahmet Selmanoglu, Kezban Ipek Demir, Zeynep Sengul Emeksiz, Emine Dibek Misirlioglu","doi":"10.2500/aap.2025.46.250011","DOIUrl":"10.2500/aap.2025.46.250011","url":null,"abstract":"<p><p><b>Background:</b> 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. <b>Objective:</b> Our study aimed to evaluate the results of direct DPT in children with a history of mild cutaneous reactions to cephalosporins. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> 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.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 3","pages":"235-239"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01DOI: 10.2500/aap.2025.46.250033
{"title":"New England Society of Allergy Spring Meeting Abstracts presented March 28, 2025, Worcester, MA.","authors":"","doi":"10.2500/aap.2025.46.250033","DOIUrl":"10.2500/aap.2025.46.250033","url":null,"abstract":"","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 3","pages":"267-268"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01DOI: 10.2500/aap.2025.46.250026
Petra Staubach, Timothy J Craig, Tomoo Fukuda, Emel Aygoren-Pursun, Roman Hakl, Julia Braverman, John-Philip Lawo, Maressa Pollen, Chiara Nenci, Philip H Li, Henriette Farkas
Background: 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. Objective: HRQoL was evaluated in patients with HAE receiving garadacimab stratified by attack-free status. Methods: 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. Results: 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. Conclusion: 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, www.clinicaltrials.gov.
{"title":"Becoming attack-free further improves health-related quality of life in patients with hereditary angioedema receiving garadacimab.","authors":"Petra Staubach, Timothy J Craig, Tomoo Fukuda, Emel Aygoren-Pursun, Roman Hakl, Julia Braverman, John-Philip Lawo, Maressa Pollen, Chiara Nenci, Philip H Li, Henriette Farkas","doi":"10.2500/aap.2025.46.250026","DOIUrl":"10.2500/aap.2025.46.250026","url":null,"abstract":"<p><p><b>Background:</b> 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. <b>Objective:</b> HRQoL was evaluated in patients with HAE receiving garadacimab stratified by attack-free status. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> 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>.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":"46 3","pages":"200-208"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-01Epub Date: 2025-04-28DOI: 10.2500/aap.2025.46.250028
Julia Braverman, Darcy Ellis, Simona Gavata-Steiger, Angeline Babitha Dhas, Revanth Muthu, Quazi S Ataher
Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusion: Evaluation of the lived experience of patients with HAE and their caregivers via 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.
{"title":"Analyzing social media conversations to gain insights into the experiences of patients with hereditary angioedema.","authors":"Julia Braverman, Darcy Ellis, Simona Gavata-Steiger, Angeline Babitha Dhas, Revanth Muthu, Quazi S Ataher","doi":"10.2500/aap.2025.46.250028","DOIUrl":"10.2500/aap.2025.46.250028","url":null,"abstract":"<p><p><b>Background:</b> 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. <b>Objective:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> Evaluation of the lived experience of patients with HAE and their caregivers <i>via</i> 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.</p>","PeriodicalId":7646,"journal":{"name":"Allergy and asthma proceedings","volume":" ","pages":"218-226"},"PeriodicalIF":2.6,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143961360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}