To assess the safety of biological therapy for severe T2 asthma (omalizumab, mepolizumab, benralizumab and reslizumab) under real-life conditions in elderly patients older than 70 years.Retrospecti...

Background: Biologics have revolutionized the treatment of many diseases. In this regard, omalizumab (OMA), an anti-IgE monoclonal antibody, is the recommended therapeutic option for patients with chronic spontaneous urticaria (CSU) refractory to second-generation H1-antihistamines. Several studies confirm the efficacy and safety of the drug. However, the literature focusing on the elderly population is scarce, as this age group is often excluded from clinical trials. Therefore, the pharmacological treatment of CSU in elderly patients is a challenge that is increased by their comorbidities and consequent polypharmacy. Objectives: We describe the real-life safety profile of OMA in elderly patients (≥70 years) with CSU and chronic inducible urticaria (CIndU). We aimed to provide data for daily clinical practice in this vulnerable patient group. Method: A retrospective review was performed of the records of patients with CSU/CIndU from May 2003 to December 2019 in the Hospital Universitario La Paz. We describe qualitative and quantitative data according to measures of central tendency. Comparisons between qualitative and quantitative data were performed with the Mann-Whitney U test and the Fisher’s test for qualitative variables. A p value <0.05 was considered statistically significant. Results and Conclusions: Eighty-nine patients were included, divided into two groups (<70 vs. ≥70 years). The overall rate of adverse events (AEs) was 48%, mainly mild. No association between age and AE was found (p = 0.789). No serious AE such as anaphylaxis was detected. CSU predominated in both groups. CIndU was less prevalent in the elderly (p = 0.017). There was no association between age and the other variables. Although the frequency of neoplasms was slightly higher in the elderly with OMA, we found no difference compared to the incidence of neoplasms in the general population. Therefore, our data suggest that OMA may be a safe treatment in elderly people with CSU/CIndU for prolonged periods of treatment, although further studies with larger samples are needed to corroborate our observations.

Background: The prevalence of cardiovascular events (CVEs) in patients with asthma varies amongst studies, with little evidence as to their prevalence in patients treated with monoclonal antibodies (mAbs). In this retrospective, observational study, we aimed to evaluate the prevalence of CVEs in patients with T2 and non-T2 asthma and to identify risk factors associated with CVEs. Methods: A total of 206 patients with severe asthma were included. Demographic variables, respiratory comorbidities and cardiovascular risk factors were collected, along with respiratory function, laboratory parameters and respiratory pharmacotherapy, including treatment with mAbs. Results: A total of 10.7% of the patients had any CVE from the date of asthma diagnosis, with a higher risk in those patients with chronic obstructive pulmonary disease (odds ratio [OR] = 5.36, 95% CI 1.76–16.31; p = 0.003), arterial hypertension (OR = 2.71, 95% CI 1.13–6.55; p = 0.026) and dyslipidaemia (OR = 9.34, 95% CI 3.57–24.44; p < 0.001). No association between mAb treatment and a CVE or between time of mAb treatment and the event was found. No significant differences were observed between the T2 and non-T2 cohort. After a multivariate analysis, dyslipidaemia was identified as an independent risk factor (OR = 13.33, 95% CI 4.49–39.58; p < 0.001), whereas regular use of inhaled corticosteroids was associated with a reduced risk of a CVE (OR = 0.103, 95% CI 0.021–0.499; p = 0.005). Further research is needed to fully understand the relationship between severe asthma and CVEs. Conclusions: This study suggests that patients with severe asthma experience a higher percentage of CVEs compared with the general population.

Cofactors are external factors that can lower the threshold dose of an allergen and amplify the severity of allergic reactions, turning mild or moderate responses into severe anaphylaxis. These include exercise, nonsteroidal anti-inflammatory drugs (NSAIDs), alcohol, menstruation, and infections. Initially described in relation to food allergens and physical activity or NSAIDs, these reactions have been labeled under various terms, such as food-dependent exercise-induced anaphylaxis (FDEIA), wheat-dependent exercise-induced anaphylaxis (WDEIA), and food-dependent NSAID-induced anaphylaxis (FDNIA). However, cofactor-enhanced food allergy (CEFA), a recently proposed concept, serves as an umbrella term to encompass these conditions and is applied in this text for consistency. Pediatric cofactor-enhanced food anaphylaxis (PCEFA) is a rare but severe condition in which a food allergy becomes significantly more severe in the presence of one or more cofactors. Cofactors are documented in 14–18.3% of pediatric food anaphylactic reactions, however, the true burden is likely higher due to frequent underdiagnosis from variable and unpredictable presentations. Exercise and infections are the most common cofactors in PCEFA, while ω-5 gliadin is the predominant allergen. CEFA is frequently misdiagnosed as idiopathic anaphylaxis, exercise-induced anaphylaxis (EIA), or asthma when subtle or delayed food triggers go undetected. Some cases may represent high-threshold food allergies rather than true cofactor-dependent anaphylaxis, challenging conventional definitions. Research on cofactors in anaphylaxis is still in its early stages, with most studies focusing on adults. More research is needed to improve diagnostic accuracy and treatment strategies for pediatric cases.