Long-Term Omalizumab in Elderly Patients with Chronic Urticaria: Is It a Safe Therapy?

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.

Safety of biological therapy in elderly patients with severe asthma.

OBJECTIVE: 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. METHODS: Retrospective data collection including clinical characteristics, comorbidities, treatment, disease control and adverse events (AE) of all patients with severe asthma on biological therapy older than 70 years seen in the Severe Asthma Unit of our hospital. RESULTS: Of 147 patients with severe asthma being treated with biologics, 21 patients older than 70 years were included. The median age of these patients was 76.3 years (range 71-86) and the majority were women (n = 18, 85.7%). There were 9 patients (42.9%) who experienced an AE related to biological treatment. Four (44.4%) were in treatment with omalizumab, two (22.2%) with mepolizumab, two patients (22.2%) with reslizumab and one (11.1%) with benralizumab. The median FEV1 (%) was 66%. These patients had a considerably higher body mass index (BMI). No significant differences were found for any other variable. Most of the AE reported were considered mild with the exception of one case of systemic AE (anaphylaxis) associated with omalizumab. CONCLUSION: This study indicates that the prescription of biological therapy in elderly patients with severe asthma seems to be safe. More evidence is needed in this particular population.

Predictors of asthma relapse in patients who attended an emergency department.

BACKGROUND: Patients with asthma exacerbations and frequent relapses that require admission to the emergency department (ED) often have more severe disease, worse quality of life, and higher use of health care resources. OBJECTIVE: The aim of this study was to identify potential predictors of relapse after patients are treated in an ED for an asthma exacerbation. METHODS: A retrospective, noninterventional cohort study was conducted in adult patients who attended the ED of a tertiary hospital in 2014 for an asthma exacerbation. We analyzed the subpopulation who experienced at least one relapse (returned to the ED < 15 days after the previous event). RESULTS: Fifty-two of 831 patients experienced 66 relapses after going to the ED (mean ± standard deviation [SD] age, 58.5 ± 23.4 years). The average ± SD probability of a relapse was 6 ± 0.8%. The frequency of episodes was higher in May and November. Twenty-four patients had ≥260 blood eosinophils/µL, including 17 who had ≥400 eosinophils/µL. Only 15% of the patients were referred to an asthma specialist at discharge. Factors related to a higher probability of relapse were the following: having multiple visits to the ED in 1 year, uncontrolled asthma, wheezing in the pulmonary auscultation, peripheral eosinophilia with ≥400 eosinophils/ µL, and being discharged in the first visit to the ED (p < 0.01 for all). CONCLUSION: In this population, patients who had multiple ED visits in 1 year, those with uncontrolled asthma, wheezing, ≥400 blood eosinophils/µL, or who had been discharged at the first ED visit are at higher risk of relapse.