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Eosinophilic Granulomatosis with Polyangiitis (EGPA) is a rare systemic disorder frequently presenting with severe asthma. Mepolizumab, an interleukin-5 inhibitor, is approved for both severe asthma and relapsing or corticosteroid-dependent EGPA, yet treatment response has traditionally been evaluated using systemic-focused scores, such as BVAS, which may underestimate asthma-specific improvements. We conducted a retrospective study of 142 patients with severe uncontrolled asthma (SUA), including 14 with EGPA, all treated with mepolizumab 100 mg every four weeks. Biologic response was assessed using asthma-focused tools, the EXACTO scale and SEPAR-REMAS criteria, which consider exacerbations, asthma control, lung function, and oral corticosteroid (OCS) use. At baseline, EGPA patients exhibited higher prevalence of nasal polyposis and OCS dependence. After one year of treatment, patients with EGPA showed numerically higher rates of good or complete response and clinical remission compared with patients with severe asthma; however, these differences did not reach statistical significance (70% vs 55.7% and 30% vs 18.5%, respectively; p = 0.03). Regarding oral corticosteroid (OCS) use, a higher proportion of EGPA patients remained on OCS after one year (p < 0.001), and the relative reduction in the number of OCS users from baseline was smaller than in the severe asthma group but without statistically significant (p = 0.55). Mean daily OCS dose increased in EGPA (9.8 to 15.3 mg) but decreased in non-EGPA patients (18.4 to 10.3 mg). These findings suggest that patients with SUA and EGPA can achieve asthma-specific improvements with 100 mg mepolizumab, highlighting the value of asthma-focused assessment tools and the need for larger multicenter studies to optimize treatment strategies.

Benralizumab is a monoclonal antibody that targets the α subunit of the IL-5 receptor. Clinical trials have demonstrated the efficacy of this agent with respect to lung function and symptom control in patients with refractory eosinophilic asthma. However, few studies have evaluated the efficacy of benralizumab after switching previous treatment with other monoclonal antibodies. We performed a multicenter retrospective study under conditions of daily clinical practice. The study population comprised consecutively included patients with severe refractory eosinophilic asthma whose initial treatment with omalizumab or mepolizumab was switched to benralizumab. Patients were evaluated at 4 and 12 months after starting treatment with benralizumab. We analyzed asthma control, number of severe exacerbations, corticosteroid cycles, visits to the emergency department, and hospital admissions, as well as lung function. Similarly, we evaluated the response to treatment according to previously established criteria. We evaluated 40 patients who switched from omalizumab (n=16) or mepolizumab (n=24) to benralizumab. The reasons for switching were lack of response in 30 cases, adverse effects in 9, and patient request in 1. Switching was followed by a significant decrease in the number of exacerbations, visits to the emergency department, and corticosteroid cycles, as well as improved ACT both at 4 and 12 months. However, no significant improvement in lung function was observed. Asthma control (including complete response and control) was achieved in 55% of patients (n=22) at 12 months. Specifically, a complete response was achieved in 30% of patients at 12 months (66.7% switching from omalizumab and 33.3% from mepolizumab). Patients diagnosed with severe refractory eosinophilic asthma who experience a partial response with omalizumab or mepolizumab could benefit from switching to benralizumab. This approach can reduce the number of exacerbations, visits to the emergency department, and corticosteroid cycles and improve control of asthma.

To study patient preference for and satisfaction with the Easyhaler device and to assess ease of training and use of the inhaler in patients previously treated with a variety of dry powder inhalers (DPIs). We designed a non-interventional, cross-sectional, single-visit observational study of adult patients with persistent asthma referred to specialized care who had previously been treated with DPI inhalers for at least 3 months. Once clinical baseline data had been checked, patients filled in questionnaires on asthma control (GINA 2019), Feeling of Satisfaction with the Inhaler (FSI-10), and adherence (TAI and Morisky-Green questionnaires). Thereafter, all patients were trained in the use of Easyhaler. We assessed ease of use and satisfaction (FSI-10) with Easyhaler, as well as inhaler device preferences. We recruited 502 patients (mean age, 50.2 ± 16.2 y; 63.1% female), of whom 485 were evaluable. In response to the main objective of the study, we compared the values of the self-completed adapted FSI-10, to measure satisfaction with the inhaler. A significantly higher score in each item of the questionnaire was recorded for Easyhaler. Overall, 38% of patients showed exclusive preference for Easyhaler (compared with 15% for the previous device) or were evenly matched in 46% of cases. In the present study, Easyhaler achieved better patient ratings in terms of preference and satisfaction than previously used DPI devices. In order to improve asthma adherence strategies, patient preferences and device choice should be taken into account.

Background Asthma exacerbations are important events that affect disease control, but predictive factors for severe or moderate exacerbations are not known. The objective was to study the predictive factors for moderate (ME) and severe (SE) exacerbations in asthma patients receiving outpatient care. Methods Patients aged > 12 years with asthma were included in the study and followed-up at 4-monthly intervals over a 12-month period. Clinical (severity, level of control, asthma control test [ACT]), atopic, functional, inflammatory, SE and ME parameters were recorded. Univariate analysis was used to compare data from patients presenting at least 1 SE or ME during the follow-up period vs no exacerbations. Statistically significant ( p  <0.1) factors were then subjected to multiple analysis by binary logistic regression. Results A total of 330 patients completed the study, most of whom were atopic (76%), women (nearly 70%), with moderate and mild persistent asthma (>80%). Twenty-seven patients (8%) had a SE and 183 had a ME (58.5%) during follow-up. In the case of SEs, the only predictive factor identified in the multiple analysis was previous SE (baseline visit OR 4.218 95% CI 1.53-11.58, 4-month follow-up OR 6.88 95% CI 2.018-23.51) and inhalation technique (OR 3.572 95% CI 1.324-9.638). In the case of MEs, the only predictive factor found in the multiple analysis were previous ME (baseline visit OR 2.90 95% CI 1.54-5.48, 4-month follow- up OR 1.702 95% CI 1.146-2.529). Conclusions The primary predictive factor for SE or ME is prior SE or ME, respectively. SEs seem to constitute a specific patient \"phenotype\", in which the sole predictive factor is prior SEs.

Introduction: Delayed initiation of mepolizumab may influence long-term disease control and the achievement of clinical and functional outcomes in patients with uncontrolled severe asthma (SUA), but no definitive conclusions have yet been established regarding the optimal timing for biologic initiation. The aim of this study was to evaluate, in a real-world clinical setting, the effect of delayed mepolizumab initiation—from the moment patients first met EMA eligibility criteria—on the treatment response (using the EXACTO scale), clinical remission (according to SEPAR-REMAS criteria) and lung function at 12 months and 3 years after treatment initiation. Material and Methods: We conducted a retrospective observational cohort study including 148 patients with SUA treated with mepolizumab from January 2017 to November 2024 in our hospital. Patients were stratified into tertiles according to delay: ≤5 months, 6–19 months, and >19 months. Baseline demographic, clinical, and lung function characteristics were analyzed. Results: Patients with shorter delay exhibited distinct significance baseline profiles, including higher eosinophil counts, lower BMI and current smoker, and better pre-treatment lung function (p < 0.05). Shorter delay was significantly associated with higher rates of good/complete response according to the EXACTO scale at both 12 months and 3 years (p < 0.05). Clinical remission rates were numerically higher in the early-treatment group, although differences did not reach statistical significance. No significant differences in lung function outcomes were observed between delay groups at either 12 months or 3 years. Conclusions: In conclusion, earlier initiation of mepolizumab after meeting EMA criteria is associated with improved clinical response, although it does not significantly influence remission rates or lung function recovery. These findings underscore the importance of timely treatment initiation and reinforce the relevance of accurate phenotypic and endotypic characterization to optimize biologic selection in SUA.

: The GALERNA study is a retrospective real-world observational study conducted across 21 hospitals in Spain, aiming to evaluate long-term clinical benefits and adherence to benralizumab in 255 adult patients with severe eosinophilic asthma (SEA) over a follow-up period of up to 144 weeks. : Primary objectives focused on assessing adherence to benralizumab, while secondary objectives included the description of severe asthma exacerbation rates, systemic corticosteroid (SCS) use, persistence to benralizumab, lung function, asthma control, and the proportion of patients achieving super-response or clinical remission. Data were collected at baseline (48 weeks prior to benralizumab initiation/index date), follow-up 1 (FUP1) (0-48 weeks), FUP2 (49-96 weeks), and FUP3 (97-144 weeks) after the index date. : At baseline, patients demonstrated a substantial disease burden characterised by impaired lung function, poorly controlled asthma, and frequent severe exacerbations. The results indicated high adherence rates to benralizumab, with 92.9% of patients receiving each of the prescribed doses of benralizumab at week 48 and 70.6% at week 144. Patients showed substantial and sustained clinical improvements, with a reduction in the proportion of individuals presenting at least one severe exacerbation from baseline to FUP3 and a 74% decrease in SCS use for the same period. Lung function also improved, with the proportion of patients achieving pre-bronchodilator FEV ≥ 80% rising to 52% at 144 weeks. Furthermore, mean Asthma Control Test (ACT) scores increased to 20.5, with 68.5% of patients achieving well-controlled asthma (ACT ≥ 20). By the end of the study, 63.6% of patients achieved super-response and 39.1% showed clinical remission, with an overall benralizumab persistence of 79.8% during all follow-up periods. : The GALERNA study provides compelling real-world evidence that benralizumab affords marked and sustained clinical benefits together with high long-term adherence in Spanish SEA patients, reinforcing its usefulness as a long-term therapeutic option in routine clinical practice.

A reduction in platelet count in critically ill patients is a marker of severity of the clinical condition. However, whether this association holds true in acute kidney injury (AKI) is unknown. We analyzed the association between platelet reduction in patients with AKI and major adverse kidney events (MAKE). In this retrospective cohort, we included AKI patients at the Hospital Civil of Guadalajara, in Jalisco, Mexico. Patients were divided according to whether their platelet count fell >21% during the first 10 days. Our objectives were to analyze the associations between a platelet reduction >21% and MAKE at 10 days (MAKE10) or at 30-90 days (MAKE30-90) and death. From 2017 to 2023, 400 AKI patients were included, 134 of whom had  > 21% reduction in platelet count. The mean age was 54 years, 60% were male, and 44% had sepsis. The mean baseline platelet count was 194 x 103 cells/µL, and 65% of the KDIGO3 patients met these criteria. Those who underwent hemodialysis (HD) had lower platelet counts. After multiple adjustments, a platelet reduction >21% was associated with MAKE10 (OR 4.2, CI 2.1-8.5) but not with MAKE30-90. The mortality risk increased 3-fold (OR 2.9, CI 1.1-7.7,  = 0.02) with a greater decrease in the platelets (<90 x 103 cells/µL). As the platelets decreased, the incidence of MAKE was more likely to increase. These associations lost significance when accounting for starting HD. In our retrospective cohort of patients with AKI,  > 21% reduction in platelet count was associated with MAKE. Our results are useful for generating hypotheses and motivating us to continue studying this association with a more robust design.

Introduction Patients with chronic kidney disease (CKD) have an increased risk of lower limbs fractures. During hospitalization for a fracture, these patients are also at higher risk of thrombotic events; therefore, prophylactic anticoagulation is often recommended. However, in advanced CKD the bleeding risk may outweigh the potential benefit of thrombosis prevention. The aim of our study was to evaluate whether enoxaparin prophylaxis compared with placebo influences the risk of major bleeding and thrombotic events in patients with advanced CKD hospitalized with lower limb fractures. Methods In a phase 2 randomized controlled trial, from March 2019 to October 2024, patients with lower limb fracture and advanced CKD were eligible. We randomly assigned 61 patients to the placebo ( N  = 30) and anticoagulation groups (enoxaparin 40 mg; N  = 31). Primary outcome was the risk of major bleeding. The main secondary objectives were risk of thrombosis, death, number of transfusions, dialysis requirement, hospitalization days, and the adverse events (AEs) related to anticoagulation. Results Both groups were similar, mean (SD) age of 65 (19) years; 54% were women, the eGFR of 24 ml/min/1.73m 2 . Hip fracture predominates (45.9%), followed by femur and tibia (31.1% and 23%, respectively). The primary outcome major bleeding occurred in 5 (16.1%) in the enoxaparin group and 4 (13.3%) in the placebo group. After adjusted analysis, comparing the enoxaparin with the placebo group, no increase in the risk of bleeding was observed (OR 1.28, CI 0.29–6.06, p  = 0.741), nor was stratifying by CKD stages (p = > 0.05). Thrombosis occurred in three (4.9%) patients: two (6.7%) in the placebo group and one (3.2%) in the enoxaparin group. Hospitalization days were fewer in the placebo group compared to the enoxaparin group (14 vs. 19, p  = 0.023), reducing the hospital stay by 5 days (95% CI − 10.52 to − 0.09; p  = 0.046). AEs attributed to the intervention, gastrointestinal bleeding occurred in 2 and 1 patient in the placebo and enoxaparin groups, respectively. Conclusions In patients with advanced CKD and lower limb fracture, prophylactic anticoagulation with enoxaparin, compared with no anticoagulation, did not promote more major bleeding. The incidence of DVT was very low in both groups; however, the study was not powered to evaluate differences in thrombosis risk, but associated with prolonged hospital stay, without clear evidence of an increased risk of major bleeding. These findings suggest that further studies are warranted to clarify the risk–benefit balance of anticoagulation in this population. Trial registration ClinicalTrials.gov, ID NCT06795698 Retrospectively registered 28/12/2024, IRB approval 257/18.