Background: Prospective real-world data concerning the early and sustained effects of benralizumab on asthma control in patients with severe eosinophilic asthma (SEA) is lacking.
Methods: XALOC-2 is a prospective, observational, multi-national, real-world study in adults with SEA treated with benralizumab. This integrated analysis assessed Asthma Control Questionnaire (ACQ) scores, achievement of 3-component clinical remission (which included well-controlled symptoms [ACQ score ≤ 0.75], no exacerbations, and no use of maintenance oral corticosteroids [mOCS]), and other clinical outcomes, over a 12-month baseline period and up to Week 56. Associations between remission status and key baseline characteristics were also assessed.
Results: 535 patients were included. Median (interquartile range) ACQ score at baseline was 3.0 (2.2-3.8). At Week 1, 58.0% (282/486) of patients had ACQ score reductions of ≥ 0.5 points (minimal clinically important difference [MCID]) and 35.0% (170/486) had reductions of ≥ 1 point (2× MCID). By Week 56, these increased to 78.6% (276/351) and 62.1% (218/351), respectively. Improved asthma control after benralizumab initiation was similar irrespective of previous biologic use status. By Week 56, clinical remission criteria were achieved in 26.7% (70/262) of patients versus 0% (0/374) at baseline. No mOCS use, lower body mass index, better asthma symptom control and higher peak blood eosinophil count at baseline were associated with meeting 3-component clinical remission criteria at Week 56.
Conclusions: Real-world patients receiving benralizumab showed early and sustained improvements in asthma symptoms, regardless of previous biologic use. More than a quarter of patients achieved clinical asthma remission after 1 year of benralizumab treatment.
Introduction: A false penicillin allergy label often leads to the unnecessary avoidance of beta-lactam antibiotics, contributing to antimicrobial resistance and suboptimal clinical outcomes. The PEN-FAST clinical decision rule is a simple, point-of-care tool with a high negative predictive value (NPV) designed to identify low-risk patients who may not require extensive allergy testing. This study aims to validate the performance of the PEN-FAST clinical decision rule in an Asian population.
Methods: A retrospective review of medical records from January 2006 to February 2023 was conducted at our institution's outpatient allergy clinic. Patients underwent skin prick and intradermal testing, followed by oral drug provocation testing (DPT) or direct oral DPT without prior skin testing (ST). Positive results were defined as positive skin test outcomes or immediate/delayed reactions following drug challenge. PEN-FAST scores were compared to allergy testing results.
Results: A total of 357 patients were included, with 85 (23.8%) undergoing direct DPT without prior ST. None had a history of severe cutaneous allergic reaction as their index reaction. The median age was 49 years (interquartile range [IQR]: 34-63), and 61.9% were female. Forty-seven patients (13.2%) had positive test results, including 26 positive reactions following DPT. PEN-FAST scores of 0-5 were distributed as follows: 25 (7.0%), 159 (44.5%), 31 (8.7%), 96 (26.9%), 4 (1.1%) and 42 (11.8%). Among those with PEN-FAST scores ≤ 2 (n = 215), 16 (7.4%) had a positive test. Of these, 7 developed urticaria, 8 developed mild delayed maculopapular exanthem and 1 had a positive skin test. A PEN-FAST score cutoff of ≤ 2 yielded sensitivity of 66.0% (95% CI: 50.7%-79.1%), specificity of 64.2% (95% CI: 58.6%-69.5%), a positive predictive value (PPV) of 21.8% (95% CI: 17.8%-26.5%) and a NPV of 92.6% (95% CI: 89.2%-94.9%). The area under the receiver operating characteristic curve was 0.66 (95% CI: 0.58-0.75).
Conclusion: The PEN-FAST clinical decision rule demonstrates a high NPV in an Asian population, supporting its potential utility in identifying individuals unlikely to have true penicillin allergy and enabling direct DPT in low-risk patients without prior ST. However, the modest area under the curve (AUC) of 0.66 reflects limited overall discriminatory ability.
Asthma is one of the most common chronic respiratory diseases, persisting across the life course and affecting approximately 300 million people worldwide. Severe asthma, defined as asthma remaining uncontrolled despite adherence to optimised high-dose inhaled corticosteroids/long-acting β2-agonist therapy and management of contributory factors, worsens upon dose reduction. In China, 3.4%–8.3% of patients with asthma have severe asthma, characterised by heterogeneity, frequent exacerbations, and considerable medical and economic burdens. Recent advances in the understanding of its pathogenesis, especially the development of biologics, have enabled new treatment strategies. This review incorporates recent progress from China regarding the epidemiology, pathogenesis, and biologic therapy for severe asthma.
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