Marek Lommatzsch

Background In SHAMAL, patients (pts) with severe eosinophilic asthma (SEA) treated with benralizumab reduced ICS use while maintaining asthma control. However, real-world evidence on physiological consequences of ICS-sparing, especially regarding body plethysmography, is limited. Methods AIR POWER is a non-interventional, prospective study investigating asthma control and ICS use in pts treated with benralizumab. In this interim analysis, we assessed asthma control, Biologics Asthma Response Score (BARS) and body plethysmography at baseline (BL), 12w and 24w. Results Early ACT changes exceeding an MCID of 3 points were observed at 12w and sustained at 24w vs BL. More than 90% showed a response (BARS 0.5 to 1 and FVC were significantly improved at 24w. Specific airway resistance (sRtot) was elevated at BL and decreased significantly at 24w. Conclusion Clinically relevant improvements in asthma control were seen at 12w and maintained until 24w. A majority responded to treatment, with significant improvement in FEV₁ and airway resistance at 24w. This suggests early and sustained benefits of benralizumab in pts with SEA in the real-world setting. erj;68/suppl_70/PA1485/TB1 T1 TB1 BL (N=101) 12w (N=77) 24w (N=44) ACT vs BL, mean ∆ (95% CI) > 3 points achieved vs BL % (n/N) 4.94 (3.88–6.01) p1 (mL/%pred (SD)) FVC (mL/%pred (SD)) FEV₁/FVC % (SD) 109.8/8.2 (27.6) 113.6/2.1 (21.8) 3.5 (15.6) 241.7/14.9 (29.1) p=0.0044 257.4/12.4 (27.4) p=0.0087 2.6 (14.2) Hyperinflation & resistance RV/TLC% (%pred) sRtot (kPAs/%pred) 141.8 1.65/158.6 149.9 1.51/145.9 134.3 1.40/135.5 p=0.0259* *mean ∆ vs BL The study was funded by AstraZeneca GmbH

Zusammenfassung: Nationale und internationale fachärztliche Leitlinien sehen zu Recht die FeNO-Messung als unverzichtbares Element der Diagnostik und des effizienten Managements von Asthma an. Die Bestimmung von FeNO in der fachärztlichen Praxis führt zu einer verbesserten Versorgung von Patienten mit Asthma, durch (1) verbesserte Diagnostik von Asthma, (2) bessere Steuerung der inhalativen Therapie, (3) genauere Prüfung der Adhärenz und (4) präzisere Evaluation einer potentiellen Biologikatherapie. Eine regelmäßige Bestimmung des FeNO sollte daher essentieller Bestandteil der fachärztlichen Betreuung von Patienten mit Asthma in Deutschland sein. Ein verbessertes Asthma-Management durch FeNO-Messungen hat auch erhebliche gesundheitsökonomische Auswirkungen, durch Reduktion von direkten und indirekten Kosten. Eine Vergütung der FeNO-Messung über die gesetzlichen Krankenversicherungen (GKV) würde daher nicht nur zu einer besseren Versorgung von Asthma-Patienten, sondern auch zu einer Reduktion von Kosten in Deutschland führen.

Background: Biologics are the first-line treatment for patients with severe, inadequately controlled asthma. They can lead to a significant reduction in (or even complete avoidance of) exacerbations, a reduction in the need for systemic glucocorticoids with their many side effects, and a marked improvement in asthma control and lung function in severe asthma. Due to the high annual costs of biologic therapy, there is legitimate interest among health insurances in guideline- and approval-compliant as well as cost-effective use of biologics in severe asthma. On the other hand, there is also legitimate interest among treating physicians in prescribing these biologics without risk of insurer repayment demands. Methodology: Using an analysis of the literature and regulatory approvals, the evidence for treatment with currently approved biologics for severe asthma—omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, and depemokimab— was documented, and supplemented by the clinical experiences of the authors. Results: Based on the guideline recommendations and approvals, recommendations are made for the use of the aforementioned biologics in the German healthcare system. In a joint effort by various professional associations (AeDA, DGP, BdP, GAN, DGAKI, GPP, GPA), documentation forms were created for all biologics approved for severe asthma, which can serve as a basis for documentation. Forms were developed both for the initiation of biologic therapy and for the documentation of biologic treatment responses in severe asthma. Conclusion: The new documentation forms concisely summarize all key points related to biologic prescription in severe asthma on a single page, serving both to ensure guideline-compliant and approval-compliant prescription and to avoid drug repayment demands.

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: Current definitions of clinical remission (CR) use different tools and thresholds to define good asthma control. Their differential impact on CR rates in severe asthma is poorly understood. Methods: Data from a real-world study in patients with SEA treated with benralizumab (imPROve Asthma, NCT04184284, total number of patients: 244 patients) were analyzed. Four-component CR (4-CR) was defined as no exacerbations, no systemic steroid treatment, stable or normal lung function, and good asthma control, for at least 12 months. The impact of 2 different asthma control measures (Asthma Control Questionnaire [ACQ] and Asthma Control Test [ACT]) with varying thresholds for good asthma control (ACQ: ≤1.5 or ≤0.75, ACT: ≥20 or ≥23) on CR rates was examined. Results: Complete data on all remission criteria were available for 131 patients after 12 months of follow-up, and 85 patients after 24 months of follow-up. After 12 months, 4-CR criteria were fulfilled in 42.7% (ACQ-6 ≤1.5), 36.9% (ACT ≥20), 24.4% (ACQ-6 ≤0.75), and 21.5% (ACT ≥23) of the patients. After 24 months, 4-CR criteria were fulfilled in 39.2% (ACQ-6 ≤1.5), 31.8% (ACT ≥20), 22.8% (ACQ-6 ≤0.75), and 17.6% (ACT ≥23) of the patients. Conclusion: CR is achievable in a substantial proportion of patients with SEA treated with benralizumab in a real-world setting. CR rates are strongly dependent on definitions of asthma control, with almost twice as high CR rates found using the ACQ-6 ≤1.5 criterion as compared with the ACT ≥23 criterion.