Mepolizumab Treatment in Severe Pediatric Asthma: First Multicentric
                    Real-World Data

Wetzke, Martin; Funken, Dominik; Ahrens, Frank O.; Gappa, Monika; Hansen, Gesine; Koerner-Rettberg, Cordula; Koester, Holger; Schulze, Johannes; Schwerk, Nicolaus; Zielen, Stefan; Happle, Christine

doi:10.1055/a-1717-2234

Cited by 5 publications

(3 citation statements)

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“…Placebo nachgewiesen werden; es fand sich kein signifikanter Einfluss auf die Lungenfunktion [288]. Eine kleinere deutsche retrospektive Real-World-Analyse konnte den positiven Effekt auf die Exazerbationsrate bei Kindern und Jugendlichen jedoch nicht nachweisen [289]. Mepolizumab ist zugelassen für schweres refraktäres eosinophiles Asthma.…”

Section: Thermoplastieunclassified

S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023

et al. 2023

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ZusammenfassungDas Management von Asthma hat sich in den letzten Jahrzehnten fundamental gewandelt. Die vorliegende Leitlinie zur Diagnostik und Therapie von Asthma wurde für pneumologisch tätige Fachärztinnen und Fachärzte entwickelt, welche detaillierte und evidenzbasierte Informationen zu den neuen diagnostischen und therapeutischen Optionen von Asthma benötigen. Die Leitlinie zeigt die neue Bedeutung der Biomarker, insbesondere der Bluteosinophilen und des exhalierten NO (FeNO), in den diagnostischen Algorithmen von Asthma. Als erste Asthma-Leitlinie weltweit benennt die vorliegende Leitlinie die nachhaltige Symptomprävention und die Asthma-Remission als Asthma-Therapieziele, welche durch den Einsatz individuell angepasster, krankheitsmodifizierender Medikamente (wie inhalative Steroide, Allergenimmuntherapie oder Biologika) erreicht werden können. Die zentrale Bedeutung der Behandlung von typischen Asthma-Komorbiditäten wird zudem betont. Schließlich wird auch auf besondere Herausforderungen im Asthma-Management eingegangen, wie bspw. die Therapie von Asthma in der Schwangerschaft, die Behandlung von schwerem Asthma oder die Diagnostik und Therapie von arbeitsbedingten Asthma-Formen.

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Section: Thermoplastieunclassified

S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023

et al. 2023

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“…Although the clinical experience with mepolizumab in pediatric asthma is often heterogeneous and with high rates of treatment discontinuation (51), this drug seems most effective in reducing exacerbations. A total of 10 children (28%) reported an exacerbation and more specifically only three patients had two exacerbations during the first 12 weeks of treatment (49).…”

Section: Exacerbation Ratementioning

confidence: 99%

Severe Pediatric Asthma Therapy: Mepolizumab

et al. 2022

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There is a growing need for advanced treatment in children with persistent and severe asthma symptoms. As a matter of fact, between 2 and 5% of asthmatic children experience repeated hospitalizations and poor quality of life despite optimized treatment with inhaled glucocorticoid plus a second controller. In this scenario, mepolizumab, a humanized monoclonal antibody, has proven to be effective in controlling eosinophil proliferation by targeting interleukin-5 (IL-5), a key mediator of eosinophil activation pathways. Mepolizumab is approved since 2015 for adults at a monthly dose of 100 mg subcutaneously and it has been approved for patients ≥ 6 years of age in 2019. Especially in children aged 6 to 11 years, mepolizumab showed a greater bioavailability, with comparable pharmacodynamics parameters as in the adult population. The recommended dose of 40 mg every 4 weeks for children aged 6 through 11 years, and 100 mg for patients ≥ 12 years provides appropriate concentration and proved similar therapeutic effects as in the adult study group. A marked reduction in eosinophil counts clinically reflects a significant improvement in asthma control as demonstrated by validated questionnaires, reduction of exacerbation rates, and the number of hospitalizations. Finally, mepolizumab provides a safety and tolerability profile similar to that observed in adults with adverse events mostly of mild or moderate severity. The most common adverse events were headache and injection-site reaction. In conclusion, mepolizumab can be considered a safe and targeted step-up therapy for severe asthma with an eosinophilic phenotype in children and adolescents.

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“…Several randomized clinical trials (RCTs) and post-marketing surveillance studies confirmed the efficacy and the safety of these monoclonal antibodies in children with allergic disease [2]. However, there is still a lack of robust real-world data [9][10][11]. The primary outcome of our study was to assess the efficacy of omalizumab and dupilumab after the initial 16 weeks of treatment in real-life settings among a cohort of pediatric patients suffering from moderate-to-severe asthma, CSU, and AD.…”

Section: Introductionmentioning

confidence: 99%

Early Assessment of Efficacy and Safety of Biologics in Pediatric Allergic Diseases: Preliminary Results from a Prospective Real-World Study

Caminiti,

Galletta,

Foti Randazzese

et al. 2024

Children

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Background: Despite the increasing interest in biologics for the management of allergic diseases, sparse real-world data are still available in the pediatric population. This study aimed to evaluate the early real-life efficacy and safety of omalizumab for patients with moderate-to-severe asthma and chronic spontaneous urticaria (CSU), and Dupilumab for patients with moderate-to-severe atopic dermatitis (AD). Methods: A prospective study enrolling children aged 6–18 years was designed to assess the efficacy and safety of biologic drugs at 16 weeks of treatment (T1). The effectiveness was measured using validated questionnaires (ACQ-5 for asthma, UAS7 for CSU, and EASI score for AD). Secondary outcome measures included reductions in inhaled corticosteroid (ICS) dosages, asthma-related hospitalizations/exacerbations, and quality of life (QoL) indicators (iNRS, sNRS, DLQI/cDLQI) for CSU and AD. Safety was expressed according to the descriptions of adverse events provided by EMA and FDA. Results: The study cohort consisted of eighteen children (mean age 12.9 ± 3.4 years). The omalizumab treatment significantly reduced ACQ-5 and UAS7 scores (p = 0.002 and p < 0.001, respectively). In patients with asthma, decreased ICS dosage and hospitalization/exacerbation rates were observed. QoL parameters significantly improved in CSU and AD patients. No severe adverse events were reported for either treatment. Conclusions: Our findings validate omalizumab and dupilumab as effective and safe therapeutic options for managing moderate-to-severe allergic diseases in children and adolescents.

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Mepolizumab Treatment in Severe Pediatric Asthma: First Multicentric Real-World Data

Cited by 5 publications

References 0 publications

S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023

S2k-Leitlinie zur fachärztlichen Diagnostik und Therapie von Asthma 2023

Severe Pediatric Asthma Therapy: Mepolizumab

Early Assessment of Efficacy and Safety of Biologics in Pediatric Allergic Diseases: Preliminary Results from a Prospective Real-World Study

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