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Observational Study
. 2021 Jul;32(5):980-991.
doi: 10.1111/pai.13484. Epub 2021 Mar 20.

Omalizumab outcomes for up to 6 years in pediatric patients with severe persistent allergic asthma

Antonio Nieto García  1 , Teresa Garriga-Baraut  2 , Ana María Plaza Martín  3 , María Nieto Cid  1   4 , Javier Torres Borrego  5 , María Del Mar Folqué Giménez  3 , Jaime Lozano Blasco  3 , Montserrat Bosque García  6 , Laura Moreno-Galarraga  7 , Miguel Tortajada-Girbés  8 , Cristina Rivas Juesas  9 , María Penín Antón  10 , María Araceli Caballero-Rabasco  11 , Mirella Gaboli  12 , Alejandro López Neyra  13 , Juan Navarro Morón  14 , Andrea Freixa Benavente  2 , Laura Valdesoiro Navarrete  6 , Esther Ballester Asensio  8 , Verónica Sanz Santiago  15 , Raquel Romero García  16 , Álvaro Gimeno Díaz de Atauri  17 , Alfredo Valenzuela Soria  18 , Mercedes Sánchez Mateos  19 , José Batlles Garrido  20 , Anselmo Andrés Martín  21 , Elena Campos Alonso  22 , Carmen Aragón Fernández  23 , Elena Vázquez Rodríguez  24 , Luz Martínez Pardo  25 , Genoveva Del-Río Camacho  26 , Ángel Mazón Ramos  1
Affiliations
Observational Study

Omalizumab outcomes for up to 6 years in pediatric patients with severe persistent allergic asthma

Antonio Nieto García et al. Pediatr Allergy Immunol. 2021 Jul.

Abstract

Background: Various studies have assessed omalizumab outcomes in the clinical practice setting but follow-up and/or number of patients included were limited. We aim to describe the long-term outcomes of pediatric patients with severe persistent allergic asthma receiving omalizumab in the largest real-life cohort reported to date.

Methods: ANCHORS was a multicenter, observational, retrospective cohort study conducted in 25 Pediatric Allergy and Pulmonology units in Spain. We collected data of patients < 18 years and initiating omalizumab between 2006 and 2018, from the year prior to omalizumab initiation to discontinuation or last available follow-up. The primary outcome was the evolution of the annual number of moderate-to-severe exacerbations compared with the baseline period.

Results: Of the 484 patients included, 101 (20.9%) reached 6 years of treatment. The mean ± standard deviation number of exacerbations decreased during the first year of treatment (7.9 ± 6.6 to 1.1 ± 2.0, P < .001) and remained likewise for up to 6 years. The other clinical parameters assessed also improved significantly during the first year and stabilized or continued to improve thereafter. The percentage of patients experiencing adverse events was consistently low, and the main reason for discontinuation was good disease evolution.

Conclusion: In this large, long-term, observational study, moderate-to-severe exacerbations decreased significantly from the first year of treatment with omalizumab. The beneficial effect was maintained in the long term, along with a good safety profile. Our results position omalizumab as an effective long-term treatment in pediatric patients with severe persistent allergic asthma.

Keywords: adolescents; anti-asthmatic agents; children; humanized monoclonal antibodies; observational study; omalizumab; real life; severe asthma.

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References

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