Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma

Odajima, Hiroshi; Ebisawa, Motohiro; Nagakura, Toshikazu; Fujisawa, Takao; Akasawa, Akira; Ito, Komei; Doi, Satoru; Yamaguchi, Koichi; Katsunuma, Toshio; Kurihara, Kazuyuki; Teramoto, Tamio; Sugai, Kazuko; Nambu, Mitsuhiko; Hoshioka, Akira; Yoshihara, Shigemi; Sato, Norio; Seko, Noriko; Nishima, Sankei

doi:10.1016/j.alit.2016.06.004

Cited by 51 publications

(34 citation statements)

References 39 publications

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“…In children <12 years old, only 5 cases were reported (with partial or complete remission in all), so the level of evidence of efficacy is very low. The safety profile is better known from extensive experience treating severe allergic asthma, and omalizumab is generally well tolerated in RCTs, although long‐term follow‐up data are not available . The main severe risk is anaphylaxis .…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Chronic spontaneous urticaria in children ‐ a systematic review on interventions and comorbidities

Cornillier

Giraudeau

Munck

et al. 2018

Pediatric Allergy Immunology

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Section: Discussionmentioning

confidence: 99%

“…The safety profile is better known from extensive experience treating severe allergic asthma, and omalizumab is generally well tolerated in RCTs, although long-term follow-up data are not available. 25 The main severe risk is anaphylaxis. 26 Our review showed more data with cyclosporine (n = 18) than omalizumab (n = 5) in children.…”

Section: Treatmentsmentioning

confidence: 99%

Chronic spontaneous urticaria in children ‐ a systematic review on interventions and comorbidities

Cornillier

Giraudeau

Munck

et al. 2018

Pediatric Allergy Immunology

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“…Also, there is reason to suppose that antieosinophil strategies may be deleterious in children, given the role of the eosinophil in immune homeostasis [74]. There are extensive paediatric data on efficacy and safety of the anti-IgE monoclonal omalizumab [75][76][77], so there should be no reason not to replicate these studies for other anti-IL-5 strategies, in the absence of a reliable biomarker of efficacy. In summary, it is essential to perform paediatric trials of these new agents that evaluate the impact of these treatments on development and long-term outcomes, and also to pursue research into biomarkers of efficacy [78].…”

Section: Conditional Lowmentioning

confidence: 99%

Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline

et al. 2019

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This document provides clinical recommendations for the management of severe asthma. Comprehensive evidence syntheses, including meta-analyses, were performed to summarise all available evidence relevant to the European Respiratory Society/American Thoracic Society Task Force's questions. The evidence was appraised using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and the results were summarised in evidence profiles. The evidence syntheses were discussed and recommendations formulated by a multidisciplinary Task Force of asthma experts, who made specific recommendations on six specific questions. After considering the balance of desirable and undesirable consequences, quality of evidence, feasibility, and acceptability of various interventions, the Task Force made the following recommendations: 1) suggest using anti-interleukin (IL)-5 and anti-IL-5 receptor α for severe uncontrolled adult eosinophilic asthma phenotypes; 2) suggest using a blood eosinophil cut-point ≥150 μL−1 to guide anti-IL-5 initiation in adult patients with severe asthma; 3) suggest considering specific eosinophil (≥260 μL−1) and exhaled nitric oxide fraction (≥19.5 ppb) cut-offs to identify adolescents or adults with the greatest likelihood of response to anti-IgE therapy; 4) suggest using inhaled tiotropium for adolescents and adults with severe uncontrolled asthma despite Global Initiative for Asthma (GINA) step 4–5 or National Asthma Education and Prevention Program (NAEPP) step 5 therapies; 5) suggest a trial of chronic macrolide therapy to reduce asthma exacerbations in persistently symptomatic or uncontrolled patients on GINA step 5 or NAEPP step 5 therapies, irrespective of asthma phenotype; and 6) suggest using anti-IL-4/13 for adult patients with severe eosinophilic asthma and for those with severe corticosteroid-dependent asthma regardless of blood eosinophil levels. These recommendations should be reconsidered as new evidence becomes available.

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“…In patients with severe allergic asthma, the add-on treatment with omalizumab has been shown to reduce the risk of exacerbations [113–117], the asthma symptoms [113,114,116,118], and the use of OCS [118] and ICS [115], as well as to improve the quality of life and lung function [113,114,116], without significant safety concerns. These beneficial effects of omalizumab first shown in randomized clinical trials have been confirmed in longer term real-life studies [119–121], and appear to be independent on patients’ comorbidities [118].…”

Section: Management Of Severe Asthmamentioning

confidence: 99%

Nordic consensus statement on the systematic assessment and management of possible severe asthma in adults

Porsbjerg

Ulrik

Skjold

et al. 2018

European Clinical Respiratory Journal

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Although a minority of asthma patients suffer from severe asthma, they represent a major clinical challenge in terms of poor symptom control despite high-dose treatment, risk of exacerbations, and side effects. Novel biological treatments may benefit patients with severe asthma, but are expensive, and are only effective in appropriately targeted patients. In some patients, symptoms are driven by other factors than asthma, and all patients with suspected severe asthma (‘difficult asthma’) should undergo systematic assessment, in order to differentiate between true severe asthma, and ‘difficult-to-treat’ patients, in whom poor control is related to factors such as poor adherence or co-morbidities. The Nordic Consensus Statement on severe asthma was developed by the Nordic Severe Asthma Network, consisting of members from Norway, Sweden, Finland, Denmark, Iceland and Estonia, including representatives from the respective national respiratory scientific societies with the aim to provide an overview and recommendations regarding the diagnosis, systematic assessment and management of severe asthma. Furthermore, the Consensus Statement proposes recommendations for the organization of severe asthma management in primary, secondary, and tertiary care.

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Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma

Abstract: Long-term treatment with omalizumab is well-tolerated and effective in children with uncontrolled severe allergic asthma. No new safety findings were identified.

Cited by 51 publications

References 39 publications

Chronic spontaneous urticaria in children ‐ a systematic review on interventions and comorbidities

Chronic spontaneous urticaria in children ‐ a systematic review on interventions and comorbidities

Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline

Nordic consensus statement on the systematic assessment and management of possible severe asthma in adults

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