Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab

Long, Aidan A.; Rahmaoui, Abdelkader; Rothman, Kenneth J.; Guinan, Eva C.; Eisner, Mark D.; Bradley, Mary S.; Iribarren, Carlos; Chen, Hubert; Carrigan, Gillis; Rosén, Karin; Szefler, Stanley J.

doi:10.1016/j.jaci.2014.02.007

Cited by 198 publications

(141 citation statements)

References 16 publications

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“…Second, there is not sufficient data regarding the safety of omalizumab; malignancy and anaphylactic reactions are side effects most strongly linked with this biologic agent so far (30,31) . However, all in all, omalizumab seems to be a safe and tolerable treatment option in patients with moderate-to-severe or severe allergic asthma (32,33) , a point that is in line with the results of this systematic review.…”

Section: Discussionsupporting

confidence: 83%

Monoclonal antibodies for the treatment of chronic rhinosinusitis with nasal polyposis: a systematic review

Tsetsos

Goudakos

Daskalakis

et al. 2018

Rhin

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Background: Μonoclonal antibodies have been proposed as a novel therapy in patients suffering from chronic rhinosinusitis with nasal polyposis (CRSwNP). The purpose of this systematic review was to evaluate their efficacy and safety.Methodology: A literature search was performed in MEDLINE, Web of Science, the Cochrane Library and multiple trial registries followed by extensive hand-searching for the identification of relevant studies. Only randomized controlled trials (RCTs) comparing the use of monoclonal antibodies with placebo or another therapy in adult patients with CRSwNP were included.Results: Anti-immunoglobin E (IgE) therapy with omalizumab was assessed in two studies, anti-interleukin (IL)-5 therapy in three studies (1 reslizumab, 2 mepolizumab) and finally anti-IL-4 and anti-IL-13 therapy in only one. With the exception of one study, biologic therapy was proved to be effective in reducing total nasal endoscopic polyp score (TPS) in treatment as compared to placebo groups. Monoclonal antibodies brought about improvement in several other outcomes, such as opacification in computed tomography (CT), quality of life measures, nasal airflow, olfaction and type 2 helper T-cell (Th2) associated biomarkers. Overall, the use of these agents was deemed safe and well-tolerated.Conclusions: This is the first systematic review showing encouraging results for the use of all three main categories of monoclonal antibodies in CRSwNP patients and highlights the need for further well-designed and with larger sample sizes RCTs.

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Section: Discussionsupporting

confidence: 83%

Monoclonal antibodies for the treatment of chronic rhinosinusitis with nasal polyposis: a systematic review

Tsetsos

Goudakos

Daskalakis

et al. 2018

Rhin

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“…106 Concerns regarding the development of malignancy with omalizumab have been initially raised but one long-term cohort study of moderate to severe asthma patients aged > 12 years did not find any significant difference in the incidence of malignancy between the omalizumab patients compared to those on standard therapy. 107 Pooled analysis of RCTs did not show any difference in malignancy outcomes between individuals on omalizumab and placebo. 108,109 Predicting response to therapy As biologic drugs are very costly, targeting individuals who are more likely to be responders is critical.…”

Section: Safetymentioning

confidence: 94%

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

FitzGerald

Lemière

Lougheed

et al. 2017

Canadian Journal of Respiratory, Critical Care, and Sleep Medic

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RATIONALE: While severe asthma affects approximately 5% of all individuals with asthma, this small minority of individuals accounts for a large proportion of the asthma-related costs. Greater understanding of the pathophysiology of asthma combined with the emergence of novel biologic therapies for severe asthma supported the need for a thorough review of the diagnosis, investigation, phenotyping, and management of severe asthma. OBJECTIVES: We aimed to propose a practical approach to distinguish uncontrolled asthma due to inadequate asthma management from severe asthma despite optimal asthma management. Moreover, based on emerging scientific evidence, we sought to provide guidance for characterizing individuals with severe asthma and considering a phenotype-specific management. We also aimed to review other novel new potential therapeutic approaches. METHODS: We systematically reviewed the relevant literature focusing on randomized controlled trials and when available, systematic reviews of randomized controlled trials. The proposed key messages, based on scientific evidence and expert opinion, were agreed upon by unanimous consensus. MAIN RESULTS: We defined severe asthma and outlined its significant impact from the societal and patient perspectives. We outlined a practical approach to distinguish severe from uncontrolled but not severe asthma, based on stepwise investigation and management of potential reasons for uncontrolled asthma. After reviewing the current evidence we concluded that: 1) Several biomarkers (e.g. sputum or blood eosinophil count, total IgE, or FeNO) can help identify potential responders to new therapeutic options; 2) Tiotropium may be considered as an add-on therapy for individuals 12 years of age and over with severe asthma uncontrolled despite combination ICS/LABA therapy; 3) The chronic use of macrolides may decrease asthma exacerbations in individuals 18 years of age and over with severe asthma independent of their inflammatory profile; 4) Children aged 6 years and older and adults who are sensitized to at least one relevant perennial allergen and who remain poorly controlled asthmatics despite high dose ICS and a second controller can benefit from the addition of anti-IgE therapy to reduce asthma exacerbations; due to the known risk of side effects associated with high-dose ICS in children, omalizumab should also be considered in children and adolescents who repeatedly exacerbate or have poor control when therapy is stepped down from high-dose to moderate-dose ICS and at least one other controller; 5) Anti-IL5 therapies may be considered for adults 18 years of age and over with severe eosinophilic asthma who experience recurrent asthma exacerbations in spite of high doses of ICS in addition to at least one other controller; and 6) Although bronchial thermoplasty has shown a decrease in asthma exacerbations in one study, its role in the treatment of severe asthma remains uncertain. CONCLUSIONS: After reviewing existing and emerging therapies for severe asthma, we developed ke...

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“…Cancer risk increase with omalizumab has not been reported in literature. In an epidemiological study conducted on omalizumab, while the malignancy rate in cohorts receiving and not receiving omalizumab was 0.84 (95% confidence interval [CI], 0.62-1.13) for all malignancies, it was 0.98 (95% CI, 0.71-1.36) when non-melanoma skin cancers were excluded (18). In another randomized, double-blind, placebo-controlled clinical trial performed by Busse et al (19), no relationship was detected between omalizumab treatment and malignancy risk.…”

Section: Discussionmentioning

confidence: 99%

Omalizumab Treatment in Patients with Severe Allergic Asthma

Tat¹,

Çilli²

2017

Istanbul Med J

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Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab

Abstract: Results from EXCELS suggest that omalizumab therapy is not associated with an increased risk of malignancy.

Cited by 198 publications

References 16 publications

Monoclonal antibodies for the treatment of chronic rhinosinusitis with nasal polyposis: a systematic review

Monoclonal antibodies for the treatment of chronic rhinosinusitis with nasal polyposis: a systematic review

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

Omalizumab Treatment in Patients with Severe Allergic Asthma

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