Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO

Chipps, Bradley E.; Zeiger, Robert S.; Luskin, Allan T.; Busse, William W.; Trzaskoma, Benjamin; Antonova, Evgeniya; Pazwash, Hooman; Limb, Susan L.; Solari, Paul G.; Griffin, Noelle M.; Casale, Thomas B.

doi:10.1016/j.anai.2017.09.056

Cited by 30 publications

(55 citation statements)

References 69 publications

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“…General characteristics of the twelve included studies that reported on study‐emergent solid epithelial cancer are summarized in Tables and . Additional details can be found in Appendix .…”

Section: Resultsmentioning

confidence: 99%

“…Collectively, these studies included a total of 11 758 participants and encompassed three study types. Three were RCTs, one was a comparative observational study (prospective cohort), and eight were non‐comparative observational studies . Their publication dates ranged from 2002 to 2018; however, 75% were published in the last 5 years.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Eight other observational studies were non‐comparative longitudinal studies that evaluated outcomes in a group of participants sampled on the basis of a single exposure (ie all subjects received omalizumab). Four studies (67%) were prospective, two were registry studies, and five were completed at a single centre. One study was funded by Novartis Pharmaceuticals, two studies were funded by both Genentech Inc and Novartis Pharmaceuticals, three declared no funding, and the others did not report on study funding.…”

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Influence of prolonged treatment with omalizumab on the development of solid epithelial cancer in patients with atopic asthma and chronic idiopathic urticaria: A systematic review and meta‐analysis

Johnston

Smith

Zheng

et al. 2019

Clin Experimental Allergy

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Objective: We investigated whether prolonged treatment with omalizumab influences development or progression of solid epithelial cancer in patients with atopic asthma or chronic idiopathic urticaria. Design: Systematic review and meta-analysis of intervention and observational studies. Randomized controlled trials were assessed for risk of bias using the Cochrane Risk of Bias tool, comparative observational studies were assessed using the Newcastle-Ottawa Scale, and non-comparative observational studies were assessed using the Joanna Briggs Institute Checklist for Prevalence Studies. Data sources: We searched MEDLINE, EMBASE, Cochrane Library and grey literature for eligible studies Eligibility criteria for included studies: Randomized, quasi-randomized, controlled clinical trials and observational studies were included if they involved patients ≥ 12 years with moderate-to-severe persistent asthma or chronic idiopathic urticaria treated with omalizumab for ≥ 40 weeks. Eligible comparators included standard of care, placebo, cromoglycate or no treatment. Results:One hundred and sixty seven unique studies were eligible for inclusion; however, only twelve (7.2%, n = 11 758) reported any outcome of interest, none of which

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Influence of prolonged treatment with omalizumab on the development of solid epithelial cancer in patients with atopic asthma and chronic idiopathic urticaria: A systematic review and meta‐analysis

Johnston

Smith

Zheng

et al. 2019

Clin Experimental Allergy

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“…OSA is a well‐known comorbidity of asthma . An important American multicentre real‐life study found prevalence of OSA in omalizumab‐eligible patients being 14.6% . A 2017 large meta‐analysis reported prevalence of OSA in adult asthma patients as 49.5% and the odds of having OSA by asthma patients was 2.64 times higher than in controls .…”

Section: Introductionmentioning

confidence: 99%

Omalizumab as add‐on therapy in a patient with severe asthma and OSA

Scioscia

Buonamico

Barbaro

et al. 2020

Respirology Case Reports

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Obstructive sleep apnoea (OSA) syndrome, the most frequent sleepdisordered breathing, is a comorbidity of asthma, whose prevalence covers about 49.5% of asthmatic adult patients. A 61-year-old female patient, affected by severe allergic asthma and obesity, started treatment with omalizumab and underwent polysomnography showing a severe OSA pattern (apnoea/hypopnoea index (AHI): 72.7). After six months, she showed functional improvement and good asthma symptoms control and underwent a new polygraphy for the persistence of the night symptoms which showed an ameliorated, despite still severe, OSA pattern (AHI: 31.9). The patient obtained complete polygraphic normalization after adequate positive airway pressure (PAP) titration. While bronchodilator efficacy in chronic obstructive pulmonary disease (COPD)/OSA overlap syndrome has been proven in raising nocturnal oxygen saturation, there is no such evidence about biological therapy in patients affected by severe asthma and OSA. This is the first documented case report that demonstrates a possible role of omalizumab in improving the OSA pattern in a patient affected by severe asthma and OSA.

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Adrenal insufficiency is a contraindication for omalizumab therapy in mast cell activation disease: risk for serum sickness

Molderings

Dumoulin

Homann

et al. 2020

Naunyn-Schmiedeberg's Arch Pharmacol

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Omalizumab is an effective therapeutic humanized murine IgE antibody in many cases of primary systemic mast cell activation disease (MCAD). The present study should enable the clinician to recognize when treatment of MCAD with omalizumab is contraindicated because of the potential risk of severe serum sickness and to report our successful therapeutic strategy for such adverse event (AE). Our clinical observations, a review of the literature including the event reports in the FDA AE Reporting System, the European Medicines Agency Eudra-Vigilance databases (preferred search terms: omalizumab, Xolair®, and serum sickness) and information from the manufacturer’s Novartis database were used. Omalizumab therapy may be more likely to cause serum sickness than previously thought. In patients with regular adrenal function, serum sickness can occur after 3 to 10 days which resolves after the antigen and circulating immune complexes are cleared. If the symptoms do not resolve within a week, injection of 20 to 40 mg of prednisolone on two consecutive days could be given. However, in MCAD patients whose adrenal cortical function is completely suppressed by exogenous glucocorticoid therapy, there is a high risk that serum sickness will be masked by the MCAD and evolve in a severe form with pronounced damage of organs and tissues, potentially leading to death. Therefore, before the application of the first omalizumab dose, it is important to ensure that the function of the adrenal cortex is not significantly limited so that any occurring type III allergy can be self-limiting.

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Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO

Abstract: ClinicalTrials.gov Identifier: NCT01922037.

Cited by 30 publications

References 69 publications

Influence of prolonged treatment with omalizumab on the development of solid epithelial cancer in patients with atopic asthma and chronic idiopathic urticaria: A systematic review and meta‐analysis

Influence of prolonged treatment with omalizumab on the development of solid epithelial cancer in patients with atopic asthma and chronic idiopathic urticaria: A systematic review and meta‐analysis

Omalizumab as add‐on therapy in a patient with severe asthma and OSA

Adrenal insufficiency is a contraindication for omalizumab therapy in mast cell activation disease: risk for serum sickness

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