Characteristics of patients with severe asthma who experienced treatment failure with omalizumab

Akaba, Tomohiro; Kondo, Mitsuko; Kobayashi, Fumi; Honda, Namio; Muramatsu, Soshi; Yagi, Osamitsu; Takamatsu, Kiyoshi; Seo, Yukako; Nonaka, Manabu; Tagaya, Etsuko

doi:10.1016/j.pupt.2021.102032

Cited by 7 publications

(5 citation statements)

References 25 publications

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“…Furthermore, Akaba et al. reported that among their cohort of 59 individuals with asthma who did not achieve adequate disease control with omalizumab, eosinophilic sinusitis was an independent risk factor for lack of asthma improvement, with an OR of 23.4 113 . Additionally, Peters et al.…”

Section: Resultsmentioning

confidence: 99%

“…112 Furthermore, Akaba et al reported that among their cohort of 59 individuals with asthma who did not achieve adequate disease control with omalizumab, eosinophilic sinusitis was an independent risk factor for lack of asthma improvement, with an OR of 23.4. 113 Additionally, Peters et al performed an indirect treatment comparison of dupilumab versus omalizumab and demonstrated greater improvement in CRSwNP outcomes (including nasal polyp score, nasal congestion, smell loss, total symptom score, and 40-Question Smell Identification Test scores) among individuals with comorbid asthma who received dupilumab. 114 The authors did not differentiate between asthma with versus without AERD/N-ERD or analyze asthma specific outcomes.…”

Section: Biologics and Crswamentioning

confidence: 99%

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Management paradigms for chronic rhinosinusitis in individuals with asthma: An evidence‐based review with recommendations

Gill

Alt

Detwiller³

et al. 2023

Int Forum Allergy Rhinol

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BackgroundDespite the significant morbidity associated with chronic rhinosinusitis (CRS) in individuals with asthma (CRSwA), there is a paucity of codified, evidence‐based management strategies for CRS in this population.MethodsUsing PubMed, Embase, and Cochrane Review Databases, a systematic review was performed covering management strategies for CRSwA. A total of 5903 articles were screened, and 70 were included for full‐text analysis. After application of exclusion criteria, 53 articles comprised the qualitative synthesis. The level of evidence was graded and benefit‐harm assessments, as well as value judgment and recommendations, were providedResultsStrong evidence confirms the benefit of oral and topical medications on sinonasal‐specific outcomes in individuals with CRSwA; there is low‐grade evidence demonstrating that these agents improve lung function and/or asthma control. Moderate to strong evidence suggests that endoscopic sinus surgery (ESS) improves both sinonasal‐ and asthma‐specific quality of life. Although there is insufficient to low evidence to indicate that ESS improves pulmonary function in this population, data indicate a positive impact of this intervention on asthma control. Biologic medications strongly improve both subjective and objective sinonasal‐ and asthma‐specific outcomes.ConclusionEvidence supports managing CRS in individuals with CRSwA in a stepwise fashion, starting with traditional nonbiologic oral and topical medication, and escalating to second‐line treatments, such as ESS and biologics. Optimal treatment of individuals who have CRSwA often requires concurrent, directed management of asthma, as not all CRS interventions impact asthma status.

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Section: Resultsmentioning

confidence: 99%

Section: Biologics and Crswamentioning

confidence: 99%

Management paradigms for chronic rhinosinusitis in individuals with asthma: An evidence‐based review with recommendations

Gill

Alt

Detwiller³

et al. 2023

Int Forum Allergy Rhinol

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“…Several studies have evaluated omalizumab effectiveness in treating severe asthma; a randomized controlled trial discovered that severe asthma patients with high blood eosinophil counts, FeNO levels, and serum periostin experienced a significant reduction in exacerbation frequency [22]. However, eosinophilic rhinosinusitis is associated with treatment failure with omalizumab, and received benralizumab as an alternative therapy [23]. That came in concordance with our data; CRS was associated with poor response to omalizumab, in addition, all cases on benralizumab had been switched from omalizumab.…”

Section: Discussionmentioning

confidence: 99%

Factors influencing poor response to type 2 targeted therapies in severe asthma: a retrospective cohort study

Al-Ahmad,

Ali,

Maher

2023

BMC Pulm Med

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Background A significant breakthrough has been made in treating severe asthma, with the recognition of various asthma phenotypes and an updated management guideline. Type 2 targeted therapies, such as benralizumab and omalizumab; have been identified as an effective treatment for severe asthma, improving patient response, lung function tests and asthma symptom control. This study aimed to evaluate factors contributing to poor response to therapy. Methods A retrospective single-center cohort study of 162 patients with severe asthma who started biologic therapy; their data were retrieved from medical records for further analysis. Poor responders were patients remained clinically and functionally uncontrolled despite even after augmenting all treatment options. Results Childhood-onset asthma, bronchiectasis, poor symptom control (ACT below 19), severe airway obstruction (< 60% predicted), and maintenance oral corticosteroid (mOCS) use were significantly associated with poor response to omalizumab and benralizumab; p = 0.0.4 and 0.01; 0.003 and 0.01; 0.01 and 0.001, 0.05 and 0.04; 0.006 and 0.02, respectively. However, chronic rhinosinusitis and IgE < 220kIU/L were associated with higher poor response rates to omalizumab (p = 0.01 and 0.04, respectively). At the same time, female patients and those with blood eosinophils level < 500 cells/mm3 had a higher poor response rate to benralizumab (p = 0.02 and 0.01, respectively). Ischemic heart disease (IHD), bronchiectasis, and continued use of OCS increased the likelihood of poor response to omalizumab by 21, 7, and 24 times (p = 0.004, 0.008, and 0.004, respectively). In contrast, the female gender, childhood-onset asthma and higher BMI increased the likelihood of poor response to benralizumab by 7, 7 and 2 times more, p = 0.03, 0.02 and 0.05, respectively. Conclusion Poor response to omalizumab treatment was independently associated with ischemic heart disease (IHD), bronchiectasis, and a history of maintenance oral corticosteroid (mOCS) use. Conversely, poor response to benralizumab therapy was independently linked to female gender, childhood-onset asthma and higher body mass index (BMI).

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“…This study revealed omalizumab-related ear disorders using a real-world pharmacovigilance database. Although omalizumab safety was generally considered tolerable, as reported in clinical trials [ 15 , 16 ], a RCT [ 16 ] and a report [ 18 ] demonstrated the onset of ear disorders after omalizumab use in patients with asthma. This study found symptoms of EOM, such as deafness, otorrhea, and tympanic membrane perforation, in omalizumab AE reports, consistent with previous studies [ 20 , 21 , 33 , 34 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, a randomized clinical trial (RCT) of omalizumab in children with asthma reported earache [ 16 ]. Other studies reported that eosinophilic comorbidities could occur during omalizumab treatment in the ear, nose, and throat (ENT), particularly eosinophilic otitis media (EOM) [ 18 ]. EOM showed a high rate of comorbidity with asthma and is characterized by discharge with a high concentration of eosinophils and high viscosity in the middle ear cavity [ 19 , 20 ].…”

Section: Introductionmentioning

confidence: 99%

Is Omalizumab Related to Ear and Labyrinth Disorders? A Disproportionality Analysis Based on a Global Pharmacovigilance Database

Park

Jung

et al. 2022

Diagnostics

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Introduction: Asthma is a chronic disease, characterized by reversible airway obstruction, hypersensitivity reactions, and inflammation. Oral corticosteroids are an important treatment option for patients with severe or steroid-resistant asthma. Biologics for asthma are recommended in patients with severe asthma, owing to their steroid-sparing effect as well as their ability to reduce the severity and aggravation of uncontrolled asthma. Most clinical trials of omalizumab in patients with asthma have suggested its tolerability and safety. However, some studies reported eosinophilic comorbidities in the ear, nose, and throat during omalizumab treatment, particularly eosinophilic otitis media. This study examined the relationship between ear disorders and omalizumab compared with that of other biologics for asthma using a large real-world database. Materials and Methods: Individual case safety reports from the Uppsala Monitoring Centre Vigibase of biologics for asthma (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) up to December 29, 2019, were used. A disproportionality analysis was performed using the proportional reporting ratio (PRR), reporting odds ratio (ROR), and information components (IC). A hierarchy analysis used the Medical Dictionary for Regulatory Activities Terminology. A tree map was generated using R studio version 4.2. Results: In 32,618 omalizumab reports, 714 adverse events (AEs) were detected as signals. Among the 714 signals, seventeen AEs were detected as signals of omalizumab-related ear and labyrinth disorders in 394 reports. Only three AEs (ear pain, ear disorder, and ear discomfort) were detected from mepolizumab. No signal was detected from reslizumab, benralizumab, and dupilumab. Conclusions: Careful monitoring of ear disorders is recommended when omalizumab treatment is started, with decreased oral corticosteroid use in patients with severe asthma. Further studies are necessary to confirm the omalizumab-related signals.

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Characteristics of patients with severe asthma who experienced treatment failure with omalizumab

Cited by 7 publications

References 25 publications

Management paradigms for chronic rhinosinusitis in individuals with asthma: An evidence‐based review with recommendations

Management paradigms for chronic rhinosinusitis in individuals with asthma: An evidence‐based review with recommendations

Factors influencing poor response to type 2 targeted therapies in severe asthma: a retrospective cohort study

Is Omalizumab Related to Ear and Labyrinth Disorders? A Disproportionality Analysis Based on a Global Pharmacovigilance Database

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