Omalizumab may protect allergic patients against COVID-19: A systematic review

Giovanni, GHIGLIONI Daniele; Laura, E.T.C.O.Z.Z.I.; Riccardo, C.A.S.T.A.G.N.O.L.I.; Gaia, B.R.U.S.C.H.I.; Laura, M.A.F.F.E.I.S.; Giovanna, MARCHISIO Paola; Luigi, MARSEGLIA Gian; Amelia, L.I.C.A.R.I.

doi:10.1016/j.waojou.2023.100741

Cited by 5 publications

(5 citation statements)

References 71 publications

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“…The safety of omalizumab is further bolstered by its use with concomitant systemic steroids and Janus kinase inhibitors (eg, baricitinib) in severely ill patients with multiple preexisting comorbidities (including advanced and/or metastatic cancer in 9/40 patients). These results correspond to observational studies that have reported the safe use of omalizumab (for its existing indications) in combination with other biologics and in severe COVID-19 illness [ 15 , 37 , 38 ].…”

Section: Discussionsupporting

confidence: 87%

“…Omalizumab is a humanized anti-immunoglobulin E (IgE) monoclonal antibody (mAb) approved for the treatment of several mast cell–mediated diseases, notably moderate-severe allergic asthma, chronic idiopathic urticaria, and nasal polyps [ 14 ]. The drug has an excellent safety profile with more than 1.99 million patient-years of exposure including children, pregnant patients, the elderly, and individuals with multiple comorbidities [ 15 , 16 ]. Mild adverse drug reactions (AEs) (ie, malaise, urticaria, dizziness, skin rash) occur in ∼8% of patients, and the rate of serious adverse events (SAEs) is 1.2%, a similar rate to placebo [ 17–19 ].…”

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confidence: 99%

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COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)—a Randomized Controlled Clinical Trial

Le,

Khoury,

et al. 2024

Open Forum Infectious Diseases

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Background Omalizumab is an anti-IgE monoclonal antibody used to treat moderate to severe chronic idiopathic urticaria, asthma and nasal polyps. Recent research suggested that omalizumab may enhance the innate antiviral response and have anti-inflammatory properties. Objective We aimed to investigate the efficacy and safety of omalizumab in adults hospitalized for COVID-19 pneumonia. Methods This was a phase II randomized, double blind, placebo-controlled trial comparing omalizumab versus placebo (in addition to standard of care) in hospitalized COVID-19 patients. The primary endpoint was the composite of mechanical ventilation and/or death at day 14. Secondary endpoints included all-cause mortality at day 28, time to clinical improvement, and duration of hospitalization. Results Of 41 patients recruited, 40 were randomized (20 received the study drug and 20 placebo). The median age of the patients was 74 years and 55.0% were male. Omalizumab was associated with a 92.6% posterior probability of a reduction in mechanical ventilation and death on day 14 with an adjusted odds ratio (aOR) of 0.11 (95% Credible Interval (CrI) 0.002-2.05). Omalizumab was also associated with a 79.4% posterior probability of reduced all-cause mortality on day 28 with an aOR of 0.45 (95% CrI 0.06-3.12). No statistically significant differences were found for the time to clinical improvement and duration of hospitalization. Numerically fewer adverse events were reported in the omalizumab group and there were no drug-related serious adverse events. Conclusion These results suggest that omalizumab could prove protective against death and mechanical ventilation in hospitalized COVID-19 patients. This study could also support the development of a phase III trial program investigating the antiviral and anti-inflammatory effect of omalizumab for severe respiratory viral illnesses requiring hospital admission.

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Section: Discussionsupporting

confidence: 87%

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confidence: 99%

COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)—a Randomized Controlled Clinical Trial

Le,

Khoury,

et al. 2024

Open Forum Infectious Diseases

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“…It is tempting to speculate that biological therapies that can modulate the activity of eosinophils, IgE, and type 2 cytokines may dampen a part of the inflammatory response to SARS-CoV-2 infection. Omalizumab, for example, binds free serum IgE and prevents its binding to IgE receptors on mast cells, reducing degranulation and mediator release [ 22 ]. Mepolizumab and benralizumab, through IL-5 signal blocking, promote a reduction in eosinophils.…”

Section: Discussionmentioning

confidence: 99%

COVID-19 Clinical Features and Outcome in Italian Patients Treated with Biological Drugs Targeting Type 2 Inflammation

Sambugaro,

Brambilla,

Costanzo

et al. 2024

Life

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This is a multicentric investigation involving two Italian centers that examined the clinical course of COVID-19 in patients receiving biological therapy targeting type 2 inflammation and those not receiving biologicals. Since the beginning of the COVID-19 pandemic, the management of respiratory and allergic disorders and the potential impact of biological therapy in the most severe forms has been a point of uncertainty. Our multicentric investigation aimed to compare the clinical course of COVID-19 and the impact of vaccination in an Italian cohort of patients with atopic disorders caused by a type 2 inflammation, such as eosinophilic asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis (AD), and chronic spontaneous urticaria (CSU). A questionnaire was given to patients coming to our outpatient clinic for the first evaluation or follow-up visit, asking for the clinical characteristics of the infection, the ongoing therapy during the infection, any relevant change, and the patient’s vaccination status. We enrolled 132 atopic patients from two Italian centers; 62 patients were on biological therapy at the time of infection (omalizumab 31%, mepolizumab 26%, benralizumab 19%, and dupilumab 24%). The median age was 56 (IQR 22.8) for patients on biologicals and 48 (IQR 26.5) for those not on biologicals (p = 0.028). The two groups were comparable in terms of sex, body mass index (BMI), smoking history, and systemic oral corticosteroid use (OCS). There were no significant differences in non-biological therapy and comorbidity between the two groups. The patients not on biological therapy had a prevalence of 87% for asthma, 52% for CRSwNP, 10% for CSU, and 6% for AD. The patients on biologicals had a prevalence of 93% for asthma, 17% for CRSwNP, and 10% for CSU. In our work, we observed that mAbs targeting type 2 inflammation in patients with COVID-19 appeared to be safe, with no worsening of symptoms, prolongation of infection, or increase in hospitalizations. Between the two groups, there were no significant differences in the duration of swab positivity (p = 0.45) and duration of symptoms (p = 0.38). During COVID-19, patients on biologicals experienced a significant increase in common cold-like symptoms (p = 0.038), dyspnea (p = 0.016), and more, but not significant, asthma exacerbations, with no significant differences between the different biologicals. Regarding the vaccination status, we observed that there was an increased number of hospitalizations among unvaccinated patients in both groups, although the difference did not reach statistical significance. No patients on biologicals reported safety issues or adverse effects associated with the use of biological treatments during COVID-19. Our investigation showed that mAbs against type 2 inflammation given during Coronavirus Disease 2019 are safe and do not impact the clinical course or main outcomes. Therefore, we found no signals suggesting that anti-Th2 biological therapy should be discontinued during SARS-CoV-2 infection. Controlled studies and analysis, including data from registries and real-life studies, are required to draw firm conclusions regarding the safety or possible advantages that anti-type 2 mAbs could offer in particular clinical contexts, such as infections.

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“…However, a systematic review of data from 155 publications provided evidence of reduced incidence and severity of upper respiratory tract infections and asthma exacerbations with omalizumab. Nevertheless, there are insufficient data on the possible positive effect of anti-IgE therapy on COVID-19 and the need for new studies to prove this effect [135].…”

Section: Bronchial Asthma and Covid-19 Treatmentmentioning

confidence: 99%

Bronchial Asthma and COVID-19: Etiology, Pathological Triggers, and Therapeutic Considerations

Starshinova,

Borozinets,

Kulpina

et al. 2024

Pathophysiology

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Bronchial asthma (BA) continues to be a difficult disease to diagnose. Various factors have been described in the development of BA, but to date, there is no clear evidence for the etiology of this chronic disease. The emergence of COVID-19 has contributed to the pandemic course of asthma and immunologic features. However, there are no unambiguous data on asthma on the background and after COVID-19. There is correlation between various trigger factors that provoke the development of bronchial asthma. It is now obvious that the SARS-CoV-2 virus is one of the provoking factors. COVID-19 has affected the course of asthma. Currently, there is no clear understanding of whether asthma progresses during or after COVID-19 infection. According to the results of some studies, a significant difference was identified between the development of asthma in people after COVID-19. Mild asthma and moderate asthma do not increase the severity of COVID-19 infection. Nevertheless, oral steroid treatment and hospitalization for severe BA were associated with higher COVID-19 severity. The influence of SARS-CoV-2 infection is one of the protective factors. It causes the development of severe bronchial asthma. The accumulated experience with omalizumab in patients with severe asthma during COVID-19, who received omalizumab during the pandemic, has strongly suggested that continued treatment with omalizumab is safe and may help prevent the severe course of COVID-19. Targeted therapy for asthma with the use of omalizumab may also help to reduce severe asthma associated with COVID-19. However, further studies are needed to prove the effect of omalizumab. Data analysis should persist, based on the results of the course of asthma after COVID-19 with varying degrees of severity.

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Omalizumab may protect allergic patients against COVID-19: A systematic review

Cited by 5 publications

References 71 publications

COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)—a Randomized Controlled Clinical Trial

COVID-19 Immunologic Antiviral Therapy With Omalizumab (CIAO)—a Randomized Controlled Clinical Trial

COVID-19 Clinical Features and Outcome in Italian Patients Treated with Biological Drugs Targeting Type 2 Inflammation

Bronchial Asthma and COVID-19: Etiology, Pathological Triggers, and Therapeutic Considerations

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