Omalizumab treatment in combination with any other biologics: Is it really a safe duo?

Yıldırım, Sema Koç; Erbağcı, Ece; Hapa, Aslı

doi:10.1111/ajd.14019

Cited by 3 publications

(2 citation statements)

References 23 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%

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%

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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“…Although detailed guidelines are available for management of omalizumab [ 132 ], there are still unmet needs that should be addressed with future research. Areas that we believe could warrant more information to optimize use of omalizumab include the potential role of CSU pathogenesis in an individual (including autoallergy, anti-IgE antibodies, and angioedema) on the response to omalizumab; combination treatment (especially with other biologics [ 133 ]) for patients with comorbidities or slow responders; influence of pregnancy (by an initial analysis, pregnancy outcomes for patients with CSU treated with omalizumab were similar to patients with asthma where no increased risk was observed [ 134 ]); and the impact of race on access [ 135 ] and response.…”

Section: Clinicians’ Perspectivementioning

confidence: 99%

Omalizumab for Patients with Chronic Spontaneous Urticaria: A Narrative Review of Current Status

Casale,

Gimenez-Arnau,

Bernstein

et al. 2023

Dermatol Ther (Heidelb)

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Chronic spontaneous urticaria (CSU) is a debilitating inflammatory disorder of the skin, characterized by a fluctuating natural history, a complex mechanism of action, and a significant burden on patients, including effect on quality of life, development of psychosocial disorders, and a range of comorbidities. Recent international guidelines recommend a therapeutic approach of first-line treatment with second generation H1-antihistamines and second-line treatment with the biologic omalizumab. Here, the salient aspects of CSU and current status of data for omalizumab for patients with CSU are reviewed, with a focus on mechanism of action, efficacy and real-world effectiveness (including patient outcomes, response, relapse, and remission), and safety (including consideration of the risk of anaphylaxis). The review also considers recent data on COVID-19, CSU, and omalizumab and presents our perspective on future needs. Overall, the data suggest that omalizumab is an effective and well-tolerated treatment for patients with CSU that provides benefits for a wide range of patients.

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Combination treatment with monoclonal antibodies for the management of severe asthma and immune-mediated inflammatory diseases: a comprehensive review

Carriera,

Caporuscio,

Fantò

et al. 2024

Monaldi Arch Chest Dis

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Biological drugs have revolutionized the management of severe asthma, and a tailored treatment approach made it possible to consider remission as an achievable treatment target. The incidence of autoimmune diseases is increasing in many parts of the world. Patients suffering from severe asthma, eligible or already treated with an asthma-approved biologic agent, may suffer from another immune-mediated inflammatory disease (IMID) that could require the simultaneous use of a second monoclonal antibody. The real-life studies available in the literature describing the concurrent administration of an asthma-approved biologic agent with another biologic for a different immune disease, obtained through a systematic search on online databases based on monoclonal antibodies, were collected and analyzed. 26 articles were included in this review according to the prespecified inclusion and exclusion criteria. All included papers were retrospective in nature. Study designs were case reports (n=18), case series (n=3), retrospective chart reviews (n=3), retrospective observational studies (n=1), and cohort studies (n=1). The study is intended to present, within the current literature, all the administered combinations of severe asthma-approved biologics with monoclonal antibodies for a different indication. Those were grouped according to the IMID for whom the second biologic agent, with a different mechanism of action, was prescribed. The combinations prescribed to the cohort of patients specifically treating uncontrolled severe asthma were deeper evaluated in the discussion section, since an analysis of these therapeutic combinations deriving from real-life experiences may be useful to optimize the management of patients with severe asthma, ultimately leading to improved patient care and outcomes. Prospective registries and future studies are required to assess the safety and efficacy of combination therapies for severe asthmatic patients who suffer from an IMID.

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Omalizumab treatment in combination with any other biologics: Is it really a safe duo?

Cited by 3 publications

References 23 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

Omalizumab for Patients with Chronic Spontaneous Urticaria: A Narrative Review of Current Status

Combination treatment with monoclonal antibodies for the management of severe asthma and immune-mediated inflammatory diseases: a comprehensive review

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