Abstract:Omalizumab, a recombinant anti-immunoglobulin E (IgE) monoclonal antibody, is indicated for moderate to severe allergic asthma, chronic spontaneous urticaria, and nasal polyps, and is approved for self-administration. However, specific guidance on identifying candidates with characteristics suitable for this type of administration is lacking. To help address this issue, this article provides practical considerations for the health care provider treating patients with omalizumab. We encourage health care provid… Show more
“…Omalizumab has been on the market since 2003 and is approved for self-administration by appropriate patients. 16,17 During the COVID-19 pandemic efforts were made to reduce non-essential hospital care, therefore self-administration of biologics, such as omalizumab, increased. 23 Patients favor home administration due to cost and time savings, with improved flexibility, and fewer hospital visits.…”
Section: Discussionmentioning
confidence: 99%
“…[12][13][14][15] The availability of omalizumab for self-administration allows for greater independence for the patient in the management of their condition. 16,17 Patient convenience for administration of omalizumab could be further improved, particularly by reducing the number of injections per dose administration. To address this issue, new product configurations of omalizumab solution for injection have been developed, specifically a single 300 mg/2 mL dose omalizumab administered in a PFS with either an autoinjector (AI) or NSD.…”
mentioning
confidence: 99%
“…Clinical trials, in adults, adolescents and children, have shown omalizumab to be generally well tolerated. 12–15 The availability of omalizumab for self‐administration allows for greater independence for the patient in the management of their condition 16,17 . Patient convenience for administration of omalizumab could be further improved, particularly by reducing the number of injections per dose administration.…”
Omalizumab is an anti‐IgE monoclonal antibody currently approved for the treatment of asthma, nasal polyps/chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Omalizumab is available as an injection in a prefilled syringe (PFS) with a needle safety device (NSD). New product configurations were developed to reduce the number of injections per dose administration, improve patient convenience and treatment compliance. The objective of this randomized open‐label 12‐week study was to demonstrate pharmacokinetic bioequivalence between (1) new PFS with autoinjector (PFS‐AI), (2) new PFS‐NSD configuration, and (3) current PFS‐NSD configuration. Each new configuration was considered bioequivalent to the current configuration if the confidence intervals (CIs) for the geometric mean ratios (GMR) were contained in the 0.80‐1.25 range for maximum concentration (Cmax), area under the concentration‐time curve until the last quantifiable measurement (AUClast), and AUC extrapolated to infinity (AUCinf). Safety was assessed throughout the study. In total, 193 healthy volunteers were randomized at 1:1:1 ratio to omalizumab 1×300 mg/2 mL via new PFS‐AI (n = 66), omalizumab 1×300 mg/2 mL via new PFS‐NSD (n = 64), or omalizumab 2×150 mg/1 mL via current PFS‐NSD (n = 63). Comparing new PFS‐AI versus current PFS‐NSD, the GMRs were: Cmax, 1.085; AUClast, 1.093; AUCinf, 1.100. Comparing new PFS‐NSD versus current PFS‐NSD, the GMRs were: Cmax, 1.006; AUClast, 1.016; AUCinf, 1.027. The 95% CIs for all GMR parameters were contained within the 0.80‐1.25 range. Safety findings were consistent with the known safety profile of omalizumab. Single‐dose omalizumab administered as the new PFS‐AI or new PFS‐NSD was bioequivalent to the current PFS‐NSD.
“…Omalizumab has been on the market since 2003 and is approved for self-administration by appropriate patients. 16,17 During the COVID-19 pandemic efforts were made to reduce non-essential hospital care, therefore self-administration of biologics, such as omalizumab, increased. 23 Patients favor home administration due to cost and time savings, with improved flexibility, and fewer hospital visits.…”
Section: Discussionmentioning
confidence: 99%
“…[12][13][14][15] The availability of omalizumab for self-administration allows for greater independence for the patient in the management of their condition. 16,17 Patient convenience for administration of omalizumab could be further improved, particularly by reducing the number of injections per dose administration. To address this issue, new product configurations of omalizumab solution for injection have been developed, specifically a single 300 mg/2 mL dose omalizumab administered in a PFS with either an autoinjector (AI) or NSD.…”
mentioning
confidence: 99%
“…Clinical trials, in adults, adolescents and children, have shown omalizumab to be generally well tolerated. 12–15 The availability of omalizumab for self‐administration allows for greater independence for the patient in the management of their condition 16,17 . Patient convenience for administration of omalizumab could be further improved, particularly by reducing the number of injections per dose administration.…”
Omalizumab is an anti‐IgE monoclonal antibody currently approved for the treatment of asthma, nasal polyps/chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Omalizumab is available as an injection in a prefilled syringe (PFS) with a needle safety device (NSD). New product configurations were developed to reduce the number of injections per dose administration, improve patient convenience and treatment compliance. The objective of this randomized open‐label 12‐week study was to demonstrate pharmacokinetic bioequivalence between (1) new PFS with autoinjector (PFS‐AI), (2) new PFS‐NSD configuration, and (3) current PFS‐NSD configuration. Each new configuration was considered bioequivalent to the current configuration if the confidence intervals (CIs) for the geometric mean ratios (GMR) were contained in the 0.80‐1.25 range for maximum concentration (Cmax), area under the concentration‐time curve until the last quantifiable measurement (AUClast), and AUC extrapolated to infinity (AUCinf). Safety was assessed throughout the study. In total, 193 healthy volunteers were randomized at 1:1:1 ratio to omalizumab 1×300 mg/2 mL via new PFS‐AI (n = 66), omalizumab 1×300 mg/2 mL via new PFS‐NSD (n = 64), or omalizumab 2×150 mg/1 mL via current PFS‐NSD (n = 63). Comparing new PFS‐AI versus current PFS‐NSD, the GMRs were: Cmax, 1.085; AUClast, 1.093; AUCinf, 1.100. Comparing new PFS‐NSD versus current PFS‐NSD, the GMRs were: Cmax, 1.006; AUClast, 1.016; AUCinf, 1.027. The 95% CIs for all GMR parameters were contained within the 0.80‐1.25 range. Safety findings were consistent with the known safety profile of omalizumab. Single‐dose omalizumab administered as the new PFS‐AI or new PFS‐NSD was bioequivalent to the current PFS‐NSD.
“…Patient monitoring is often recommended after the first three doses of the drug because anaphylaxis—although rare—is more likely to occur within this time frame [ 26 ]. In the last 2 years, the FDA has also approved home self-administration of omalizumab [ 27 ].…”
Chronic spontaneous urticaria (CSU) is a condition in which wheals, angioedema, and pruritus occur spontaneously and recurrently for at least 6 weeks. The etiology of this disease is partially dependent on production of autoantibodies that activate and recruit inflammatory cells. Although the wheals can resolve within 24 h, symptoms have a significant detrimental impact on the quality of life of these patients. Standard therapy for CSU includes second-generation antihistamines and omalizumab. However, many patients tend to be refractory to these therapies. Available treatments such as cyclosporine, dapsone, dupilumab, and tumor necrosis factor alpha (TNFa) inhibitors have been used with success in some cases. Furthermore, various biologics and other novel drugs have emerged as potential treatments for this condition, and many more are currently under investigation in randomized clinical trials.
“…1 for a summary). Moreover, omalizumab is approved for self-administration by appropriate patients with CSU and this has many practical and psychological benefits [ 129 – 131 ] and could contribute to improvements in QoL. Fig.…”
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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