The impact of home treatment and self-administration of omalizumab on chronic urticaria

Wiuff, Anne Christine; Wiis, Malthe Alexander Knudsgaard; Heilskov, Sofine; Frølunde, Anne Sofie; Sørensen, Jennifer Astrup; Deleuran, Mette; Thomsen, Simon Francis; Vestergaard, Christian

doi:10.1016/j.waojou.2022.100725

Cited by 2 publications

(2 citation statements)

References 16 publications

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“…23 Patients favor home administration due to cost and time savings, with improved flexibility, and fewer hospital visits. 16,23,24 Auto-injector devices have become well established for many products used in various diseases with demonstrated benefits. [18][19][20] The new omalizumab PFS-AI is a single-use disposable device that will administer 1x300 mg/2 mL into subcutaneous tissue upon cap removal and device actuation, and requires no skin pinching.…”

Section: Discussionmentioning

confidence: 99%

“…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 16,23,24 . Auto‐injector devices have become well established for many products used in various diseases with demonstrated benefits 18–20 …”

Section: Discussionmentioning

confidence: 99%

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Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers

Sangana,

Xu,

Shah

et al. 2024

Clinical Pharm in Drug Dev

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers

Sangana,

Xu,

Shah

et al. 2024

Clinical Pharm in Drug Dev

View full text Add to dashboard Cite

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Cost‐of‐illness analysis of chronic urticaria clinical management in five countries of Latin America

Sánchez,

Álvarez,

Larco

et al. 2025

Clinical & Translational All

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IntroductionChronic spontaneous urticaria (CSU) is a disease with a high impact on the quality of life of patients. There are some evaluations of the economic cost of the disease in developed countries, but there is little information about the economic cost of the disease in developing countries. Our aim was to assess the economic diagnostic and therapeutic expenses of CSU in five Latin American (LA) countries.MethodsA noninterventional multicenter cross‐sectional study was conducted in five LA countries: Brazil, Colombia, Ecuador, Mexico, and Peru. To determine the frequency of medical interventions as well as clinical and sociodemographic characteristics of CSU patients, questionnaires were administered to patients, primary care physicians, allergists, and dermatologists. In each country, diagnostics and therapeutic expenses were calculated by reviewing medical records, health insurance, and interviews. The main outcome was the yearly economic burden from the healthcare insurance perspective in each country.ResultsAccording to the projected costs, Brazil had the highest urticaria cost per patient/year (7009.4 USD), followed by Mexico (3695.1 USD), Ecuador (3132.8 USD), Peru (2693.9 USD), and Colombia (2392.8 USD); the cost and the frequency of use of omalizumab and antihistamines explain the total cost differences between countries. Interventions such as medical visits and exams had similar costs between countries and represented less than 10% of total urticaria cost analysis in the five countries.ConclusionThe cost of the CSU in LA varies widely based on the health insurance coverage, the cost of the therapies, and the frequency of therapies used. Strengthening national health systems, as well as following the recommendations of international guidelines, seems to reduce the cost of CSU and improve the quality of patients.

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The impact of home treatment and self-administration of omalizumab on chronic urticaria

Cited by 2 publications

References 16 publications

Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers

Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers

Cost‐of‐illness analysis of chronic urticaria clinical management in five countries of Latin America

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