Global registry aiming to improve angioedema care with real-world data
In 2 years, CARE has enrolled 500 patients across 18 countries
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An international registry collecting real-world data from people with recurrent angioedema — marked by repeated swelling episodes — has enrolled more than 500 patients across 18 countries in its first two years, according to a new study.
The database’s rapid expansion shows it’s already becoming “a robust global real-world resource” for recurrent forms of the rare disorder, the researchers wrote in detailing “what the first [two] years … have taught us.”
The team noted that the Chronic Angioedema Registry, dubbed CARE, has earned high satisfaction ratings from physicians at participating centers, and has been “achieving predefined milestones on schedule” for patient recruitment. Still, administrative and regulatory hurdles remain the main obstacles to broader participation, the researchers noted.
“Addressing regulatory and organizational barriers and strengthening tailored support and communication strategies will be essential to sustain growth, enhance participation, and maximize its long-term scientific and clinical impact,” the team wrote.
The study, “The Chronic Angioedema Registry: what the first 2 years since the implementation of the global registry have taught us,” was published in the journal Frontiers in Allergy.
Recurrent angioedema refers to a group of conditions marked by repeated episodes of swelling in the deeper layers of the skin or in the mucus membranes, which can result from a variety of underlying causes. Most commonly, it occurs as a consequence of chronic urticaria, also known as mast cell-mediated angioedema. Rarer forms include hereditary angioedema (HAE) and acquired angioedema caused by deficiency of C1 inhibitor (C1-INH), as well as rarer forms of HAE that occur despite normal C1-INH levels.
Questions remain despite major advances in angioedema care
While major advances in recent years have led to a better understanding of — and new treatments for — several forms of recurrent angioedema, many questions remain about how these diseases progress over time and how well therapies work in routine clinical practice. There’s also still not a lot of data on how angioedema affects patients’ quality of life outside controlled clinical trials.
These knowledge gaps are particularly pronounced for rarer forms of HAE, where relatively few patients have been studied, the researchers noted.
“Well-designed disease-specific registries, especially in rare diseases, can address gaps in clinical research and disease management with the overall aim of improving patient care,” the team wrote.
To learn more about the day-to-day experiences of people with angioedema, CARE was launched in October 2023. Unlike clinical trials, which follow patients and evaluate treatments under carefully controlled conditions, the international web-based registry collects real-world data. It’s open to people with any form of recurrent angioedema undergoing routine medical care across multiple countries and healthcare systems.
Participating centers complete a structured onboarding process that includes signing a collaboration agreement and obtaining local ethics approval. The centers also receive training on the registry platform. After providing informed consent, participants complete digital questionnaires regarding their symptoms, disease control, quality of life, and treatment response. Their physicians, meanwhile, record diagnoses and other clinical information. Follow-up questionnaires are completed every three to six months.
Study IDs ways to improve global registry
In this study, an international team of researchers assessed CARE’s first two years, examining patient enrollment, expansion into new centers, and implementation into clinical practice. The team also surveyed physicians from the Angioedema Centers of Reference and Excellence (ACARE), a global network of more than 100 specialized centers in more than 40 countries, to identify barriers during onboarding, overall satisfaction with the registry, and communication preferences.
By December 2025, CARE had enrolled 550 patients from 23 specialized centers in 18 countries, reaching both of its recruitment goals on schedule — 250 patients within the first year and 500 within the second. Since its launch, 22 centers have joined the registry, representing an average growth of about 10 new centers per year.
The largest number of patients were enrolled at ACARE in Berlin, Moscow, and Cape Town, South Africa. HAE was the most common diagnosis, accounting for 239 patients, including 25 HAE cases with normal C1-INH levels. Another 179 patients had mast cell–mediated angioedema, while 14 had acquired angioedema.
The physician survey involved 22 clinicians from 18 countries across five world regions. At the time of the survey, eight centers were already enrolling patients, while the remaining sites were still progressing through the onboarding process, including obtaining ethics approval, finalizing collaboration agreements, or preparing to begin recruitment.
By systematically addressing identified barriers and continuously adapting support measures based on user feedback, CARE is well positioned to further expand its global footprint and scientific impact.
The biggest barriers to joining CARE were administrative. Nearly two-thirds of respondents identified delays in ethics committee reviews, competing clinical priorities, limited staff time, and lengthy hospital approval procedures as major obstacles. In contrast, lack of awareness about how to join CARE, insufficient promotion of the registry, and limited support from the CARE Office were considered relatively minor barriers.
Despite these hurdles, overall satisfaction with CARE was high, averaging 4.3 of 5, with the highest ratings reported by centers already recruiting patients. Flexible regulatory requirements, stronger onboarding support, translated registry materials, and additional training resources — such as tutorials, templates, and videos — were identified as key measures to encourage participation, according to the study.
In-person meetings such as those at international congresses and conferences, along with newsletters and online meetings, were physicians’ preferred ways to receive registry updates.
“CARE has demonstrated rapid growth, high user satisfaction, and increasing international adoption within its first two years,” the researchers wrote. “By systematically addressing identified barriers and continuously adapting support measures based on user feedback, CARE is well positioned to further expand its global footprint and scientific impact.”
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