Atopic dermatitis is often under-treated despite various co-morbidities, reveal real-world data

Experts at Medaffcon have perused volumes of real-world data on patients with atopic dermatitis to provide new insights into co-morbidities and treatment patterns associated with the chronic skin condition.

Atopic dermatitis, or eczema, is often not treated according to guidelines despite its correlation with various co-morbidities and high disease burden especially in severe cases, reveal two collaborative large-scale studies by AbbVie and Medaffcon.

The presence of co-morbidities demonstrates that the effects of the condition are not limited to the skin, highlights Dr. Ville Kiiski, co-author of the studies and dermatologist at Aava Medical Centre.

“Atopic eczema is associated with elevated morbidity on a very broad basis across organ systems,” he tells. “Together the findings of these two studies underscore that, along with sound response and symptom management, it’d be important to investigate the effects of medications on co-morbidities in future long-term studies.”

The causes of the co-morbidities vary from inflammation to sleep disorders, psychosocial effects, and the increased infection risk arising from skin injury, insufficient barrier function and changes in the microbiome.

“Many are likely the sum of several factors,” says Dr. Kiiski.

The under-treated nature of the condition, in turn, is attributable to factors such as lack of therapeutic compliance stemming from treatment fatigue, unwarranted fears and concerns, and frustration with suboptimal effectiveness of earlier treatments.

Data from six national registers

The idea for the research project came from AbbVie. Dr. Jaakko Kopra, medical manager at Abbvie, tells that the company realised in autumn 2019 that surprisingly few studies about atopic eczema have been published in Finland.

“And the studies were mostly a few decades old,” he adds. “This was surprising because atopic eczema is very common across Northern Europe. In Finland, it can be regarded almost as a chronic public disease.”

“At the time new treatment options were also changing the treatment of atopic eczema, creating a need to better understand the prevalence, disease burden, resource use and treatment patterns in Finland.”

Almost 128,500 patients were identified for the retrospective studies based on real-world data, including records from both primary and secondary healthcare, produced in Finland in 2013–2019. The studies therefore provide a comprehensive overview of co-morbidities and treatment patterns associated with the condition prior to the introduction of treatments such as biologics and Janus kinase (JAK) inhibitors.

The data were obtained from nationwide registers maintained by six data administrators: the two largest private healthcare providers in Finland, Mehiläinen and Terveystalo, and the Finnish Institute for Health and Welfare (THL), Finnish Centre for Pensions, Social Insurance Institution of Finland (Kela), and Statistics Finland.

Access to all the data was granted by the Finnish Social and Health Data Permit Authority (Findata).

“The idea today is that there’s one authority that processes the applications, handles communication with the different registers and combines the data. That’s how Findata’s establishment made it possible for us to obtain data from this many different registers and compile them into such a massive set,” says Johanna Vikkula, data scientist at Medaffcon.

Examining such a high number of patients would be effectively impossible without digital data and the single-window access point, she believes.

“It’s great that we’ve had the opportunity to pore through the data exhaustively, truly delve into the different aspects of atopic dermatitis and publish the findings one piece at a time rather than stuffing them all together.”

The study was designed, its results analysed and interpreted, and the publishing plan determined in collaboration between AbbVie and Medaffcon, tells Dr. Kopra.

“This has been a close collaborative effort from start to finish,” he stresses. “The project was launched already in 2019, and I don’t think the last findings will be published until 2024. These kinds of studies require multidisciplinary collaboration, commitment and good communication – and previous experience doesn’t hurt either.”

For real-world evidence, pros outweigh cons

Real-world data have been critical for enhancing understanding of atopic dermatitis within the medical community, views Dr. Kiiski from Aava Medical Centre.

“Real-world data have been very important to better understand the development needs and overall situation. Real life differs enormously from the optimised settings of clinical pharmaceutical studies,” he tells.

Using real-world data does present its own challenges, though, which require a thorough understanding of the data, clinical processes and record-keeping practices, and the nature and treatment of the condition in question.

“Because we’re talking about real-world data, there may be some missing values or entries that are subject to interpretation,” tells Medaffcon’s Vikkula. “In any kind of study based on real-world evidence, I’d say we spend the lion’s share of our time on processing and cleaning up the data, whereas the analyses themselves can be performed a lot quicker.”

One common challenge is establishing a set of criteria that identifies patients with the condition that is the focus of the study – without wrongly excluding or including anyone. The research team achieved this by relying primarily on disease codes in patient records and reimbursement codes for medication purchases.

Determining the severity of the condition for each patient was an even greater challenge, according to Dr. Kiiski and Vikkula. The team ultimately established three severity groupings – mild, moderate and severe – based on a number of variables, such as the consumption of topical medications and frequency of different clinic contacts.

“It’s extremely difficult to define the severity of a disease where the symptoms ebb and flow pronouncedly and there’s no numerical value for the severity in the registers. The indirect measurements we used included contacts with specialised hospital care, and data on phototherapy periods, topical purchases and systemic medications,” recounts Dr. Kiiski.

Relying on several criteria also reduced the risk of error in the groupings, adds Vikkula. For instance, if a patient was grouped incorrectly due to non-adherence to topical medications, they would have likely satisfied another criterion and ended up in the appropriate grouping.

“Despite the challenges – the data not always being comprehensive and possibly containing some mistakes – I’m confident that the major conclusions are always valid,” she concludes.