Much more than just a skin condition: putting patients at the heart of care

One of the most innovative concepts to emerge from research in recent years is that the patient is the best indicator of the status of their own condition. Unlike many chronic conditions, there are no reliable biomarkers for CSU that allow for the precise measurement of clinical activity or the degree of therapeutic control. For this reason, assessment must necessarily be based in part on the patient’s own experience.

Patient-Reported Outcomes (PROs) make it possible to measure aspects that the doctor cannot observe directly, such as the intensity of itching, sleep quality, limitations in family and social life, work productivity, psychological impact and the patient’s perception of control over their condition. Modern medicine now regards these parameters as genuine clinical treatment objectives, on a par with the objective data collected by the doctor during a consultation.

The International Guidelines are now the world’s leading reference for the management of urticaria. The document introduces a principle designed to change everyday clinical practice, as at each consultation the patient must be assessed across three key dimensions: disease activity, level of control and impact on quality of life. For this reason, specific Patient-Reported Outcome Measures (PROMs) are recommended:

- for disease activity: UAS7 (Urticaria Activity Score 7)

- for monitoring the condition (UCT – Urticaria Control Test)

- for quality of life: CU-Q2oL and DLQI

- for patients with angioedema: AAS, AECT and AE-Qo.

The guidelines also emphasise that the therapeutic aim must be complete control of the disease, leading to a return to a normal quality of life, rather than merely alleviating symptoms.

One of the most important Italian real-world studies is based on the international AWARE registry, which followed 247 patients with chronic urticaria from 24 specialist centres in Italy over a two-year period. The main objective of the study was to assess changes in Patient-Reported Outcomes during treatment, using validated tools such as the DLQI, UAS7, CU-Q2oL and WPAI.

The results clearly illustrate the burden of the disease. At the start of the study, over 90 per cent of patients had active wheals; around 43 per cent suffered from angioedema;  the average duration of the disease was around five years. Even more significant was the impact on quality of life.

Almost one in two patients reported that the condition had a moderate, severe or extremely severe impact, according to the DLQI, whilst only 19% stated that CSU did not interfere with their daily lives.

Over the two-year observation period, specialist treatment led to a marked improvement.

The mean DLQI score fell progressively, from 7.5 to 3.0, whilst the CU-Q2oL questionnaire also showed a marked reduction in the impact of the disease. At the same time, UAS7 scores and the frequency of wheals and angioedema decreased.

These figures confirm what has also been demonstrated by leading international clinical trials: when inflammation is effectively controlled, the patient’s overall well-being also improves.

However, the AWARE study highlights a very important finding.

After two years of follow-up, almost 19% of patients continued to experience at least a moderate impact on their quality of life; up to half of the patients still had suboptimal disease control, depending on their treatment; around 50% continued to experience hives; 15% still reported episodes of angioedema. This means that a mere reduction in symptoms does not necessarily equate to a return to a normal life. It is precisely here that PROs take on fundamental clinical significance.

As has been the case with psoriasis, atopic dermatitis and rheumatoid arthritis, the ‘treat-to-target’ approach is also gaining ground in the management of chronic urticaria. The aim is no longer to achieve partial improvement, but to attain complete control of the condition.

Ideally, the patient should have a UAS7 score of 0 or a UAS7 score of ≥7 (well-controlled disease),  a UCT score of ≥12 (well-controlled disease), a return to a good quality of life, and no further limitations in work, social and family life.

To achieve this objective, it is essential to listen systematically to the patient using standardised tools, which enable the treatment to be adapted in a timely and personalised manner.

The most recent development concerns the digitisation of Patient-Reported Outcomes. Smartphone applications such as ‘Cruse control’, developed by the UCARE network – a network of specialist centres for the study and management of chronic urticaria spread across numerous countries – now enable patients to record their symptoms, itching, the appearance of wheals, episodes of angioedema and quality of life on a daily basis. This data can be shared with the specialist centre, enabling more dynamic management of treatment and greater personalisation of the care pathway. The digital collection of PROs is set to become an integral part of clinical practice in the coming years.

Chronic spontaneous urticaria is a condition that manifests itself on the skin, but its impact goes far beyond hives and itching. It affects sleep, work, social life, mental health and the ability to plan one’s daily routine.

Research in recent years and the latest international guidelines have definitively established that the assessment of CSU cannot be limited to a physical examination. Patient-reported outcomes (PROs) are now essential tools for understanding the true burden of the disease and for guiding treatment decisions.

The Italian experience from the AWARE study shows that clinical improvement is generally accompanied by a recovery in quality of life, but it also highlights that a significant proportion of patients continue to live with major limitations despite treatment. For this reason, listening to patients’ views in a structured way is no longer an option, but rather a standard of good clinical practice.

The challenge facing modern dermatology and allergology is not merely to eliminate hives: it is to restore a life free from the condition to the patient.

*Head of the Department of Allergic and Occupational Dermatology at the IRCCS Ca’ Granda Foundation, Maggiore Policlinico Hospital, Milan