The CRISALIS network (F-CRIN) and Toulouse University Hospital launch WIDUSA, a groundbreaking clinical study

Severe asthma, a reality still too heavy

Despite available treatments, around 130,000 people in France, mostly women (2/3), with an average age of around 50, live with a severe and resistant form of the disease, marked by frequent attacks, reduced respiratory capacity, limited physical exertion and a strong impact on their quality of life.

In recent years, the advent of biotherapies has transformed the management of these patients: these treatments - injectable monoclonal antibodies - target precise molecules of asthmatic inflammation and offer spectacular results, with patients sometimes showing no symptoms at all under treatment.

But three major problems persist:

• The optimal duration of treatment is unknown: stopping injections after a year often results in a rapid relapse, within two to three months.
• The very high cost of these treatments raises questions about their prolonged use, especially if it turns out that some patients no longer need them.
• The adverse effects of prolonged treatment remain poorly understood, in the absence of hindsight beyond three years of use.

To address these three issues, the CRISALIS network (F-CRIN) dedicated to severe asthma and the Toulouse University Hospital are launching a large-scale national study to answer a question that remains unanswered: is it possible to discontinue dupilumab (Dupixent®), an expensive but highly effective treatment for severe asthma, without worsening patients' state of health? Objective: to assess, in severe asthma patients treated with the compound for more than three years and in remission for at least a year, whether stopping treatment is as effective as continuing it to maintain a good quality of life and prevent attacks.

The WIDUSA study: a world first

Dupilumab, a biologic treatment marketed since 2020 that targets a molecule involved in bronchial inflammation, has shown spectacular results in reducing asthma attacks. But there are no data beyond three years of treatment. The challenge is to pave the way for optimizing therapeutic follow-up, while limiting costs and unnecessary injections.

Baptised WIDUSA, coordinated by Pr Laurent Guilleminault, co-coordinator of the CRISALIS network (F-CRIN), pulmonologist and allergist at Larrey Hospital (Toulouse University Hospital), this ground-breaking study is based on a randomized, controlled clinical trial. It will compare, over a two-year period, two groups of patients with severe asthma controlled for at least three years on dupilumab: one group continuing treatment, the other testing supervised discontinuation of the drug.

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205 patients recruited throughout France, a hope to lighten treatments without compromising their efficacy

Financed by the French Ministry of Health (Programme Hospitalier en Recherche Clinique National, PHRCN), the WIDUSA study plans to include 205 adult patients in some 30 hospital centers from the start of the academic year. Participation is free, voluntary and has no impact on the quality of medical follow-up. Volunteers will benefit from rigorous follow-up every six months, identical to that for routine care. In the event of a crisis, the treatment can be readapted at any time.

If the results are conclusive, thousands of patients could space out or stop their injections, while still being closely monitored. A prospect that would improve their quality of life and significantly reduce the cost to the healthcare system, while providing answers about the long-term safety of biotherapies.

*Sources: Santé publique France, Haute Autorité de Santé (HAS), Société de pneumologie de langue française (SPLF)