November 2024 digest

AD evidence-based medicine outcome instruments: how to better integrate patients’ preferences?

Dear Colleagues, Dear Friends,

A recently published study funded by Galderma investigates with the quantitative method named discrete choice experiment (DCE) the preference of patients and physicians when prescribing systemic treatments for AD. This DCE method is increasingly used in healthcare to elicit preferences from participants (patients, payers, commissioners) without directly asking them to state their preferred options. DCE participants are presented with a series of alternative hypothetical scenarios containing several variables or “attributes”, each of which may have a few variations or “levels”. They are asked to state their preferred choice between 2 or 3 competing scenarios, each of which consists of a combination of these attributes/levels.
As said by the authors, patient-centricity is of increasing importance in regulatory and reimbursement decisions for chronic diseases where mortality is not the major issue. European agencies have been placing greater emphasis on patient experience and patient preference data. In the context of AD, pruritus intensity and sleep loss, which are part of the validated composite SCORAD scoring system, are now emphasized vs considering only signs of disease intensity and body surface involved.
However, the US FDA relies mostly on the physician’s global assessment IGA (cleared, almost cleared) which has the interest of being simple for investigators but is poorly validated. EASI, which is a modification of the psoriasis score PASI substituted for psoriasis intensity items with 4 intensity items defined in SCORAD, was promoted by the HOME consortium as a validated alternative to IGA but is not sensitive enough to changes in mild to moderate disease, and includes neither oozing/crusting, which is important in pediatric AD, nor xerosis/dryness which is important especially on black skin where erythema is difficult to score.
The interest of Galderma in publishing this paper needs to be considered in the context of the entry on the market of nemolizumab. In Japan, nemolizumab is marketed by Chugai/Mahuro and is approved for the treatment of prurigo nodularis in adults and children aged ≥13 years, as well as in “pruritus associated with atopic dermatitis” in children aged ≥6 and <13 years. For Europe and severe adult AD patients, Durno et al show clearly, based on a large sample in Germany and the UK, the weight of the items “Itch due to eczema”, “Time to itch relief”, and “Sleep loss due to eczema” both assigned by patients and by physicians – DOI: 10.1080/09546634.2024.2417966.
Time to revise the HOME consensus and make simplified recommendations to assess AD with a composite score?

Best wishes,

Alain TAÏEB
President ISAD

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