Development of a questionnaire for the detection of flares in atopic dermatitis treated with biologics and small molecules: a pilot study.

Abstract

Background: Proper identification and management of flare in atopic dermatitis (AD) is complex, especially in patients being treated with biological drug or small molecules. To date, the definition of flare is not agreed upon. Available scores such as the ADCT (AD control tool) are administered retrospectively to the patient and do not cover key aspects such as self-medication with topical steroids. In the present pilot study, we propose a daily questionnaire to be administered to the patient for proper identification of flares.

Methods: Patients under dupilumab, tralokinumab and upadacitinib filled out for all days in the first month of treatment a daily questionnaire focused on pruritus and topical steroids application. During the in-clinic visit, the physician based on the diary will assess the number and presence of: 1) increase in NRSp (numerical rating score, pruritus) score ≥4 compared to the previous day; 2) increase in topical steroid or topical calcineurin inhibitor applications ≥1 compared with the previous day. Flares were defined as worsening from the previous condition daily, meaning an increased itching or increase of steroid or calcineurin inhibitor application. Topical medication application is considered good proxy for worsening of disease that is easily recorded by the patient.

Results: Forty-seven patients completed at least 1-month questionnaires. Thirteen patients reported at least one flare, and 6 of these patients reported clinical flares (pruritus) in the first months of treatment. Most reported a single episode, while 2 patients reported 2 episodes during the first month, 1 patient reported 15 episodes during the first month, and all three of these patients were on dupilumab. Regarding dupilumab, 38% of patients experienced at least one episode of flares in the first month. 17% of patients on tralokinumab experienced flares. No patients experienced flares on upadacitinib.

Conclusions: The pilot and observational nature does not allow validation of the questionnaire-used, which therefore needs wider integration in clinical use and studies confirming its usefulness. Implementing a questionnaire such as ours that evaluates flares in clinical practice could optimize the therapeutic management of the atopic patient being treated with systemic medication whether biologic or small molecules.