Background and importance Atopic dermatitis (AD) is one of the most common cutaneous inflammatory diseases. Intense itching and rash can significantly compromise the patient’s quality of life. Treatment of AD was based on topical/systemic non-specific anti-inflammatories drugs, immunosuppressants or phototherapy. In 2016, the Italian marketing authority (AIFA) approved dupilumab for severe AD treatment. This monoclonal antibody inhibits the signal transduction of interleukin 4 and interleukin 13, implicated in the inflammatory cascade of the pathology.
Aim and objectives The purpose of this work was to describe dupilumab’s use in real clinical practice and to compare its effectiveness with the marketing authorisation trials.
Material and methods The efficacy and safety of dupilumab were evaluated over 52 weeks in a randomised, double blind, placebo controlled clinical trial (LIBERTY_AD_CHRONOS). Disease index for patients enrolled in our structure (January 2019 to June 2020) was recorded in an anonymous database built by matching administrative data and the AIFA monitoring register. The χ2 test was used to show a statistically significant difference between the clinical trial and real life.
Results 166 patients were enrolled during the observed period: median age 43 years (range 25–58), 58% men. At baseline: EASI median value was 28 (range 25–32), NRS was 8 (range 8–9) and DLQI was 21 (range 15–25). After 52 weeks, 60 patients were reassessed. EASI median value was 4 (range 2–7.8), NRS was 2 (range 1–3) and DLQI was 3 (range 2–5). The average percentage reduction in EASI was −81.2% (SD 21.3%), NRS −69.9% (27.0%) and DLQI −15.9% (7.5%). A reduction of 75% in EASI value was recorded for 47 patients (78%).
Conclusion and relevance In our structure, 47 (78%) patients had at least a 75% reduction in EASI compared with 58 (65%) in the LIBERTY_AD_CHRONOS study. The average percentage reduction in EASI in our structure was −81.2±21.3 compared with −78.4±4.4 in the trial. Although the efficacy data seemed to be different, the χ2 test showed that there was no statistically significant difference between the trial data and our data (P>0.05). Full compliance with the eligibility criteria, also guaranteed by AIFA’s monitoring database, confirmed the efficacy of dupilumab in the real world setting with therapy outcomes similar to the marketing authorisation trial.
References and/or acknowledgements
Blauvelt A, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY_AD_CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017;389:2287–303.
Conflict of interest No conflict of interest