Background and Importance Dupilumab, an anti-IL-4/13, is a monoclonal antibody approved for the treatment of moderate-to-severe atopic dermatitis (AD). So far, few studies have evaluated dupilumab effectiveness and safety in real clinical practice.
Aim and Objectives To evaluate the effectiveness, safety and treatment adherence of dupilumab in patients with AD in clinical practice.
Material and Methods We conducted a retrospective study carried out in a tertiary hospital. We included all AD patients treated with dupilumab with a minimum follow-up of 52 weeks.
We collected the following data from electronic medical records: age, gender, previous treatments, eczema area and severity index (EASI) and dermatology life quality index (DLQI) at baseline and at 52 weeks of follow-up, adverse effects and treatment adherence (calculated by medication possession ratio [MPR]).
Effectiveness was determined by the change in the EASI and DLQI values at 52 weeks compared to baseline. Safety endpoints were the number and type of adverse effects (AE) during the follow-up period.
Results In total, 61 patients were included in the study. The mean age ( ± SD) was 40 ( ± 18) years. Thirty-five patients (57%) were men.
As previous topical treatments, 100% of patients had received corticosteroids; whereas 49%, tacrolimus. Besides, 70% had underwent phototherapy. Regarding systemic treatment, 79% had received corticosteroids; 70%, cyclosporine; 25%, mycophenolate mofetil; 25%, azathioprine; and 28%, methotrexate.
Mean ( ± SD) EASI and DLQI baseline values were 33 ± 11 and 19 ± 5, respectively. At 52 weeks follow-up, these indexes were 2 ± 3 and 4 ± 5, respectively. The reduction in EASI and DLQI was statistically significant (p<0.001). During this period, AE were reported in 22 patients (36%): conjunctivitis (20%), arthralgia (5%), herpes virus infection (5%) and paradoxical psoriasis (3%) were the most common ones. Three treatments were discontinued due to ineffectiveness, 4 due to AE and 2 because of clinical remission.
The mean MPR ( ± SD) was 100 ± 14%, which demonstrates good rates of therapeutic adherence. No patient presented a MPR <75%, so we could not determine the impact of this variable on treatment effectiveness.
Conclusion and Relevance Our study shows that dupilumab is an effective and safe drug for moderate-to-severe DA. Our cohort experienced a statistically significant improvement in EASI and DLQI at 52 weeks of treatment. Additionally, therapeutic adherence was very high.
Conflict of Interest No conflict of interest
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