Meta-analysis of the efficacy and safety of dupilumab in the treatment of atopic dermatitis in children and adults
Moderate to severe atopic dermatitis (AD) is accompanied by strong inflammatory processes that can occur anywhere on the skin, intense itching, and pain. The biologic dupilumab is a promising molecule for the treatment of severe forms of this condition – results from a recently published meta-analysis indicate that this therapy is not only effective but also well-tolerated by patients.
Impact of Dupilumab on Inflammatory Pathways
Atopic dermatitis is a chronic skin disease associated with systemic comorbidities. Troublesome symptoms often lead to sleep disturbances, psychological problems, and an overall significantly reduced quality of life. Dupilumab, registered for use in the EU in 2017, is a human monoclonal antibody that blocks interleukins IL-4 and IL-13, which are key factors in the development of type 2 inflammatory diseases such as AD, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and eosinophilic esophagitis. In the treatment of AD, subcutaneously administered dupilumab is indicated for systemic treatment of severe AD in children from 6 months and moderate to severe AD in adults and adolescents from 12 years of age.
Included Studies and Monitored Parameters
A total of 14 studies were included in the systematic review of clinical research, 12 of which were conducted in the adult population (n = 3817) and 2 in children and adolescents (n = 618). These were placebo-controlled randomized clinical trials evaluating the safety and effectiveness of dupilumab in the treatment of AD, including monitoring clinical symptoms, particularly itching (Pruritus Numeric Rating Scale - PNRS), quality of life, and adverse events. The intensity of AD was assessed using scoring systems EASI (The Eczema Area and Severity Index), SCORAD (Severity Scoring Atopic Dermatitis), and IGA (The Investigators' Global Assessment).
Results
Patients treated with dupilumab showed a reduction in EASI scores (standardized mean difference [SMD] -0.98; 95% confidence interval [CI] -1.09 to -0.88). Overall disease calming was also reflected in a reduction in SCORAD index (mean difference [MD] -31.56; 95% CI -33.75 to -29.36). A decrease in values on the numerical PNRS scale (MD -29.24; 95% CI -32.11 to -26.37) also indicated a significant reduction in itching intensity.
Patients treated with dupilumab more often achieved a reduction of EASI score by ≥ 75% (relative risk [RR] 2.89; 95% CI 2.47-3.38) and also a reduction in IGA value to ≤ 1 (RR 3.47; 95% CI 2.96-4.06) compared to those who received a placebo. When comparing subgroups (adults vs. children/adolescents), the results were comparable.
No increased incidence of adverse events was observed with the administration of dupilumab compared to placebo.
Conclusion
The systematic review and meta-analysis of the results of 14 studies indicate that dupilumab improves clinical symptoms and quality of life in children, adolescents, and adults with atopic dermatitis, with a safety profile comparable to placebo.
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Sources:
1. Koskeridis F., Evangelou E., Ntzani E. E. et al. Treatment with dupilumab in patients with atopic dermatitis: systematic review and meta-analysis. J Cutan Med Surg 2022 Nov-Dec; 26 (6): 613-621, doi: 10.1177/12034754221130969.
2. Kučera Z. Newly registered substances - dupilumab. Journal of Czech Pharmacists 2019; 91 (2): 22.
3. What is the EASI score and how is it calculated? prolekare.cz, 19. 5. 2021. Available at: www.prolekare.cz/tema/systemova-lecba-ad-a-astmatu/detail/co-je-to-skore-easi-a-jak-se-pocita-127063
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