INTRODUCTION
Atopic dermatitis (AD) is a chronic skin disease affecting millions of people worldwide, with an increasing rate in adults and teenagers. It is characterized by severe pruritus, eczematous lesions, and recurrent exacerbations. Atopic dermatitis impairs the integrity of the skin barrier and is often associated with comorbid conditions such as asthma, allergic rhinitis, and food allergies. Together, these conditions contribute to significant physical discomfort and psychological distress, negatively impacting the quality of life in individuals with moderate to severe forms of the disease [1, 2].
Although topical therapies are sufficient for mild AD, moderate to severe cases often require systemic interventions. However, traditional systemic treatments such as corticosteroids and immunosuppressants pose risks with long-term use, including increased susceptibility to infections, organ toxicity and malignancies. In this context, dupilumab, a fully human monoclonal antibody directed against the interleukin (IL) - 4 receptor α (IL-4Rα) subunit, represents a novel and targeted approach to treating AD. By inhibiting IL-4 and IL-13 signalling, cytokines central to the type 2 inflammatory response in AD, dupilumab addresses the immune abnormalities underlying the disease. Since its approval, dupilumab has demonstrated efficacy in reducing disease severity and improving quality of life in patients with moderate to severe AD. Clinical and real-world studies have shown significant and sustained improvements in the Eczema Area and Severity Index (EASI), pruritus and overall skin condition [3]. In addition to enabling symptoms control, dupilumab provides patients with sustained relief. Dupilumab therapy is also considered safe, in contrast to conventional immunosuppressive agents. Patients receiving conventional systemic treatment require regular laboratory monitoring due to the high incidence of adverse effects.
This article aims to evaluate the efficacy, impact on quality of life, and safety profile of dupilumab in the treatment of moderate to severe atopic dermatitis (AD). By synthesizing evidence from clinical trials, extended research, and observational data, this review seeks to clarify the therapeutic role of dupilumab in managing AD. The article highlights both the benefits and limitations of this biologic agent, offering practical insights for clinicians regarding its use and potential risks in patients with AD [4].
EFFICACY, QUALITY OF LIFE IMPROVEMENTS AND SAFETY OF DUPILUMAB IN THE TREATMENT OF MODERATE-TO-SEVERE ATOPIC DERMATITIS
Dupilumab is a monoclonal antibody that targets IL-4Rα. It has been proved by the results of clinical trials and open label extension studies to be highly effective in alleviating atopic dermatitis symptoms, namely – pruritus and eczematous lesions. This is evidenced by the use of standardized resources such as the Eczema Area and Severity Index (EASI) and the Investigator’s Global Assessment (IGA). In the research studies like LIBERTY AD ADOL and LIBERTY AD PED-OLE using of dupilumab showed significant changes for the better in EASI scores within weeks of still treatment and sustained effects that were observed after 1 year of continuous treatment. Moreover, a meta-analysis of Phase III trials demonstrated that patients treated with dupilumab achieved a clinically meaningful reduction in EASI and IGA scores, with nearly 75% improvement from baseline in EASI observed by week 16.
In addition to alleviating symptoms, dupilumab significantly improves patients’ quality of life. AD being a chronic condition characterized by pruritus, discomfort, and sleep disturbances, profoundly affects daily functioning and mental health. Treating patients with dupilumab has resulted in major enhancements in Dermatology Life Quality Index (DLQI) and Patient-Oriented Eczema Measure (POEM) scores. Also in the open-label LIBERTY AD OLE study, patients reported major improvements in general quality of life which includes better sleep schedule, lack of mood swings and far better social life which surely has a large impact on overall patients’ wellbeing [5].
Furthermore, observational studies have corroborated that dupilumab treatment leads to significant relief from anxiety and depression, which commonly accompany the physical symptoms of AD, in a substantial proportion of patients. The safety profile of dupilumab is generally favorable. The majority of adverse events associated with dupilumab treatment are mild to moderate, with the most common being injection site reactions and conjunctivitis; the latter is reported in approximately 10–20% of patients across studies [6]. These adverse effects typically do not necessitate treatment discontinuation, as demonstrated in a multicenter open-label extension study where most patients experiencing mild to moderate adverse events continued dupilumab treatment without interruption. Numerous studies indicate that serious adverse events are very rare. More commonly observed mild adverse events include nasopharyngitis and upper respiratory tract infections. Long-term data further confirm these safety findings and support the use of dupilumab for moderate-to-severe atopic dermatitis. Additionally, over 90% of patients with moderate-to-severe AD report satisfaction with their dupilumab treatment outcomes.
These studies highlight the therapeutic potential of dupilumab in patients with AD who have demonstrated inadequate response to conventional long-term treatments. Dupilumab has consistently demonstrated efficacy in reducing disease burden across diverse demographic and clinical populations in real-world clinical practice. Moreover, laboratory safety assessments corroborate the favorable safety profile of dupilumab, revealing minimal alterations in laboratory parameters associated with immune function and organ toxicity during prolonged treatment. A systematic review of safety data from clinical trials found no statistically significant differences in liver enzymes, blood counts or serum creatinine levels between dupilumab and placebo groups, thus highlighting its relative safety for long-term use [7]. In addition, long-term open-label studies have demonstrated the efficacy and safety of dupilumab in the continuous treatment of moderate-to-severe Alzheimer’s disease over an extended period of time [8].
CONCLUSIONS
Dupilumab is proving to be a transformative treatment for moderate-to-severe atopic dermatitis. The evidence presented confirms significant improvements in clinical outcomes, quality of life, and sustained long-term efficacy. Its mechanism, which targets the IL-4 and IL-13 pathways, provides a precise approach to alleviating the underlying inflammatory processes responsible for AD. This results in marked reduction of the disease severity, pruritus, and eczematous lesions, as demonstrated in clinical trials and real-world studies. Furthermore, dupilumab has an excellent safety profile, with the majority of adverse events being mild to moderate and manageable, allowing for continued treatment. This represents a significant advantage over conventional systemic therapies, which often have more restrictive side effects. Evidence from various patient populations demonstrates that dupilumab is a safe, effective and long-term therapeutic option for patients whose AD remains inadequately controlled by other treatments. It addresses a critical need in the management of this chronic and debilitating disease.
