Effectiveness and safety of dupilumab in moderate-to-severe atopic dermatitis: a 24- and 48-week cohort from Colombia

1 Introduction

AD is a chronic, pruritic, inflammatory skin disease with a relapsing–remitting course that typically begins in early childhood but may persist in or first develop in adulthood (Guttman-Yassky et al., 2025; Sidbury et al., 2023; Davis et al., 2024; Ständer, 2021; Chu et al., 2024). Diagnosis is clinical and relies on age-specific patterns of eczematous lesions, intense pruritus, recurrent or chronic evolution, and a personal or family history of atopy such as asthma, allergic rhinitis or food allergy (Guttman-Yassky et al., 2025; Sidbury et al., 2023; Ständer, 2021; Schoch et al., 2025). Associated features—including xerosis, keratosis pilaris, ichthyosis vulgaris, hand eczema, lip dermatitis, elevated serum IgE, epidermal barrier dysfunction and type-2 immune activation—contribute to increased susceptibility to bacterial, viral and fungal skin infections (Guttman-Yassky et al., 2025; Ständer, 2021). Differential diagnosis with psoriasis, contact dermatitis, scabies, and seborrheic dermatitis is essential, as complementary tests are rarely required (Sidbury et al., 2023; Chu et al., 2024; Schoch et al., 2025).

Global AD prevalence varies widely by region, age group, and diagnostic criteria. Contemporary estimates in children range from 1.5% to 10.7%, with the highest burdens reported in Central Asia, high-income Asia–Pacific and Western Europe (Jin et al., 2025). International cross-sectional surveys report a broader range, with pediatric prevalence varying from approximately 2.7%–20.1% across countries (Silverberg et al., 2021). Latin America ranks among the regions with the greatest pediatric burden: ISAAC Phase 3 reports prevalence rates of 3.2%–25% in children aged 6–7 years and 3.4%–30.2% in adolescents aged 13–14 years, with regional averages of approximately 11% (Solé et al., 2010). Colombia shows particularly elevated prevalence, reaching 20.9% in children and 24.6% in adolescents, with some local studies reporting rates as high as 25%–30% in school-aged populations (Solé et al., 2010; Soares et al., 2023; Odhiambo et al., 2009). These estimates place Colombia among the countries with the highest reported pediatric AD prevalence globally, particularly within Latin America, underscoring a substantial regional disease burden. Potential contributors to the elevated burden of AD in Latin America may include environmental exposures, socioeconomic disparities and ethnic/racial heterogeneity characteristic of the region (Soares et al., 2023).

Beyond prevalence, AD imposes a profound psychosocial and economic burden. Sleep disturbance—affecting 47%–80% of children and up to 87% of adults—is a major contributor to behavioral problems, attention deficits, impaired school and work performance, and caregiver exhaustion (Chu et al., 2024; Barbarot et al., 2022; Artusa et al., 2024). Neuropsychiatric comorbidities such as anxiety, depression, suicidal ideation, attention-deficit/hyperactivity disorder and, less frequently, autism spectrum disorders, occur more frequently in individuals with AD and correlate with disease severity; parents of affected children also show increased rates of anxiety and depression (Guttman-Yassky et al., 2025; Chu et al., 2024; Schoch et al., 2025; Thyssen et al., 2023). This caregiver burden further amplifies the overall societal impact of AD. Social and physical activities are often restricted due to visible skin changes and stigma (Chu et al., 2024; Schoch et al., 2025).

Healthcare utilization and costs rise markedly in moderate-to-severe AD, particularly when systemic therapy is required. Patients requiring systemic therapies such as cyclosporine often exhibit increased ambulatory visits, medication use and laboratory monitoring due to the need for close safety surveillance and management of treatment-related adverse events, while phototherapy may also contribute to healthcare utilization in selected settings (Igarashi et al., 2019; Armstrong et al., 2019). Annual direct medical costs among patients eligible for systemic treatment in high-income settings may exceed €5,000, and indirect costs due to productivity loss often double the total economic burden (Ariëns et al., 2019). In the United States, expenditures in patients treated with systemic immunosuppressants—including cyclosporine—are reported to be up to six-fold higher than in those not requiring systemic therapy (Armstrong et al., 2019; Mohan and Lio, 2015). Although cost structures differ across health systems, these findings highlight the substantial economic burden associated with more severe AD.

Conventional AD management follows a stepwise approach that integrates general skin care, topical therapies, phototherapy and systemic immunosuppressants. However, these strategies do not specifically target the underlying type-2 inflammatory pathway central to atopic dermatitis pathogenesis. Emollients are fundamental for barrier repair and maintenance (Ständer, 2021; Mohan and Lio, 2015; Edwards et al., 2024; Guttman-Yassky et al., 2019; Mahajan et al., 2025). Topical corticosteroids remain first-line for flares but their long-term use is constrained by adverse effects, especially on sensitive areas. Topical calcineurin inhibitors provide an effective alternative or adjunct, particularly for facial and flexural involvement (Ständer, 2021; Mohan and Lio, 2015; Guttman-Yassky et al., 2019; Mahajan et al., 2025; Frazier and Bhardwaj, 2020). Although phototherapy is effective, its accessibility is often limited (Ständer, 2021; Guttman-Yassky et al., 2019; Mahajan et al., 2025; Frazier and Bhardwaj, 2020; Wallace, 2022). Traditional systemic immunosuppressants—cyclosporine, methotrexate, azathioprine and mycophenolate mofetil—are restricted by slow onset of action, cumulative toxicities requiring close monitoring, limited suitability in children and lack of specificity for type-2 inflammation, and long-term use is further constrained by adverse events (Ständer, 2021; Mohan and Lio, 2015; Guttman-Yassky et al., 2019; Mahajan et al., 2025; Frazier and Bhardwaj, 2020; Wallace, 2022; Chu, 2021).

Dupilumab, a fully human monoclonal antibody targeting IL-4Rα and inhibiting IL-4/IL-13 signaling, has substantially changed the therapeutic landscape of moderate-to-severe AD. International and regional clinical practice guidelines recommend dupilumab as first-line systemic therapy for patients inadequately controlled with medium-to high-potency topical corticosteroids, with clinical trials and meta-analyses consistently demonstrating rapid and sustained improvements in disease signs, pruritus, sleep and quality of life, without increased rates of serious adverse events, although conjunctivitis occurs more frequently than with placebo (Chu et al., 2024; Paller et al., 2022). Dupilumab is approved for 6 months of age and above and has shown robust efficacy and safety across infants, children, adolescents and adults (Paller et al., 2022; Beck et al., 2025). Treatment reduces type-2 biomarkers—including TARC/CCL17, total IgE, LDH and memory B-cell type-2 subsets—and reverses proteomic and metabolic abnormalities, improving epidermal differentiation and barrier integrity (Beck et al., 2025; Starrenburg et al., 2024; Goleva et al., 2025). Dupilumab may be used alone or with topical corticosteroids and does not require prior failure of classic systemic immunosuppressants or phototherapy (Chu et al., 2024).

Given the high burden of AD in Latin America—particularly in Colombia—and the limitations of conventional therapy, real-world data are critical to complement randomized trials and capture treatment performance under routine clinical conditions. This study aimed to evaluate the real-world effectiveness and safety of dupilumab in a large cohort of pediatric and adult patients with moderate-to-severe AD in Colombia, assessing changes in disease severity, symptom control, quality of life and therapeutic goal attainment over 24 and 48 weeks.

2 Methods

This was an observational, retrospective cohort study designed to evaluate the real-world effectiveness and safety of dupilumab in patients with moderate-to-severe AD. Data were extracted from anonymized clinical, administrative and pharmacy records within a large nationwide Colombian health insurance system operating as an integrated network of care. All encounters are documented in a centralized digital platform containing structured and unstructured information; the centralized nature of the database minimizes fragmentation of care and reduces loss of outcome information.

Patients initiating dupilumab were identified between 1 January 2020 and 31 December 2023 and followed through 31 December 2024. The index date was defined as the first dupilumab administration, from which baseline demographic and clinical characteristics were obtained. Patients were followed for 48 weeks.

2.1 Study population

Eligible participants were male or female patients aged ≥6 years with a clinical diagnosis of moderate-to-severe AD who initiated dupilumab during the study period and maintained continuous insurance coverage. Moderate-to-severe AD was defined according to treating dermatologist assessment, consistent with Colombian clinical practice guidelines and eligibility for systemic therapy with dupilumab (Asociación Colombiana de Dermatología y Cirugía Dermatológica AsoColDerma et al., 2018). A minimum of 48 weeks of available follow-up was required. Patients were excluded when clinical documentation was insufficient to support the study objectives. All therapeutic decisions, including prior and concomitant treatments, followed routine clinical practice. Dupilumab dosing adhered to standard age- and weight-based recommendations.

3 Outcomes

Effectiveness endpoints included both clinician-reported instruments (SCORing Atopic Dermatitis [SCORAD] index and Eczema Area and Severity Index [EASI]) and patient-reported outcomes, including the Atopic Dermatitis Control Tool (ADCT), administered to patients aged ≥12 years; the Dermatology Life Quality Index (DLQI) for patients aged ≥16 years; the Children’s Dermatology Life Quality Index (CDLQI) for patients aged 6 to <16 years; and the Patient-Oriented Eczema Measure (POEM). Analyses of patient-reported outcomes were restricted to patients within the validated age range of each instrument. All instruments were assessed at baseline and during routine follow-up, with primary evaluations at weeks 24 and 48; all are validated for use in AD and widely employed in both clinical trials and real-world studies.

Established cut-offs, derived from published consensus and clinical trial benchmarks, were used to define therapeutic target attainment for each scale:SCORAD <25, SCORAD-50 and SCORAD-75; EASI-50, EASI-75 and EASI-90; ADCT <7; POEM <8; and DLQI 0–1. While therapeutic target attainment reflects achievement of predefined disease control states, clinically meaningful change thresholds capture clinically meaningful improvement from baseline. These thresholds were defined as ≥8-point improvement for SCORAD, ≥7 points for EASI, ≥4 points for DLQI and POEM, based on previously published validation and responsiveness studies (Schram et al., 2012; Blauvelt et al., 2017). For ADCT, a more conservative threshold of ≥5 points was prespecified based on clinical judgment, although published studies suggest lower minimal important change values (Zhang et al., 2025).

Target-attainment and clinically meaningful change thresholdsanalyses were conducted using paired datasets, restricted to patients with valid measurements at baseline and at the corresponding follow-up time (week 24 or week 48). No imputation was performed for missing data. Safety outcomes consisted of adverse events documented in routine clinical records. Event severity was classified according to routine clinical documentation and operationalized based on the need for medical intervention, treatment discontinuation, or hospitalization. Given the observational nature of the study, causality between dupilumab exposure and observed outcomes cannot be definitively established.

3.1 Statistical analysis

Baseline characteristics were summarized using medians with interquartile ranges for continuous variables and frequencies with percentages for categorical variables. Longitudinal effectiveness was evaluated using linear mixed-effects models with random intercepts for individuals and fixed effects for time (baseline, week 24 and week 48). Estimated marginal means (EMM), 95% confidence intervals and percentage changes from baseline were reported.

For therapeutic target outcomes and clinically meaningful change thresholds, the proportion of responders was calculated using Wilson 95% confidence intervals. Analyses were restricted to participants with paired measurements at each time point. Statistical significance was defined as p < 0.05.

3.2 Ethical considerations

The study used anonymized secondary data and involved no patient contact or modification of clinical care. The protocol adhered to the principles of the Declaration of Helsinki and was approved by the institutional Research Ethics Committee (Minute No. 176, 25 March 2025).

4 Results

A total of 1,046 patients who received dupilumab between 1 January 2020, and 31 December 2023, were identified. Of these, 497 were excluded because the indication for treatment was other than AD, and 2 additional patients were excluded for being younger than 6 years at treatment initiation. No patients were excluded due to incomplete clinical documentation. After applying all eligibility criteria, 547 patients were included in the final analysis (Figure 1). Of the 547 included patients, 428 contributed to the 24-week analyses and 349 to the 48-week analyses.

Among the included patients, 51.9% were male (n = 284). The cohort comprised 8.4% children aged 6–11 years (n = 46), 22.3% adolescents aged 12–17 years (n = 122), and 69.3% adults aged ≥18 years (n = 379). The median treatment duration was 48 weeks (IQR, 26–48). Most patients resided in Antioquia (48.8%), Cundinamarca (16.8%), and Valle del Cauca (8.4%), and nearly all were affiliated with the private insurance regimen (94.2%). The most frequent comorbidities were allergic rhinitis (38.9%) and asthma (19.2%), followed by urticaria (13.0%) and eosinophilic esophagitis (0.4%). No cases of chronic rhinosinusitis with nasal polyposis were identified (Table 1).

TABLE 1. Baseline sociodemographic and clinical characteristics of patients with atopic dermatitis.

Includes Atlántico, Bolívar, Caldas, Córdoba, Quindío, Risaralda, and Santander.

Across all clinician- and patient-reported outcomesreductions were observed at both 24 and 48 weeks. In mixed-effects models, SCORAD decreased by −59.3% at week 24 and −65.2% at week 48, whereas EASI decreased by −71.9% and −79.3%, respectively (all p < 0.001); patient-reported outcomes showed parallel reductions: DLQI decreased by −66.8% and −67.1%, ADCT by −64.0% and −66.4%, and POEM by −60.0% and −66.8% at 24 and 48 weeks, respectively (Table 2; Figure 2).

TABLE 2. Longitudinal changes in clinician- and patient-reported outcomes at 24 and 48 weeks.

EMM, estimated marginal mean.

n = number of patients contributing to the mixed-effects model for each scale.

Therapeutic target attainment was consistently high across scales. At week 24, 85.1% achieved EASI-50, 60.8% achieved EASI-75, and 31.1% achieved EASI-90; corresponding proportions at week 48 were 86.5%, 63.5%, and 36.5%. Disease control thresholds were also achieved across multiple scales.: ADCT <7 was reached by 75.5% at week 24% and 73.2% at week 48, while POEM <8 was achieved by 64.4% and 67.2%, respectively. Minimal clinically important differences were reached by approximately 70%–90% of patients across all scales (Table 3). All observed reductions exceeded established clinically meaningful change thresholds, supporting clinical relevance beyond statistical significance.

TABLE 3. Therapeutic target attainment and minimal clinically important differences at 24 and 48 weeks.

Denominators include only patients with valid baseline and follow-up measurements.

4.1 Age-stratified analyses

Reductions in disease severity scores and patient-reported outcomes were observedin both pediatric and adult patients, with similar response trajectories acrossage groups over time (Table 4; Figure 3). At 24 weeks, percentage reductions across SCORAD, DLQI, ADCT, EASI and POEM were large in both groups, ranging from approximately −60% to −76% in children and −58% to −69% in adults. These reductions persisted through week 48, with pediatric patients showing reductions of roughly −62% to −77% across scales, while adults showed reductions ranging from approximately −63% to >80% depending on the outcome measure. All changes were statistically significant (p < 0.001 vs. baseline.

TABLE 4. Percentage change in outcomes from baseline by age group at 24 and 48 weeks.

Values represent estimated percentage change from baseline derived from linear mixed-effects models with random intercepts. Negative values indicate improvement. p values correspond to comparisons versus baseline.

4.2 Treatment duration analyses

When analyses were restricted to patients with ≥24 weeks of treatment, effect estimates were similar to those observed inthe full cohort. At 24 weeks, percentage reductions were −61.6% for SCORAD, −72.4% for EASI, −67.3% for DLQI, −63.2% for ADCT and −59.8% for POEM; at week 48, reductions were maintained or increased across all measures. Among those completing ≥48 weeks of treatment, reductions across outcome measures persisted through follow-up (Table 5; Figure 4).

TABLE 5. Percentage change in outcomes from baseline by treatment duration (≥24 and ≥48 weeks).

Values approaching zero indicate floor effects in the statistical model.

4.3 Safety

Adverse reactions were infrequent and generally mild. The most reported events were headache (5.7%), skin rash (3.1%) and malaise (2.7%). Ocular events were uncommon, with allergic conjunctivitis documented in 1.6% of patients (Table 6).

TABLE 6. Frequency of adverse reactions reported with dupilumab.

5 Discussion

In this large real-world cohort, dupilumab was associated with sustained reductions across multiple clinician- and patient-reported outcomes through 48 weeks. Observed changes consistently exceeded established minimal clinically important difference thresholds across several scales, supporting the clinical relevance of the observed treatment response. These findings reinforce the reproducibility of dupilumab’s therapeutic effect in routine clinical practice and closely mirror the response patterns observed in pivotal phase 3 trials across adult, adolescent and pediatric populations. In SOLO-1 and SOLO-2, dupilumab induced rapid and robust reductions in EASI, SCORAD, pruritus NRS, POEM and DLQI, with pruritus relief occurring within the first days of treatment (Simpson et al., 2016). Similar clinically meaningful improvements were demonstrated in LIBERTY AD ADOL and LIBERTY AD PEDS, where validated clinically meaningful change thresholds were consistently achieved across severity indices and quality-of-life measures (Simpson et al., 2020; Paller et al., 2020). The parallelism between our real-world outcomes and controlled trial results underscores the robustness of dupilumab’s efficacy across diverse age groups and disease phenotypes. These findings are also consistent with Chinese real-world evidence demonstrating substantial dupilumab effectiveness across pediatric, adult and elderly populations, with comparable or even greater responses observed in younger patients (Song et al., 2023).

Real-world evidence from other regions further supports our observations. The Dutch BioDay registry reported progressive improvement through 52 weeks, with more than 70% of patients achieving EASI-75 by 1 year (Ariëns et al., 2021). Similarly, Ferrucci et al. demonstrated sustained long-term effectiveness and safety across follow-up periods extending up to 48 months in a large Italian real-world cohort of more than 2,500 patients (Ferrucci et al., 2024). French multicenter data similarly showed marked reductions in SCORAD and EASI within the first 3 months of treatment (Faiz et al., 2019), while Japanese post-marketing surveillance confirmed meaningful reductions in disease severity maintained through 1 year (Saeki et al., 2023). Pediatric cohorts from Spain and additional real-world settings have reported rapid improvements from week four onward, high drug-survival rates exceeding 90%, and durable clinical benefits through long-term follow-up (Iznardo et al., 2024; Yang et al., 2024). Although heterogeneity in study design and follow-up precludes direct comparison, the overall consistency in magnitude, trajectory and durability of response strengthens confidence in dupilumab’s effectiveness beyond controlled trial environments.

The safety profile observed in this study was favorable and aligned with findings from clinical trials and international real-world cohorts. No new or unexpected safety findings emerged compared with previously published dupilumab studies. Across pivotal studies involving adults, adolescents and children, conjunctivitis is the most frequent treatment-related adverse event, while serious adverse events remain uncommon (Simpson et al., 2016; Simpson et al., 2020; Paller et al., 2024). Real-world cohorts from Europe and Asia similarly report predominantly mild ocular adverse reactions without new safety signals (Ariëns et al., 2021; Faiz et al., 2019; Saeki et al., 2023; Iznardo et al., 2024; Yang et al., 2024). In our cohort, adverse events were infrequent and generally mild, consistent with dupilumab’s established tolerability profile. Nevertheless, adverse event capture in routine clinical documentation may underestimate the frequency of mild or transient symptoms, particularly ocular events, which are well described across dupilumab studies.

This study has several strengths. It represents one of the largest real-world assessments of dupilumab in Latin America and provides a comprehensive evaluation of both clinician- and patient-reported outcomes using longitudinal modelling to characterize response trajectories over 48 weeks. The inclusion of pediatric and adult populations enhance generalizability, and the consistency of our findings with international evidence reinforces external validity, particularly in a middle-income healthcare setting where real-world data remains limited.

However, limitations should be acknowledged. The retrospective design is susceptible to incomplete clinical documentation, variable follow-up intervals and missing data, and the absence of a comparator group limits causal inference. Adverse events were derived exclusively from routine clinical records, which may contribute to under-reporting. Additionally, the study reflects a single healthcare system, potentially limiting generalizability to other settings; however, the concordance with global real-world and clinical trial evidence mitigates this concern.

6 Conclusion

In this large real-world cohort from a Latin American healthcare system, dupilumab demonstrated substantial and durable improvements in atopic dermatitis severity, pruritus and quality of life across pediatric and adult populations, with a favorable safety profile consistent with pivotal trials and international observational studies. The magnitude and trajectory of clinical response reinforce dupilumab’s effectiveness in routine practice and extend evidence to a diverse, treatment-refractory population underrepresented in clinical trials. Despite the inherent limitations of a retrospective design, the alignment of our findings with global real-world data strengthens confidence in dupilumab as a reliable long-term therapeutic option for moderate-to-severe atopic dermatitis.

Correction note

A correction has been made to this article. Details can be found at: 10.3389/fddsv.2026.2020589.

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Footnotes

Edited by: Indrajit Banerjee, SSR Medical College, Mauritius

Reviewed by: Song Xiaoting, Capital Medical University, China

Przemysław Hałubiec, Jagiellonian University Medical College, Poland