Dupilumab Effective for Pediatric Patients with Atopic Dermatitis at 16 Weeks

Dupilumab treatment of atopic dermatitis led to clinically relevant improvements within a 16-week timeframe, according to a recent study from Spain, and the drug’s safety and efficacy continued over 52 weeks.1

This research was authored by a team led by Eulalia Baselga Torres, from the dermatology unit at Hospital Sant Joan de Déu in Barcelona. Torres et al. highlighted dupilumab’s use as a human monoclonal antibody that can impact interleukin (IL)-4 and IL-13 signalling, adding that it has been licensed in various countries for treatment of atopic dermatitis in patients beginning at 6 months of age.2

The research team highlighted the value of this study’s real-world data in routine clinical settings in Spain, noting atopic dermatitis’s burden on patients and caregivers.

“The present study aimed to describe the management, effectiveness and safety data of dupilumab in Spain in adolescents (12–17 years of age) with moderate to severe [atopic dermatitis], and in children (6–11 years of age) with severe [atopic dermatitis], in the context of real clinical practice,” Torres and colleagues wrote.1

Trial Design Details

The study was titled READAP, with the design being retrospective, multicenter, and observational. The investigators looked at patients who had been given dupilumab treatment for atopic dermatitis over a minimum of 3 months, collecting data from medical records in the timeframe between March - September 2023.

Specifically, the investigators included adolescents in the age range of 12–17 who had moderate to severe atopic dermatitis. They defined a diagnosis of this skin condition by an Eczema Area and Severity Index (EASI) score ≥16. The researchers determined that children ages 6–11 years with severe disease would be defined by an EASI score of ≥21 at the time of dupilumab initiation.

The participants of the analysis were required by the team to have completed at least 3 months of dupilumab treatment, additionally noting that subjects could not be part of any clinical research during this period.

Overall, the study’s primary aim had been to describe the patient population in terms of clinical course of disease, demographics, comorbid conditions, scores in terms of life quality (QoL) with tools such as the Dermatology Life Quality Index (DLQI) and Peak Pruritus Numerical Rating Scale (PP-NRS), and disease severity as determined by EASI and Investigator's Global Assessment (IGA) scores.

Additionally, the investigators assessed any previous and concurrent medications utilized for treating atopic dermatitis. The team also assessed dupilumab responses among subjects by looking into severity changes and life quality rankings at the 16, 24, and 52-week marks relative to baseline, as well as assessing the safety of the medication.

By the study’s conclusion, a total of 211 individuals were included, with 69.6% of them at initiation reporting an IGA score of 4 and, consequently, severe disease. The research team found that the median DLQI and PP-NRS scores among the subjects had been 17 and 8, respectively, suggesting QoL issues and severe levels of itch.

Among 69.7% of participants, they observed comorbid atopic conditions. Additionally, the researchers noted that 97.1% of subjects had received systemic treatments prior to dupilumab, with oral corticosteroids being the most common.

Major Findings

The investigative team concluded that dupilumab therapy resulted in substantial improvements in participants’ disease severity. Specifically, the team found that at the 16 and 52-week marks, mean reductions in EASI scores from baseline had been −77.5% and −84.7%, respectively.

The researchers also noted that 71.8% and 82.4% of the trial’s subjects were shown to have achieved EASI scores of ≤7. The research team also reported 70.5% of subjects successfully improving by at least a 75% in their EASI scores (EASI-75) by the 16-week mark.

This EASI score increase went up to 78% by the 52-week mark. In a similar vein, it was noted that 36.5% of participants reported a 90% improvement (EASI-90) at 16 weeks and that this rose to 48.4% at 52 weeks.

Dupilumab was shown to be well-tolerated, as the investigators identified no serious adverse events. Mild side effects included treatment-related conjunctivitis among 6.2% of subjects and eosinophilia among 1.4%, neither of which resulted in treatment cessation.

Quality of life was also noted as having improved, with the research team highlighting that 70% of trial participants had at least a 4-point reduction of in their PP-NRS score and 87% showed at least a 6-point reduction on the DLQI by the 52-week mark.

“Consequently, the results obtained corroborate those of previous pivotal and real-world studies,” they wrote. “This information will be important to better understand how dupilumab works in real clinical practice in children and adolescents, and to learn about the characteristics of the patients who were treated with dupilumab after its approval as the first innovative drug in both subgroups.”1

References

1. Baselga Torres E, Ivars M, Prat C, Vicente A, Feito Rodríguez M, Maseda Pedrero R, et al. Real-life retrospective multicentre study to describe the use of dupilumab in paediatric patients with atopic dermatitis in Spain: patient profile, effectiveness and safety. JEADV Clin Pract. 2024; 1–9. https://doi.org/10.1002/jvc2.565.
2. Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014; 371: 130–139.