Dupilumab Effective, Safe Long-Term for Adolescents with Severe Atopic Dermatitis

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Dupilumab treatment of moderate-to-severe atopic dermatitis is a safe and effective long-term therapy option for adolescents, according to a recent single-center study conducted in Italy.¹

This new research was authored in part by Alessandra Chiei-Gallo, MD, from the department of pathophysiology and transplantation at the Università degli Studi Di Milano in Milan. The team noted that the European Medical Agency had given dupilumab an approval in August 2019 for adolescents aged ≥12 years with moderate-to-severe disease.

However, Chiei-Gallo et al. noted that real-world research looking into the long-term impact of the drug (>52 week) among adolescents had been reported less often.

“In 2023, we conducted a study on an Italian group of adolescents with moderate-to-severe AD undergoing 52 weeks of dupilumab treatment,” Chiei-Gallo and colleagues wrote. “We now present our single-center experience with dupilumab for AD in adolescents, with a follow-up of up to 3 years, focusing on a different cohort.”^1,2

Background and Trial Design

The team looked at 94 adolescents in the age range of ≥12 years with severe atopic dermatitis treated with dupilumab at a standard dose. None of these patients were previously treated with other biologics or Janus kinase inhibitors.

Clinical scores were evaluated by the study’s initiation, including subjects’ Pruritus Numerical Rating Scale (P-NRS), Eczema Area Severity Index (EASI), Dermatology Life Quality Index (DLQI), Sleep Disturbance NRS (SD-NRS), Atopic Dermatitis Control Tool (ADCT), and Patient-Oriented Eczema Measure (POEM). At 16-week intervals, they were also recorded.

The investigators, as of June 2024, followed 94 individuals over periods ranging from 4 - 224 weeks. At the 156-week mark, 87.2% of subjects continued the treatment. Meanwhile, 6.4% of the subjects were lost to follow-up, and another 6.4% discontinued dupilumab. The team added that 2.1% did so for personal reasons and 4.3% given a reported loss of efficacy.

Rates of drug survival were noted by the research team as 98.6% at the 52-week mark and 93.8% at both the 104 and 156-week mark. The team observed adverse events (AEs) among 5.3% of the participants, adding that 2.1% had reported temporary eosinophilia and 3.2% reported mild conjunctivitis.

However, the investigators noted there were no severe AEs which led to treatment discontinuation among the participants.

Major Findings

A significant clinical response to dupilumab therapy was reported by the investigators in terms of both safety and overall efficacy, with subjects having marked and sustained improvements across all of the clinical measures assessed by the team by the 52-week mark. This analysis represented the first real-world assessment of 3-year drug survival among adolescents treated with dupilumab.

The research team noted that a proportion of the participants successfully achieved minimal disease activity, which had been defined as P-NRS≤1, EASI-90, and SD-NRS≤1. The team highlighted that there were rates of minimal disease activity of 22.4%, 28.9%, 24.3%, 32.7%, and 38.5% at the 16, 32, 52, 104, and 156-week marks, respectively.

Long-term improvements were found to have been sustained. The baseline clinical scores from this study, including EASI, P-NRS, and SD-NRS, were shown by the investigators to closely align with those of prior research, though they noted that baseline EASI scores were noticeably higher compared to the LIBERTY AD PED-OLE study.

At the 52-week mark, the research team also found that 94.3% of subjects successfully achieved EASI-75. They noted that this was higher than the findings from LIBERTY AD PED-OLE (81.2%) and that it was comparable to another study’s rate of 96.67%.

In terms of EASI-90 rates of achievement at the 52-week mark, the rate of 64.3% in this analysis was lower than another study’s rate of 73.33% but higher than LIBERTY AD PED-OLE (56.4%). The investigators attributed their superior outcomes compared to clinical trial data potentially to lower baseline disease severity.

The research team also found that, unlike other real-world research, their study did not identify any cases of facial redness, flushing, nasopharyngitis, fatigue,upper respiratory infections, or headaches, all of which had been common in the LIBERTY AD PED-OLE study.

“In conclusion, our experience confirms excellent clinical outcomes, suggesting dupilumab is a safe and effective long-term option for adolescents,” they wrote.¹

References

1. ^{Chiei-Gallo, A., Barei, F., Calzari, P., Pisapia, A., Marzano, A.V. and Ferrucci, S.M. (2024), Long-term efficacy and safety of dupilumab in adolescents with severe atopic dermatitis: a 3-year real-life study. Int J Dermatol. https://doi.org/10.1111/ijd.17514.}
2. ^{Stingeni L, Bianchi L, Antonelli E, Caroppo ES, Ferrucci SM, Gurioli C, et al. A 52-week update of a multicentre Italian real-world experience on effectiveness and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis. J Eur Acad Dermatol Venereol. 2023; 37(3): e384–e388. https://doi.org/10.1111/jdv.18648.}