Study Highlights 5-Year Real-World Survival of Dupilumab for Atopic Dermatitis

Credit: Pexels

Dupilumab treatment of patients with moderate-to-severe atopic dermatitis maintains a high level of retention and sustained improvement up to 5 years, according to recent findings, with the most common reason for discontinuation being lack of efficacy.¹

These results were the conclusion of new research highlighted in an abstract at the 2024 Revolutionizing Atopic Dermatitis Mid-Year Virtual Update. The abstract was titled ‘Five-year real-world drug survival of dupilumab for moderate-to-severe atopic dermatitis in adult patients: A Canadian multicenter retrospective study.’

The analysis itself was authored in part by Siddhartha Sood, MD. Sood and colleagues noted that their multicenter retrospective review followed an Italian study with a similar aim looking at patients with severe disease.²

“While our group previously reported two-year drug survival of dupilumab for moderate-to-severe atopic dermatitis (AD), limited real-world evidence regarding retention of dupilumab is available in the long-term beyond this time point,” the investigators wrote.¹

Trial Design and Findings

There were 3 institutions in Canada at which the investigators’ retrospective multicenter study was conducted, with their research including adults with moderate-to-severe atopic dermatitis who had been treated with dupilumab.

The researchers included a total of 160 subjects, all of whom had a mean age of 45.5 years. They noted that 53.1% of the participants had been female and that previously-used systemic medications among the study cohort included prednisone for 33.8%, methotrexate for 36.9%, and cyclosporine for 20.6%.

In terms of inclusion criteria, the research team looked at all individuals who initiated their treatment prior to November 2019. There was a follow-up period that extended up to 5 years, with the team’s data being finalized as of November 2024.

The investigators estimated subjects’ drug survival rates through the use of a Kaplan-Meier curve. Those who decided to discontinue their treatment for reasons which had no association with safety or effectiveness, as well as those lost to follow-up, were censored in their final analysis.

At each follow-up, the investigative team took note of both clinician-assessed and patient-reported adverse events (AEs). They also reported on participants’ rationale for discontinuation of their treatments and estimated times to discontinuation.

By the 5-year mark, findings from the team’s nonresponder imputation analysis showed that 55.6% of the study participants had succeeded in achieving an Investigator Global Assessment (IGA) score of 0 or 1. The investigators also concluded that 43.8%, 39.7%, and 28.8% of the subjects had Eczema Area and Severity Index improvements of 75%, 90%, and 100% (EASI75, EASI90, and EASI100), respectively.

When they looked at observed cases, the investigative team noted that rates had been substantially higher. They highlighted that 97.8% reported IGA scores of 0 or 1 and 94.1%, 85.3%, and 61.8% reported successful achievement of EASI75, EASI90, and EASI100, respectively.

The researchers found that the most common AEs in the fourth and fifth years were noted as ocular surface disease in 3.4%, paradoxical head/neck dermatitis for 1.7%, and herpes simplex in 0.9% of those reporting AEs.

They further observed that the cessation of dupilumab treatment took place among 28.1% of cases, with the most frequently-reported events resulting in drug discontinuation being ocular surface disease among 17.8%, paradoxical head/neck dermatitis among 4.4%, and injection site reactions among 4.4%.

In the team’s overall assessment of AEs, it was written that events had been observed among 38.8% of those involved during the treatment period. They calculated drug survival probabilities for the treatment at 86% after a single year, noting a slight decline to 79.9% by the fifth year.

“Our results demonstrate that dupilumab maintains a high level of retention up to 5 years and provides sustained control of moderate-to-severe [atopic dermatitis],” they concluded.¹

References

1. ^{Five-year real-world drug survival of dupilumab for moderate-to-severe atopic dermatitis in
   adult patients: A Canadian multicenter retrospective study. Presented as part of the 2024 Revolutionizing Atopic Dermatitis Mid-Year Virtual Update. December 8, 2024. Date accessed: December 23, 2024.}
2. ^{Barei F, Calzari P, Valtellini L, Chiei Gallo A, Perego G, Tavecchio S, Zussino M, Marzano AV, Ferrucci S. Five-year real-world drug survival of dupilumab in severe atopic dermatitis and associate predictors. J Dermatolog Treat. 2024 Dec;35(1):2404718. doi: 10.1080/09546634.2024.2404718. Epub 2024 Oct 13. PMID: 39396818.}