The overall probability of dupilumab survival for atopic dermatitis (AD) patients at the 4-year mark is around 80%, according to recent findings, with leading reasons for discontinuation of the drug being inefficacy related to personal satisfaction.¹

These findings and others were the results of new research looking both at probability rates of survival for dupilumab as well as patients’ rationale for cessation of the treatment. The drug, a human monoclonal antibody known to inhibit the key inflammatory cytokines of eczema.

This new analysis looking at dupilumab’s long term data was authored by Bark-Lynn Lew, from the Department of Dermatology at Kyung Hee University Hospital at Gang-dong in Seoul.

While Lew and colleagues acknowledge that the treatment has been shown to be efficacious in long-term AD treatment, many of those who are put on the drug will end up terminating for several different reasons.² These were a major motivator behind the conducting of this new retrospective research analysis.

Background and Findings

The investigators used a retrospective analysis study design, looking at individuals from March 2019 - April 2023 who were in the age range of ≥18 years with moderate-to-severe AD given dupilumab treatment. The demographic data as well as Eczema Area and Severity Index (EASI) scores and laboratory data were gathered by the research team during the analysis.

Among those who terminated their treatment, the information the team gathered centered on the duration of therapy and the patients’ reported rationale for their discontinuation. They looked at the efficacy of the drug at the 16 and 52-week points through the use of EASI, EASI-75, and -90, with every one of the adverse events being noted as well.

Overall, the research team reported that the probability of drug survival at the 4-year mark was shown to be about 80.4%, aligning with prior research. The investigators ended up including 102 individuals in their research, and the team found that. 19.6% of the study’s subjects reported discontinuing therapy following a mean of about 29.9 weeks.

Within the set of patients that had continued dupilumab therapy, the team also reported that the proportion of females was shown to be notably lower, adding that the mean total IgE level was much higher compared to the discontinuation arm of the study. They found no major distinctions in other types of research parameters.

Among the subjects in the drug discontinuation cohort, the reasons given for patient withdrawal (n = 25) included primary loss of efficacy for 40.0%, notable adverse events for 20.0%, high financial burden for 16.0%, short treatment interval discomfort for 12.0%, pregnancies for 8.0%, and clinical remission for 4.0%.

The investigators found that from the time from drug initiation to termination, in the timeframe of about 6 months, dissatisfaction with efficacy loss among 50.0% and high costs for 25.0% were the major reasons given for patients’ cessation of dupilumab. Conversely, among those who went over a single year, discontinuation was shown to become more prevalent due to adverse events for 37.5% and discomfort with short treatment intervals for 25.0%.

The team’s data represented a prolonged survival analysis of the drug, and the 80.4% range they identified was similar to that of most 2-year survival rates in prior data which were around the 80% range.

While ineffectiveness was often cited as the primary rationale for patients’ termination of therapy, the noted mean EASI scores at 16 and 52 weeks were found not to have showed major differences between the 2 arms. This finding, the investigators noted, indicated that discontinuation from inefficacy was affected most by individual subjective satisfaction ratings, predominantly due to paradoxical face and neck flare.

“Strengths from the current study is that we analyzed the reasons of discontinuation by treatment period,” Lew and colleagues wrote. “Our study confirmed that the longer the dupilumab treatment period, the higher the rate of discontinuation due to discomfort with short interval between treatments requiring a visit the hospital every 2 weeks, or adverse events such as paradoxical facial erythema.”

References

1. ^{Kang, D.-H., Kwon, S.-H. and Lew, B.-L. (2023), Four-year long-term drug survival of dupilumab analyzed by treatment period in patients with moderate to severe atopic dermatitis: A real-world retrospective study. J Dermatol. https://doi.org/10.1111/1346-8138.17017.}
2. ^{Simpson EL, Paller AS, Siegfried EC, Boguniewicz M, Sher L, Gooderham MJ, et al. Efficacy and safety of Dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020; 156: 44–56.}