Successful tapering of dupilumab in patients with atopic dermatitis with low disease activity:a large pragmatic daily practice study from the BioDay registry

BACKGROUND: Limited data is available regarding patient-centered dosing of dupilumab for atopic dermatitis (AD) in daily practice.OBJECTIVES: To evaluate our patient-centered dupilumab dosing regimen in daily practice, to assess prognostic factors for successful tapering and to estimate medication-related cost savings.METHODS: This prospective multicenter study included adult AD patients, participating in the BioDay registry, treated with dupilumab for ≥1.3 years. Interval prolongation was considered in case of dupilumab standard dose for ≥1 year and persistent controlled AD (Eczema Area and Severity Index (EASI)≤7); ≥six months). Primary endpoints were the mean EASI and Numeric Rating Scale (NRS)-pruritus after start of tapering. Prognostic factors for successful tapering were analyzed with logistic regression and a cost saving analysis was performed.RESULTS: A total of 595 patients were included, of which 401 patients (mean EASI 2.5 (SD 2.3)); NRS-pruritus of 2.4 (SD 1.9) at start tapering) prolonged dupilumab interval. In 83.3% of these patients tapering was successful; most patients used dupilumab every 3 or 4 weeks (Q3W/Q4W). A significant small increase was observed for EASI (highest mean 3.5) and NRS-pruritus (highest mean 3.2) (p&lt;0.0001), however scores remained low. Predicting successful tapering showed non-significant odds ratios for all incorporated variables. The estimated cost saving was 3,977,033.98 EUR for 401 patients between January 2019-June 2022.CONCLUSIONS: This study showed successful tapering of dupilumab in 83.3% of AD patients who attempted tapering while maintaining controlled disease and with the majority using Q3W/Q4W. Interval prolongation can be both beneficial for the patient and from a socio-economic perspective.</p

Dupilumab Drug Survival and Associated Predictors in Patients With Moderate to Severe Atopic Dermatitis: Long-term Results From the Daily Practice BioDay Registry

Importance: Long-term data on dupilumab drug survival in patients with atopic dermatitis (AD) are scarce. Furthermore, little is known about the factors associated with drug survival of dupilumab in AD. Objective: To describe the drug survival of dupilumab in patients with AD and to identify associated predictors. Design, Setting, and Participants: This cohort study was based on data from the multicenter prospective daily practice BioDay registry, in which 4 university and 10 nonuniversity hospitals in the Netherlands participated. Analysis included patients (age ≥18 years) participating in the BioDay registry with a follow-up of at least 4 weeks. The first patient treated with dupilumab was recorded in the BioDay registry in October 2017; data lock took place in December 2020, and data analysis was performed from October 2017 to December 2020. Main Outcomes and Measures: Drug survival was analyzed by Kaplan-Meier survival curves and associated characteristics by using univariate and multivariate Cox regression analysis. Results: A total of 715 adult patients with AD (mean [SD] age, 41.8 [16.0] years; 418 [58.5%] were male) were included with a 1-year, 2-year, and 3-year overall dupilumab drug survival of 90.3%, 85.9%, and 78.6%, respectively. Characteristics associated with shorter drug survival owing to ineffectiveness were the use of immunosuppressant drugs at baseline (hazard ratio [HR], 2.64; 95% CI, 1.10-6.37) and being a nonresponder at 4 weeks (HR, 8.68; 95% CI, 2.97-25.35). Characteristics associated with shorter drug survival owing to adverse effects were the use of immunosuppressant drugs at baseline (HR, 2.69; 95% CI, 1.32-5.48), age 65 years or older (HR, 2.94; 95% CI, 1.10-7.87), and Investigator Global Assessment score of very severe AD (HR, 3.51; 95% CI, 1.20-10.28). Conclusions and Relevance: This cohort study demonstrated a good overall 1-year, 2-year, and 3-year dupilumab drug survival. Patients using immunosuppressive therapy at baseline and those with an absence of treatment effect at week 4 tended to discontinue treatment owing to ineffectiveness more frequently. Using immunosuppressant drugs at baseline, older age, and Investigator Global Assessment score of very severe AD were characteristics associated with an increased risk for discontinuation owing to adverse effects. These data provide more insight and new perspectives regarding dupilumab treatment in AD and can contribute to the optimization of patient outcomes

Dupilumab Drug Survival and Associated Predictors in Patients With Moderate to Severe Atopic Dermatitis Long-term Results From the Daily Practice BioDay Registry

IMPORTANCE Long-term data on dupilumab drug survival in patients with atopic dermatitis (AD) are scarce. Furthermore, little is known about the factors associated with drug survival of dupilumab in AD. OBJECTIVE To describe the drug survival of dupilumab in patients with AD and to identify associated predictors. DESIGN, SETTING, AND PARTICIPANTS This cohort studywas based on data from the multicenter prospective daily practice BioDay registry, in which 4 university and 10 nonuniversity hospitals in the Netherlands participated. Analysis included patients (age >= 18 years) participating in the BioDay registry with a follow-up of at least 4 weeks. The first patient treated with dupilumab was recorded in the BioDay registry in October 2017; data lock took place in December 2020, and data analysis was performed from October 2017 to December 2020. MAIN OUTCOMES AND MEASURES Drug survivalwas analyzed by Kaplan-Meier survival curves and associated characteristics by using univariate and multivariate Cox regression analysis. RESULTS A total of 715 adult patients with AD (mean [SD] age, 41.8 [16.0] years; 418 [58.5%] were male) were included with a 1-year, 2-year, and 3-year overall dupilumab drug survival of 90.3%, 85.9%, and 78.6%, respectively. Characteristics associated with shorter drug survival owing to ineffectiveness were the use of immunosuppressant drugs at baseline (hazard ratio [HR], 2.64; 95% CI, 1.10-6.37) and being a nonresponder at 4 weeks (HR, 8.68; 95% CI, 2.97-25.35). Characteristics associated with shorter drug survival owing to adverse effects were the use of immunosuppressant drugs at baseline (HR, 2.69; 95% CI, 1.32-5.48), age 65 years or older (HR, 2.94; 95% CI, 1.10-7.87), and Investigator Global Assessment score of very severe AD (HR, 3.51; 95% CI, 1.20-10.28). CONCLUSIONS AND RELEVANCE This cohort study demonstrated a good overall 1-year, 2-year, and 3-year dupilumab drug survival. Patients using immunosuppressive therapy at baseline and those with an absence of treatment effect at week 4 tended to discontinue treatment owing to ineffectiveness more frequently. Using immunosuppressant drugs at baseline, older age, and Investigator Global Assessment score of very severe AD were characteristics associated with an increased risk for discontinuation owing to adverse effects. These data provide more insight and new perspectives regarding dupilumab treatment in AD and can contribute to the optimization of patient outcomes