TY - JOUR
T1 - Dupilumab Drug Survival and Associated Predictors in Patients With Moderate to Severe Atopic Dermatitis
T2 - Long-term Results From the Daily Practice BioDay Registry
AU - Spekhorst, Lotte S
AU - de Graaf, Marlies
AU - Zuithoff, Nicolaas P A
AU - van den Reek, Juul M P A
AU - Kamsteeg, Marijke
AU - Boesjes, Celeste M
AU - Romeijn, Geertruida L E
AU - Loman, Laura
AU - Haeck, Inge
AU - Oosting, Albert J
AU - de Boer-Brand, Astrid
AU - Touwslager, Wouter R H
AU - Flinterman, Annebeth
AU - van Lynden-van Nes, Anneke M T
AU - Gostynski, Antoni H
AU - de Bruin-Weller, Marjolein S
AU - Schuttelaar, Marie-Louise
N1 - Funding Information:
reported grants from Sanofi Genzyme and personal fees from Sanofi Genzyme/Regeneron Pharmaceuticals during the conduct of the study; and nonfinancial support from Sanofi Genzyme, personal fees from LEO Pharma and Eli Lilly, and grants from Sanofi Genzyme outside the submitted work. Dr van den Reek reported other from AbbVie (carried out clinical trials, visited symposia, speaking fees, attended advisory board), Celgene (carried out clinical trial, visited symposium), Janssen (carried out clinical trials, visited symposia, speaking fees, attended advisory board), Bristol Myers Squibb (received speaking fees/attended advisory board), Almirall (received speaking fees/ attended advisory board), LEO Pharma (received speaking fees/attended advisory board), Novartis (received speaking fee), UCB (received speaking fees/attended advisory board), Eli Lilly (received speaking fees/attended advisory board) outside the submitted work; all funding is not personal and goes to the independent research fund of the Department of Dermatology of Radboudumc Nijmegen, the Netherlands. Ms Boesjes reported personal fees from Eli Lilly and Company outside the submitted work. Dr Gostynski reported personal fees from advisory board for Sanofi and AbbVie outside the submitted work; and has shares (stock) in Novartis, UCB, GlaxoSmithKline, Pfizer, AbbVie, Johnson & Johnson, Sanofi, AstraZeneca, Krystal Biotech, Incyte Corp. Dr de Bruin-Weller reported grants and personal fees from Sanofi Genzyme paid to the institution during the conduct of the study; and grants (paid to the institution) from AbbVie, Pfizer, Lilly, and LEO Pharma and personal fees (speaker and consultant) from AbbVie, Pfizer, Lilly, Galderma, Almirall, Leo Pharma, Aslan, Janssen, and Arena outside the submitted work. Dr Schuttelaar reported other (financial support, BioDay registry) from University Medical Center Utrecht during the conduct of the study; and grants from Pfizer, Sanofi Genzyme, and Novartis and personal fees from Eli Lilly, AbbVie, Galderma, LEO Pharma, and Sanofi Genzyme outside the submitted work. No other disclosures were reported.
Publisher Copyright:
© 2022 American Medical Association. All rights reserved.
PY - 2022/9
Y1 - 2022/9
N2 - 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.
AB - 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.
KW - PLACEBO
U2 - 10.1001/jamadermatol.2022.3014
DO - 10.1001/jamadermatol.2022.3014
M3 - Article
C2 - 35947364
SN - 2168-6068
VL - 158
SP - 1048
EP - 1056
JO - JAMA Dermatology
JF - JAMA Dermatology
IS - 9
ER -