Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials

被引:5
作者
Silverberg, Jonathan, I [1 ]
Boguniewicz, Mark [2 ,3 ]
Hanifin, Jon [4 ]
Papp, Kim A. [5 ]
Zhang, Haixin [6 ]
Rossi, Ana B. [7 ]
Levit, Noah A. [6 ]
机构
[1] George Washington Univ, Sch Med & Hlth Sci, Washington, DC 20052 USA
[2] Natl Jewish Hlth, Dept Pediat, Div Allergy Immunol, Denver, CO USA
[3] Univ Colorado, Sch Med, Denver, CO USA
[4] OHSU Hosp Dermatol Clin, Portland, OR USA
[5] Prob Med Res, Waterloo, ON, Canada
[6] Regeneron Pharmaceut Inc, 777 Old Saw Mill River Rd, Tarrytown, NY 10591 USA
[7] Sanofi, Cambridge, MA USA
关键词
Age; Atopic dermatitis; Dupilumab; Treatment efficacy; ADOLESCENTS; PLACEBO; ECZEMA; HEALTH;
D O I
10.1007/s13555-022-00822-x
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Introduction: Adults with atopic dermatitis (AD) commonly report adult-onset disease. AD is associated with different genetics, lesion morphology and distribution, and symptoms by age of onset. Yet little is known about possible differences in treatment efficacy between adults with adult-onset or childhood-onset AD. Methods: We evaluated the efficacy of dupilumab by age of AD onset in adults with moderate-to-severe AD, using pooled data from the LIBERTY AD SOLO 1 and 2 studies (NCT02277743, NCT02277769). Results were stratified based on self-reported age of AD onset, divided into four age subgroups: 0-4, 5-9, 10-19, and over 20 years. Results: This analysis included 460 patients treated with placebo and 457 treated with dupilumab 300 mg every 2 weeks (q2w), with a mean patient age of 38 years. Most patients (53.2%) reported AD onset at 0-4 years, with 14% at 5-9 years, 13.4% at 10-19 years, and 18.5% at 20 years or older. Dupilumab significantly improved AD signs and symptoms over 16 weeks compared with placebo, regardless of age of onset. Dupilumab treatment resulted in a significantly greater proportion of patients achieving Eczema Area and Severity Index (EASI)-50, EASI-75, and EASI-90 (50%, 75%, and 90% improvement from baseline EASI, respectively), and clear or almost clear skin (Investigator's Global Assessment score 0 or 1) across all age-of-onset subgroups compared with placebo. In addition, EASI improvements were significant across all anatomical regions in all subgroups. Weekly average peak pruritus Numerical Rating Scale and Dermatology Life Quality Index also improved consistently and significantly with dupilumab versus placebo, regardless of age of onset. Conclusion: Despite possible differences in presentation and progression of AD linked to age of onset, dupilumab showed similar significant and sustained improvements in AD signs, symptoms, and quality of life in adults compared with placebo, over 16 weeks of treatment.
引用
收藏
页码:2731 / 2746
页数:16
相关论文
共 33 条
[1]   International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale [J].
Abuabara, Katrina ;
Silverberg, Jonathan, I ;
Simpson, Eric L. ;
Paller, Amy S. ;
Eichenfield, Lawrence F. ;
Bissonnette, Robert ;
Krueger, James ;
Harris, John E. ;
Dalfonso, Laura ;
Watkins, Stephanie E. ;
Crawford, Julie M. ;
Thaci, D. ;
Guttman-Yassky, Emma .
BMJ OPEN, 2020, 10 (11)
[2]   Epidemiology of atopic dermatitis in adults: Results from an international survey [J].
Barbarot, S. ;
Auziere, S. ;
Gadkari, A. ;
Girolomoni, G. ;
Puig, L. ;
Simpson, E. L. ;
Margolis, D. J. ;
de Bruin-Weller, M. ;
Eckert, L. .
ALLERGY, 2018, 73 (06) :1284-1293
[3]   Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3 [J].
Battisti, Wendy P. ;
Wager, Elizabeth ;
Baltzer, Lise ;
Bridges, Dan ;
Cairns, Angela ;
Carswell, Christopher I. ;
Citrome, Leslie ;
Gurr, James A. ;
Mooney, LaVerne A. ;
Moore, B. Jane ;
Pena, Teresa ;
Sanes-Miller, Carol H. ;
Veitch, Keith ;
Woolley, Karen L. ;
Yarker, Yvonne E. .
ANNALS OF INTERNAL MEDICINE, 2015, 163 (06) :461-+
[4]   Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial [J].
Blauvelt, Andrew ;
de Bruin-Weller, Marjolein ;
Gooderham, Melinda ;
Cather, Jennifer C. ;
Weisman, Jamie ;
Pariser, David ;
Simpson, Eric L. ;
Papp, Kim A. ;
Hong, H. Chih-Ho ;
Rubel, Diana ;
Foley, Peter ;
Prens, Errol ;
Griffiths, Christopher E. M. ;
Etoh, Takafumi ;
Pinto, Pedro Herranz ;
Pujol, Ramon M. ;
Szepietowski, Jacek C. ;
Ettler, Karel ;
Kemeny, Lajos ;
Zhu, Xiaoping ;
Akinlade, Bolanle ;
Hultsch, Thomas ;
Mastey, Vera ;
Gadkari, Abhijit ;
Eckert, Laurent ;
Amin, Nikhil ;
Graham, Neil M. H. ;
Pirozzi, Gianluca ;
Stahl, Neil ;
Yancopoulos, George D. ;
Shumel, Brad .
LANCET, 2017, 389 (10086) :2287-2303
[5]   Adult-Onset Atopic Dermatitis: Presentations and Progress [J].
Chan, Airiss R. ;
Sandhu, Vijay K. ;
Drucker, Aaron M. ;
Fleming, Patrick ;
Lynde, Charles W. .
JOURNAL OF CUTANEOUS MEDICINE AND SURGERY, 2020, 24 (03) :267-272
[6]   Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension [J].
Cork, M. J. ;
Thaci, D. ;
Eichenfield, L. F. ;
Arkwright, P. D. ;
Hultsch, T. ;
Davis, J. D. ;
Zhang, Y. ;
Zhu, X. ;
Chen, Z. ;
Li, M. ;
Ardeleanu, M. ;
Teper, A. ;
Akinlade, B. ;
Gadkari, A. ;
Eckert, L. ;
Kamal, M. A. ;
Ruddy, M. ;
Graham, N. M. H. ;
Pirozzi, G. ;
Stahl, N. ;
DiCioccio, A. T. ;
Bansal, A. .
BRITISH JOURNAL OF DERMATOLOGY, 2020, 182 (01) :85-96
[7]   Evolution of pathologic T-cell subsets in patients with atopic dermatitis from infancy to adulthood [J].
Czarnowicki, Tali ;
He, Helen ;
Canter, Talia ;
Han, Joseph ;
Lefferdink, Rachel ;
Erickson, Taylor ;
Rangel, Stephanie ;
Kameyama, Naoya ;
Kim, Hyun Je ;
Pavel, Ana B. ;
Estrada, Yeriel ;
Krueger, James G. ;
Paller, Amy S. ;
Guttman-Yassky, Emma .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2020, 145 (01) :215-228
[8]   Atopic dermatitis endotypes and implications for targeted therapeutics [J].
Czarnowicki, Tali ;
He, Helen ;
Krueger, James G. ;
Guttman-Yassky, Emma .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2019, 143 (01) :1-11
[9]   Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFE) [J].
de Bruin-Weller, M. ;
Thaci, D. ;
Smith, C. H. ;
Reich, K. ;
Cork, M. J. ;
Radin, A. ;
Zhang, Q. ;
Akinlade, B. ;
Gadkari, A. ;
Eckert, L. ;
Hultsch, T. ;
Chen, Z. ;
Pirozzi, G. ;
Graham, N. M. H. ;
Shumel, B. .
BRITISH JOURNAL OF DERMATOLOGY, 2018, 178 (05) :1083-1101
[10]  
EMA. European Medicines Agency. DUPIXENT® (dupilumab), 2021, SUMMARY PRODUCT CHAR