Footnotes

^a Type 2 cytokines (eg, IL-4/IL-13/IL-31) may also be produced by other immune cells such as ILC2.³²

Abbreviations

AD, atopic dermatitis; IL, interleukin; PN, prurigo nodularis; TARC, thymus and activation-regulated chemokine.

References

1. Williams KA et al. J Am Acad Dermatol. 2020;83(6):1567-1575.

2. Tsoi LC et al. J Allergy Clin Immunol. 2022;149(4):1329-1339.

3. Haddad E-B et al. Dermatol Ther (Heidelb). 2022;12(7):1501-1533.

4. Belzberg M et al. J Invest Dermatol. 2021;141(9):2208-2218.e14.

5. Palomares O et al. Immunol Rev. 2017;278(1):219-236.

6. Stott B et al. J Allergy Clin Immunol. 2013;132(2):446-454.e5.

7. Keegan AD et al. Fac Rev. 2021;10:71.

8. Beck LA et al. JID Innov. 2022;2(5):100131.

9. Weidinger S et al. Nat Rev Dis Primers. 2018;4(1):1.

10. Boesjes CM et al. Clin Exp Allergy. 2024;54(4):294-296.

11. Wirnsberger G et al. Eur J Immunol. 2006;36(7):1882-1891.

12. Kim BS et al. Presented at the Aspen Allergy Congress (AAC 2025); July 23-27, 2025; Aspen, CO, USA.

13. DUPIXENT Summary of Product Characteristics, 11/2025.

14. Silva-Filho JL et al. Biophys Rev. 2014;6(1):111-118.

15. Bieber T. Nat Rev Drug Discov. 2022;21(1):21-40.

16. Punnonen J et al. J Allergy Clin Immunol. 1997;100(6 Pt 1):792-801.

17. Romagnani S. J Allergy Clin Immunol. 2004;113(3):395-400.

18. Beck LA et al. J Allergy Clin Immunol. 2025;155(1):135-143.

19. Yosipovitch G et al. Nat Med. 2023;29(5):1180-1190.

20. Miake S et al. Int J Mol Sci. 2019;20(16):4053.

21. Edukulla R et al. J Biol Chem. 2015;290(21):13510-13520.

22. Oetjen LK et al. Cell. 2017;171(1):217-228.e13.

23. Nguyen JK et al. Arch Dermatol Res. 2020;312(2):81-92.

24. Serezani APM et al. J Allergy Clin Immunol. 2017;139(1):142-151.e5.

25. Silverberg JI, Kantor R. Dermatol Clin. 2017;35(3):327-334.

26. Mack MR et al. Front Mol Neurosci. 2023;16:1258823.

27. Pène J et al. Proc Natl Acad Sci USA. 1988;85(18):6880-6884.

28. Park CO et al. EBioMedicine. 2024;103:105121.

29. Wang F et al. Cell. 2021;184(2):422-440.e17.

30. Halling AS et al. J Allergy Clin Immunol. 2023;151(6):1550-1557.e6.

31. Catherine J, Roufosse F. Semin Immunopathol. 2021;43(3):439-458.

32. Bartemes KR, Kita H. J Allergy Clin Immunol. 2021;147(5):1531-1547.

SIGNIFICANT IMPROVEMENT IN ITCH, SKIN CLEARANCE, AND QoL IN HAND AND FOOT AD¹⁰

LIBERTY AD HAFT (12+)

Significant results in itch seen as early as Week 1, skin clearance at Week 2, and both sustained through Week 16^10,c,d

Significant results in skin clearance seen as early as Week 2 and sustained through Week 16^10,c,d

Significant results in QoL seen as early as Week 2 and sustained through Week 16^10,c,f

CHILDREN AGED 6 MONTHS TO 5 YEARS WITH SEVERE AD HAD RAPID CONTROL  AFTER THE FIRST DOSE AND SUSTAINED UP TO 16 WEEKS²⁰

VISIBLE RESULTS

STUDY DESIGNS

LIBERTY AD CHRONOS was a randomized, double-blind, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis (N=740), randomized to DUPIXENT 300 mg Q2W + TCS (n=106) or placebo + TCS (n=315) for 52 weeks. Coprimary endpoints were the proportion of patients achieving EASI-75, and an IGA score of 0 or 1 with a reduction from baseline of ≥2 points at Week 16. The most common comorbid type 2 immune diseases at baseline were allergies (other than food allergy), allergic rhinitis, and asthma.²

LIBERTY AD SOLO 1 (N=671), and LIBERTY AD SOLO 2 (N=708) were two independent, randomized, double-blind, placebo-controlled, parallel-group trials of identical design in adults with moderate-to-severe atopic dermatitis, randomized to DUPIXENT 300 mg or placebo weekly or the same dose of dupilumab every other week alternating with placebo for 16 weeks. The coprimary endpoints were proportion of patients with EASI-75, and proportion of patients with both IGA 0 to 1 and a reduction from baseline of ≥2 points, at Week 16.²⁶

RELIEVE-AD was a prospective, longitudinal survey on disease control and treatment satisfaction among adult patients in the US with atopic dermatitis.²⁷

In the BALISTAD study a total of 52 subjects were enrolled, of which 26 participants were each enrolled into the AD cohort and the healthy volunteers (HV) cohort. AD subjects received dupilumab at Day 1 and Weeks 2, 4, 6, 8, 10, 12, and 14 subcutaneously at a loading dose of 600 mg with subsequent doses of 300 mg. The doses were decreased to 400 mg loading dose and 200 mg subsequent doses if subject’s weight was below 60 kg. HV subjects were age and gender-matched with AD subjects and did not receive any treatment.¹⁷

LIBERTY AD HAFT was a randomized phase 3 trial in adults and adolescents with moderate-to-severe hand and foot atopic dermatitis inadequately controlled with topical prescription therapies. Patients were given dupilumab monotherapy or placebo. Adults and adolescents with a body weight ≥60 kg who received DUPIXENT were given 300 mg Q2W after a 600 mg loading dose. Adolescents with a body weight <60 kg who received DUPIXENT were given 200 mg after a 400 mg loading dose. Adult patients had chronic hand and/or foot eczema for at least 3 years and adolescents for 1 year. At baseline, 72.2% had an IGA of hand and foot score of 3 (moderate), and 27.8% had an IGA of hand and foot score of 4 (severe), and weekly averaged Peak Pruritus NRS was 7.1 on a scale of 0 to 10.¹⁰

LIBERTY AD PRESCHOOL was a two-part phase 2/3 trial. The phase 3 randomized, double-blind, placebo-controlled 16-week trial (Part B) was in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis (N=162), randomized to DUPIXENT 200 mg (for children weighing ≥5 to <15 kg) or 300 mg (for children weighing ≥15 to <30 kg) Q4W (n=83) or placebo (n=79), plus low-potency TCS. Coprimary endpoints were the proportion of patients achieving EASl-75 and an IGA score of 0 or 1 at Week 16.^1,28

LIBERTY AD PEDS was a randomized, double-blind, placebo-controlled trial in children aged 6-11 years with severe atopic dermatitis (N=367) whose disease was inadequately controlled by topical treatment, randomized to DUPIXENT 300 mg Q4W + TCS, 100/200 mg Q2W + TCS, or placebo + TCS for 16 weeks. Coprimary endpoints were the proportion of patients achieving EASl-75 and an IGA score of 0 or 1 with a reduction from baseline of ≥2 points at Week 16.^1,29

LIBERTY AD ADOL was a randomized, double-blind, placebo-controlled, parallel-group study in adolescents with 
moderate-to-severe atopic dermatitis (N=251) whose disease was inadequately controlled by topical treatment, 
randomized to DUPIXENT 200/300 mg Q2W or placebo for 16 weeks. Coprimary endpoints were the proportion of 
patients achieving EASI-75 and an IGA score of 0 or 1 with a reduction from baseline of ≥2 points at Week 16.^1,30

AD-1412 was a global, multicenter, phase 2a, open-label, ascending dose, cohort study in children aged ≥6 to <18 years 
with atopic dermatitis. In the phase 2a study, patients received DUPIXENT 2 mg/kg or 4 mg/kg once, followed by 8 weeks 
of pharmacokinetic sampling, thereafter receiving the same dose QW for 4 weeks with 8-week safety follow-up. Primary endpoint was characterization of the pharmacokinetic profile of DUPIXENT. Secondary endpoints included incidence of 
AEs and percentage change from baseline in EASI and PP-NRS score.³¹


LIBERTY AD PED-OLE is an ongoing phase 3, OLE trial in pediatric patients aged ≥6 months to <18 years with moderate-
to-severe atopic dermatitis who participated in DUPIXENT parent trials. Patients received DUPIXENT 300 mg Q4W. If patients did not achieve an IGA score of 0/1 within at least 16 weeks from start of treatment with 300 mg Q4W, they 
could be uptitrated to 200 mg Q2W (for body weight <60 kg) or 300 mg Q2W (for body weight ≥60 kg) at Week 16 or 
prior to Week 16 at the discretion of the treating physician. The study consisted of a screening period (Day -28 to Day -1) between exit from the parent study and entry into the OLE study, a treatment period that lasts until regulatory approval of the product for the age group of the patients in their geographical region, and a 12-week follow-up period. Primary endpoints were incidence and rate of TEAEs. Secondary outcomes included incidence and rate of SAEs, TEAEs of special interest, and efficacy and assessment of QoL up to Week 52.^31-33

A retrospective study conducted at a single tertiary care center in Italy, which included 126 patients with severe AD who were treated with DUPIXENT for at least 48 months at standard doses (600 mg at the baseline, then 300 mg every other week). Patients who had discontinued therapy even temporarily for more than one month were excluded. The aim of the study was to evaluate the trend of patient-reported outcomes (PROs) during DUPIXENT treatment over 4 years and their correlation with clinical response. Scores for EASI and PROs, Pruritus NRS, Sleep NRS, POEM, ADCT, and DLQI were collected at baseline, after one month of treatment, after 4 months of treatment, and then every 4 months until 48 months of treatment.¹³

A multicenter, retrospective, dynamic cohort study conducted to assess the long-term effectiveness and safety of DUPIXENT up to 48 months in patients with moderate-to-severe AD in a real-world setting. 2576 patients were included from 24 Italian dermatological centers from June 2018 to July 2022, of whom 2066 and 110 had data available for analysis at 12 and 48 months respectively. DUPIXENT was prescribed according to recommendations of the Italian Drug Agency (AIFA), and patients were allowed to use rescue medications (including topical corticosteroids or topical calcineurin inhibitors) as prescribed by their treating physicians once or twice a day for AD control in critical areas. EASI scores and PROs, including weekly average NRS for pruritus and sleep disturbances as well as DLQI, recorded at baseline and at 4, 12, 24, 36, and 48 months of follow-up were extracted. Primary endpoint was to identify predictors of MDA achievement at available timepoints, and secondary endpoints included achievement of EASI-75, EASI-90, and EASI-100, as well as PROs reductions at available timepoints.¹¹

LIBERTY AD OLE was a multicenter, open-label trial in adults with moderate-to-severe atopic dermatitis (N=2677). At enrollment, patients initiated a regimen of subcutaneous dupilumab, 200 mg, weekly (400-mg loading dose). The regimen was amended in June 2014 to dupilumab, 300 mg, weekly (600-mg loading dose) based on a dose-ranging study and again in November 2019 to dupilumab, 300 mg, every 2 weeks to align with the regulatory regimen approvals. The primary outcome was incidence and rate of TEAEs. Key secondary outcomes included incidence and rate of serious TEAEs, percentage of patients with an IGA score of 0/1, and percentage of patients with ≥75% improvement in EASI from baseline (EASI-75).³⁴

A retrospective study of 2576 patients with moderate-to-severe AD who were treated with dupilumab as standard care at 24 Italian dermatological centers from June 2018 to July 2022. The primary endpoint was to identify predictors of MDA achievement at available timepoints of 4, 12, 24, 36, and 48 months. Secondary endpoints included achievement of EASI-75, EASI-90, and EASI-100, as well as PRO reductions.¹¹

BioDay is an ongoing, prospective, multicenter observational study of 1286 patients of all ages with a median (IQR) age of 38 (26-54) years from the BioDay registry (4 academic and 10 nonacademic Dutch hospitals), all treated with dupilumab between October 2017 and December 2022. Adults (≥18 years) received a loading dose of subcutaneous dupilumab, 600 mg, at baseline, followed by 300 mg every other week. Primary clinical effectiveness outcomes included EASI, IGA, and NRS for pruritus in the past week.³⁵

In DUPISTAD (Dupilumab Effect on Sleep in AD Patients), a phase 4, randomized, double-blind, placebo-controlled study, the primary endpoint was the percentage change in sleep quality from baseline to Week 12, assessed using a novel NRS. This study specifically focused on the impact of dupilumab on sleep in adults with moderate-to-severe atopic dermatitis. A total of 188 patients were enrolled in the study. 127 patients received DUPIXENT, while 61 patients received placebo. Patients were randomized in a 2:1 ratio (DUPIXENT:placebo). Participants randomized to the active treatment arm received DUPIXENT 
300 mg administered as a subcutaneous injection Q2W. This typically followed a loading dose of 600 mg on Day 1 for the DUPIXENT group. Concomitant topical corticosteroids were permitted. After the initial 12-week, double-blind, placebo-controlled phase, all patients entered an open-label phase and received DUPIXENT 300 mg Q2W for a further 12 weeks.¹²

LIBERTY AD SOLO-CONTINUE was a randomized, double-blind, phase 3 clinical trial conducted from March 25, 2015, to October 18, 2016 at 185 sites in North America, Europe, Asia, and Japan. Patients with moderate-to-severe AD who received DUPIXENT treatment and achieved an Investigator’s Global Assessment score of 0 or 1 or 75% improvement in Eczema Area and Severity Index score (EASI-75) at Week 16 in 2 previous DUPIXENT monotherapy trials (LIBERTY AD SOLO 1 and 2) were rerandomized in SOLO-CONTINUE. After completing SOLO-CONTINUE, patients were followed up for up to 12 weeks or enrolled in an open-label extension. Data were analyzed from December 5 to 12, 2016.⁹

Footnotes

^a P<0.0001.¹

^b Based on ≥4-point improvement in DLQI.²

^c BSA of each hand=1%.³⁶

^d Improvements in itch at Week 1 and skin clearance at Week 2 were nominally significant.¹⁰

^e Hand and foot AD.

^f Improvement in QoL at Week 2 was nominally significant.¹⁰

^g QoL improvement was measured by the Quality of Life in Hand Eczema Questionnaire, a disease-specific instrument that consists of 30 items that are grouped by 4 domains of health-related quality of life: symptoms, emotions,  functioning, and treatment and prevention. QoLHEQ single scores (κ-coefficient of agreement, 0.431) were not at all,  0–10; slightly, 11–39; moderately, 40–61; strongly, 62–86; and very strongly, ≥87.³⁷

^h A total of 52 subjects were enrolled, of which 26 participants were each enrolled into the AD cohort and the healthy volunteers (HV) cohort. AD subjects received dupilumab at Day 1 and Weeks 2, 4, 6, 8, 10, 12, and 14 subcutaneously  at a loading dose of 600 mg with subsequent doses of 300 mg. The doses were decreased to 400 mg loading dose and  200 mg subsequent doses if subject’s weight was below 60 kg. HV subjects were age and gender-matched with AD  subjects and did not receive any treatment.¹⁷

ⁱ Longitudinal TEWL AUC10 data (the sum of TEWL measurements collected at the surface of the skin and after 5 and 10 skin tape strips represented as median with 95% confidence interval by skin type [lesional, nonlesional, and healthy skin]).¹⁷

^j At baseline, the median TEWL AUC10 in AD lesional skin was significantly different from that of healthy volunteers (P<0.0001).¹⁷

^k At Week 16, the adjusted mean (95% CI) TEWL AUC10 in AD lesional skin was not significantly different from that of healthy volunteers (ANCOVA; P=0.261).¹⁷

^l CDLQI was measured in patients ≥4 years of age.²⁰

Abbreviations

AD, atopic dermatitis; ADCT, Atopic Dermatitis Control Tool; AE, adverse event; ANCOVA, analysis of covariance; AUC, area under the curve; BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; HFE, hand-foot eczema; HR, hazard ratio; IGA, Investigator’s Global Assessment; LS, least squares; M, month; NRS, Numeric Rating Scale; OLE, open-label extension; POEM, Patient Oriented Eczema Measure; QW, once weekly; Q2W, once every 2 weeks; Q4W, once every 4 weeks; QoL, quality of life; QoLHEQ, Quality of Life in Hand Eczema Questionnaire; SAE, serious adverse event; TCI, topical calcineurin inhibitors; TCS, topical corticosteroids; TEAE, treatment-emergent adverse event.

References

1. DUPIXENT Summary of Product Characteristics, 11/2025. 
2. Blauvelt A et al. Lancet 2017;389(10086):2287-2303. 
3. Blauvelt A et al. Lancet 2017;389(10086):2287-2303 [suppl.]. 
5. Blauvelt A et al. Br J Dermatol 2019;181(1):196-197. 
6. Merola JF et al. J Am Acad Dermatol 2021;84(2):495-497. 
7. Thaçi D et al. J Dermatol Sci 2019;94(2):266-275. 
8. Simpson EL et al. Poster presented at the 14th Georg Rajka International Symposium on Atopic Dermatitis (ISAD 2024); October 24-26, 2024; Doha, Qatar. 
9. Worm M et al. JAMA Dermatol 2020;156(2):131-143. 
10. Simpson EL et al. J Am Acad Dermatol 2024;90(6):1190-1199. 
11. Ferrucci S et al. Clin Exp Dermatol 2024;49(12):1561-1572. 
12. Merola JF et al. Br J Dermatol 2023;189(6):685-694. 
13. Barei F et al. Pharmaceuticals 2024;17(1):117. 
14. Bosma AL et al. J Dermatol 2021;48(9):1305-1314. 
15. Ariëns LFM et al. Acta Derm Venereol 2021;101:adv00573. 
16. Simpson EL et al. J Allergy Clin Immunol 2023;152(5):1179-1195. 
17. Berdyshev E et al. Allergy 2022;77(11):3388-3397. 
18. Blauvelt A et al. Adv Ther 2023;40(1):367-380. 
19. Lin TL et al. Ann Allergy Asthma Immunol 2025;134(3):333-340.e6. 
20. Paller AS et al. Adv Ther 2024;41(3):1046-1061. 
21. Paller AS et al. Poster presented at the 24th European Society for Pediatric Dermatology (ESPD) Congress; May 29-31, 2025; Brussels, Belgium. 
24. Tsai SYC et al. Allergy 2024;79(10):2748-2758. 
25. Zirpel H et al. J Dermatolog Treat 2024;35(1):2421429. 
26. Simpson EL et al. N Engl J Med 2016;375(24):2335-2348. 
27. Kimball AB et al. Dermatol Ther (Heidelb) 2023;13(9):2107-2120. 
28. Paller AS et al. Lancet 2022;400(10356):908-919. 
29. Paller AS et al. J Am Acad Dermatol 2020;83(5):1282-1293. 
30. Simpson EL et al. JAMA Dermatol 2020;156(1):44-56. 
31. Cork MJ et al. Br J Dermatol 2020;182(1):85-96. 
32. Blauvelt A et al. Am J Clin Dermatol 2022;23(3):365-383. 
33. Cork MJ et al. Dermatol Ther (Heidelb) 2023;13(11):2697-2719. 
34. Beck LA et al. Am J Clin Dermatol 2020;21(4):567-577. 
35. Boesjes CM et al. JAMA Dermatol 2024;160(10):1044-1055. 
36. Minnesota Department of Health. Determining Total Body Surface Area. April 2019. Accessed June 13, 2025. https://www.health.state.mn.us/communities/ep/surge/burn/tbsa.pdf 
37. Oosterhaven JAF et al. J Invest Dermatol 2020;140(4):785-790.

Footnotes

^a Includes the 226 patients who switched from 300 mg QW to 300 mg Q2W in Amendment 9 (Nov. 2019).²

^b All serious treatment-related TEAEs were observed in 1 or 2 patients each. MedDRA-preferred terms reported in 2 patients each were gastroenteritis, influenza, pneumonia, urosepsis, and Hodgkin disease.²

^c Eye disorders and oral herpes occurred predominately in atopic dermatitis studies.¹

^d From postmarketing reporting.¹

^e The frequencies for eye pruritus, blepharitis, and dry eye were common, and ulcerative keratitis was uncommon in atopic dermatitis studies.¹

Abbreviations

AD, atopic dermatitis; MedDRA, Medical Dictionary for Regulatory Activities; QW, once weekly; Q2W, once every 2 weeks;  TEAE, treatment-emergent adverse event.

References

1. DUPIXENT Summary of Product Characteristics, 11/2025.

2. Beck LA et al. JAMA Dermatol 2024;160(8):805-812.

Footnotes

^a Moderate-to-severe AD in patients aged 12+ years; severe AD in patients aged 6 months to 11 years.¹

Abbreviations

AD, atopic dermatitis; Q2W, once every 2 weeks; Q4W, once every 4 weeks.

References

1. DUPIXENT Summary of Product Characteristics, 11/2025.

2. Derakhshandeh R et al. Expert Opin Drug Deliv 2025;22(5):747-756.

Footnotes

^a As demonstrated for up to 3 years in the open-label extension study.

^b Based on the Pharmacovigilance Risk Assessment Committee recommendations.

^c DUPIXENT is not an immunosuppressant.^6,20

^d In adults only.

^e The BioDay registry is a prospective multicenter registry that contains daily practice data on the effectiveness and safety of
DUPIXENT for the treatment of AD.^12,16

^f Includes topical medications, systemic steroids, and systemic immunosuppressants.¹²

Abbreviations

AD, atopic dermatitis; EASI, Eczema Area and Severity Index; IL, interleukin; QoL, quality of life.

References

1. Blauvelt A et al. Lancet. 2017;389(10086):2287-2303.

2. Blauvelt A et al. Lancet. 2017;389(10086):2287-2303 [suppl.].

3. Simpson EL et al. JAMA Dermatol. 2020;156(1):44-56.

4. Paller AS et al. Adv Ther. 2024;41(3):1046-1061.

5. Paller AS et al. J Am Acad Dermatol. 2020;83(5):1282-1293.

6. DUPIXENT Summary of Product Characteristics, 11/2025.

7. Blauvelt A et al. Am J Clin Dermatol. 2022;23(3):365-383.

8. Cork MJ et al. Dermatol Ther (Heidelb). 2023;13(11):2697-2719.

9. Boesjes CM et al. JAMA Dermatol. 2024;160(10):1044-1055.

10. Ferrucci S et al. Clin Exp Dermatol. 2024;49(12):1561-1572.

11. Tsai SYC et al. Allergy. 2024;79(10):2748-2758.

12. Spekhorst LS et al. JAMA Dermatol. 2022;158(9):1048-1056.

13. Beck LA et al. Am J Clin Dermatol. 2022;23(3):393-408.

14. Beck LA et al. JAMA Dermatol. 2024;160(8):805-812.

15. Kimball AB et al. Dermatol Ther (Heidelb). 2023;13(9):2107-2120.

16. Spekhorst LS et al. Allergy. 2020;75(9):2376-2379.

17. Weidinger S et al. Nat Rev Dis Primers. 2018;4(1):1.

18. Silverberg JI et al. Acta Derm Venereol. 2021;101(11):adv00585.

19. Paller AS et al. Lancet. 2022;400(10356):908-919.

20. Gandhi NA et al. Nat Rev Drug Discov. 2016;15(1):35-50.