MOD/MOA

MOD

MOA

MORE PRECISION TO TARGET BOTH IL-4 AND IL-13 TO IMPACT TYPE 2 INFLAMMATION AT THE SOURCE^1,3

Patient Types

MORE POSSIBILITIES FOR PATIENTS WITH TYPE 2 ASTHMA¹

Patient profiles are representative and are not actual patients. Individual results may vary.

Efficacy

Lung Function (>1 biomarker, FeNO, EOS)

>1 biomarker

BETTER BREATHING MEANS MORE POSSIBILITIES FOR PATIENTS WITH TYPE 2 ASTHMA⁵

In a post-hoc analysis, patients with more than one elevated biomarker had significant improvement in FEV₁ at Week 52⁵

SOME PATIENTS GAINED MORE THAN A HALF-LITER IMPROVEMENT IN LUNG FUNCTION⁵

^a 440 mL improvement in pre-BD FEV1 from baseline at Year 3 with DUPIXENT 300 mg Q2W (n=51) in patients with EOS ≥300 and allergic asthma on high-dose ICS.
^b 530 mL improvement in pre-BD FEV1 from baseline at Year 3 with DUPIXENT 300 mg Q2W (n=70) in patients with EOS ≥300 and FeNO ≥25 on high-dose ICS.
^c 440 mL improvement in pre-BD FEV1 from baseline at Year 3 with DUPIXENT 300 mg Q2W (n=57) in patients with FeNO ≥25 and allergic asthma on high-dose ICS.
^d 500 mL improvement in pre-BD FEV1 from baseline at Year 3 with DUPIXENT 300 mg Q2W (n=34) in patients with EOS ≥300, FeNO ≥25 and allergic asthma on high-dose ICS.
^a-d Single-arm, open-label extension study - descriptive statistics available (no p-value).

Elevated FeNO

BETTER BREATHING MEANS MORE POSSIBILITIES FOR TYPE 2 ASTHMA PATIENTS WITH ELEVATED FeNO^18,22

The figure is reproduced by Sanofi based on ref. 22 figure 2.

~3 YEARS OF SUSTAINED RELIEF was seen in the OLE study^18,c

PER GINA, ELEVATED FeNO IS STRONGLY PREDICTIVE OF TREATMENT RESPONSE WITH DUPIXENT²³

^a Primary endpoint was Week 12.
^b LSM difference, 360 mL (95% CI: 230, 480 mL).
^c As observed across a 52-week trial (QUEST) and a 96-week, open-label extension trial (TRAVERSE) of adult and adolescent patients.

Elevated EOS

BETTER BREATHING MEANS MORE POSSIBILITIES FOR PATIENTS WITH ELEVATED EOS²²

The figure is reproduced by Sanofi based on reference 22, figure 2.

~3 YEARS OF SUSTAINED RELIEF was seen in the OLE study^18,c

PER GINA, ELEVATED EOS IS STRONGLY PREDICTIVE OF TREATMENT RESPONSE WITH DUPIXENT²³

^a Primary endpoint was Week 12.
^b LSM difference, 300 mL (95% CI: 180, 410 mL).
^c As observed across a 52-week trial (QUEST) and a 96-week, open-label extension trial (TRAVERSE) of adult and adolescent patients.

Exacerbations (>1 biomarker, FeNO, EOS)

>1 biomarker

MORE FREEDOM FROM EXACERBATIONS ACROSS PATIENTS WITH TYPE 2 ASTHMA⁵

In a post-hoc analysis, patients with more than one elevated biomarker had significant exacerbation reductions at Week 52⁵

^a 59% reduction in annualized severe exacerbations at Week 52 with DUPIXENT 200/300 mg + SOC (n=141) vs placebo + SOC (n=93) (0.270 vs 0.612) (P<0.0001) in patients with EOS ≥300 and allergic asthma on high-dose ICS.
^b 73% reduction in annualized severe exacerbations at Week 52 with DUPIXENT 200/300 mg + SOC (n=180) vs placebo + SOC (n=104) (0.189 vs 0.396) (P<0.0001) in patients with EOS ≥300 and FeNO ≥25 on high-dose ICS.
^c 64% reduction in annualized severe exacerbations at Week 52 with DUPIXENT 200/300 mg + SOC (n=165) vs placebo + SOC (n=99) and (0.241 vs 0.534) (P<0.0001) in patients with FeNO ≥25 and allergic asthma on high-dose ICS.
^d 75% reduction in annualized severe exacerbations at Week 52 with DUPIXENT 200/300 mg + SOC (n=91) vs placebo + SOC (n=64) (0.152 vs 0.412) (P<0.0001) in patients with EOS ≥300, FeNO ≥25, and allergic asthma on high-dose ICS.

Elevated FeNO

MORE FREEDOM FROM EXACERBATIONS FOR PATIENTS WITH ELEVATED FeNO^18,22

Significant exacerbation reduction for type 2 asthma patients with FeNO ≥25 ppb at Week 52, sustained for ~3 years^18,22

Patient profiles are representative and are not actual patients. Individual results may vary.

up to

69% reduction^24,a

~3 YEARS OF SUSTAINED PROTECTION was seen in the OLE study^18,b

PER GINA, ELEVATED FeNO IS STRONGLY PREDICTIVE OF TREATMENT RESPONSE WITH DUPIXENT²³

^a In annualized severe exacerbations at Week 52 (QUEST) with DUPIXENT 200 mg + SOC (n=145) vs placebo + SOC (n=78) (0.40 vs 1.30) (P<0.001), and 55% reduction with DUPIXENT 300 mg + SOC (n=159) vs placebo + SOC (n=89) (0.57 vs 1.26) (P<0.001).
^b As observed across a 52-week trial (QUEST) and a 96-week, open-label extension trial (TRAVERSE) of adult and adolescent patients.

A severe exacerbation event was defined as a deterioration of asthma requiring the use of systemic corticosteroids for ≥3 days or hospitalization or an ED visit. The population in dupilumab asthma trials included patients on medium- to high-dose ICS. All data presented above represent the high-dose ICS population.

Elevated EOS

MORE FREEDOM FROM EXACERBATIONS FOR PATIENTS WITH ELEVATED EOS²²

Significant exacerbation reduction for type 2 asthma patients with elevated baseline EOS at Week 52, sustained for ~3 years²²

Patient profiles are representative and are not actual patients. Individual results may vary.

EOS ≥150 cells/μL
up to

55% Reduction^22,a

EOS ≥300 cells/μL
up to

66% Reduction^22,b

EOS ≥500 cells/μL
up to

70% Reduction^5,c

~3 YEARS OF SUSTAINED PROTECTION was seen in the OLE study^18,d

PER GINA, ELEVATED EOS IS STRONGLY PREDICTIVE OF TREATMENT RESPONSE WITH DUPIXENT²³

^a In annualized severe exacerbations at Week 52 with DUPIXENT 200 mg + SOC (n=223) vs placebo + SOC (n=126) (0.56 vs 1.24) (P<0.001), and up to 53% reduction with DUPIXENT 300 mg + SOC (n=228) vs placebo + SOC (n=127) (0.53 vs 1.15) (P<0.001).
^b In annualized severe exacerbations at Week 52 with DUPIXENT 300 mg + SOC (n=144) vs placebo + SOC (n=79) (0.51 vs 1.48) (P<0.001), and up to 59% reduction with DUPIXENT 200 mg + SOC (n=128) vs placebo + SOC (n=80) (0.55 vs 1.35) (P<0.001).
^c As observed across a 52-week trial (QUEST) and a 96-week, open-label extension trial (TRAVERSE) of adult and adolescent patients. Only statistic available (no p-value).
^d As observed across a 52-week trial (QUEST) and a 96-week, open-label extension trial (TRAVERSE) of adult and adolescent patients. Only statistic available (no p-value).

A severe exacerbation event was defined as a deterioration of asthma requiring the use of systemic corticosteroids for ≥3 days or hospitalization or an ED visit.

The population in dupilumab asthma trials included patients on medium- to high-dose ICS. All data presented above represent the high-dose ICS population.

OCS Elimination (24 weeks, 49-58 weeks)

24 weeks

DUPIXENT DOES MORE TO ELIMINATE OCS²⁴

Patient profiles are representative and are not actual patients. Individual results may vary.

^a 86% of patients reduced or eliminated OCS use by Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 68% with placebo + SOC (n=107) (P<0.001).
^b 220 mL improvement in pre-bronchodilator FEV1 at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 10 mL with placebo + SOC (n=107) (LSM difference, 220 mL [95% CI: 90, 340 mL]).
^c 59% reduction in annualized rate of severe exacerbations at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs placebo + SOC (n=107) (0.65 vs 1.60; rate ratio: 0.41 [95% CI: 0.26, 0.63]).

49-58 weeks

DUPIXENT DOES MORE TO ENSURE PATIENTS REMAIN OCS FREE¹⁹

Patient profiles are representative and are not actual patients. Individual results may vary.

^a 86% of patients reduced or eliminated OCS use by Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 68% with placebo + SOC (n=107) (P<0.001).
^b 220 mL improvement in pre-bronchodilator FEV1 at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs 10 mL with placebo + SOC (n=107) (LSM difference, 220 mL [95% CI: 90, 340 mL]).
^c 59% reduction in annualized rate of severe exacerbations at Week 24 with DUPIXENT 300 mg + SOC (n=103) vs placebo + SOC (n=107) (0.65 vs 1.60; rate ratio: 0.41 [95% CI: 0.26, 0.63]).

Mucus Plugs

DUPIXENT AND MUCUS PLUGS^4,6

^a In the high-dose ICS population, 3.8 decrease in global mucus score at Week 24 from baseline score of 8.3 with DUPIXENT 300 mg + SOC (n=34) vs 1.5 increase from baseline score of 6.9 with placebo + SOC (n=21) (LSM difference: -5.3 [95% CI: - 7.704, -2.821], nominal P<0.0001).
^b Mucus scores range from 0 to 20, with higher scores indicating airway occlusion. Scores between 0.5 to 3.5 indicate low mucus levels, and scores between 4 and 20 indicate high mucus levels.^26
c In the ITT population, 3.48 decrease in global mucus score at Week 24 from baseline score of 7.2 with DUPIXENT 300 mg + SOC (n=72) vs 1.44 increase from baseline score of 6.9 with placebo + SOC (n=37) (LSM difference: -4.92 [0.80]), nominal P<0.001.
^d Pearson’s correlation coefficient for mucus score/pre-BD FEV1: r[60]=-0.61, nominal P<0.001.
^e LS mean change in ACQ-7 score from baseline at Week 24: -1.4 from 2.9 at baseline with DUPIXENT + SOC (n=72) vs -0.6 from 3.0 at baseline with placebo + SOC (n=37) (LSM difference vs placebo: -0.7 [95% CI: -1.1, -0.4]; nominal P<0.001).

ACQ-5 and AQLQ

DUPIXENT DOES MORE TO IMPROVE ASTHMA CONTROL AND QUALITY OF LIFE¹

Significantly improved ACQ-5 and AQLQ(S) scores in patients with type 2 asthma at Week 52^1,a

Patient profiles are representative and are not actual patients. Individual results may vary.

ACQ-5
up to

76% of patients improved asthma control^1,b

AQLQ(S)
up to

71% of patients improved QoL^1,c

^a The responder rate was defined as an improvement in core of 0.5 or more (scale range 0-6 for ACQ-5 and 1-7 for AQLQ[S]).
^b 76% ACQ-5 responders within ACQ-5 with DUPIXENT 300 mg + SOC (n=277) vs 64% with placebo + SOC (n=159), and 74% with DUPIXENT 200 mg + SOC (n=262) vs 65% with placebo + SOC (n=141) in patients on medium-to-high dose ICS with FeNO ≥25.
^c 71% AQLQ(S) responders with DUPIXENT 300 mg + SOC (n=239) vs 55% with placebo + SOC (n=124), and 65% with DUPIXENT 300 mg + SOC (n=248) vs 55% with placebo + SOC (n=129) in patients on medium-to-high dose ICS with EOS ≥300.

Study Designs (adolescents/adults, children)

adolescents/adults

DUPIXENT WAS STUDIED IN A CLINICAL PROGRAM THAT ENROLLED ~3,000 PATIENTS^1,22,24,28

Clinical trials included patients (12+) with uncontrolled, moderate-to-severe asthma driven by type 2 inflammation^1,22,24,28

^a With 400 mg loading dose.
^b With 600 mg loading dose.
^c OCS-dependent patients required daily oral corticosteroids, in addition to regular use of high-dose–inhaled corticosteroids plus an additional controller.
^d OCS dose was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained.

Safety

Safety

~6 YEARS OF ESTABLISHED SAFETY IN ASTHMA¹

DUPIXENT was consistently well-tolerated across adult and adolescent asthma patients, exhibiting a safety profile similar to that observed in pediatric populations^1,a

^a As observed across 3 randomized, placebo-controlled, multicenter trials of 24 to 52 weeks duration (DRI12544, QUEST, and VENTURE), and a 96-week, open-label extension trial (TRAVERSE) and another 3-year open-label extension study (TRAVERSE CONTINUATION), in adult and adolescent patients. The safety profile observed in the pediatric asthma clinical study (a 52-week multicenter, randomized, double-blind, placebo-controlled study [VOYAGE]) was similar to that seen in adults.
^b Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000).
^c From postmarketing reporting.
^d Eye disorders and oral herpes occurred predominantly in atopic dermatitis studies. The frequencies for eye pruritus, blepharitis, and dry eye were common, and ulcerative keratitis was uncommon in atopic dermatitis studies. In adults with moderate-to-severe atopic dermatitis, the safety and tolerability profile of DUPIXENT has been studied for 4 years in an open-label extension study and was demonstrated to be generally consistent with the 52-week data.

API

ABBREVIATED PRESCRIBING INFORMATION

Dosing

Dosing

PATIENTS OR CAREGIVERS CAN ADMINISTER AT HOME OR YOU CAN ADMINISTER IN OFFICE

Recommended dosing schedules by patient types¹:

SmPC

^a Advise atopic dermatitis patients with comorbid asthma not to adjust or stop their asthma treatments without consultation with their physicians. For patients with severe asthma and who are on oral corticosteroids, or for patients with severe asthma and comorbid moderate-to-severe atopic dermatitis or adults with comorbid severe chronic rhinosinusitis with nasal polyposis, use an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week, which should be administered as a subcutaneous injection.
^b 300 mg=2 mL solution.
^c 200 mg=1.14 mL solution.

Administration

DUPIXENT is intended for use under the guidance of a healthcare provider¹

• DUPIXENT can be injected by a patient or caregiver at home after training in a subcutaneous injection technique using the auto-injection pen (for adults and adolescents) or pre-filled syringe
• Physicians or nurses should provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use, according to the Instructions for Use
• DUPIXENT can be administered in the office under the guidance of a healthcare provider if the patient or caregiver is not an appropriate candidate to administer the injection

SmPC

Resources

ACQ-5, Asthma Control Questionnaire, 5-Item version
ACQ-5-IA, Asthma Control Questionnaire-5, Interviewed Administered
ACQ-7-IA, Asthma Control Questionnaire-7, Interviewer Administered
AQLQ(S), Asthma Quality of Life Questionnaire
BD, bronchodilator
COPD, chronic obstructive pulmonary disease
CRS, chronic rhinosinusitis
CRSwNP, chronic rhinosinusitis with nasal polyps
CSU, chronic spontaneous urticaria
CT, computed tomography
ED, emergency department
EoE, eosinophilic esophagitis
EOS, eosinophils
FeNO, fraction of exhaled nitric oxide
FEV₁, forced expiratory volume in 1 second
FEF, Forced Expiratory Flow
FRI, functional respiratory imaging
GINA, Global Initiative for Asthma
HCPs, healthcare professionals
HD-ICS, high-dose inhaled corticosteroids
HRCT, high-resolution computed tomography
ICS, inhaled corticosteroids
ILC2, type 2 innate lymphoid cells
ISAR, International Severe Asthma Registry
ITT, intention-to-treat
LABA, long-acting beta agonist
LAMA, long-acting muscarinic antagonist
LSM, least squares mean
LTRA, leukotriene receptor antagonist
OCS, oral corticosteroids
OLE, open-label extension
OR, odds ratio
PAQLQ(S)-IA, Pediatric Asthma Quality of Life Questionnaire with Standardized Activities-Interviewer Administered
PACQLQ, Pediatric Asthma Caregiver’s Quality of Life Questionnaire
PROs, patient-reported outcomes
PSBL, parent study baseline
Q2W, once every 2 weeks
Q4W, once every 4 weeks
QoL, quality of life
SCS, systemic corticosteroid
SE, standard error
siRaw, airway resistance
siVaw, airway volume
SOC, standard of care
TLC, total lung capacity
TSLP, thymic stromal lymphopoietin

References

1. DUPIXENT Summary of Product Characteristics, 2024.

2. Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35-50. doi:10.1038/nrd4624

3. Brusselle GG, Koppelman GH. Biologic therapies for severe asthma. N Engl J Med. 2022;386(2):157-171. doi:10.1056/NEJMra2032506

4. Castro, M, Papi A, Porsbjerg C, et al. Effect of dupilumab on airway inflammation and mucus plugs measured with functional respiratory imaging: results from a randomised, double-blind, placebo-controlled study in patients with type 2 asthma (VESTIGE). Lancet. Forthcoming 2024

5. Pavord ID, Bourdin A, Papi A, et al. Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of inhaled corticosteroids dose. Allergy. 2023;78(11):2921-2932. doi:10.1111/all.15792

6. Shah PA, Brightling C. Biologics for severe asthma—which, when and why? Respirology. 2023;28:709–721. doi:10.1111/resp.14520

7. Porsjberg C, Dunican EM, Lugogo NI, et al. Effect of dupilumab treatment on mucus plugging and mucus volume in type 2 asthma: the phase 4 VESTIGE trial. Poster presented at the International Conference of the American Thoracic Society (ATS). May 17-22, 2024. San Diego, CA. Poster A34.

8. IQVIA Sanofi Integrated DUPIXENT Platform, data through August 31, 2024.

9. Denton E. Price DB, Tran TN, et al. Cluster analysis of inflammatory biomarker expression in the International Severe Asthma Registry. J Allergy Clin Immunol Pract. 2021;9(7):2680-2688.e7. doi:10.1016/j.jaip.2021.02.059

10. Robinson D, Humbert M, Buhl R, et al. Revisiting type 2-high and type 2-low airway inflammation in asthma: current knowledge and therapeutic implications. Clin Exp Allergy. 2017;47(2):161-175. doi:10.1111/cea.12880

11. Hammad H, Lambrecht BN. Dendritic cells and epithelial cells: linking innate and adaptive immunity in asthma. Nat Rev Immunol. 2008;8(3):193-204. doi:10.1038/nri2275

12. Alving K, Malinovschi A. Basic aspects of exhaled nitric oxide. In: European Respiratory Monograph. European Respiratory Society Publications; 2010;49:1-31.

13. Saatian B, Rezaee F, Desando S, et al. Interleukin-4 and interleukin-13 cause barrier dysfunction in human airway epithelial cells. Tissue Barriers. 2013;1(2):e24333. doi:10.4161/tisb.24333

14. Manson ML, Säfholm J, James A, et al. IL-13 and IL-4, but not IL-5 nor IL-17A, induce hyperresponsiveness in isolated human small airways. J Allergy Clin Immunol. 2020;145(3):808-817.e2. doi:10.1016/j.jaci.2019.10.037

15. Bonser LR, Zlock L, Finkbeiner W, Erle DJ. Epithelial tethering of MUC5AC-rich mucus impairs mucociliary transport in asthma. J Clin Invest. 2016;126(6):2367- 2371. doi:10.1172/JCI84910

16. Lee CG, Homer RJ, Zhu Z, et al. Interleukin-13 induces tissue fibrosis by selectively stimulating and activating transforming growth factor beta(1). J Exp Med. 2001;194(6):809-821. doi:10.1084/jem.194.6.809

17. Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022;10(1):11-25. doi:10.1016/S2213- 2600(21)00322-2

18. Sher LD, Wechsler ME, Rabe KF, et al. Dupilumab reduces oral corticosteroid use in patients with corticosteroid-dependent severe asthma: an analysis of the phase 3, open-label extension TRAVERSE trial. Chest. 2022;162(1):46-55. doi:10.1016/j.chest.2022.01.071

19. Maspero JF, Peters AT, Chapman KR, et al. Long-term safety of dupilumab in patients with moderate-to-severe asthma: TRAVERSE Continuation Study. J Allergy Clin Immunol Pract. 2024:12(4)991-997.e6. doi:10.1016/j.jaip.2023.12.043

20. Bacharier LB, Maspero JF, Katelaris CH, et al. Assessment of long-term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION): an open-label extension study. Lancet Respir Med. 2024;12(1):45-54. doi:10.1016/S2213-2600(23)00303-X

21. Bourdin A, Papi AA, Corren J, et al. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021;76(1):269-280. doi:10.1111/all.14611

22. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2024. Accessed June 14, 2024. https://ginasthma.org/wpcontent/uploads/2024/05/GINA-2024-Strategy-Report- 24_05_22.WMS.pdf

23. Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018;378(26):2475-2485. doi:10.1056/NEJMoa1804093

24. Tang M, Elicker BM, Henry T, et al. Mucus plugs persist in asthma, and changes in mucus plugs associate with changes in airflow over time. Am J Respir Crit Care Med. 2022;205(9):1036-1045. doi:10.1164/rccm.202110-2265OC

25. Porsjberg C, Dunican EM, Lugogo NI, et al. Effect of dupilumab treatment on mucus plugging and mucus volume in type 2 asthma: the phase 4 VESTIGE trial. Supplementary Results, 2024.

26. Castro, M, Papi A, Porsbjerg C, et al. Effect of dupilumab on airway inflammation and mucus plugs measured with functional respiratory imaging: results from a randomised, double-blind, placebo-controlled study in patients with type 2 asthma (VESTIGE). Lancet. Forthcoming 2024.

27. Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-tosevere uncontrolled asthma. N Engl J Med. 2018;378(26):2486-2496. doi:10.1056/NEJMoa1804092

28. Wenzel S, Castro M, Corren J, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high dose inhaled corticosteroids plus a long-acting ß2 agonist: a randomised double-blind placebocontrolled pivotal phase 2b dose-ranging trial. Lancet. 2016;388(10039):31-44. doi:10.1016/S0140-6736(16)30307-5

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MAT-BE-2500019-v2.0 01/2025