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DUPIXENT is the first-line systemic choice for achieving lasting change in patients as young as 6 years old with atopic dermatitis*

*DUPIXENT is indicated to treat adults and adolescents with moderate-to-severe atopic dermatitis, and children aged 6 years to 11 years old with severe atopic dermatitis who are candidates for systemic therapy1

  1. DUPIXENT Summary of Product Characteristics. August 2023

MODERATE-TO-SEVERE ATOPIC DERMATITIS IS A CHRONIC, DEBILITATING INFLAMMATORY DISEASE THAT REQUIRES LONG-TERM CONTROL1

Nour, 28

Frustrated with recurrent disease
exacerbations despite using her
topical treatments

 

Topical + oral corticosteroids

 

Khalid, 16

Experiences persistent lesions and itch

 

TCS + immunosuppress-ant

 

Farah, 7

Wakes up at night due to intense itching
 

TCS + topical calcineurin inhibitors

 

Bader, 32

Experiences recurrent disease exacerbations

 

TCS

 

Abeer, 65

Experiences persistent disease
 

TCS + immunosuppress-ant

Illustrative patient profiles, not actual patients.

  1. Leung DYM et al. J Clin Invest 2004; 113:651—657.

    NOUR, 28

    “I’ve had this disease since I was a child. I’ve tried countless topical treatments and my skin is still sore and itchy. What’s the point?”

    About Nour

      Works in retail

      Diagnosed with atopic dermatitis as a child

      Inadequately controlled with TCS
          - Painful lesions in flexural areas, erythema, and edema
          - Recurring, uncontrolled flares

    Impact on QoL

      Missed several work days and worried about career progression

      Unable to focus at work due to itch disrupting sleep

      Avoids exercise and clothes that expose arms or legs

      Wants to have a baby but is worried about the effects of her treatment on the baby

    Treatment

      Longstanding history of medium-to-high potency TCS with intensive and time-
         consuming application regimen

      Occasional oral corticosteroids – experienced temporarily altered mood and bruising easily

    Goals

      Develop her career in the retail industry

      Have a baby in the near future

      Desperate to control her atopic dermatitis so that she can live her life fully

    Illustrative patient profile, not actual patient

    KHALID, 16

    "The lesions on my face are the worst. I wish they would go away”

    About Khalid

      High school student

      Enjoys sports

      Diagnosed with atopic dermatitis at 8 years old

      Inadequately controlled despite TCS
          - Lesions in high impact areas
          - Dry skin, chronic pruritus, and skin erosions

    Impact on QoL

      Seven prolonged school absences this year and grades have fallen

      Unable to concentrate at school as itch interrupts sleep

      Worried about exams and atopic dermatitis limiting his course choice at university

      Self-conscious about his skin so avoids socializing

      Parents are worried about the effect of atopic dermatitis on Khalid and his education

    Treatment

      Frequent medium-to-high potency TCS

      Immunosuppressant treatment – Stopped early as muscle weakness experienced

    Goals

      Go to university

      Socialize more like his friends do

      Start dating

      Find a treatment that does not need to be administered daily

      Like his parents, George wants to focus on school rather than on his disease

    Illustrative patient profile, not actual patient

    FARAH, 7

    "My skin really hurts, it’s so itchy I can’t sleep at night”

    About Farah

      Diagnosed with atopic dermatitis at 1 year old

      Inadequately controlled with TCS and topical calcineurin inhibitors
          - Chronic lesions on neck and across the body
          - Frequent worsening of disease

    Impact on QoL

      Missed school days causing her parents to miss work

      Cries at night as she is unable to sleep due to itching

      Feels isolated from her classmates and anxious about her atopic dermatitis

      Parents are worried about the impact of missing school on her development

    Treatment

      Has not achieved control of her disease since diagnosis

      Medium-to-high potency TCS and topical calcineurin inhibitors

    Goals

      Wants the itching and lesions to go away

      Wants to go to school and see her friends

      Parents want to find a treatment that works and is safe for longterm use

      Parents don’t want her life choices to be restricted by her atopic dermatitis

    llustrative patient profile, not actual patient

    1. Irvine AD and Mina-Osorio P. Br J Dermatol 2019; 181:895–906.
    2. Margolis JS et al. JAMA Dermatol 2014; 150(6):593–600.

    PATIENTS WANT THEIR DISEASE UNDER CONTROL, WHATEVER THEIR AGE

    The continuous burden of atopic dermatitis can have far-reaching impact on the QoL of patients and their families1–3

    70%
    experience sleep loss. 5* In general, sleep loss can have a negative effect on neurocognitive performance6

    20%
    miss school because of the disease5*

    86%
    avoid everyday activities, and over 50% feel unhappy or depressed2

    38%
    alter their educational or career trajectory due to the disease7

    80
    nights of sleep a year can be
    impacted by the disease in adults2

    12
    weeks of work productivity are lost per year due to disease in adults8

    64%
    experience problems at work including itch, fatigue, pain, and psychological complaints9

    THE BURDEN OF INADEQUATELY CONTROLLED ATOPIC DERMATITIS MAY BECOME CUMULATIVE AND IMPACT PATIENTS THROUGHOUT THEIR LIVES1-3

    *The age of children included in the Eczema Society of Canada Atopic Dermatitis Quality of Life Report survey ranged from 0 to 18 years.

     

    PATIENTS WITH ATOPIC DERMATITIS MAY NEED A TREATMENT THEY CAN RELY ON FOR THE LONG-TERM

    Atopic dermatitis has a highly fluctuating and unpredictable course of disease1

    A chronic, inadequately controlled
    disease driven by persistent
    underlying inflammation2,3

    Patients may experience
    intensified disease activity for 30–
    50% of the year4

    Treatment using a reactive, episodic approach does not address the fluctuating and unpredictable nature of atopic dermatitis1,5

    1. Bieber T. Nat Rev Drug Discov. 2022; 21(1):21–40.
    2. Gittler J et al. J Allergy Clin Immunol 2012; 130:1344–1354.
    3. Guttman-Yassky E et al. J Allergy Clin Immunol 2011; 127:1420–1432.
    4. Zuberbier T et al. J Allergy Clin Immunol 2006; 118:226–232.
    5. Leung DYM et al. J Clin Invest 2004; 113:651–657.

    PATIENTS WITH ATOPIC DERMATITIS MAY NEED A TREATMENT THEY CAN RELY ON FOR THE LONG-TERM

    For proactive and continuous control of their underlying inflammation1

    A more sustainable treatment paradigm proactively targets the persistent underlying inflammation with a safety profile that allows for continuous treatment2-4

    Adequately controlled disease with
    long-term improvements in signs,
    symptoms, and QoL

    1. Leung DYM et al. J Clin Invest 2004; 113:651–657.
    2. Wollenberg A et al. J Eur Acad Dermatol Venereol 2018; 32(6):850–878.
    3. Wollenberg A et al. Ann Dermatol 2012; 24(3):253–260.
    4. Wollenberg A et al. J Eur Acad Dermatol Venereol 2018; 32(5):657–682.

    IL-4 AND IL-13 ARE TWO KEY MEDIATORS OF TYPE 2 INFLAMMATION AND IMPACT SKIN BARRIER DYSFUNCTION1,2

    IL-4 is the central driver of Th2 cell differentiation and
    activation2

    IL-4 creates a feedback loop, which perpetuates the inflammatory process2


    IL-4 AND IL-13 HAVE OVERLAPPING FUNCTIONS, BUT IL-4 HAS AN EXCLUSIVE ROLE5

    IL-4 and IL-13 both mediate inflammation and barrier dysfunction but only IL-4 promotes differentiation of Th cells from Th0 to Th25


    NONLESIONAL SKIN IS NOT NORMAL SKIN

    In atopic dermatitis, subclinical inflammation is also present in nonlesional skin1,6,7

    Normal skin

    Nonlesional skin

    1. Gittler JK et al. J Allergy Clin Immunol 2012; 130:1344–1354.
    2. Capozza K et al. Dermatitis 2020;31(3): 223–227.
    3. Biedermann T et al. Front Immunol 2015; 6:353.
    4. Rerknimitr P et al. Inflamm Regen 2017; 37:14.
    5. Beck L et al. JID Innova ons 2022; doi: https://doi.org/10.1016/j.xjidi.2022.100131.
    6. Gandhi NA et al. Nat Rev Drug Discov 2016; 15:35–50.
    7. Artis D and Spits H. Nature 2015; 517:293–301.


    DUPIXENT IS THE FIRST AND ONLY TARGETED IMMUNOMODULATOR TO SPECIFICALLY TARGET TWO KEY MEDIATORS OF TYPE 2 INFLAMMATION, IN THE PATHOPHYSIOLOGY OF ATOPIC DERMATITIS - IL-4 AND IL-131,2

    Avoids broad spectrum
    immunosuppression through targeting
    disease-specific pathways1

    Inhibits IL-4 and IL-13 signaling, reducing
    type 2 inflammation, improving skin lesions
    and breaking the itch-scratch cycle1

     

    DUAL INHIBITION OF BOTH IL-13 AND IL-4 BY TARGETING A SINGLE RECEPTOR IL-4R (IL-4Rα)1

    DUPIXENT is not an immunosuppressant1

    RAPID AND SUSTAINED CONTROL AFTER THE FIRST DOSE1-4

    Sustained improvement of itch, skin clearance, and QoL up to 52 weeks1–4
    Rapid relief of itch and increased skin clearance, and QoL after the first dose1–4

    Skin Clearance

    65% of patients achieved EASI-75 at Week 521
    ~50% of patients achieved EASI-90 on DUPIXENT + TCS compared to ~15% with placebo + TCS at week 521*

    Itch Relief

    ~60% mean percentage improvement in pruritus NRS score from baseline to Week 521,3

    Quality of Life

    80% of patients achieved a clinically meaningful improvement† in DLQI at Week 521,4

    ≥80%

    response rate‡ based on improvements in lesions, itch, or QoL5

    ≥84%

    of patients experienced no flares with DUPIXENT + TCS over 52 weeks (vs 57% with placebo + TCS)6

     

    RAPID AND SUSTAINED IMPROVEMENT IN SKIN CLEARANCE AFTER THE FIRST DOSE1,2 

    18+ YEARS

    Proportion of patients achieving EASI-75 from baseline to Week 521,2

    Coprimary endpoints in LIBERTY AD CHRONOS:2
    -39% of DUPIXENT + TCS patients achieved IGA 0 or 1 vs 12% of placebo + TCS patients at Week 16
    - 69% of DUPIXENT + TCS patients achieved EASI-75 vs 23% of placebo + TCS patients at Week 16
    **Nominal P-value

    RAPID AND SUSTAINED IMPROVEMENT IN ITCH AFTER THE FIRST DOSE1,3

    18+ YEARS

    Mean percentage improvement in pruritus NRS score from baseline to Week 521,3

    **Nominal P-value

    RAPID AND SUSTAINED IMPROVEMENT IN QUALITY OF LIFE AFTER THE FIRST DOSE1,4

    18+ YEARS

    Patients achieving clinically meaningful improvement* in DLQI1,4

    * Defined as a ≥ 4-point improvement in DLQI on a 0–30 point scale
    **Nominal P-value

    DUPIXENT REDUCED SLEEP LOSS7,8

    18+ YEARS

    Mean sleep NRS score with DUPIXENT from baseline to Week 16 7*

    Patients who reported no days of sleep disturbance with DUPIXENT from baseline to Weeks 16 and 528**

    Sleep NRS is a single-item scale ranging from 0 (“best possible sleep”) to 10 (“worst possible sleep”)
    *Retrospective, multicenter cohort study of adults with moderate-to-severe atopic dermatitis treated with DUPIXENT between June 2018 and February 2019 (N=109) from a national patient access program authorized by the Italian Medical Agency. Patients received an initial loading dose of 600mg DUPIXENT, followed by 300mg Q2W for 16 weeks, in line with the label. Data were collected from medical records including: demographic variables, disease pattern, atopic dermatitis phenotype, location of lesions, and previous treatments. EASI score, pruritus NRS, and DLQI score were assessed at baseline and after 4 and 16 weeks of treatment.
    **Percentage of pa ents, treated with DUPIXENT 300mg Q2W + TCS in LIBERTY AD CHRONOS, who reported no days of sleep disturbances. Days with sleep disturbance were assessed using item 2 on the Patient-Oriented Eczema Measure (POEM)

    DUPIXENT IMPROVED MEASURES OF ANXIETY AND DEPRESSION1

    18+ YEARS

    Patients who were depressed or anxious at baseline achieving a clinically meaningful improvement at Week 521

    HADS-A and HADS-D scores of <8 are considered ‘normal’
    At baseline in LIBERTY AD CHRONOS, 47% and 56% of patients had a HADS-A and HADS-D score ≥8, indicative of clinical symptoms of anxiety or depression, in the Placebo + TCS and DUPIXENT 300mg Q2W + TCS groups, respectively

    1. Blauvelt A et al. Lancet 2017; 389(10086):2287–2303.
    2. Data on file (AD-1224 CSR EASI). Sanofi and Regeneron Pharmaceu cals, Inc. 2022.
    3. Blauvelt A et al. Lancet 2017; 389(10086):2287–2303. [suppl.].
    4. Data on file (AD-1224 CSR DLQI). Sanofi and Regeneron Pharmaceu cals, Inc. 2022.
    5. Silverberg JI et al. Acta Derm Venereol 2021; 101(11):adv00585.
    6. Merola JF et al. J Am Acad Dermatol 2021; 84(2):495–497.
    7. Fargnoli MC et al. J Dermatolog Treat 2021; 32(5):507–513.
    8. Beck LA et al. J Eur Acad Dermatol Venereol 2021; 35(2):e130–e133.
    9. Barbarot S et al. J Dermatolog Treat 2022;33(1):266-277.
    10. Data on file (pa ent profiles SOLO) Sanofi and Regeneron Pharmaceu cals, Inc. 2022.
    11. Silverberg JI et al. Br J Dermatol 2019; 181:80–87.


    RAPID AND SUSTAINED CONTROL AFTER THE FIRST DOSE

    Rapid relief of itch and increased skin clearance, and QoL after the first dose1–4,5-13

    Skin Clearance

    ~40% of patients achieved EASI-75 at Week 161

    Itch Relief

    ~50% mean percentage improvement in pruritus NRS score from baseline to Week 161

    Quality of Life

    ~60% of patients achieved a clinically meaningful improvement† in CDLQI at Week 16 3,4

    ≥80%

    response rate‡ based on improvements in lesions, itch, or QoL1-3

    RAPID AND SUSTAINED IMPROVEMENT IN SKIN CLEARANCE AFTER THE FIRST DOSE1,2

    12-17 YEARS

    Proportion of patients achieving EASI-75 from baseline to Week 161,2

    Coprimary endpoints in LIBERTY AD ADOL:1
    - 24% of DUPIXENT patients achieved IGA 0 or 1 vs 2% of placebo patients at Week 16
    - 42% of DUPIXENT patients achieved EASI-75 vs 8% of placebo patients at Week 16
    *Nominal P-value

    RAPID AND SUSTAINED IMPROVEMENT IN ITCH AFTER THE FIRST DOSE1

    12-17 YEARS

    Mean percentage improvement in pruritus NRS score from baseline to Week 161

    RAPID AND SUSTAINED IMPROVEMENT IN QUALITY OF LIFE AFTER THE FIRST DOSE3,4

    12-17 YEARS

    Patients achieving clinically meaningful improvement* in CDLQI3,4

    *Defined as a ≥ 6-point improvement in CDLQI on a 0–30 point scale
    **Nominal P-value

    DUPIXENT REDUCED SLEEP LOSS3

    12-17 YEARS

    Mean improvement in SCORAD VAS sleep component from baseline to Week 163

    The SCORAD VAS sleep component is a scale ranging from 0 (“no sleeplessness”) to 10 (“worst imaginable sleeplessness“)
    At baseline in LIBERTY AD ADOL, the mean SCORAD VAS sleep component score was 5.6 and 5.4 in the placebo and DUPIXENT 200mg/300mg Q2W groups, respectively

    1. Simpson EL et al. JAMA Dermatol 2020; 156(1):44–56.
    2. Data on file (AD-1526 EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    3. Paller AS et al. Am J Clin Dermatol 2020; 21:119–131.
    4. Data on file (AD-1526 CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    5. Blauvelt A et al. Lancet 2017; 389(10086):2287–2303.
    6. Blauvelt A et al. Lancet 2017; 389(10086):2287–2303. [suppl.].
    7. Data on file (AD-1224 CSR DLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    8. Paller AS et al. J Am Acad Dermatol 2020; 83(5):1282–1293.
    9. Data on file (AD-1652 CSR CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    10. Paller AS et al. Poster presented at the 44th Annual Meeting of the Society for Pediatric Dermatology; 2019; July 11–14; Austin, TX, USA. Poster P-16.
    11. Data on file (AD-1539 EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    12. Data on file (AD-1539 pruritus NRS). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    13. Data on file (AD-1539 CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    14. Paller AS et al. Presenta on at the 19th European Society for Pediatric Dermatology Annual Mee ng; 2019; May 2–4; Dubrovnik, Croa a.
    15. Simpson EL et al. Poster presented at the Annual Conference of the Pediatric Dermatology Research Alliance; 2019; November 14–16; Chicago, IL, USA.


    RAPID AND SUSTAINED CONTROL AFTER THE FIRST DOSE

    Rapid relief of itch and increased skin clearance, and QoL after the first dose1–4,5-13

    Skin Clearance

    ~70% of patients achieved EASI-75 at Week 161

    Itch Relief

    ~55% mean percentage improvement in pruritus NRS score from baseline to Week 161

    Quality of Life

    ~80% of patients achieved a clinically meaningful improvement** in CDLQI at Week 164

    ~95%

    Response rate† based on improvements in lesions, itch, or QoL5

    DUPIXENT REDUCED SLEEP LOSS3

    12-17 YEARS

    Mean improvement in SCORAD VAS sleep component from baseline to Week 163

    The SCORAD VAS sleep component is a scale ranging from 0 (“no sleeplessness”) to 10 (“worst imaginable sleeplessness”)
    At baseline in LIBERTY AD PEDS, the mean SCORAD VAS sleep component score was 6.0 and 6.8 in the placebo and DUPIXENT 300mg Q4W +TCS groups, respectively. DUPIXENT 200mg is also available for children aged 6–11 15kg to <60kg, based on physician’s assessment.

    DUPIXENT IMPROVED MEASURES OF ANXIETY AND DEPRESSION1

    6-11 YEARS

    Mean change in PROMIS depressive symptoms at Week 161

    Mean change in PROMIS anxiety score at Week 161

    The PROMIS pediatric depressive symptoms short form scale ranges from a score of 36.2 to 84.7, where a higher score indicates a greater severity of depressive symptoms during the past 7 days. The PROMIS pediatric anxiety short form scale ranges from a score of 34.6 to 86.4, where a higher score indicates a greater severity of anxiety during the past 7 days.

    At baseline in LIBERTY AD PEDS, the mean PROMIS depressive symptoms score was 55.0 and 58.1 in the placebo + TCS and DUPIXENT 300mg Q4W + TCS groups, respectively. At baseline, the mean PROMIS anxiety score was 57.3 and 59.8 in the placebo + TCS and DUPIXENT 300mg Q4W +TCS groups, respectively. DUPIXENT 200mg is also available for children aged 6–11 15kg to <60kg, based on physician’s assessment.

    1. Paller A et al. J Am Acad Dermatol 2020; 83(5):1282–1293.
    2. Data on file (AD-1652 CSR EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    3. Data on file (AD-1652 CSR pruritus NRS). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    4. Data on file (AD-1652 CSR CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    5. Data on file (AD-1652 response rate). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    6. Shumel B and Rossi AB. The Dermatologist 2020; 28(8):42–46.

    RAPID AND SUSTAINED CONTROL – CONSISTENT ACROSS ALL AGES
    Rapid relief of itch and increased skin clearance, and QoL after first dose1–10

      Adult
    (300mg Q2W + TCS at Week 52)1-3    		 Adolescent
    (200/300mg Q2W at Week 16)6-7    		 Child
    (300mg Q4W + TCS at Week 16)4-5
    Skin Clearance
    Proportion of patients achieving EASI-75    		 65% 42% 70%
    Itch Relief
    Mean percentage improvement in pruritus NRS score from baseline    		 56% 48% 55%
    Quality of Life
    Proportion of patients achieving a clinically meaningful improvement in quality of life measures    		 80% 61% 77%

    Consistent improvements in itch, skin clearance, and quality of life across age groups – demonstrated in adults through to children as young as 6 years when treated with DUPIXENT compared to placebo1–10

    1. Blauvelt A et al. Lancet 2017; 389(10086):2287–2303.
    2. Blauvelt A et al. Lancet 2017; 389(10086):2287–2303. [suppl.].
    3. Data on file (AD-1224 CSR DLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    4. Paller A et al. J Am Acad Dermatol 2020; 83(5):1282–1293.
    5. Data on file (AD-1652 CSR CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    6. Simpson EL et al. JAMA Dermatol 2020; 156(1):44–56.
    7. Paller AS et al. Poster presented at the 44th Annual Mee ng of the Society for Pediatric Dermatology; 2019; July 11–14; Aus n, TX, USA. Poster P-16.
    8. Data on file (AD-1539 EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    9. Data on file (AD-1539 pruritus NRS). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    10. Data on file (AD-1539 CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.

    A UNIQUE, LONG-TERM SAFETY AND TOLERABILITY PROFILE ESTABLISHED UP TO 52 WEEKS IN ADULTS1 

    Safety profile established in over 10,000 clinical trial patients spanning multiple age groups across 3 indications – atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis1,3

    No routine lab monitoring required1

    LIBERTY AD CHRONOS
    (Week 52)

    Discontinuation rates due to AEs were lower than placebo at 52 weeks1 Comparable rates of infections reported, including serious and opportunistic2 Lower rates of non-herpetic skin infections vs placebo+ TCS1
    1.8%
    DUPIXENT +TCS    		 VS 7.6%
    Placebo +TCS    		 0.2%
    DUPIXENT +TCS    		 VS 0.6%
    Placebo +TCS    		 10.9%
    DUPIXENT +TCS    		 VS 17.8%
    Placebo +TCS

    DUPIXENT HAS A DEMONSTRATED SAFETY PROFILE UNDERPINNED BY TARGETED IMMUNOMODULATION NOT BROAD SUPPRESSION2-4

    UNIQUE LONG-TERM SAFETY PROFILE

    Safety and tolerability up to Week 52 in adults1

    Adverse reactions for DUPIXENT in clinical studies2
    System Organ Class Frequency Adverse Reaction
    Infections and infestations Common Conjunctivitis*
    Oral herpes*
    Blood and lymphatic system disorders Common Eosinophilia
    Immune system disorders Uncommon
    Rare    		 Angioedema#
    Anaphylactic reaction, serum sickness reaction
    Eye disorders Common
    Uncommon
    Rare    		 Conjunctivitis allergic*
    Keratitis*#,blepharitis*†, eye pruritus*†, dry eye*†;
    Ulcerative keratitis*†#
    Skin and subcutaneous tissue disorders Uncommon Facial rash#
    Musculoskeletal and connective tissue disorders Common Arthralgia#
    General disorders and administration site conditions Common Injection site reactions (includes erythema,
    oedema, pruritus, pain, and swelling)

    If a systemic hypersensitivity reaction (immediate or delayed) occurs, DUPIXENT should be discontinued immediately and appropriate therapy initiated20

    Patients who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination2

    Patients with moderate-to-severe atopic dermatitis and comorbid asthma should not adjust or stop their asthma treatments without consulting their physicians. Monitor patients with comorbid asthma carefully following discontinuation of DUPIXENT2

    Most patients experiencing conjunctivitis recovered or were recovering during the treatment period2

    Treat any pre-existing helminth infections prior to initiating treatment with DUPIXENT. If patients become infected while receiving treatment and do not respond to anti-helminth treatment, discontinue treatment until infection resolves2

    *Adverse event reported at SOC level of the MedDRA hierarchy. **Adverse event reported at the high-level term of the MedDRA hierarchy. †Conjunctivitis (highlevel term) includes the PTs conjunctivitis allergic, conjunctivitis bacterial, atopic keratoconjunctivitis, and conjunctivitis.‡Adjudicated.

    1. Blauvelt A et al. Lancet 2017; 389:2287–2303.
    2. DUPIXENT Summary of Product Characteristics, August 2023.
    3. Guttman-Yassky E et al. J Allergy Clin Immunol 2019; 143:155-172.
    4. Grieco T et al. Clin Dermatol 2021; 39(6):1083-1087.

    ADOLESCENT SAFETY AND TOLERABILITY PROFILE CONSISTENT WITH ADULTS BASED IN 16 WEEKS DATA1,4 

    SAFETY PROFLE ESTABLISHED IN OVER 10,000 CLINICAL TRIAL PATIENTS SPANNING MULTIPLE AGE GROUPS ACROSS 3 INDICATIONS – ATOPIC DERMATITIS, ASTHMA, AND CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS1,3

    No routine lab monitoring required1

    LIBERTY AD CHRONOS
    (Week 52)

    No discontinuations due to AEs with DUPIXENT1 No serious AEs reported with DUPIXENT1 Lower rates of non-herpetic skin infections vs placebo1
    0%
    DUPIXENT    		 VS 1.2%
    Placebo    		 0%
    DUPIXENT    		 VS 1.2%
    Placebo    		 9.8%
    DUPIXENT    		 VS 18.8%
    Placebo

    DUPIXENT HAS A DEMONSTRATED SAFETY PROFILE UNDERPINNED BY TARGETED IMMUNOMODULATION NOT BROAD SUPPRESSION2-4

    UNIQUE LONG-TERM SAFETY PROFILE

    Safety and tolerability up to Week 16 in adolescents in LIBERTY AD ADOL1

    AEs in ≥5% of patients during the 16-week treatment period in LIBERTY AD ADOL1
    Adverse event, n (%) DUPIXENT 200 0r 300mg Q2W (n=82) Placebo (n=85)
    Skin infection (adjudicated) 9 (11.0) 17 (20.0)
    Upper respiratory tract infection 10 (12.2) 15 (17.6)
    Headache 9 (11.0) 9 (10.6)
    Conjunctivitis* 8 (9.8) 4 (4.7)
    Nasopharyngitis 3 (3.7) 4 (4.7)
    Infections and infestations (SOC) 34 (41.5) 37 (43.5)
    Injection site reactions 7 (8.5) 3 (3.5)
    Herpes viral infections 1 (1.2) 3 (3.5)

    If a systemic hypersensitivity reaction (immediate or delayed) occurs, DUPIXENT should be discontinued immediately and appropriate therapy initiated20

    Patients who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination2

    Patients with moderate-to-severe atopic dermatitis and comorbid asthma should not adjust or stop their asthma treatments without consulting their physicians. Monitor patients with comorbid asthma carefully following discontinuation of DUPIXENT2

    Most patients experiencing conjunctivitis recovered or were recovering during the treatment period2

    Treat any pre-existing helminth infections prior to initiating treatment with DUPIXENT. If patients become infected while receiving treatment and do not respond to anti-helminth treatment, discontinue treatment until infection resolves2

    *Includes the atopic keratoconjunctivitis, conjunctivitis, conjunctivitis allergic, conjunctivitis bacterial, conjunctivitis viral.

    1. Simpson EL et al. JAMA Dermatol 2020; 156(1):44–56.
    2. DUPIXENT Summary of Product Characteristics. August 2023.
    3. Guttman-Yassky E et al. J Allergy Clin Immunol 2019; 143:155-172.
    4. Grieco T et al. Clin Dermatol 2021; 39(6):1083-1087.

    A UNIQUE SAFETY AND TOLERABILITY PROFILE ESTABLISHED UP TO WEEK 16 IN CHILDREN AS YOUNG AS 6 YEARS OLD1,3

    SAFETY PROFLE ESTABLISHED IN OVER 10,000 CLINICAL TRIAL PATIENTS SPANNING MULTIPLE AGE GROUPS ACROSS 3 INDICATIONS – ATOPIC DERMATITIS, ASTHMA, AND CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS1,4

    No routine lab monitoring required1

    LIBERTY AD CHRONOS
    (Week 52)

    No discontinuations due to AEs with DUPIXENT2 Comparable rate of serious AEs between DUPIXENT + TCS and placebo + TCS2 Lower rates of skin infections vs placebo + TCS2
    0%
    DUPIXENT +TCS    		 VS 1.7%
    Placebo +TCS    		 1.7%
    DUPIXENT +TCS    		 VS 1.7%
    Placebo +TCS    		 5.8%
    DUPIXENT +TCS    		 VS 13.3%
    Placebo +TCS

    DUPIXENT HAS A DEMONSTRATED SAFETY PROFILE UNDERPINNED BY TARGETED IMMUNOMODULATION NOT BROAD SUPPRESSION1,4,5

    UNIQUE SAFETY PROFILE

    Safety and tolerability up to Week 16 in children 6–11 years in LIBERTY AD PEDS2

    AES IN >5% OF PATIENTS DURING THE 16 WEEK TREATMENT PERIOD IN LIBERTY AD PEDS1
    Adverse event, n (%) DUPIXENT 300mg Q4W + TCS (n=120) Placebo (n=120)
    Nasopharyngitis 15 (12.5) 8 (6.7)
    Upper respiratory tract infection 13 (10.8) 12 (10.0)
    Vomiting 6 (5.0) 8 (6.7)
    Headache 6 (5.0) 10 (8.3)
    Conjunctivitis* 8 (6.7) 5 (4.2)
    Skin infection (adjudicated)** 7 (5.8) 16 (13.3)
    Injection site reactions 7 (8.5) 3 (3.5)
    Injection site reactions† 12 (10.0) 7 (5.8)

    If a systemic hypersensitivity reaction (immediate or delayed) occurs, DUPIXENT should be discontinued immediately and appropriate therapy initiated1

    Patients who develop conjunctivitis that does not resolve following standard treatment should undergo ophthalmological examination1

    Patients with moderate-to-severe atopic dermatitis and comorbid asthma should not adjust or stop their asthma treatments without consulting their physicians. Monitor patients with comorbid asthma carefully following discontinuation of DUPIXENT1

    Most patients experiencing conjunctivitis recovered or were recovering during the treatment period1

    Treat any pre-existing helminth infections prior to initiating treatment with DUPIXENT. If patients become infected while receiving treatment and do not respond to anti-helminth treatment, discontinue treatment until infection resolves1

    DUPIXENT 200mg Q2W is also available for children aged 6–11 15kg to <60kg, based on physician’s assessment. *Conjunctivitis cluster (narrow conjunctivitis) includes preferred terms conjunctivitis, conjunc tivitis allergic, conjunctivitis bacterial, conjunctivitis viral, and atopic keratoconjunctivitis. **Skin infec ons were adjudicated on a case-by-case basis and included bacterial, viral, and fungal infections. †Adverse event reported at the high-level term of the MedDRA hierarchy.

    1. DUPIXENT Summary of Product Characteristics. August 2023.
    2. Paller AS et al. J Am Acad Dermatol 2020; 83:1282–1293.
    3. Data on File (AD 1434 Compliance). Sanofi and Regeneron Pharmaceuticals, Inc. 2019.
    4. Guttman-Yassky E et al. J Allergy Clin Immunol 2019; 143:155-172.
    5. Grieco T et al. Clin Dermatol 2021; 39(6):1083-1087.

    A UNIQUE SAFETY AND TOLERABILITY PROFILE DEMONSTRATED IN PATIENTS AS YOUNG AS 6 YEARS OLD1-3

    Only atopic dermatitis therapy approved in patients as young as 6 years1

    DUPIXENT has a unique safety profile underpinned by targeted immunomodulation and not broad immunosuppression1-3

    Not metabolized through the liver or excreted through the kidneys2

    No requirement for initial lab testing or ongoing lab monitoring5

    No known drug-drug interactions2
      Adult
    (Week 52)6    		 Adolescent
    (Week 16)7    		 Child
    (Week 16)8
    No or lower rate of discontinuations due to AEs vs placebo 1.8%
    DUPIXENT +TCS    		 VS 7.6%
    Placebo +TCS    		 0.0%
    DUPIXENT    		 VS 1.2%
    Placebo    		 0.0%
    DUPIXENT +TCS    		 VS 1.7%
    Placebo +TCS
    Comporable rate of serious AEs vs placebo 3.6%
    DUPIXENT +TCS    		 VS 5.1%
    Placebo +TCS    		 0.0%
    DUPIXENT    		 VS 1.2%
    Placebo    		 1.7%
    DUPIXENT +TCS    		 VS 1.7%
    Placebo +TCS
    Lowe rates of non-herpetic skin infections vs placebo 10.9%
    DUPIXENT +TCS    		 VS 17.8%
    Placebo +TCS    		 9.8%
    DUPIXENT    		 VS 18.8%
    Placebo    		 5.8%
    DUPIXENT +TCS    		 VS 13.3%
    Placebo +TCS

    The safety profile of DUPIXENT is consistent across ages groups – from children aged 6 years through to adults6-9

    1. DUPIXENT Summary of Product Characteristics. August 2023.
    2. Guttman-Yassky E et al. J Allergy Clin Immunol 2019; 143:155-172.
    3. Grieco T et al. Clin Dermatol 2021; 39(6):1083-1087.
    4. Wollenberg A et al. Br J Dermatol 2020;182(5):1120–1135.
    5. Blauvelt A et al. Lancet 2017; 389:2287–2303.
    6. Simpson EL et al. JAMA Dermatol 2020; 156(1):44–56.
    7. Paller AS, et al. J Am Acad Dermatol. 2020; 83(5):1282–1293.
    8. Data on file (AD-1526 adverse events). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.

    CONSISTENT RESULTS SEEN THROUGH 4 YEARS OF REAL-WORLD EXPERIENCE

    Location Skin clearance (EASI) Itch (pruritus) Qualityof life (DLQI)
    Japan
    (N=153)1    		 85%
    Mean percent change from baseline to Week 80    		 58%
    Mean percentage change from baseline to week 80    		 74%
    Mean percentage change from baseline to week 80
    USA and Canada
    (N=563)2    		 82%
    Mean improvement from baseline to Month 18    		 61%
    Mean improvement from baseline to Month 18    		 77%
    Mean improvement from baseline to Month 18
    Italy
    (N=165)3    		 89%
    Mean improvement from baseline to Week 52    		 84%
    Mean improvement from baseline to Week 52    		 90%
    Mean improvement from baseline to Week 52
    The Netherlands
    (N=218)4    		 85%
    Mean percent change from baseline to Week 52    		 71%
    Mean percent change from baseline to Week 52    		 83%
    Mean percent change from baseline to Week 52
    The UK
    (N=156)3    		 91%
    Median improvement from baseline to Week 26–30    		 N/A 91%
    Median improvement from baseline to Week 26–30
    Germany
    (N=56)3    		 79%
    Mean improvement from baseline to Week 24    		 56%
    Mean improvement from baseline to Week 24    		 66%
    Mean improvement from baseline to Week 24
    Spain
    (N=70)7    		 77%
    Mean improvement from baseline to Week 24    		 N/A 63%
    Mean improvement from baseline to Week 24
    Austria
    (N=94)8    		 78%
    Mean improvement from baseline to Week 24    		 N/A 71%
    Mean improvement from baseline to Week 24
    South Korea
    (N=99)9    		 88%
    Mean percent change from baseline to Week 52    		 66%
    Mean percent change from baseline to Week 52    		 69%
    Mean percent change from baseline to Week 52
    France
    (N=241)10    		 77%
    Mean percent change from baseline to Week 12    		 N/A 69%
    Mean percent change from baseline to Week 12

    1. de Wijs LEM et al. Br J Dermatol 2021; 185(3):555–562.
    2. Bagel J et al. Poster presented at the 30th Congress of the European Academy of Dermatology and Venereology; 2021; September 29–October 2; Virtual Meeting. Poster P0257.
    3. Napolitano M et al. Dermatol Ther (Heidelb) 2021; 11:355–361.
    4. Ariëns LFM et al. Acta Derm Venereol. 2021;101(10):adv00573.
    5. Kreeshan FC et al. Dermatol Ther (Heidelb) 2021; 11:149–160.
    6. Abraham S et al. Br J Dermatol 2020; 183:382-384.
    7. Armario-Hita JC et al. Br J Dermatol 2019; 181:1072–1074.
    8. Quint T et al. J Clin Med 2020; 9(4):1241.
    9. Jang DH et al. Sci Rep. 2021;11(1):23539.
    10. Faiz S et al. J Am Acad Dermatol 2019; 81(1):143–151.

    FAVORABLE TOLERABILITY PROFILE ACROSS REAL-WORLD STUDIES

    TOLERABILITY PROFILE IN REAL-WORLD STUDIES

    Low discontinuation rates across studies1-4

    2%
    At 52 weeks**

    2%
    At 52 weeks**

    2%
    At 52 weeks**

    2%
    At 52 weeks**

    RANDOMIZED CONTROL TRIAL

    LIBERTY AD CHRONOS

    Discontinuation rate6*

    2%

    At 52 weeks

    No lab monitoring required3-5
    No lab monitoring required3-5

    0%

    1%

    7%

    LIBERTY AD CHRONOS

    Injection site reactions6*6*

    15%

    ONLY ATOPIC DERMATITIS THERAPY WITH 4 YEARS SAFETY DATA7

    1. Napolitano M et al. Dermatol Ther (Heidelb) 2021; 11:355–361.
    2. Quint T et al. J Clin Med 2020; 9(4):1241.
    3. Kreeshan FC et al. Dermatol Ther (Heidelb) 2021; 11:149–160.
    4. de Wijs LEM et al. Br J Dermatol 2020; 182(2):418–426.
    5. Uchida H et al. J Am Acad Dermatol 2021; 84(2):547–550.
    6. Blauvelt A et al. Lancet 2017; 389:2287–2303.
    7. Beck L et al. Am J Clin Dermatol 2022; 23(3):393–408.

    REAL-WORLD STUDIES OF DUPIXENT DEMONSTRATE GREATER LEVELS OF PERSISTENCE THAN THAT SEEN IN THE CHRONOS PIVOTAL TRIAL1–5

    PERSISTENCE IN REAL-WORLD STUDIES

    97%**
    At 52 weeks (105/109)1

    		 88%**
    At 204 weeks (95/109)1

    91%†
    At 52 weeks (366/402)

    		 88%†
    At 104 weeks (104/109)1

    94%‡
    At 86 weeks (225/240)3

    		  

    82%§
    At 69 weeks (123/149)4

    		  

    87%
    At 6 months (310/357)4

    		  

    RANDOMIZED CONTROL TRIAL

    LIBERTY AD CHRONOS*

    86%

    At 52 weeks (77/90)

     

    At 2 years real-world evidence demonstrates >80% persistence2,6

    Real-world studies of DUPIXENT demonstrate greater levels of persistence at 52 weeks than clinical trials1-5

    1. Hong M and Silverberg JI. Poster presented at the virtual Revolutionizing Atopic Dermatitis (RAD) Conference; 2020; April 5; Chicago IL, USA.
    2. Spekhorst LS et al. Allergy 2020; 75(9):2376–2379.
    3. Pereyra-Rodriquez JJ et al. Br J Dermatol 2021; 184(1): 175–176.
    4. Dal Bello G et al. Dematol Ther 2020; 33(6):e13979.
    5. Igawa K et al. Poster presented at the 30th Congress of the European Academy of Dermatology and Venereology; 2021; September 29–October 2; Virtual
    6. Meeting. Poster P0272. 6. de Wijs LEM et al. Br J Dermatol 2020; 182(2):418–426
    7. Blauvelt A et al. Lancet 2017; 389:2287–2303.

    START WITH EASE, STAY WITH CONFIDENCE

    From initiation to follow-up, DUPIXENT makes it easy for ALL AGE GROUPS to achieve lasting relief1-20

    85% PATIENT SATISFACTION WITH DUPIXENT TREATMENT AT 1 YEAR21

    DUPIXENT HAS HIGH LEVELS OF PATIENT SATISFACTION21,22

    85%

    OF ADULT PATIENTS TREATED WITH DUPIXENT WERE VERY/EXTREMELY/ SOMEWHAT SATISFIED AT 12 MONTHS VS 18% BEFORE STARTING

    AFTER INITIATING DUPIXENT, THE PROPORTION OF PATIENTS WHO WERE EXTREMELY SATISFIED INCREASED AT EACH FOLLOW-UP

    Prospective, longitudinal patient survey of adult patients who had not been treated with DUPIXENT prior to this study (N=699). A sensitivity analysis, pattern mixture modelling (PMM) was conducted for imputation of missing values.

    1. DUPIXENT Summary of Product Characteristics. August 2023.
    2. Wollenberg A et al. Br J Dermatol 2020;182(5):1120-1135.
    3. Blauvelt A et al. Lancet 2017; 389:2287–2303. [suppl.].
    4. Data on file (AD-1224 CSR EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    5. Data on file (AD-1224 CSR DLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    6. Data on file (AD-1652 CSR EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    7. Data on file (AD-1652 CSR pruritus NRS). Sanofi and Regeneron Pharmaceticals, Inc. 2022.
    8. Data on file (AD-1652 CSR CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    9. Data on file (AD-1539 EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    10. Data on file (AD-1539 pruritus NRS). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    11. Data on file (AD-1539 CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    12. Data on file (AD-1526 EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    13. Data on file (AD-1526 pruritus NRS). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    14. Data on file (AD-1526 CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    15. Beck L et al. Am J Clin Dermatol 2022; 1–16. doi: 10.1007/s40257-022-00685-0.
    16. Blauvelt A et al. Lancet 2017; 389:2287–2303.
    17. Blauvelt A et al. Poster presented at the Revolutionizing Atopic Dermatitis Conference; 2021; June 13; Virtual Conference. Poster 469.
    18. Cork MJ et al. Presented at the 2021 Revolutionizing Atopic Dermatitis (RAD) Conference; Virtual Conference; June 13, 2021.
    19. Simpson EL et al. Poster presented at the 30th Congress of the European Academy of Dermatology and Venereology; 2021; September 29–October 2; Virtual Meeting. Poster P0723.
    20. Kojanova M et al. J Dermatolog Treat. 2022. doi: 10.1080/09546634.2022.2043545.
    21. Strober B et al. JAMA Dermatol 2022; 158(2):142–150.
    22. Strober B et al. JAMA Dermatol. 2022;158(2):142–150. [suppl.]

    DUPIXENT GIVES YOUR PATIENTS CONVENIENT ADMINISTRATION OPTIONS

    DUPIXENT offers biweekly dosing for adults, adolescents, and children who weigh 60kg or more, and dosing once every four weeks for children ≥15 to <60kg1

    DUPIXENT now provides you and your patients with a pre-filled syringe1

    DUPIXENT gives your patients the choice of at-home or in-office administration1

    1. DUPIXENT Summary of Product Characteristics. August 2023.

    RAPID AND SUSTAINED CONTROL – CONSISTENT ACROSS ALL AGES

    Sustained improvement of itch, skin clearance, and quality of life up to 52 weeks, with rapid control after first dose1-16

    UNIQUE LONG-TERM SAFETY PROFILE

    Only atopic dermatitis therapy

    Approved in patients as young as 6 years1

    START WITH EASE, STAY WITH CONFIDENCE

    DUPIXENT is not an immunosuppressant1

    85% patient satisfaction with DUPIXENT treatment at 1 year in adults17*

    ~340,000 ATOPIC DERMATITIS PATIENTS TREATED WITH DUPIXENT WORLDWIDE18

    *In adult patients with atopic dermatitis

    1. DUPIXENT Summary of Product Characteristics. August 2023.
    2. Blauvelt A et al. Lancet 2017; 389:2287–2303.
    3. Data on file (AD-1224 CSR). Sanofi and Regeneron Pharmaceuticals, Inc. 2016.
    4. Blauvelt A et al. Lancet 2017; 389:2287–2303. [suppl.].
    5. Data on file (AD-1224 CSR DLQI rate). Sanofi and Regeneron Pharmaceuticals, Inc. 2021.
    6. Data on file (AD-1652 CSR EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2019.
    7. Data on file (AD-1652 CSR CDLQI rate). Sanofi and Regeneron Pharmaceuticals, Inc. 2019.
    8. Paller AS et al. J Am Acad Dermatol 2020; 83(5):1282–1293.
    9. Cork MJ et al. Poster presented at the Revolutionizing Atopic Dermatitis Conference; 2021; June 13; Virtual Conference. Poster 468.
    10. Data on file (AD-1652 CSR pruritus NRS). Sanofi and Regeneron Pharmaceuticals, Inc. 2019.
    11. Simpson EL et al. JAMA Dermatol 2020; 156(1):44–56.
    12. Data on file (AD-1526 CSR EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2019.
    13. Paller AS et al. Am J Clin Dermatol 2020; 21:119–131.
    14. Data on file (AD-1539 EASI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    15. Data on file (AD-1539 pruritus NRS). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    16. Data on file (AD-1539 CDLQI). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.
    17. Strober B et al. JAMA Dermatol 2022;158(2):142–150.
    18. Data on file (Patient numbers, May 2022). Sanofi and Regeneron Pharmaceuticals, Inc. 2022.

    MAT-BH-2400435/V1/August 2024