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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

Reference

  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.

Reference

  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

References

  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

References

  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

References

  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

References

  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

References

  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

References

  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.

References

  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

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. 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.

References

  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.

References

  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.

References

  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

References

  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

References

  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

References

  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

References

  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.

References

  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

Reference

  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

References

  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