Eczema Awareness Month

IT'S A CHALLENGE

Does uncontrolled moderate-to-severe atopic dermatitis control your patients? How do you know when their current treatment is not enough? Take these challenges to see what uncontrolled moderate-to-severe atopic dermatitis looks like across age groups, skin tones, and body regions, and what's achievable with DUPIXENT.

CASE STUDY CHALLENGE

In patients aged 6+ months with uncontrolled moderate-to-severe atopic dermatitis

What does
uncontrolled
look like ACROSS
AGE GROUPS?

Your patients may not always know how to tell you their current topical Rx treatment is not enough.

EVALUATE CASE STUDIES IN PATIENTS
FROM INFANCY TO ADULTHOOD

Try using the Investigator’s Global Assessment (IGA) tool below

Case study based on
actual patient photo.

Patient 1: Age 3

Signs and symptoms

Assessed with an IGA of 3 (moderate)
Exhibited uncontrollable itching and scratching on legs and feet (BSA 11%) with excoriated lesions

Treatment history

Prescribed oral and topical steroids
Oatmeal baths, wet wraps, and other home remedies
were not enough

Answer: Yes

This patient seems to be uncontrolled

With an IGA of 3 (moderate) despite topical Rx therapy, this patient may be an appropriate candidate for DUPIXENT.
DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months
and older with moderate-to-severe atopic dermatitis whose disease is not adequately
controlled with topical prescription therapies or when those therapies are not
advisable. DUPIXENT can be used with or without topical corticosteroids.

DOES THIS PATIENT SEEM UNCONTROLLED?

SOLVE MORE CASE STUDIES

Case study based on
actual patient photo.

Patient 2: Age 6

Signs and symptoms

Assessed with an IGA of 4 (severe)
Reported extremely pruritic lesions on hands and face (BSA 12%) that would crack and bleed

Treatment history

Prescribed oral and topical steroids
Steroids would work temporarily, but once treatment ended, lesions and itch would return

Answer: Yes

This patient seems to be uncontrolled

With an IGA of 4 (severe) despite topical Rx therapy, this patient may be an appropriate
candidate for DUPIXENT. DUPIXENT is indicated for the treatment of adult and pediatric
patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease
is not adequately controlled with topical prescription therapies or when those therapies are
not advisable. DUPIXENT can be used with or without topical
corticosteroids.

DOES THIS PATIENT SEEM UNCONTROLLED?

SOLVE MORE CASE STUDIES

Case study based on
actual patient photo.

Patient 3: Adolescent

Signs and symptoms

Assessed with an IGA of 4 (severe)
Exhibited extremely itchy, scaly skin on extremities
(BSA 14%) with severe lesions

Treatment history

Topical prescription therapies worked for a while,
but they stopped working
Chlorine baths and wet wraps were also ineffective

Answer: Yes

This patient seems to be uncontrolled

DOES THIS PATIENT SEEM UNCONTROLLED?

SOLVE MORE CASE STUDIES

Case study based on
actual patient photo.

Patient 4: Adult

Signs and symptoms

Assessed with an IGA of 3 (moderate)
Exhibited flare-ups, which started as red patches of itchy skin (BSA 14%) that would transition into more white, discolored lesions that were still itchy

Treatment history

Tried a number of different holistic remedies
Prescribed allergy medications and topical corticosteroids
Treatments worked for a while, but stopped working

Answer: Yes

This patient seems to be uncontrolled

With an IGA of 3 (moderate) despite topical Rx therapy, this patient may be an appropriate candidate for DUPIXENT.
DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months
and older with moderate-to-severe atopic dermatitis whose disease is not adequately
controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

DOES THIS PATIENT SEEM UNCONTROLLED?

SOLVE MORE CASE STUDIES

IGA Scale Assessment Tool

A 0‑ to 4‑point scoring system for evaluating overall severity of atopic
dermatitis skin lesions^1,4

Not an
actual
patient.

Severe Disease

Severe erythema and severe papulation/ infiltration

Not an
actual
patient.

Moderate Disease

Moderate erythema and moderate papulation/ infiltration

Not an
actual
patient.

Mild Disease

Mild erythema and mild papulation/ infiltration

Not an
actual
patient.

Almost Clear

Just perceptible erythema and just perceptible papulation/ infiltration

Not an
actual
patient.

Clear

No inflammatory signs of atopic dermatitis

Clear
Almost
Clear
Mild
Disease
Moderate
Disease
Severe
Disease

SEE IGA SCALE

PROVIDER PERSPECTIVE Helping treat a child’s incessant itch

Brittany Craiglow, MD, shares how she knew that topical Rx therapy was not enough for her young patient’s moderate atopic dermatitis—and what she did about it.

You name it, she tried it.
She was very itchy…you know,
itchy day and night.”

DUPIXENT is indicated for the treatment of patients aged 6 months and older with moderate-to-severe
atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or
when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

Please view entire video for clinical trial efficacy and safety data and accompanying link for full
Prescribing Information.

Hear Dr Craiglow’s DUPIXENT story

INDICATION

DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

DR DEL ROSSO: Hi I’m Dr Jim Del Rosso and this is the Beyond the Surface series. Today on the green couch...

We are very pleased to welcome Dr Brittany Craiglow, who is a board-certified dermatologist and a board-certified pediatric dermatologist who practices in Fairfield, Connecticut. Welcome, Brittany.

DR CRAIGLOW: So great to see you, Jim. Thanks for having me.

DR DEL ROSSO: We're going to be talking about a disease state that is close to both of us: atopic dermatitis.

DR CRAIGLOW: So as a pediatric dermatologist...I see a lot of it, and it's actually one of my favorite things to treat.

DR DEL ROSSO: So Brit, can you tell us about the patient you want to discuss today?

DR CRAIGLOW: It’s a girl. She is now 10 years old. I met her when she was about 7. She has skin type probably 4 or 5. She had more moderate disease, I would say.

Her mom was very clear that her itch was becoming increasingly problematic...You know, at 8 years old, she was starting to have homework, she said she would look over while she was...doing her math worksheet or whatever and seeing her scratching. She started to feel a little bit more self-conscious.

In different patients, particularly those with darker skin types often, it looks a little bit different...it was hard to actually even see it...

...but she was covered in follicular eczema.

DR DEL ROSSO: So they hit that tipping point of becoming frustrated with everything previously.

DR CRAIGLOW: She had tried kind of everything under the sun, you name it. She had tried it...She was very itchy...itchy night and day basically, and the family was feeling frustrated and really hoping that there might be something else for her to try.

DR DEL ROSSO: How did you explain why DUPIXENT was your next recommended step for their treatment?

DR CRAIGLOW: She had tried numerous topical corticosteroids of varying potencies and varying vehicles. She tried topical calcineurin inhibitors and she remained really poorly controlled.

When I said, look, there’s something beyond creams, it was sort of like their eyes lit up. In fact...I say it’s not an immunosuppressant, it’s not a steroid.

I try to explain the drug, the mechanism, the safety profile all first...then I’ll say, because of the way the medicine works, it needs to be delivered by an injection.

The most common adverse reactions with an incidence of greater than or equal to 1% in adults at Week 16 in clinical trials were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection and dry eye.

I think for me, safety profile is, you know, probably actually the most important thing, especially when treating children and to have a medicine that has a...long term safety profile, like DUPIXENT, it is really, really welcome for me as a pediatric dermatologist.

DR DEL ROSSO: So now, DUPIXENT therapy has been initiated.

DR CRAIGLOW: I saw her back...she said she was already...less itchy...at Week 16. Her skin was actually clear...And the family has just been really thrilled with her progress. And...eczema isn’t at the forefront of decision-making.

DR DEL ROSSO: So that’s a great ending to the story about your patient and that they did...well.

DR CRAIGLOW: Yeah, thank you so much for having me. It really was a pleasure. It’s always, you know, I think it’s even more fun to see these kids in real life, but a second best is to be able to talk about and share their stories.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.

Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization. Advise patients to report new onset or worsening joint symptoms. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.

Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile in pediatric patients through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis, with hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.

USE IN SPECIFIC POPULATIONS

Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

Please see accompanying link to full Prescribing Information.

SKIN TONE CHALLENGE

In patients aged 6+ months with uncontrolled moderate-to-severe atopic dermatitis

HOW DOES ATOPIC DERMATITIS PRESENT
IN SKIN OF COLOR?

Signs of uncontrolled moderate-to-severe atopic dermatitis may manifest differently in skin of color. Therefore, recognizing how erythema and other clinical signs may present in darker skin tones continues to be important.^5,6

Which PHOTOS are consistent
with Atopic Dermatitis?
(Choose all that apply)

Submit

All photos are consistent with ATOPIC DERMATITIS

Edema, skin warmth, or scaling are some indications of underlying erythema.
In darker skin, it may appear violet.^7,8

DUPIXENT ACROSS SKIN TONES

Itch reduction and skin clearance IN CHRONOS

>3x as many adult patients achieved clear or almost-clear skin (IGA 0 or 1) with DUPIXENT + TCS
than with placebo + TCS at Week 16 (CHRONOS: 39% vs 12%, P<0.0001; primary endpoint)^9,10,a,b

Significant itch reduction in adults (Peak Pruritus NRS) at Week 2 (≈18% vs 8%; P=0.0062) and Week 16
(59% vs 20%; P<0.0001) with DUPIXENT + TCS vs placebo + TCS in CHRONOS (secondary endpoint)^9,10,a,b

In a post hoc analysis of 3 pooled trials (2 monotherapy and 1 concomitant TCS trial) in adults

With Dupixent, skin clearance and itch reduction was generally
consistent across all tested racial groups vs comparator¹¹

Black/African American | Asian | White

Definitive conclusions cannot be made, as this analysis was performed on only 16-week data,
did not directly compare dose regimens, and only a small number of black/African American
patients were available for analysis.

^aResponder defined as IGA 0 or 1 (clear or almost clear) with a reduction of ≥2 points on a 0-4 IGA scale at Week 16 in all adult trials
(primary efficacy outcome) and at Week 52 in CHRONOS (other endpoint).

^bEmollient background regimen/therapy was required.

CLINICAL TRIAL DESIGNS
AND TRIAL RESULTS

Trial Designs: A total of 917 adults in SOLO 1 and SOLO 2, 251 adolescents (12‑17 years) in AD‑1526, 162 infants to preschoolers (6 months to 5 years) in AD‑1539 (16 weeks each), and 421 adults in CHRONOS (52 weeks) with moderate‑to‑severe atopic dermatitis and 367 children (6‑11 years) in AD‑1652 (16 weeks) with severe disease inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. All patients in CHRONOS, AD‑1652, and AD‑1539 received concomitant TCS. All DUPIXENT‑treated adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose, adolescents <60 kg and children ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose, children 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose; infants to preschoolers 15 kg but <30 kg received 300 mg Q4W, and infants to preschoolers 5 kg but <15 kg received 200 mg Q4W. In SOLO 1, SOLO 2, CHRONOS, AD‑1526, and AD‑1539 patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72 , and BSA involvement ≥10%. In AD‑1652, patients had an IGA score of 4, an EASI score ≥21, and BSA involvement ≥15%. At baseline, 52% of adults, 46% of adolescents, and 23% of infants to preschoolers had an IGA score of 3 (moderate); 48% of adults, 54% of adolescents, and 77% of infants to preschoolers had an IGA of 4 (severe); mean EASI score was 33 for adults, 36 for adolescents, 37.9 for children, and 34.1 for infants to preschoolers; weekly averaged Peak Pruritus NRS was 7 for adults, 8 for adolescents, and 7.8 for children on a scale of 0 to 10; and weekly average of daily Worst Scratch/Itch NRS was 7.6 for infants to preschoolers on a scale of 0 to 10.^9,12

Trial Results: The primary endpoint in SOLO 1, SOLO 2, CHRONOS, and AD‑1526 was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2‑point improvement at Week 16 (38% and 36% of adults treated with DUPIXENT vs 10% and 9% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 39% of adults treated with DUPIXENT + TCS vs 12% with placebo + TCS in CHRONOS, P<0.0001; and 24% of adolescents treated with DUPIXENT vs 2% with placebo in AD‑1526, P<0.001). In AD‑1652 (6‑11 years), the primary endpoint was the proportion of subjects with an IGA 0 or 1 at Week 16 (39% of children ≥30 kg treated with DUPIXENT + TCS vs 10% with placebo + TCS, 30% of children <30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS). In AD‑1539 (6 months to 5 years), the primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (28% of infants to preschoolers treated with DUPIXENT + TCS vs 4% with placebo + TCS, P<0.0001). Other endpoints included the change proportion of subjects with EASI‑75 at Week 16; 51% and 44% of adults treated with DUPIXENT vs 15% and 12% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 69% of adults treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001; 42% of adolescents treated with DUPIXENT vs 8% with placebo in AD‑1526, P<0.001; 75% of children ≥30 kg treated with DUPIXENT + TCS vs 26% with placebo + TCS, and 75% of children <30 kg treated with DUPIXENT + TCS vs 28% with placebo + TCS in AD‑1652; and 53% of infants to preschoolers treated with DUPIXENT + TCS vs 11% with placebo + TCS in AD‑1539, P<0.0001), ≥4‑point improvement in the Peak Pruritus NRS at Week 16 (41% and 36% of adults treated with DUPIXENT vs 12% and 10% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 59% of adults treated with DUPIXENT + TCS vs 20% with placebo + TCS in CHRONOS, P<0.0001; 37% of adolescents treated with DUPIXENT vs 5% with placebo in AD‑1526, P<0.001; 61% of children ≥30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS and 54% of children <30 kg treated with DUPIXENT + TCS vs 12% with placebo + TCS in AD‑1652), and ≥4‑point improvement in the Worst Scratch/Itch NRS at Week 16 (48% of infants to preschoolers treated with DUPIXENT + TCS vs 9% with placebo + TCS in AD‑1539, P<0.0001).^9,10,12‑15

BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator's Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; Q4W, once every 4 weeks; TCS, topical corticosteroids.

See Visible results ACROSS
SKIN TONES WITH DUPIXENT

Use the slider to see before and after treatment with DUPIXENT.

Patient 1 Patient 2 Patient 3

Before
TreatmentBASELINE: IGA 4
(severe) After
TreatmentWEEK 16: IGA 0
(clear)

Patient 1: Adult

Actual adult patient being treated with DUPIXENT. Not a clinical trial patient. This patient was
on concomitant therapies, such as TCS, phototherapy, etc, at their prescribing physician’s
discretion. Scoring was designated by the treating physician. Because this was a real-world
patient, other factors may have influenced their treatment results.

Individual results may vary.

A clinical responder was defined by achieving IGA 0 or 1 and a ≥2-point improvement
from baseline.⁹

In CHRONOS, 39% of DUPIXENT + TCS adult patients achieved clear or almost‑clear skin
(IGA 0 or 1) vs 12% with placebo + TCS at Week 16 (P<0.0001).^9,10

SEE MORE DATA

Before
TreatmentBASELINE: IGA 4
(severe) After
TreatmentWEEK 16: IGA 3
(moderate)

Patient 2: Child

Actual 6-year-old patient in a phase 3 pediatric DUPIXENT trial (AD-1652). The study
population included children aged 6-11 years with only severe atopic dermatitis, and who
were prescribed concomitant TCS based on the clinical trial program.

Individual results may vary.

A clinical responder was defined as a patient achieving IGA 0 or 1.⁹

This child patient did not meet the primary endpoint in the clinical trial based on their
IGA score at Week 16

In AD-1652 at Week 16, 39% of children treated with DUPIXENT + TCS (≥30 kg; 200 mg Q2W)
achieved clear or almost-clear skin (IGA 0 or 1) vs 10% with placebo + TCS; 30% vs 13% of
children <30 kg (300 mg Q4W + TCS vs placebo + TCS).^9,13

SEE MORE DATA

Before
TreatmentBASELINE: IGA 4
(severe) After
TreatmentWEEK 16: IGA 0
(clear)

Patient 3: Infant to preschooler

Actual 4-year-old patient in a phase 3 DUPIXENT trial (AD-1539) in infants to preschoolers (aged 6 months to 5 years). Patients were prescribed concomitant low-potency TCS based on the clinical trial program.

Individual results may vary.

A clinical responder was defined as a patient achieving IGA 0 or 1.⁹

In AD-1539 at Week 16, 28% of infants to preschoolers treated with DUPIXENT + TCS achieved clear or almost-clear skin (IGA 0 or 1) vs 4% with placebo + TCS (P<0.0001).^9,12

SEE MORE DATA

TAKE THE BODY REGION
CHALLENGE NEXT

PROVIDER PERSPECTIVE Helping find relief for patients of color

Jenny Murase, MD, talks about unmasking severe atopic dermatitis in her patient of color with Fitzpatrick skin type 4 (0-6 scale) and her journey with DUPIXENT.

Unless we actually ask the right questions…we will
underdiagnose the patient.”

Please view entire video for clinical trial efficacy and safety data and accompanying link for full
Prescribing Information.

Hear Dr Murase’s DUPIXENT story

INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

DR DEL ROSSO: Hi, I'm Dr Jim Del Rosso and this is the Beyond the Surface series. Today on the green couch, we're very pleased to have with us Dr Jenny Murase, who is a board-certified dermatologist practicing in Mountain View, California, and is also on faculty at the University of California San Francisco in Dermatology. Great to see you today, Jenny.

DR MURASE: It's great to see you as well, Jim, and I'm so happy to be here. Atopic dermatitis is such an important topic, and it is a passion of mine, so I'm so glad to have this opportunity to talk to you today.

DR DEL ROSSO: Jenny, you've seen patients, most of them have had atopic dermatitis for a while, they've been on other treatments, have seen other clinicians. In that setting, what do you find to be the most challenging about treating these atopic dermatitis patients?

DR MURASE: Because I'm a consultative dermatologist, most of the patients referred to me are patients that other dermatologists were unable to treat effectively. So, I would say the majority of my patients have moderate-to-severe disease. I care for a lot of patients with Type III to VI skin given that in the area I practice, in the San Francisco Bay area, there are many patients that come from all over the world. And I think one thing that I've noticed over time when I'm caring for these medical consultative patients that come in with really recalcitrant disease and severe atopic dermatitis is oftentimes, they go underdiagnosed…

…and I've grown to appreciate how important it is that the level of pigmentation in the skin can mask the degree of erythema and redness that is present in the skin. So, unless we actually ask the right questions as dermatologists and find out…how much they are itching…

…we will underdiagnose the patient…

So, it's very important for our patients with skin of color with atopic dermatitis that we're asking the right questions and we're really doing our best to get an assessment of the severity of their pruritus.

DR DEL ROSSO: A lot of times as clinicians we're thinking a lot of these things, but we're not necessarily conveying it to the patient, so how would they really know the process that we're going through, so we have to verbalize it.

DR MURASE: Also, just asking, “is this red for you? Do you feel like your skin is inflamed?” When the pigmentation is masking our ability to see the degree of erythema, we have to ask the right questions.

DR DEL ROSSO: Now let's hear about the patient you want to discuss with us today.

DR MURASE: My patient was in her early 40s; she was the mother of 2 children working within Silicon Valley. She had Type IV skin, and she was half Malaysian, half Filipino. She had eczema since she was a child, and it did not remit during her teenage years, so she had it up until her early 40s; and had really always struggled with it throughout her life.

DR DEL ROSSO: So, what would you say was the most bothersome sign or symptom that she presented with?

DR MURASE: By far and away the most bothersome sign when she first presented was the degree of itch that she was experiencing. It was an incessant itch…

DR DEL ROSSO: What other treatments had your patient used before you started them on DUPIXENT?

DR MURASE: She had had atopic dermatitis throughout her entire life, ever since early childhood so she had been on many prescription topical corticosteroids, prescription topical calcineurin inhibitors, she had taken oral immunosuppressant medication.

DUPIXENT is not an immunosuppressant and it is not a corticosteroid.

VOICEOVER: The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.

DR DEL ROSSO: Jenny, you've started DUPIXENT therapy for this patient. What did you see as far as the itch, the appearance of her skin, what did you observe and what did she express to you?

DR MURASE: The itch had reduced dramatically and just the decrease in the itch alone was the thing that I think that she was the most thrilled about.

Because of the fact that she was darker pigmentation, it was more difficult for me to appreciate how red she truly was. It wasn't until she had had skin that wasn't involved with atopic dermatitis that she really truly understood the severity of her disease.

DR DEL ROSSO: Jenny, thanks so much for being here today to talk about atopic dermatitis and to share your patient's story with us.

DR MURASE: Thank you so much for having me because I know my patient is not alone. I know that there are thousands of people out there like her.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

USE IN SPECIFIC POPULATIONS

Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

Please see accompanying link to full Prescribing Information.

BODY REGION CHALLENGE

In patients aged 6+ months with uncontrolled moderate-to-severe atopic dermatitis

WHERE DO LESIONS MOST COMMONLY APPEAR IN ADULTS?

Lesion location may be a consideration when trying to determine disease severity.
While the distribution of lesions varies from patient to patient, atopic dermatitis commonly appears in certain regions.¹⁶

SELECT THE MOST COMMON
SITES OF LESIONS
IN ADULTS

^aFlexural includes antecubital and popliteal fossae.

^bExtensor includes extensor elbows and knees.

CLINICAL TRIAL DESIGNS
AND TRIAL RESULTS

Trial Designs: 917 adults in SOLO 1 and SOLO 2, 251 adolescents (12‑17 years) in AD‑1526, 162 infants to preschoolers (6 months to 5 years) in AD‑1539 (16 weeks each), and 421 adults in CHRONOS (52 weeks) with moderate‑to‑severe atopic dermatitis and 367 children (6‑11 years) in AD‑1652 (16 weeks) with severe disease inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. All patients in CHRONOS, AD‑1652, and AD‑1539 received concomitant TCS. All DUPIXENT‑treated adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose, adolescents <60 kg and children ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose, children 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose; infants to preschoolers 15 kg but <30 kg received 300 mg Q4W, and infants to preschoolers 5 kg but <15 kg received 200 mg Q4W. In SOLO 1, SOLO 2, CHRONOS, AD‑1526, and AD‑1539 patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement ≥10%. In AD‑1652, patients had an IGA score of 4, an EASI score ≥21, and BSA involvement ≥15%. At baseline, 52% of adults, 46% of adolescents, and 23% of infants to preschoolers had an IGA score of 3 (moderate); 48% of adults, 54% of adolescents, and 77% of infants to preschoolers had an IGA of 4 (severe); mean EASI score was 33 for adults, 36 for adolescents, 37.9 for children, and 34.1 for infants to preschoolers; weekly averaged Peak Pruritus NRS was 7 for adults, 8 for adolescents, and 7.8 for children on a scale of 0 to 10; and weekly average of daily Worst Scratch/Itch NRS was 7.6 for infants to preschoolers on a scale of 0 to 10.^9,12

Trial Results: The primary endpoint in SOLO 1, SOLO 2, CHRONOS, and AD‑1526 was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2‑point improvement at Week 16 (38% and 36% of adults treated with DUPIXENT vs 10% and 9% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 39% of adults treated with DUPIXENT + TCS vs 12% with placebo + TCS in CHRONOS, P<0.0001; and 24% of adolescents treated with DUPIXENT vs 2% with placebo in AD‑1526, P<0.001). In AD‑1652 (6‑11 years), the primary endpoint was the proportion of subjects with an IGA 0 or 1 at Week 16 (39% of children ≥30 kg treated with DUPIXENT + TCS vs 10% with placebo + TCS, 30% of children <30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS). In AD‑1539 (6 months to 5 years), the primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (28% of infants to preschoolers treated with DUPIXENT + TCS vs 4% with placebo + TCS, P<0.0001). Other endpoints included change in the proportion of subjects with EASI‑75 at Week 16; 51% and 44% of adults treated with DUPIXENT vs 15% and 12% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 69% of adults treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001; 42% of adolescents treated with DUPIXENT vs 8% with placebo in AD‑1526, P<0.001; 75% of children ≥30 kg treated with DUPIXENT + TCS vs 26% with placebo + TCS, and 75% of children <30 kg treated with DUPIXENT + TCS vs 28% with placebo + TCS in AD‑1652; and 53% of infants to preschoolers treated with DUPIXENT + TCS vs 11% with placebo + TCS in AD‑1539, P<0.0001), ≥4‑point improvement in the Peak Pruritus NRS at Week 16 (41% and 36% of adults treated with DUPIXENT vs 12% and 10% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 59% of adults treated with DUPIXENT + TCS vs 20% with placebo + TCS in CHRONOS, P<0.0001; 37% of adolescents treated with DUPIXENT vs 5% with placebo in AD‑1526, P<0.001; 61% of children ≥30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS and 54% of children <30 kg treated with DUPIXENT + TCS vs 12% with placebo + TCS in AD‑1652), and ≥4‑point improvement in the Worst Scratch/Itch NRS at Week 16 (48% of infants to preschoolers treated with DUPIXENT + TCS vs 9% with placebo + TCS in AD‑1539, P<0.0001).^9,10,12‑15

SEE EASI RESULTS WITH DUPIXENT ACROSS
BODY REGIONS AT 1 YEAR

Improvement in lesion extent and severity (EASI) from baseline measured
across body regions in adults at Week 16 and Week 52 (post hoc analysis)^1,17,a,b

Select body region to see EASI data

Definitive conclusions cannot be made for these results at Week 16 and Week 52, as this was a post hoc analysis. Data were not multiplicity controlled, and P values were nominal.

LSM, least squares mean.

^aAs in the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.¹⁰

^bIn CHRONOS, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.¹⁰

HEAD AND NECK

LSM change in EASI score from
baseline at Week 52

71^%

38^%

DUPIXENT 300 mg Q2W + TCS (n=104)

Placebo + TCS (n=304)

Week 16: 72% for DUPIXENT + TCS (n=104); 35% for placebo + TCS (n=304)

TRUNK

LSM change in EASI score from
baseline at Week 52

80^%

45^%

DUPIXENT 300 mg Q2W + TCS (n=104)

Placebo + TCS (n=304)

Week 16: 79% for DUPIXENT + TCS (n=104); 44% for placebo + TCS (n=304)

UPPER EXTREMITIES
(INCLUDES HANDS)

LSM change in EASI score from
baseline at Week 52

77^%

43^%

DUPIXENT 300 mg Q2W + TCS (n=104)

Placebo + TCS (n=304)

Week 16: 74% for DUPIXENT + TCS (n=104); 40% for placebo + TCS (n=304)

LOWER EXTREMITIES
(INCLUDES FEET)

LSM change in EASI score from
baseline at Week 52

81^%

44^%

DUPIXENT 300 mg Q2W + TCS (n=104)

Placebo + TCS (n=304)

Week 16: 77% for DUPIXENT + TCS (n=104); 41% for placebo + TCS (n=304)

CLINICAL TRIAL DESIGNS
AND TRIAL RESULTS

Trial Designs: 917 adults in SOLO 1 and SOLO 2, 251 adolescents (12-17 years) in AD-1526, 162 infants to preschoolers (6 months to 5 years) in AD-1539 (16 weeks each), and 421 adults in CHRONOS (52 weeks) with moderate-to-severe atopic dermatitis and 367 children (6-11 years) in AD-1652 (16 weeks) with severe disease inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. All patients in CHRONOS, AD-1652, and AD-1539 received concomitant TCS. All DUPIXENT-treated adults and adolescents ≥60 kg received 300 mg Q2W after a 600 mg loading dose, adolescents <60 kg and children ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose, children 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose; infants to preschoolers 15 kg but <30 kg received 300 mg Q4W, and infants to preschoolers 5 kg but <15 kg received 200 mg Q4W. In SOLO 1, SOLO 2, CHRONOS, AD-1526, and AD-1539 patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement ≥10%. In AD-1652, patients had an IGA score of 4, an EASI score ≥21, and BSA involvement ≥15%. At baseline, 52% of adults, 46% of adolescents, and 23% of infants to preschoolers had an IGA score of 3 (moderate); 48% of adults, 54% of adolescents, and 77% of infants to preschoolers had an IGA of 4 (severe); mean EASI score was 33 for adults, 36 for adolescents, 37.9 for children, and 34.1 for infants to preschoolers; weekly averaged Peak Pruritus NRS was 7 for adults, 8 for adolescents, and 7.8 for children on a scale of 0 to 10; and weekly average of daily Worst Scratch/Itch NRS was 7.6 for infants to preschoolers on a scale of 0 to 10.^9,12

Trial Results: The primary endpoint in SOLO 1, SOLO 2, CHRONOS, and AD-1526 was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (38% and 36% of adults treated with DUPIXENT vs 10% and 9% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 39% of adults treated with DUPIXENT + TCS vs 12% with placebo + TCS in CHRONOS, P<0.0001; and 24% of adolescents treated with DUPIXENT vs 2% with placebo in AD-1526, P<0.001). In AD-1652 (6-11 years), the primary endpoint was the proportion of subjects with an IGA 0 or 1 at Week 16 (39% of children ≥30 kg treated with DUPIXENT + TCS vs 10% with placebo + TCS, 30% of children <30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS). In AD-1539 (6 months to 5 years), the primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (28% of infants to preschoolers treated with DUPIXENT + TCS vs 4% with placebo + TCS, P<0.0001). Other endpoints included the proportion of subjects with EASI-75 at Week 16; 51% and 44% of adults treated with DUPIXENT vs 15% and 12% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 69% of adults treated with DUPIXENT + TCS vs 23% with placebo + TCS in CHRONOS, P<0.0001; 42% of adolescents treated with DUPIXENT vs 8% with placebo in AD-1526, P<0.001; 75% of children ≥30kg treated with DUPIXENT + TCS vs 26% with placebo + TCS, and 75% of children <30 kg treated with DUPIXENT + TCS vs 28% with placebo + TCS in AD-1652; and 53% of infants to preschoolers treated with DUPIXENT + TCS vs 11% with placebo + TCS in AD-1539, P<0.0001), ≥4-point improvement in the Peak Pruritus NRS at Week 16 (41% and 36% of adults treated with DUPIXENT vs 12% and 10% with placebo in SOLO 1 and SOLO 2, respectively, P<0.001; 59% of adults treated with DUPIXENT + TCS vs 20% with placebo + TCS in CHRONOS, P<0.0001; 37% of adolescents treated with DUPIXENT vs 5% with placebo in AD-1526, P<0.001; 61% of children ≥30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS and 54% of children <30 kg treated with DUPIXENT + TCS vs 12% with placebo + TCS in AD-1652), and ≥4-point improvement in the Worst Scratch/Itch NRS at Week 16 (48% of infants to preschoolers treated with DUPIXENT + TCS vs 9% with placebo + TCS in AD-1539, P<0.0001).^9,10,12-15

PROVIDER PERSPECTIVE Helping get a grip on itch

Gina Mangin, PA-C, talks about managing her patient’s intense itch and real
experience with DUPIXENT.

He was having to wear gloves, and that was difficult in the
hot, humid weather here in Florida.”

Please view entire video for clinical trial efficacy and safety data and accompanying link for full
Prescribing Information.

Hear Gina Mangin, DUPIXENT story

INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

DR DEL ROSSO: Hi, I’m Dr Jim Del Rosso and this is the Beyond the Surface series. Today on the green couch...we’re pleased to have with us Gina Mangin, a dermatology physician assistant who practices in Orlando, Florida. Gina, it’s great to see you today.

GINA MANGIN: Hi Dr Del Rosso, it’s so great to see you as well.

DR DEL ROSSO: I’d like to start by asking you, what’s a day in the life of Gina Mangin, as a physician assistant?

GINA MANGIN: So, I’ve been practicing dermatology for 13 years. As a PA, I diagnose, I treat, and I manage dermatological conditions; that includes atopic dermatitis...any kind of aspect of medical dermatology, I am there to assist our team in taking care of our patients.

DR DEL ROSSO: So, Gina, let’s get down to the nitty-gritty and talk about the patient you want to discuss with us today.

GINA MANGIN: The patient I’m going to describe to you today is a 68-year-old male who came and saw me with moderate-to-severe atopic dermatitis that was involving his back, his hands, and his feet.

The biggest symptom that he had was itch, which he described as controlling his life.

He had failed prescription topical corticosteroids. He was also a groundskeeper at a golf course, so he was always in contact with different chemicals, and he was having to wear gloves, and that was difficult in the hot, humid weather here in Florida, because wearing those gloves...in the hot weather just exacerbated the itch.

DR DEL ROSSO: Can you describe your patient’s treatment history and how it led you to prescribe DUPIXENT?

GINA MANGIN: When he met me, the only treatments he had been on were topical corticosteroids and IM cortisone injections.

...and unfortunately he still had breakthrough and was relying on that IM cortisone injection.

After that he wanted to talk a little bit more about DUPIXENT.

DR DEL ROSSO: When you prescribed DUPIXENT to your patient, what were your overall thoughts on DUPIXENT’s safety profile?

GINA MANGIN: The safety profile of all the medications that we prescribe patients is super important, and for DUPIXENT...in all age groups, from children as young as 6 to adolescents and adults.

DR DEL ROSSO: How did the fact that DUPIXENT is not an immunosuppressant and is not a steroid impact your opinion of DUPIXENT?

GINA MANGIN: ...my patients are so worried about any type of immunosuppressing type of medication and using steroids...

DR DEL ROSSO: Now they’re starting on DUPIXENT therapy...What did you see in this patient as far as improvement early on, like within the first few weeks of treatment?

GINA MANGIN: He had told me his itching had improved at about the 2- to 4-week mark...

He’s been on DUPIXENT now, I believe, for approximately 9 months...at that 4-month mark to which I saw him, his skin was clear...but then I also asked him, how are things for you now? And his specific words were...“the atopic dermatitis is no longer controlling my life.”

DR DEL ROSSO: I know how exciting it is as a clinician that the disease is being controlled rather than the disease controlling the patient.

Thanks a lot, Gina. I think that was a great story and very well explained.

GINA MANGIN: Thank you so much, and thank you for allowing me to share my patient’s story with you today.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Atopic Dermatitis Patients with Co-morbid Asthma: Advise patients not to adjust or stop their asthma treatments without consultation with their physicians.

USE IN SPECIFIC POPULATIONS

Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. To enroll or obtain information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

Please see accompanying link to full Prescribing Information.

In patients aged 6+ months with uncontrolled
moderate-to-severe atopic dermatitis
TAKING CONTROL OF UNCONTROLLED AD

See what’s achievable with DUPIXENT