NEMLUVIO CLINICAL STUDY RESULTS IN ECZEMA

Shown to deliver relief you can see and feel

Not an actual patient.

Lasting skin healing starts from within

By Week 16, 44% of those using NEMLUVIO® + topicals saw an improvement of at least 75% or more in the severity of their eczema (atopic dermatitis) and the extent of their skin affected by it (vs 29% with placebo + topicals).1*

BEFORE TREATMENT

AFTER TREATMENT

26-YEAR-OLD MALE. Actual
patient from clinical trial. Individual
results may vary.

AFTER 1 YEAR WITH TREATMENT

75+%

CLEARER SKIN

Most of those in clinical trials had significantly clearer skin after 1 year2

26-YEAR-OLD MALE. Actual patient from clinical trial. Individual results may vary.

Response defined as EASI-75 (improvement of at least 75%).1

Clear or almost clear skin was defined as a 1 or below on the IGA scale, where 0 was clear and 4 was severe, with a 2-point or more improvement from baseline.1

The most common side effects for those using NEMLUVIO + topicals were headache, joint pain, muscle ache, and hives. Headache was the most common at 5% (vs 4% with placebo + topicals), with each of the other side effects occurring at 1% (vs 0% with placebo + topicals).1

NEMLUVIO quickly relieves the urge to scratch

AS SOON AS

48

hours2*

 

After 1 year of treatment, 8 out of 10 adults and adolescents experienced continued itch relief2†

PP-NRS response defined as a ≥4-point improvement from baseline. Data from Phase 3 clinical study (ARCADIA 1) post hoc descriptive analysis of daily PP-NRS improvement; consistent results seen in ARCADIA 2. Significant improvement was achieved at 48 hours (9% with NEMLUVIO + TCS/TCI vs 3% with placebo + TCS/TCI, P≤0.001).1,2

Itch relief over 56 weeks was reported using the Pruritus VAS component of SCORAD, a measurement of eczema severity, where 0 was no itch and 10 was the worst itch imaginable based on an average assessment of the past 3 days or nights.2

Before and after 16 weeks with NEMLUVIO

All images are actual patients from clinical trial.

Actual 26-year-old male patient at baseline with eczema (atopic deramtitis) on arms and chest.
Actual 26-year-old male patient at Week 16 with improved eczema (atopic dermatitis) on chest and arms. Actual 26-year-old male patient at Week 16 with improved eczema (atopic dermatitis) on chest and arms.
 

BEFORE TREATMENT

AFTER TREATMENT

26-YEAR-OLD MALE.
Actual patient from
clinical trial.
Individual results
may vary.

26-YEAR-OLD MALE.
Individual results may vary.

Actual 42-year-old male patient at baseline with eczema (atopic dermatitis) on back and arms. Actual 42-year-old male patient at baseline with eczema (atopic dermatitis) on back and arms.
Actual 42-year-old male patient at Week 16 with improved eczema (atopic dermatitis) on back and arms. Actual 42-year-old male patient at Week 16 with improved eczema (atopic dermatitis) on back and arms.
 

BEFORE TREATMENT

AFTER TREATMENT

42-YEAR-OLD MALE.
Actual patient from
clinical trial.
Individual results
may vary.

42-YEAR-OLD MALE.
Individual results may vary.

Actual 67-year-old female patient at baseline with eczema (atopic dermatitis) on legs. Actual 67-year-old female patient at baseline with eczema (atopic dermatitis) on legs.
Actual 67-year-old female patient at Week 16 with improved eczema (atopic dermatitis) on legs. Actual 67-year-old female patient at Week 16 with improved eczema (atopic dermatitis) on legs.
 

BEFORE TREATMENT

AFTER TREATMENT

67-YEAR-OLD FEMALE.
Actual patient from
clinical trial.
Individual results
may vary.

67-YEAR-OLD FEMALE.
Individual results may vary.

Actual 23-year-old male patient at baseline with eczema (atopic dermatitis) on back of neck. Actual 23-year-old male patient at baseline with eczema (atopic dermatitis) on back of neck.
Actual 23-year-old male patient at Week 16 with improved eczema (atopic dermatitis) on back of neck. Actual 23-year-old male patient at Week 16 with improved eczema (atopic dermatitis) on back of neck.
 

BEFORE TREATMENT

AFTER TREATMENT

23-YEAR-OLD MALE.
Actual patient from
clinical trial.
Individual results
may vary.

23-YEAR-OLD MALE.
Individual results may vary.

26-year-old male.

42-year-old male.

67-year-old female.

23-year-old male.

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PROVEN TO SIGNIFICANTLY
IMPROVE SLEEP

38% of those using NEMLUVIO + topicals experienced an improvement in sleep (vs 20% with placebo + topicals) by Week 16.1

Results were based on a 4-point or more improvement on the SD-NRS,
where 0 was no sleep loss and 10 was no sleep at all.2


NEMLUVIO was studied in the treatment of
eczema (atopic dermatitis)

Over 1700 adult and adolescent participants (age 12 or older) with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies1

Studies evaluated measurements of itch, skin healing, and effect on sleep, among other factors1

Favorable safety profile1

Learn more about the experience of participants in NEMLUVIO clinical trials.

NEMLUVIO was evaluated in 2 Phase 3 clinical trials and a long-term study. Results shown are from the first clinical trial (ARCADIA 1) and the long-term study.1 Topicals used in the ARCADIA studies included topical corticosteroids and topical calcineurin inhibitors.1,2
 

EASI=Eczema Area and Severity Index; PP-NRS=Peak Pruritus Numerical Rating Scale; SCORAD=Scoring Atopic Dermatitis; TCI=topical calcineurin inhibitor; TCS=topical corticosteroid; VAS=visual analog scale.

References: 1. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.. 2. Galderma Laboratories, L.P.; data on file.

Important Safety Information

Indications: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used:

  • to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.
  • to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.

Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

  • are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO.
  • are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

  • Breathing problems or wheezing
  • Swelling of the face, lips, mouth, tongue, or throat
  • Fainting, dizziness, feeling lightheaded
  • Fast pulse
  • Swollen lymph nodes
  • Joint pain
  • Fever
  • Skin rash (red or rough skin)
  • Nausea or vomiting
  • General ill feeling
  • Cramps in your stomach area

The most common side effects of NEMLUVIO include:

  • Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches
  • Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information.