STUDY DESIGN

Name: Nemluvio HCP
Creator: Nemluvio

Over 1700 adult and adolescent patients took part in the ARCADIA Phase 3 clinical trials for atopic dermatitis^1,2

ARCADIA 1 and ARCADIA 2 were identically designed, multicenter, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 studies that evaluated NEMLUVIO in patients aged ≥12 years with moderate-to-severe AD not adequately controlled with TCS/TCI.^1,2*

TO CAPTURE THE REALITY OF MANY PATIENTS WITH AD, THE ARCADIA TRIALS ONLY INCLUDED THOSE WHO FAILED WITH TCS/TCI^1-5

ENROLLMENT

Patients with moderate-to-severe AD defined by^1,2:

PP-NRS ≥4
IGA ≥3

EASI ≥16
BSA ≥10%

SCREENING AFTER
2-4 WEEKS OF TCS/TCI

Patients who were no longer moderate to severe after a run-in period of 2-4 weeks of TCS/TCI did not continue into the ARCADIA trials^1,2

CONTINUATION

Only patients who were still moderate to severe after 2-4 weeks of TCS/TCI continued into the ARCADIA trials^1,2

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ARCADIA 2 is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, pivotal Phase 3 study that evaluated NEMLUVIO® in adults aged ≥12 years who had moderate-to-severe AD not adequately controlled with TCS/TCI.

CO-PRIMARY ENDPOINTS AT WEEK 16¹

Proportion of patients achieving:

EASI response (≥75% improvement in EASI from baseline)
IGA success (clear [IGA 0] or almost clear [IGA 1] skin and a ≥2-point reduction from baseline)

SELECT SECONDARY ENDPOINTS¹

Proportion of patients achieving:

PP-NRS improvement ≥4 points from baseline at Weeks 1, 2, 4, and 16
PP-NRS <2 at Weeks 4 and 16
SD-NRS improvement ≥4 points from baseline at Week 16

Assessments & Scales

INVESTIGATOR GLOBAL ASSESSMENT (IGA)^1,6

Clinician-reported outcome to assess the severity of AD
Scale ranges from 0 (clear) to 4 (severe)
Treatment success defined as 0 (clear) or 1 (almost clear) and a ≥2-point improvement from baseline

An image of an IGA scale from 0 to 4, with a score of 4 showing on the scale.

ECZEMA AREA AND SEVERITY INDEX (EASI-75)^1,7

Clinician-reported outcome to evaluate the severity of AD
EASI integrates body surface areas and the intensity of lesions into 1 composite score
EASI-75 = ≥75% improvement in EASI score from baseline

PEAK PRURITUS NUMERICAL RATING SCALE (PP-NRS)^1,6

Patient-reported outcome designed to measure the worst itch over the previous 24-hour period
Treatment success defined as at least a 4-point improvement from baseline

An image of a PPNRS scale from 0 to 10, with a score of 10 showing on the scale.

SCORAD (SEVERITY SCORING OF ATOPIC DERMATITIS)^2,8

VAS (visual analog scale; component pruritus)
- Patient-reported outcome to assess itch severity in AD
- Evaluated on a 0 to 10 scale based on average assessment for the previous 3 days or nights

BODY SURFACE AREA (BSA)^1,2,8

Clinician-reported outcome to evaluate the extent of AD
BSA measures the percent of the body's surface that is visually affected by AD
Patients with a BSA ≥10 (10% of their body surface affected) were included in the ARCADIA trials

ARCADIA Long-Term Extension (LTE) Study Design

The ARCADIA LTE is an ongoing prospective, multicenter, open-label study. The objective is to assess the long-term safety and efficacy of NEMLUVIO in adults and adolescents aged ≥12 years with moderate-to-severe AD from baseline up to 200 weeks.^1,3

ARCADIA 1 and 2 patients who received the rescue medication during the study period, nonresponders at Week 16, patients who received rescue medications prior to a 48-week visit, and patients who completed the maintenance period were eligible for the LTE.^1,3

The ARCADIA LTE enrolled patients from ARCADIA 1 and 2 plus patients from a blinded lead-in study, for a total of 1751 patients. As of September 2022,^† 741 patients completed a Week 56 assessment.³

Lasting Skin Healing³

Discover how NEMLUVIO helped most patients with AD achieve lasting skin clearance³

SEE THE DIFFERENCE

Fast Itch Relief⁹

See how NEMLUVIO provided fast and lasting itch relief⁹

VIEW THE DATA

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Concomitant low- or medium-potency TCS and/or TCI were administered for at least 14 days prior to baseline and continued during the trial. Based on disease activity, these   concomitant therapies could be tapered and/or discontinued at investigator discretion.^1,2

Interim analysis cutoff date was September 30, 2022.³

AD=atopic dermatitis; BSA=body surface area; EASI=Eczema Area and Severity Index; IGA=Investigator Global Assessment; LTE=long-term extension; PP-NRS=Peak Pruritus Numerical Rating Scale; Q4W=every 4 weeks; Q8W=every 8 weeks; SD-NRS=Sleep Disturbance Numerical Rating Scale; TCI=topical calcineurin inhibitor; TCS=topical corticosteroid; TNFɑ=tumor necrosis factor alpha.

References: 1. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P. 2. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SRE.118161 [ARCADIA 1]; September 2023. 3. Galderma Laboratories, L.P.; data on file. Clinical Study Report RD.06.SIR.118163 [ARCADIA LTE]; October 2023. 4. Misery L, Brenaut E, Pierre O, et al. Chronic itch: emerging treatments following new research concepts. Br J Pharmacol. 2021;178(24):4775-4791. doi:10.1111/bph.15672 5. Orfali RL, Aoki V. Blockage of the IL-31 pathway as a potential target therapy for atopic dermatitis. Pharmaceutics. 2023;15(2):577. doi:10.3390/pharmaceutics15020577 6. Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389(17):1579-1589. doi:10.1056/NEJMoa2301333 7. Hanifin JM, Baghoomian W, Grinich E, Leshem YA, Jacobson M, Simpson WL. THe Eczema ARea and Severity Index—a practical guide. Dermatitis. 2022;33(3):187-192.doi:10.1097/DER.0000000000000895. 8. Gooderham MJ, Bissonnette R, Grewal P, et al. Approach to the assessment and management of adult patients with atopic dermatitis: a consensus document. Section II: tools for assessing the severity of atopic dermatitis. J Cutan Med Surg. 2018;22(1_suppl):10S-16S. doi:10.1177/1203475418803628 9. Galderma Laboratories, L.P.; data on file.

IMPORTANT SAFETY INFORMATION

INDICATIONS: NEMLUVIO^® (nemolizumab-ilto) is an interleukin-31 receptor alpha antagonist indicated for:

the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
the treatment of adults with prurigo nodularis.

CONTRAINDICATION: NEMLUVIO is contraindicated in patients with known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO.

WARNINGS AND PRECAUTIONS:
Hypersensitivity reactions have been reported with NEMLUVIO use. If clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy, and discontinue NEMLUVIO. Avoid use of live vaccines during treatment with NEMLUVIO.

ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥1%) are:

Atopic Dermatitis: headache (including migraine), arthralgia, urticaria, and myalgia.
Prurigo Nodularis: headache, dermatitis atopic, eczema, and eczema nummular.

USE IN SPECIFIC POPULATIONS:
Pregnancy: There are no adequate and well-controlled studies on NEMLUVIO in pregnant women. The limited available information on NEMLUVIO use during pregnancy is not sufficient to inform a drug- associated risk of major birth defects or miscarriage in humans. Human IgG antibodies are known to cross the placental barrier; therefore, NEMLUVIO may be transmitted from the mother to the developing fetus.

Lactation: There are no data on the presence or transfer of NEMLUVIO in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure to NEMLUVIO on the breastfed infant are unknown. NEMLUVIO has not been administered to nursing/lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age for the treatment of moderate-to-severe atopic dermatitis or pediatric patients younger than 18 years of age for the treatment of prurigo nodularis.

Please see full Prescribing Information, including Patient Information.

STUDY DESIGN

Over 1700 adult and adolescent patients took part in the ARCADIA Phase 3 clinical trials for atopic dermatitis1,2

CO-PRIMARY ENDPOINTS AT WEEK 161

SELECT SECONDARY ENDPOINTS1

Assessments & Scales

INVESTIGATOR GLOBAL ASSESSMENT (IGA)1,6

ECZEMA AREA AND SEVERITY INDEX (EASI-75)1,7

PEAK PRURITUS NUMERICAL RATING SCALE (PP-NRS)1,6

SCORAD (SEVERITY SCORING OF ATOPIC DERMATITIS)2,8

BODY SURFACE AREA (BSA)1,2,8