LASTING SKIN HEALING

NEMLUVIO heals nodules to deliver skin clearance in PN1

Male patient at baseline with prurigo nodularis nodules on the shoulders. Male patient at baseline with prurigo nodularis nodules on the shoulders.
Male patient at Week 16 with healed prurigo nodularis nodules on the shoulders. Male patient at Week 16 with healed prurigo nodularis nodules on the shoulders.
 

Baseline

Week 16

SAM (SHOULDER)
Actual patient image. Individual results may vary.

SAM (SHOULDER)
Actual patient image. Individual results may vary.

Female patient at baseline with prurigo nodularis nodules on the upper back. Female patient at baseline with prurigo nodularis nodules on the upper back.
Female patient at Week 16 with healed prurigo nodularis nodules on the upper back. Female patient at Week 16 with healed prurigo nodularis nodules on the upper back.
 

Baseline

Week 4

SAM (UPPER BACK)
Actual patient image. Individual results may vary.

SAM (UPPER BACK)
Actual patient image. Individual results may vary.

Female patient at baseline with prurigo nodularis nodules on the arms. Female patient at baseline with prurigo nodularis nodules on the arms.
Female patient at Week 16 with healed prurigo nodularis nodules on the arms. Female patient at Week 16 with healed prurigo nodularis nodules on the arms.
 

Baseline

Week 16

SAM (ARM)
Actual patient image. Individual results may vary.

SAM (ARM)
Actual patient image. Individual results may vary.

Female patient at baseline with prurigo nodularis nodules on the chest. Female patient at baseline with prurigo nodularis nodules on the chest.
Female patient at Week 16 with healed prurigo nodularis nodules on the chest. Female patient at Week 16 with healed prurigo nodularis nodules on the chest.
 

Baseline

Week 16

ROBERTA (CHEST)
Actual patient image. Individual results may vary.

ROBERTA (CHEST)
Actual patient image. Individual results may vary.

Patient at baseline with prurigo nodularis nodules on the hands. Patient at baseline with prurigo nodularis nodules on the hands.
Patient at Week 16 with healed prurigo nodularis nodules on the hands. Patient at Week 16 with healed prurigo nodularis nodules on the hands.
 

Baseline

Week 16

ROBERTA (HANDS)
Actual patient image. Individual results may vary.

ROBERTA (HANDS)
Actual patient image. Individual results may vary.

Patient at baseline with prurigo nodularis nodules on the back. Patient at baseline with prurigo nodularis nodules on the back.
Patient at Week 16 with healed prurigo nodularis nodules on the back. Patient at Week 16 with healed prurigo nodularis nodules on the back.
 

Baseline

Week 16

ROBERTA (BACK)
Actual patient image. Individual results may vary.

ROBERTA (BACK)
Actual patient image. Individual results may vary.

Previous

Next

Sam (shoulder)

Sam (upper back)

Sam (arm)

Roberta (chest)

Roberta (hands)

Roberta (back)

REVIEW STUDY DESIGN 

Baseline IGA score was 4, and at Week 16, it had improved to 2.2

Previous

Next

>75%

of nodules healed in more than half of patients taking NEMLUVIO by Week 16 vs 17% with placebo (P<0.0001)1†

Data above from OLYMPIA 2. In OLYMPIA 1, 41% of patients taking NEMLUVIO achieved >75% nodule healing* vs 12% with placebo at Week 16.1,3

Over 9 out of 10 patients saw >75% of nodules healed with nearly 3 years of treatment4‡

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86% of NEMLUVIO® patients achieved 75% or more of healed nodules in over 3 years.
Image
86% of NEMLUVIO® patients achieved 75% or more of healed nodules in over 3 years.

Data based on PAS item 5b (>75% healed pruriginous lesions) interim analysis of patients during Week 148 of the OLYMPIA LTE. No imputations for missing data. The OLYMPIA LTE is an ongoing prospective, multicenter, single-arm, open-label study up to 184 weeks.4

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Sleep Improvement1

Patients saw meaningful improvements in their sleep while taking NEMLUVIO1

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Favorable Safety Profile6

NEMLUVIO offers a favorable safety profile and requires no preliminary lab evaluations or ongoing lab monitoring6

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.