Moderate-to-severe atopic dermatitis (AD)

Active Ingredient: Nemolizumab

Indication for Nemolizumab

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Nemolizumab is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy.

For this indication, competent medicine agencies globally authorize below treatments:

An initial dose of 60 mg, followed by 30 mg given every 4 weeks and thereafter 30 mg every 8 weeks

For:

Dosage regimens

Subcutaneous, 60 milligrams nemolizumab, one dose. Afterwards, subcutaneous, 30 milligrams nemolizumab, once every 4 weeks, over the duration of 16 weeks. Afterwards, subcutaneous, 30 milligrams nemolizumab, once every 8 weeks.

Detailed description

The recommended dose is:

  • An initial dose of 60 mg, followed by 30 mg given every 4 weeks (Q4W)
  • After 16 weeks of treatment, for patients who achieve clinical response, the recommended maintenance dose is 30 mg every 8 weeks (Q8W)

Nemolizumab can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. Any use of topical therapies should be tapered and subsequently discontinued when the disease has sufficiently improved.

Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis. Some patients with initial partial response may further improve with continued treatment beyond 16 weeks. Once clinical response is achieved, the recommended maintenance dose of nemolizumab is 30 mg every 8 weeks.

Missed dose

If a dose is missed, it should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.

Dosage considerations

The subcutaneous injection should be administered into the front upper thighs or abdomen avoiding the 5 cm area around the navel. Injection into the upper arm should only be performed by a caregiver or healthcare professional.

For subsequent doses, it is recommended to rotate the injection site with each dose. Nemolizumab should not be injected into skin that is tender, inflamed, swollen, damaged or has bruises, scars or open wounds.

Active ingredient

Nemolizumab

Nemolizumab is a humanised IgG2 monoclonal antibody that inhibits interleukin-31 (IL-31) signalling by binding selectively to interleukin-31 receptor alpha (IL-31 RA). IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis. Nemolizumab inhibited IL-31-induced responses including the release of proinflammatory cytokines and chemokines.

Read more about Nemolizumab

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