Paediatric plaque psoriasis

Active Ingredient: Ustekinumab

Indication for Ustekinumab

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)
Therapeutic intent: Curative procedure

Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

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

0.75 mg/kg for patients weighting <60 kg, 45 mg for patients weighting ≥60 - ≤100 kg and 90 mg for patients weighting >100 kg at Weeks 0 and 4, then every 12 weeks thereafter

For:

Dosage regimens

Regimen A: In case that patient weight is ≤ 60 kg, subcutaneous, 0.75 milligrams ustekinumab per kilogram of body weight, once every 4 weeks, 2 doses in total. Afterwards, in case that patient weight is ≤ 60 kg, subcutaneous, 0.75 milligrams ustekinumab per kilogram of body weight, once every 12 weeks.

Regimen B: In case that patient weight is ≥ 60 kg and patient weight is ≤ 100 kg, subcutaneous, 45 milligrams ustekinumab, once every 4 weeks, 2 doses in total. Afterwards, in case that patient weight is ≥ 60 kg and patient weight is ≤ 100 kg, subcutaneous, 45 milligrams ustekinumab, once every 12 weeks.

Regimen C: In case that patient weight is ≥ 100 kg, subcutaneous, 90 milligrams ustekinumab, once every 4 weeks, 2 doses in total. Afterwards, in case that patient weight is ≥ 100 kg, subcutaneous, 90 milligrams ustekinumab, once every 12 weeks.

Detailed description

The recommended dose of ustekinumab based on body weight is shown below.

Ustekinumab should be administered at Weeks 0 and 4, then every 12 weeks thereafter.

Recommended dose of ustekinumab for paediatric psoriasis:

Body weight at the time of dosingRecommended Dose
<60 kg0.75 mg/kg
≥60 - ≤100 kg45 mg
>100 kg90 mg

Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.

Active ingredient

Ustekinumab

Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells. Abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

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