Plaque psoriasis

Active Ingredient: Ustekinumab

Indication for Ustekinumab

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

Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).

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

45 or 90 mg once as initial dose, followed by 45 mg 4 weeks later, and thereafter 45 mg every 12 weeks

For:

Dosage regimens

Regimen A: In case that patient weight is ≤ 100 kg, subcutaneous, 45 milligrams ustekinumab, one dose, over the duration of 4 weeks. Afterwards, in case that patient weight is ≤ 100 kg, subcutaneous, 45 milligrams ustekinumab, one dose, over the duration of 4 weeks. Afterwards, in case that patient weight is ≤ 100 kg, subcutaneous, 45 milligrams ustekinumab, once every 12 weeks.

Regimen B: In case that patient weight is ≥ 100 kg, subcutaneous, 90 milligrams ustekinumab, one dose, over the duration of 4 weeks. Afterwards, in case that patient weight is ≥ 100 kg, subcutaneous, 45 milligrams ustekinumab, one dose, over the duration of 4 weeks. Afterwards, in case that patient weight is ≥ 100 kg, subcutaneous, 45 milligrams ustekinumab, once every 12 weeks.

Detailed description

The recommended posology of ustekinumab is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.

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

Patients with body weight >100 kg

For patients with a body weight >100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter. In these patients, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy.

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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