Active Ingredient: Ustekinumab
Ustekinumab, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifyin anti-rheumatic drug (DMARD) therapy has been inadequate.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Subcutaneous, 45 milligrams ustekinumab, one dose, over the duration of 4 weeks. Afterwards, 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, once every 12 weeks.
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. Alternatively, 90 mg may be used in patients with a body weight >100 kg.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
For:
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, subcutaneous, 45 milligrams ustekinumab, once every 4 weeks, 2 doses in total. Afterwards, in case that patient weight is ≥ 60 kg, subcutaneous, 45 milligrams ustekinumab, once every 12 weeks.
Regimen C: In case that patient weight is ≥ 100 kg and there is plaque psoriasis, subcutaneous, 90 milligrams ustekinumab, once every 4 weeks, 2 doses in total. Afterwards, in case that patient weight is ≥ 100 kg and there is plaque psoriasis, subcutaneous, 90 milligrams ustekinumab, once every 12 weeks.
Administer ustekinumab subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.
The recommended dose of ustekinumab for pediatric patients (6 to 17 years old) with psoriatic arthritis, based on body weight, is shown below.
Recommended Dose of Ustekinumab for Subcutaneous Injection in Pediatric Patients (6 to 17 years old) with Psoriatic Arthritis:
| Body Weight of Patient at the Time of Dosing | Recommended Dose |
|---|---|
| less than 60 kg* | 0.75 mg/kg |
| 60 kg or more | 45 mg |
| greater than 100 kg with co-existent moderate-to-severe plaque psoriasis | 90 mg |
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