Active Ingredient: Secukinumab
Secukinumab, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
Secukinumab, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in years is ≥ 6 and patient weight is ≤ 50 kg, subcutaneous, 75 milligrams secukinumab, once weekly, 5 doses in total. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≤ 50 kg, subcutaneous, 75 milligrams secukinumab, once monthly.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, subcutaneous, 150 milligrams secukinumab, once weekly, 5 doses in total. Afterwards, in case that patient age in years is ≥ 6 and patient weight is ≥ 50 kg, subcutaneous, 150 milligrams secukinumab, once monthly.
The recommended dose is based on body weight and administered by subcutaneous injection at weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing. Each 75 mg dose is given as one subcutaneous injection of 75 mg. Each 150 mg dose is given as one subcutaneous injection of 150 mg.
Recommended dose for juvenile idiopathic arthritis:
| Body weight at time of dosing | Recommended dose |
|---|---|
| <50 kg | 75 mg |
| ≥50 kg | 150 mg |
Available data suggest that a clinical response is usually achieved within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Secukinumab is to be administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
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