FDA Approves Stelara (ustekinumab) for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
The FDA has approved ustekinumab (Stelara) for multiple inflammatory conditions, expanding treatment options for clinicians managing chronic diseases. The approval covers adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis and active psoriatic arthritis, as well as adult patients with moderately to severely active Crohn's disease and ulcerative colitis. This provides a targeted biologic therapy option across a range of immune-mediated disorders, with dosing regimens tailored by condition, age, and weight.
Ustekinumab is administered via subcutaneous injection for psoriasis and psoriatic arthritis, with weight-based dosing in pediatric populations. For Crohn's disease and ulcerative colitis, it involves an initial intravenous infusion followed by subcutaneous maintenance doses. The approval is based on clinical trial data referenced in the label, supporting its use in patients who are candidates for phototherapy or systemic therapy.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Ustekinumab is a human interleukin-12 and -23 antagonist.
Ustekinumab is indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis (PsA), moderately to severely active Crohn's disease (CD), moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy, active psoriatic arthritis (PsA).
Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage: Weight less than or equal to 100 kg: 45 mg initially and 4 weeks later, then every 12 weeks. Weight greater than 100 kg: 90 mg initially and 4 weeks later, then every 12 weeks. Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage: Weight less than 60 kg: 0.75 mg/kg; 60 kg to 100 kg: 45 mg; greater than 100 kg: 90 mg; administered initially, 4 weeks later, then every 12 weeks. Psoriatic Arthritis Adult Subcutaneous Recommended Dosage: 45 mg initially and 4 weeks later, then every 12 weeks; for patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg: 90 mg initially and 4 weeks later, then every 12 weeks. Psoriatic Arthritis Pediatric 6 years of Age and Older Subcutaneous Recommended Dosage: Weight 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; administered initially, 4 weeks later, then every 12 weeks. Crohn's Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dose: Weight up to 55 kg: 260 mg; greater than 55 kg to 85 kg: 390 mg; greater than 85 kg: 520 mg; as a single infusion. Crohn's Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage: 90 mg subcutaneously 8 weeks after initial intravenous dose, then every 8 weeks.
Trial data not available in label.
Not reported in label.
Not reported in label.
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