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 indications, expanding treatment options for inflammatory conditions. It is now indicated for adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for active psoriatic arthritis in the same age groups. Additionally, it is approved for adult patients with moderately to severely active Crohn's disease and ulcerative colitis, offering a new biologic option for these gastrointestinal disorders.
Ustekinumab works as a human interleukin-12 and -23 antagonist, targeting key cytokines involved in inflammation. The approval provides clinicians with a versatile therapy that can be administered subcutaneously for most indications, with an intravenous option for initial dosing in Crohn's disease and ulcerative colitis. This broadens the arsenal against chronic inflammatory diseases, potentially benefiting patients who have not responded to other treatments.
The dosing regimens vary by condition and patient characteristics, including weight-based adjustments for pediatric patients and those with higher body weight. For plaque psoriasis and psoriatic arthritis, maintenance dosing is every 12 weeks after initial loading doses, while Crohn's disease and ulcerative colitis maintenance is every 8 weeks following an intravenous induction. This structured approach aims to optimize efficacy across diverse patient populations.
＋ 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 Range (kilograms) Dosage less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks. Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage: Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg greater than 100 kg 90 mg. Psoriatic Arthritis Adult Subcutaneous Recommended Dosage: The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks. Psoriatic Arthritis Pediatric 6 years of Age and Older Subcutaneous Recommended Dosage: Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) 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. Crohn's Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dose: A single intravenous infusion using weight-based dosing: Weight Range (kilograms) Recommended Dose up to 55 kg 260 mg (2 vials) greater than 55 kg to 85 kg 390 mg (3 vials) greater than 85 kg 520 mg (4 vials). Crohn's Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage: A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.
In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects. Trial data not available in label.
Not reported in label.
Not reported in label.
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