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FDA approved Stelara (ustekinumab) for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitisThe FDA has approved a new drug called Stelara for several inflammatory conditions

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Key Takeaway
Consider ustekinumab for inflammatory conditions with weight-based dosing in adults and pediatrics.

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)
Mechanism of Action

Ustekinumab is a human interleukin-12 and -23 antagonist.

Indication & Patient Population

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).

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration has approved a medication called Stelara for treating several inflammatory conditions. This drug, also known by its scientific name ustekinumab, is now approved for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. These are all conditions where the body's immune system causes inflammation that can lead to skin problems, joint pain, or digestive issues.

Stelara is approved for both adults and children as young as 6 years old with psoriasis or psoriatic arthritis. For Crohn's disease and ulcerative colitis, it's approved for adults. The way the drug is given depends on the condition - some patients receive injections under the skin, while others start with an IV infusion followed by injections. The approval means doctors now have another treatment option to consider for patients with these chronic conditions.

This approval was based on clinical trial data showing the drug's effectiveness and safety profile. It provides what's called a targeted biologic therapy, which means it works on specific parts of the immune system rather than broadly suppressing the entire immune system. The FDA's decision expands treatment choices for people living with these conditions.

It's important to remember that while this approval gives doctors another tool to help patients, every person's situation is different. The most important thing for anyone with these conditions is to have an honest conversation with their own healthcare provider about whether this treatment might be appropriate for their specific situation. Only a doctor who knows your complete medical history can help determine what treatment approach is right for you.

What this means for you:
Stelara is now approved for several inflammatory conditions, giving doctors another treatment option to consider.

Study Details

Study typeFda approval
PublishedSep 2009
View Original Abstract ↓
1 INDICATIONS AND USAGE Ustekinumab is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) moderately to severely active Crohn's disease (CD) . ( 1.3 ) moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO) , who are candidates for phototherapy or systemic therapy. ( 1.1 ) active psoriatic arthritis (PsA) . ( 1.2 ) 1.1 Plaque Psoriasis (PsO) Ustekinumab is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) Ustekinumab is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn's Disease (CD) Ustekinumab is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis Ustekinumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
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