Ustekinumab (Stelara) for Plaque Psoriasis, Crohn's Disease, & More – Guidelines+ Monograph

Ustekinumab (Stelara) is a human interleukin-12 and -23 antagonist with multiple adult and pediatric indications. Stelara was first indicated to treat adults with moderate to severe plaque psoriasis in 2009, and has subsequently received additional U.S. Food and Drug Administration (FDA)-approved indiciations. Stelara is currently approved for the treatment of adult and pediatric patients with moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease, along with being approved for use in the treatment of adults with moderately to severely active ulcerative colitis. Most recently, in April 2026, the FDA approved Stelara for the treatment of pediatric patients 2 years and older with moderately to severely active Crohn's disease.

Read on to learn more about Stelara, including its warnings and precautions, dosage and administration information, appearance in clinical practice guidelines, and more.

Medication Overview:

• Brand Name: Stelara
• Generic Name: ustekinumab
• Treatment for: Moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis
• Company: Johnson & Johnson
• Initial FDA Approval: September 2009

Warnings and Precautions:

• Infections: Serious infections have occurred. Avoid starting Stelara during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue Stelara until the infection resolves.
• Theoretical Risk for Particular Infections: Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances.
• Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with Stelara. Initiate treatment of latent TB before administering Stelara.
• Malignancies: Stelara may increase risk of malignancy. The safety of Stelara in patients with a history of or a known malignancy has not been evaluated.
• Serious Hypersensitivity Reactions: If a severe or other clinically significant hypersensitivity reaction occurs, discontinue Stelara immediately and initiate appropriate medical treatment.
• Posterior Reversible Encephalopathy Syndrome (PRES): If PRES is suspected, treat promptly, and discontinue Stelara.
• Immunizations: Avoid use of live vaccines in patients during treatment with Stelara. 
• Noninfectious Pneumonia: Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of Stelara. If diagnosis is confirmed, discontinue Stelara and institute appropriate treatment.

Dosage and Administration:

• Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage:
  • Weight less than or equal to 100 kg: 45 mg administered subcutaneously initially and four weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
  • Weight greater than 100 kg: 90 mg administered subcutaneously initially and four 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, four weeks later, then every 12 weeks thereafter:
  • Weight less than 60 kg: 0.75 mg/kg
  • Weight 60 kg to 100 kg: 45 mg
  • Weight greater than 100 kg: 90 mg

• Psoriatic Arthritis Adult Subcutaneous Recommended Dosage:
  • The recommended dosage is 45 mg administered subcutaneously initially and four 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 Patients 6 Years of Age and Older Subcutaneous Recommended Dosage: Weight-based dosing is recommended at the initial dose, four weeks later, then every 12 weeks thereafter:
  • Weight less than 60 kg: 0.75 mg/kg
  • Weight 60 kg or more: 45 mg
  • Weight greater than 100 kg with co-existent moderate-to-severe plaque psoriasis: 90 mg

• Crohn’s Disease Initial Adult Intravenous Recommended Dose: A single intravenous infusion using weight-based dosing:
  • Weight 55 kg or less: 260 mg
  • Weight greater than 55 kg to 85 kg: 390 mg
  • Weight greater than 85 kg: 520 mg

• Crohn’s Disease Maintenance Adult Subcutaneous Recommended Dosage: A subcutaneous 90 mg dose eight weeks after the initial intravenous dose, then every eight weeks thereafter.

• Crohn’s Disease Initial Pediatric Intravenous Recommended Dose: For patients weighing 10 kg or more: A single intravenous infusion using weight based dosing:
  • Weight 10 kg to 25 kg: 10 mg/kg
  • Weight greater than 25 kg to 55 kg: 260 mg
  • Weight greater than 55 kg to 85 kg: 390 mg
  • Weight greater than 85 kg: 520 mg

• Crohn’s Disease Maintenance Pediatric Subcutaneous Recommended Dosage: The recommended maintenance dosage in pediatric patients using weight-based dosing is:
  • 10 kg to 35 kg: a subcutaneous 2.5 mg/kg dose administered 8 weeks after the initial intravenous dose, then every eight weeks thereafter.
  • Greater than 35 kg: a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every eight weeks thereafter.

• Ulcerative Colitis Initial Adult Intravenous Recommended Dose: A single intravenous infusion using weight-based dosing:
  • Weight up to 55 kg: 260 mg
  • Weight greater than 55 kg to 85 kg: 390 mg
  • Weight greater than 85 kg: 520 mg

• Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage: A subcutaneous 90 mg dose eight weeks after the initial intravenous dose, then every eight weeks thereafter.

Contraindications:

Clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in Stelara.

Adverse Reactions:

Most common adverse reactions are: 

• Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue.

• Crohn’s Disease in Adults: 
  • induction (≥3%): vomiting
  • maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis

• Ulcerative Colitis in Adults:
  • induction (≥3%): nasopharyngitis
  • maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea

Examples of ustekinumab in Guidelines

• Management of Crohn’s Disease in Adults
  • American College of Gastroenterology (ACG)
  • June 2025
  • “Biosimilar infliximab, adalimumab, and ustekinumab are effective treatments for patients with moderate-to-severe CD and can be used for de novo induction and maintenance therapy.”

• Pharmacological Management of Moderate to Severe Ulcerative Colitis
  • American Gastroenterological Association (AGA)
  • November 2024
  • “In adult outpatients with moderate-to-severe UC, the AGA recommends the use of infliximab, golimumab, vedolizumab, tofacitinib, upadacitinib, ustekinumab, ozanimod, etrasimod, risankizumab, and guselkumab, and suggests the use of adalimumab, filgotinib, and mirikizumab over no treatment.”

• Management and Treatment of Psoriasis with Biologics
  • American Academy of Dermatology (AAD)
  • February 2019
  • “Ustekinumab is recommended as a monotherapy treatment option for use in adult patients with moderate-to-severe plaque psoriasis.”

Please note: This article is current as of August 3, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.

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