What is the appropriate prescribing information for Stelara (ustekinumab) in adults with moderate‑to‑severe plaque psoriasis, active psoriatic arthritis, or moderate‑to‑severe Crohn’s disease who have failed conventional systemic therapy or other biologics?

Stelara (Ustekinumab) Prescribing Information

Indications and Patient Selection

Stelara is FDA-approved for adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately-to-severely active Crohn's disease, and moderately-to-severely active ulcerative colitis, and is also approved for pediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis. 1

When to Choose Ustekinumab Over Other Biologics

• Select ustekinumab as first-line therapy for patients with concurrent psoriatic arthritis, as recommended by the American College of Rheumatology 2
• Choose ustekinumab for patients with a history of inflammatory bowel disease, as secukinumab (the otherwise superior first-line agent for pure plaque psoriasis) may worsen IBD 2
• Consider ustekinumab for patients with palmoplantar psoriasis, nail psoriasis, scalp psoriasis, or pustular/erythrodermic variants, where it has broader evidence than newer IL-23 inhibitors 3
• Ustekinumab offers dose escalation flexibility (increasing to 90 mg or shortening interval to every 8 weeks) for inadequate responders, unlike fixed-dose alternatives 3

Important caveat: For patients with pure plaque psoriasis without joint involvement or IBD history, secukinumab is superior, achieving 79% PASI 90 response at week 16 compared to 57.6% with ustekinumab 2

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Dosing Protocols

Plaque Psoriasis and Psoriatic Arthritis (Adults)

Weight-based dosing is mandatory:

• Patients ≤100 kg: 45 mg subcutaneously at weeks 0 and 4, then every 12 weeks 2, 1
• Patients >100 kg: 90 mg subcutaneously at weeks 0 and 4, then every 12 weeks 2, 1

The 90 mg dose provides greater efficacy in heavier patients, though 45 mg also shows efficacy 1

Plaque Psoriasis and Psoriatic Arthritis (Pediatric, 6-17 years)

Administer at weeks 0 and 4, then every 12 weeks: 1

• <60 kg: 0.75 mg/kg (requires volume calculation from 45 mg/0.5 mL vial) 1
• 60-100 kg: 45 mg 1
• >100 kg: 90 mg 1

Crohn's Disease and Ulcerative Colitis (Adults)

• Induction: Intravenous weight-based dosing (refer to full prescribing information for IV dosing) 1
• Maintenance: 90 mg subcutaneously every 8 weeks 1, 4

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Pre-Treatment Screening Requirements

Complete the following mandatory screening before initiating ustekinumab:

• Tuberculosis screening for both active and latent infection; do not start therapy with active TB 2, 5
• Hepatitis B screening; untreated hepatitis B is a relative contraindication 5
• Active infection assessment; defer therapy until any active infection or sepsis resolves 5
• Screen for history of malignancy, though long-term data show no definitive increased risk 3

Unlike secukinumab, ustekinumab does not require special caution for inflammatory bowel disease history—in fact, it is FDA-approved for Crohn's disease and ulcerative colitis 1, 6

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Vaccination Strategy

Live Attenuated Vaccines

• Administer all live vaccines at least 2-4 weeks before starting ustekinumab 5
• Live vaccines are absolutely contraindicated once therapy begins due to risk of severe or fatal vaccine strain infections 5
• Live vaccines include: BCG, measles, mumps, rubella, yellow fever, oral polio, and oral typhoid 5

Inactivated Vaccines

• Pneumococcal vaccine is strongly recommended before starting therapy 5
• Annual influenza vaccination should be administered; ustekinumab does not interfere with immune response 5
• COVID-19 vaccines should be given as soon as eligible 5
• Inactivated vaccines are safe to administer during ongoing ustekinumab therapy 5

Critical distinction: Unlike methotrexate, IL-12/23 inhibitors do not significantly impair vaccine response 5

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Safety Profile and Monitoring

Common Adverse Events

• Ustekinumab is generally well-tolerated with no specific patterns of infection, as reported by the National Psoriasis Foundation 2
• Most adverse events are mild, including respiratory tract infections, nasopharyngitis, headaches, and injection site reactions 7, 8
• Serious infections and malignancies are rare in long-term follow-up 8, 4

Ongoing Monitoring

• No routine laboratory monitoring is required beyond standard clinical assessment 7
• Monitor for signs of serious infection; temporarily discontinue if serious infection develops 4
• Infection rates remain stable with cumulative exposure 7

Key safety advantage: Ustekinumab has a more favorable safety profile than secukinumab regarding mucocutaneous candida infections (which occur at 1.9 per 100 patient-years with secukinumab) 5

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Combination Therapy Considerations

• Combine with high-potency topical corticosteroids with or without vitamin D analogues to augment efficacy 2
• Consider combining with methotrexate, acitretin, or narrowband UVB phototherapy for improved outcomes 2
• Do not combine with other biologics; such combinations carry unknown risks 5

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Dose Escalation for Inadequate Response

For patients with suboptimal response:

• Increase from 45 mg to 90 mg in patients initially dosed at 45 mg 3
• Shorten dosing interval from every 12 weeks to every 8 weeks 3

This flexibility is a key advantage of ustekinumab over fixed-dose biologics like tildrakizumab 3

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Duration of Therapy

• Continue therapy indefinitely without a predetermined stopping point for sustained efficacy 5
• Clinical response is maintained through at least 3 years of continuous treatment 7, 8
• Consider discontinuation only if there is no clinical response after an adequate trial period 5