Stelara® (Ustekinumab) Therapy

Targeted IL-12/IL-23 Inhibitor for IBD, Psoriasis & Psoriatic Arthritis

Understanding Stelara® (Ustekinumab)

Stelara (ustekinumab) represents a significant advancement in the treatment of immune-mediated inflammatory diseases. As a fully human monoclonal antibody, it offers a unique mechanism of action by targeting the shared p40 subunit of interleukin-12 (IL-12) and interleukin-23 (IL-23), key drivers of inflammation in conditions like Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. For an overview of GI biologics, IV iron, and related outpatient infusion care at CarePoint, see our gastroenterology infusion therapy page.

What is Stelara?

Stelara (ustekinumab) is a targeted biologic therapy that has transformed the treatment landscape for several chronic inflammatory diseases. Approved initially in 2009, its indications have expanded significantly, supported by robust clinical trial and real-world evidence demonstrating durable efficacy and a well-established safety profile.

FDA-Approved Indications

Stelara is approved for multiple immune-mediated inflammatory diseases:

Crohn's Disease

Moderately to severely active Crohn's disease in adults and children (≥40 kg) who have failed or are intolerant to conventional therapy or TNF blockers.

Ulcerative Colitis

Moderately to severely active ulcerative colitis in adults with inadequate response to conventional or biologic therapy. First and only IL-12/IL-23 inhibitor for UC.

Plaque Psoriasis

Moderate-to-severe plaque psoriasis in adults and children (≥6 years) who are candidates for phototherapy or systemic therapy.

Psoriatic Arthritis

Active psoriatic arthritis in adults, used alone or in combination with methotrexate to reduce joint inflammation and prevent structural damage.

How Stelara Works: Mechanism of Action

Stelara's distinctive mechanism centers on the shared p40 protein subunit of the cytokines IL-12 and IL-23:

Targeting the IL-12/IL-23 Pathway

  • IL-12 promotes Th1 cell pathways, associated with interferon-gamma production and granulomatous inflammation typical of Crohn's disease
  • IL-23 promotes Th17 cell pathways, associated with IL-17 production and mucosal damage in colitis and skin inflammation in psoriasis
  • Ustekinumab binds with high specificity to the p40 subunit, preventing these cytokines from attaching to their receptors on immune cells
  • This blockade disrupts the downstream inflammatory signaling cascade, leading to reduced inflammation and disease symptoms

The "Upstream" Advantage

Targeting IL-12 and IL-23 represents an "upstream" intervention. While TNF inhibitors block a specific inflammatory product, Stelara blocks the differentiation of the cells that produce inflammatory mediators. This explains why patients who are "primary non-responders" to drugs like infliximab (Remicade) or adalimumab (Humira) often achieve remission with Stelara.

Dosing and Administration

Crohn's Disease & Ulcerative Colitis

For gastrointestinal indications, treatment must initiate with a weight-based intravenous (IV) infusion for induction, followed by subcutaneous maintenance injections:

IV Induction Dosing (Weight-Based)

Patient Body Weight IV Dose Vials Required (130 mg/26 mL)
≤ 55 kg 260 mg 2 Vials
> 55 kg to 85 kg 390 mg 3 Vials
> 85 kg 520 mg 4 Vials

Maintenance: 90 mg subcutaneous injection 8 weeks after induction, then every 8 weeks thereafter.

Clinical Efficacy

Crohn's Disease: UNITI Program

The UNITI clinical trials demonstrated significant efficacy in both TNF-refractory and biologic-naïve patients:

TNF-Refractory Patients

33.7% of patients achieved clinical response at Week 6 compared to 21.5% on placebo, offering hope for patients who have "run out of options."

Biologic-Naïve Patients

55.5% of patients achieved clinical response at Week 6, demonstrating even more robust efficacy when used earlier in the disease course.

Long-Term Durability

At 5 years (Week 252), 55% of patients maintained clinical remission, with 93% of those in remission being steroid-free.

Ulcerative Colitis: UNIFI Program

Key Results

  • Week 8 Induction: 19% achieved clinical remission, 58% experienced clinical response, 17% achieved histologic-endoscopic mucosal improvement
  • Week 44 Maintenance: 45% in remission, 43% in steroid-free remission, 44% achieved histologic-endoscopic mucosal improvement
  • 4-Year Extension: 58% maintained clinical remission, 67% showed endoscopic improvement, 96.4% of those in remission were corticosteroid-free

Histologic-Endoscopic Mucosal Improvement (HEMI) represents the deepest form of tissue repair and is associated with significantly lower risk of disease relapse, hospitalization, and colectomy.

Plaque Psoriasis: PHOENIX Trials

Skin Clearance Results

  • PASI 75 (75% improvement): 67-69% of patients at Week 12 compared to 3% on placebo
  • PASI 90 (90% improvement): 36-42% of patients achieved near-complete skin clearance
  • 5-Year Follow-up: 76-79% of patients maintained PASI 75 response, demonstrating long-term durability

Psoriatic Arthritis: PSUMMIT Trials

Joint Protection

  • ACR20 Response: 42-50% of patients achieved significant improvement at Week 24 compared to 20-23% on placebo
  • Radiographic Progression: Significantly less joint erosion and joint space narrowing compared to placebo, proving Stelara is a true disease-modifying antirheumatic drug (DMARD)
  • Enthesitis and Dactylitis: Significant efficacy in resolving these painful and debilitating manifestations of PsA

Safety Profile

Common Side Effects

The most frequently reported side effects are generally mild and include:

  • Headache
  • Nasopharyngitis (common cold)
  • Upper respiratory tract infections
  • Injection site reactions (redness, pain, swelling)
  • Fatigue
  • Nausea

Serious Risks and Warnings

Important Safety Information

  • Infections: Stelara may increase the risk of serious infections (bacterial, fungal, viral). Patients should be evaluated for tuberculosis (TB) before and during treatment. Active infections are a contraindication.
  • Hypersensitivity: Serious allergic reactions, including anaphylaxis and angioedema, can occur. This is a key reason for supervised IV induction at CarePoint Infusion.
  • Malignancy: The risk of malignancies, including non-melanoma skin cancer, may be increased. Patients should be monitored for new skin lesions.
  • Posterior Reversible Encephalopathy Syndrome (PRES): Rare but serious neurological condition. If suspected, therapy must be discontinued immediately.

Pre-Treatment Screening

Before starting Stelara, patients should undergo:

  • Tuberculosis testing (PPD skin test or QuantiFERON blood test)
  • Hepatitis B and C screening
  • Complete medical history including infections
  • Vaccination status review
  • Routine blood work (CBC, liver function tests)

What to Expect at CarePoint Infusion

IV Infusion for Crohn's Disease and Ulcerative Colitis

The initial IV induction for Crohn's and Colitis involves administering a weight-based dose directly into the bloodstream. This procedure requires specialized clinical expertise:

Continuous Monitoring

Vital signs (blood pressure, heart rate, temperature, oxygen saturation) are checked at baseline, during infusion as needed, and post-infusion.

Emergency Preparedness

Our center is equipped with emergency medications (epinephrine, corticosteroids, antihistamines) and protocols to manage hypersensitivity reactions immediately.

Comfortable Environment

Patients are treated in comfortable leather reclining chairs with complimentary Wi-Fi, snacks, and beverages, allowing work or relaxation during treatment.

Serving Northeast Ohio Communities

CarePoint Infusion Center provides professional Stelara (ustekinumab) infusion and injection therapy for Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis throughout Northeast Ohio. We serve patients from Cleveland, Beachwood, Akron, and surrounding communities in Cuyahoga County, Summit County, and beyond.

We conveniently serve patients from:

Cleveland Beachwood Hudson Solon Westlake Shaker Heights University Heights Lyndhurst South Euclid Mayfield Heights Warrensville Heights Orange Village Pepper Pike Chagrin Falls Akron Canton Youngstown

And throughout Cuyahoga County, Summit County, Mahoning County, and Northeast Ohio. Contact us today to schedule your consultation.

Insurance and Financial Support

CarePoint Infusion works with most major insurance plans. Our team will:

  • Verify your insurance coverage before your first appointment
  • Help you understand your out-of-pocket costs
  • Assist with prior authorization requirements
  • Provide information about manufacturer patient assistance programs
  • Work with you to explore all available financial assistance options

Janssen CarePath Support

Janssen, the manufacturer of Stelara, offers the Stelara withMe Savings Program. Eligible commercially insured patients may pay as little as $5 per dose for their medication. This program has an annual maximum benefit but significantly reduces out-of-pocket costs for most patients. Ask our staff about eligibility and enrollment.

Getting Started

If your doctor has prescribed Stelara, CarePoint Infusion is here to provide your treatment in a supportive, professional setting. We coordinate directly with your prescribing physician to ensure seamless care.

Contact CarePoint Infusion today to schedule a consultation or your first infusion appointment:

  • Phone: 216-755-4044
  • Address: 23215 Commerce Park Suite 318, Beachwood, OH 44122
  • Hours: Monday-Friday, 9:00 AM - 5:00 PM

Visit our Contact page to send us a message or request an appointment.

Additional Resources

Learn more about related treatments and services:

Important Safety Information & Disclaimer

This information is provided for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

Stelara® is a registered trademark of Janssen Biotech, Inc. CarePoint Infusion is not affiliated with Janssen.

For complete information, please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for Stelara, or visit www.stelarahcp.com.