STELARA (Ustekinumab)
Interleukin inhibitor for psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis
STELARA (ustekinumab) is a biologic medicine that works by blocking interleukin-12 (IL-12) and interleukin-23 (IL-23), key cytokines involved in inflammation. It is used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn's disease, and moderate to severe ulcerative colitis. Given as subcutaneous injections or intravenous infusion, STELARA has demonstrated strong efficacy and a well-established safety profile across multiple large-scale clinical trials.
Quick Facts
Key Takeaways
- STELARA is a biologic that blocks IL-12 and IL-23, reducing inflammation in psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
- For psoriasis, injections are given at weeks 0 and 4, then every 12 weeks — offering a convenient maintenance schedule compared to many other biologics.
- Common side effects include upper respiratory infections, headache, fatigue, and injection site reactions, which are generally mild.
- Live vaccines must be avoided during treatment, and your doctor should screen for tuberculosis before starting STELARA.
- Biosimilar versions (Imuldosa, Yesintek, WEZENLA, STEQEYMA, Usymro) are becoming available, potentially increasing accessibility and reducing cost.
What Is STELARA and What Is It Used For?
Quick Answer: STELARA (ustekinumab) is a biologic medicine classified as a monoclonal antibody. It targets and blocks interleukin-12 (IL-12) and interleukin-23 (IL-23) — proteins that play a central role in driving inflammatory immune responses. STELARA is prescribed for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
STELARA contains the active substance ustekinumab, a fully human IgG1 kappa monoclonal antibody. Monoclonal antibodies are laboratory-engineered proteins designed to recognize and bind to specific target molecules in the body. In the case of ustekinumab, the target is the p40 protein subunit shared by both IL-12 and IL-23. By binding to this shared subunit, STELARA prevents these interleukins from interacting with their receptor (IL-12Rβ1) on the surface of immune cells, effectively dampening the overactive immune response that drives inflammation.
STELARA belongs to a class of medicines called immunosuppressants. These agents work by selectively suppressing parts of the immune system that are responsible for chronic inflammation. Unlike broad-spectrum immunosuppressants, STELARA's mechanism of action is highly targeted, which contributes to its favorable safety profile relative to some older immunosuppressive therapies.
Plaque Psoriasis
Plaque psoriasis is a chronic autoimmune skin disease characterized by raised, red, scaly patches (plaques) on the skin, often accompanied by nail involvement. It affects approximately 2–3% of the global population. STELARA is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and in children and adolescents aged 6 years and older with moderate to severe disease who cannot tolerate or have not responded to phototherapy or other systemic treatments.
Clinical trials such as PHOENIX 1 and PHOENIX 2 demonstrated that approximately 67–76% of patients treated with STELARA achieved at least 75% improvement in their Psoriasis Area and Severity Index (PASI 75) score by week 12, compared to only 3–4% of patients receiving placebo. These results have been sustained over five years of continuous treatment in long-term extension studies.
Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic inflammatory joint disease that typically occurs in individuals with psoriasis. It can cause pain, stiffness, and swelling in and around the joints, potentially leading to permanent joint damage if left untreated. STELARA is indicated for adults with active psoriatic arthritis who have had an inadequate response to prior disease-modifying anti-rheumatic drug (DMARD) therapy.
In the PSUMMIT 1 and PSUMMIT 2 clinical trials, STELARA significantly improved joint symptoms, physical function, and skin disease compared to placebo. It has also been shown to slow the radiographic progression of joint damage. STELARA can be used alone or in combination with methotrexate for psoriatic arthritis.
Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease (IBD) that can affect any part of the gastrointestinal tract, from mouth to anus. It causes symptoms such as abdominal pain, diarrhea, weight loss, and fatigue. STELARA is approved for the treatment of moderate to severe Crohn's disease in adults and children weighing at least 40 kg who have had an inadequate response to, lost response to, or were intolerant of conventional therapy or a TNF-alpha inhibitor.
The UNITI clinical program (UNITI-1, UNITI-2, and IM-UNITI) demonstrated that STELARA induced clinical response in a significantly higher proportion of patients compared to placebo, including patients who had previously failed anti-TNF therapy. Maintenance of clinical remission was achieved with subcutaneous injections every 8 or 12 weeks.
Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that causes inflammation and ulceration of the inner lining of the colon and rectum. STELARA is indicated for adults with moderate to severe ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant of conventional therapy or a biologic agent.
In the UNIFI clinical program, STELARA demonstrated significant improvements in clinical response, clinical remission, and endoscopic improvement compared to placebo. Both the intravenous induction dose and the subcutaneous maintenance regimen showed robust efficacy across a broad range of patient populations.
What Should You Know Before Taking STELARA?
Quick Answer: Before starting STELARA, your doctor needs to evaluate you for active infections (especially tuberculosis), review your vaccination history, and assess your risk for cancer. You should not take STELARA if you have an active, clinically significant infection or if you are allergic to ustekinumab or any of its components.
Contraindications
Do not use STELARA if you have a known hypersensitivity (allergy) to ustekinumab or any of the excipients in the formulation (L-histidine, L-histidine monohydrochloride monohydrate, polysorbat 80, sucrose, water for injections). Allergic reactions can range from skin rash to severe anaphylaxis, which is a medical emergency.
STELARA should not be used if you have an active infection that your doctor considers clinically significant. This includes active tuberculosis, severe sepsis, or opportunistic infections. Your doctor will conduct a thorough medical history and physical examination before prescribing STELARA, including a tuberculosis screening test. If latent tuberculosis is detected, treatment for tuberculosis should be initiated before starting STELARA.
Warnings and Precautions
Before starting STELARA, inform your doctor about all of your medical conditions, including:
- Previous allergic reactions: If you have ever had an allergic reaction to STELARA or any other biologic medicine, report this immediately. Serious allergic reactions, including anaphylaxis, have been reported rarely with ustekinumab.
- Infections: Because STELARA suppresses part of the immune system, it may increase your susceptibility to infections, including serious infections. Tell your doctor if you currently have an infection or if you have recurring infections. Watch for signs of infection during treatment, including fever, cough, burning during urination, or wounds that do not heal.
- Cancer history: Immunosuppressive medicines like STELARA may increase the risk of certain cancers. If you have a history of cancer or have been treated with other biologic agents for psoriasis, the risk may be further elevated. Your doctor will weigh the benefits and risks carefully.
- Tuberculosis (TB) exposure: Tell your doctor if you have recently been in contact with someone who has tuberculosis. You will be tested for TB before treatment begins, and if you are at risk, you may need to take anti-tuberculosis medication before starting STELARA.
- New or changing skin lesions: Report any new or changing lesions within psoriasis plaques or on normal skin, as immunosuppression may increase the risk of skin cancer.
- Concurrent immunosuppressive therapy: The safety of using STELARA with other immunosuppressive agents or phototherapy (UV light treatment) has not been fully established. Combining these treatments may further increase the risk of immune-related complications.
- Age over 65: Older adults may be more susceptible to infections during STELARA treatment. Your doctor will monitor you more closely.
Lupus-like reactions, including cutaneous lupus and lupus-like syndrome, have been reported in some patients receiving ustekinumab. Seek immediate medical attention if you develop a red, raised, scaly rash (sometimes with a darker border) on sun-exposed skin, or if you experience joint pain alongside skin changes.
Heart attacks and strokes have been observed in a clinical study of patients with psoriasis treated with STELARA. Your doctor will regularly monitor your cardiovascular risk factors and ensure they are being managed appropriately. Seek immediate medical attention if you experience chest pain, weakness or abnormal sensation on one side of the body, facial drooping, or changes in speech or vision.
Children and Adolescents
STELARA is not recommended for children with psoriasis under 6 years of age, children with Crohn's disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis or ulcerative colitis, as studies have not been conducted in these populations. For children aged 6 and older with moderate to severe plaque psoriasis, the dose is calculated based on body weight.
Pregnancy and Breastfeeding
There is limited clinical experience with STELARA in pregnant women. Animal studies have not demonstrated direct harmful effects on fetal development. However, as a precautionary measure, it is preferable to avoid using STELARA during pregnancy. Women of childbearing potential should use effective contraception during treatment and for at least 15 weeks after the last dose.
STELARA can cross the placenta and may be detected in the serum of infants born to mothers who received the drug during pregnancy. If you received STELARA during pregnancy, your infant may have a higher risk of infection. Live vaccines (such as BCG, MMR, and varicella vaccines) should not be given to your infant for the first 12 months of life unless the infant's doctor specifically advises otherwise.
Ustekinumab may be excreted in breast milk in very small amounts. Discuss with your doctor whether to breastfeed or to use STELARA. You and your doctor should make a decision together based on the benefits and risks to both you and your child.
Driving and Operating Machinery
STELARA has no known or negligible effect on the ability to drive or operate machinery.
How Does STELARA Interact with Other Drugs?
Quick Answer: STELARA has relatively few drug interactions compared to many other immunosuppressants. The most important interactions involve live vaccines (which must be avoided during treatment), other immunosuppressive agents, and allergen immunotherapy injections. No formal drug-drug interaction studies have shown clinically significant interactions with common medications.
Because STELARA targets specific interleukins (IL-12 and IL-23) rather than broadly suppressing the immune system through small molecule pathways, it has a favorable drug interaction profile. However, several important considerations remain. Always inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Live vaccines (BCG, MMR, varicella, rotavirus, live influenza, yellow fever) | Risk of vaccine-related infection due to immunosuppression | Contraindicated during STELARA treatment. Complete live vaccinations at least 2 weeks before starting therapy. |
| Other immunosuppressants (ciclosporin, methotrexate at immunosuppressive doses, azathioprine) | Potentially additive immunosuppression; increased infection risk | Concurrent use not formally studied. Exercise caution and monitor for infections. |
| Other biologic therapies (TNF inhibitors, IL-17 inhibitors, JAK inhibitors) | Potentially additive immunosuppression | Avoid concurrent use. Allow adequate washout period when switching between biologics. |
Other Considerations
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Allergen immunotherapy injections | Unknown effect; potential alteration of immune response to allergen desensitization | Inform your doctor. The clinical significance is not established. |
| Inactivated vaccines (flu, pneumococcal, COVID-19) | Immune response may be reduced | Generally safe to administer, but antibody response may be lower. Discuss timing with your doctor. |
| CYP450-metabolized drugs (warfarin, theophylline) | IL-12/IL-23 blockade may normalize CYP450 levels altered by chronic inflammation | Monitor therapeutic drug levels when starting or stopping STELARA in patients on narrow therapeutic index drugs. |
Unlike many small molecule immunosuppressants, ustekinumab does not undergo hepatic metabolism through the cytochrome P450 enzyme system. It is cleared through proteolytic degradation, similar to endogenous immunoglobulins. This means that STELARA is unlikely to cause pharmacokinetic drug interactions with most conventional medications. However, chronic inflammation can suppress CYP450 enzyme activity; when STELARA reduces inflammation, CYP450 activity may normalize, potentially affecting the metabolism of concomitant medications that are CYP450 substrates.
Infant Vaccination After Maternal STELARA Use
If you received STELARA during pregnancy, it is critical to inform your baby's healthcare provider before the infant receives any vaccinations. Live vaccines such as BCG (used to prevent tuberculosis) are not recommended for the first 12 months of life unless the baby's doctor specifically advises otherwise, because the infant may have residual levels of ustekinumab that could interfere with the immune response to live vaccines.
What Is the Correct Dosage of STELARA?
Quick Answer: STELARA dosing depends on the condition being treated and the patient's body weight. For psoriasis and psoriatic arthritis, the standard dose is 45 mg subcutaneously (or 90 mg for patients over 100 kg), given at weeks 0 and 4, then every 12 weeks. For Crohn's disease and ulcerative colitis, induction begins with a weight-based IV infusion, followed by 90 mg subcutaneously every 8 or 12 weeks.
STELARA should always be used under the guidance and supervision of a physician experienced in treating the conditions for which it is indicated. Self-injection may be an option after proper training, but the first injections are typically administered by a healthcare professional.
Adults — Psoriasis and Psoriatic Arthritis
Standard Dosing Schedule
| Body Weight | Induction Dose | Maintenance Dose | Route |
|---|---|---|---|
| ≤ 100 kg | 45 mg at Week 0 and Week 4 | 45 mg every 12 weeks | Subcutaneous injection |
| > 100 kg | 90 mg at Week 0 and Week 4 | 90 mg every 12 weeks | Subcutaneous injection |
Adults — Crohn's Disease and Ulcerative Colitis
Weight-Based IV Induction Followed by SC Maintenance
| Phase | Dose | Route | Timing |
|---|---|---|---|
| Induction | ~6 mg/kg (weight-based) | Intravenous infusion | Single dose (Week 0) |
| First maintenance | 90 mg | Subcutaneous injection | 8 weeks after IV induction |
| Ongoing maintenance | 90 mg | Subcutaneous injection | Every 12 weeks (or every 8 weeks) |
For some patients, the doctor may prescribe 90 mg every 8 weeks instead of every 12 weeks during the maintenance phase, based on clinical response.
Children and Adolescents (6 years and older) — Psoriasis
Weight-Based Pediatric Dosing
| Body Weight | Dose | Schedule |
|---|---|---|
| < 60 kg | 0.75 mg/kg | Week 0, Week 4, then every 12 weeks |
| 60–100 kg | 45 mg | Week 0, Week 4, then every 12 weeks |
| > 100 kg | 90 mg | Week 0, Week 4, then every 12 weeks |
Children (≥ 40 kg) — Crohn's Disease
For children weighing at least 40 kg with moderate to severe Crohn's disease, the dosing regimen follows the same pattern as adults: an initial weight-based intravenous induction dose of approximately 6 mg/kg, followed by 90 mg subcutaneously at 8 weeks, then 90 mg every 12 weeks (or every 8 weeks based on clinical response).
Missed Dose
If you forget to take a scheduled dose of STELARA, contact your doctor or pharmacist as soon as possible. Do not take a double dose to make up for a missed injection. Your doctor will help you reschedule the injection and determine the best time for your next dose.
Overdose
If you have received or been given too much STELARA, contact your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty. In clinical studies, single doses up to 6 mg/kg intravenously have been administered without dose-limiting toxicity. In case of overdose, the patient should be monitored for signs and symptoms of adverse reactions, and appropriate symptomatic treatment should be initiated.
How STELARA Is Administered
STELARA is given as an injection under the skin (subcutaneous injection) for psoriasis, psoriatic arthritis, and maintenance treatment of IBD. For Crohn's disease and ulcerative colitis, the initial dose is given as an intravenous (IV) infusion by a healthcare professional.
After appropriate training, patients or their caregivers may self-administer subcutaneous injections at home. Suitable injection sites include the upper thigh or the abdomen (at least 5 cm from the navel). Avoid injecting into areas of skin affected by psoriasis. If a 90 mg dose is required using 45 mg vials, two injections should be given at two different sites in immediate succession, each with a new needle and syringe.
Remove the vial from the refrigerator approximately 30 minutes before injection to allow it to reach room temperature. Do not shake the vial vigorously. Inspect the solution: it should be clear to slightly opalescent, colorless to slightly yellow. Do not use if the solution is discolored, cloudy, or contains visible particles.
What Are the Side Effects of STELARA?
Quick Answer: Like all medicines, STELARA can cause side effects, although not everyone experiences them. The most common side effects include upper respiratory infections, headache, fatigue, and injection site reactions. Serious but rare side effects include severe allergic reactions, serious infections, and, very rarely, certain skin conditions such as exfoliative dermatitis.
STELARA has been evaluated in extensive clinical trials involving thousands of patients across all four indications. The overall safety profile is well-characterized, and most side effects are mild to moderate in severity. Long-term safety data spanning over 5 years of continuous treatment in psoriasis patients have confirmed the consistent safety profile observed in the initial pivotal trials.
Contact your doctor or seek emergency care immediately if you experience: difficulty breathing or swallowing, low blood pressure (dizziness, lightheadedness), swelling of the face, lips, mouth, or throat, widespread skin rash or hives, fever with rash, or signs of a serious infection such as persistent fever, night sweats, or unexplained weight loss.
Common Side Effects
May affect up to 1 in 10 people
- Upper respiratory tract infections (nasopharyngitis, common cold)
- Diarrhea
- Nausea
- Vomiting
- Fatigue (tiredness)
- Dizziness
- Headache
- Itching (pruritus)
- Back pain, muscle pain, or joint pain
- Sore throat
- Redness and pain at the injection site
- Sinusitis (sinus infection)
Uncommon Side Effects
May affect up to 1 in 100 people
- Cellulitis (skin and tissue infection)
- Herpes zoster (shingles)
- Lower respiratory tract infections
- Dental infections
- Vaginal yeast infections
- Depression
- Nasal congestion
- Injection site reactions (bleeding, bruising, hardness, swelling, itching)
- Weakness
- Facial palsy (Bell's palsy) — usually temporary
- Pustular psoriasis (change in psoriasis type with redness and small yellow/white blisters)
- Skin peeling (exfoliation)
- Acne
Rare Side Effects
May affect up to 1 in 1,000 people
- Severe allergic reactions (anaphylaxis) — difficulty breathing, low blood pressure, swelling of face or throat
- Allergic lung reactions and lung inflammation
- Exfoliative dermatitis (redness and skin peeling over a large body area)
- Erythrodermic psoriasis (generalized redness and scaling)
- Vasculitis (inflammation of small blood vessels, potentially causing skin redness with small red or purple bumps, fever, or joint pain)
Very Rare Side Effects
May affect up to 1 in 10,000 people
- Bullous pemphigoid (blistering skin condition)
- Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed areas, possibly with joint pain)
Infections During Treatment
STELARA can reduce the immune system's ability to fight infections. Some infections can become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis), or parasites. Opportunistic infections — infections that primarily occur in people with weakened immune systems — have been reported, including opportunistic infections affecting the brain (encephalitis, meningitis), lungs, and eyes.
Be vigilant for the following signs of infection during STELARA treatment:
- Fever, flu-like symptoms, night sweats, unexplained weight loss
- Persistent cough, shortness of breath, feeling tired or breathless
- Warm, red, and painful skin, or a painful skin rash with blisters
- Burning sensation during urination
- Diarrhea
- Visual disturbances or vision loss
- Headache, stiff neck, sensitivity to light, nausea, or confusion
If you notice any signs of infection, contact your doctor immediately. Your doctor may decide that you should stop using STELARA until the infection resolves. Also inform your doctor about any open cuts or wounds, as these may become infected.
Skin Reactions
Increased skin redness and scaling over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. Report any such symptoms to your doctor immediately. These conditions may occasionally develop as a natural change in the type of psoriasis symptoms rather than as a side effect of the medication.
How Should You Store STELARA?
Quick Answer: Store STELARA in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the vials or prefilled syringes in their original carton to protect from light. Do not shake vigorously.
Proper storage is essential to maintain the effectiveness and safety of STELARA. As a biologic medicine containing a protein (monoclonal antibody), STELARA is sensitive to temperature extremes, light exposure, and mechanical stress.
- Temperature: Store in a refrigerator between 2°C and 8°C (36°F and 46°F). Do not freeze. If the product has been accidentally frozen, do not use it.
- Light protection: Keep the vial or prefilled syringe in its original carton to protect from light.
- Do not shake: Vigorous shaking may damage the protein structure of ustekinumab, rendering the medicine ineffective.
- Keep out of reach of children.
- Check before use: Do not use the product after the expiration date printed on the label (the last day of the stated month). Do not use if the solution is discolored, cloudy, or contains visible foreign particles.
- Single use only: STELARA vials and prefilled syringes are for single use. Any unused medicine remaining in the vial or syringe should be discarded.
Do not dispose of medicines in household waste or via the sewage system. Ask your pharmacist about proper disposal of unused medicines. These measures help protect the environment.
What Does STELARA Contain?
Quick Answer: Each STELARA vial contains 45 mg of ustekinumab in 0.5 mL of solution. Inactive ingredients include L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E 433), sucrose, and water for injections.
The active substance in STELARA is ustekinumab, a fully human IgG1 kappa monoclonal antibody produced in a well-characterized murine myeloma cell line using recombinant DNA technology.
Inactive Ingredients (Excipients)
- L-histidine — acts as a buffer to maintain the correct pH of the solution
- L-histidine monohydrochloride monohydrate — buffer component
- Polysorbate 80 (E 433) — a surfactant that prevents protein aggregation. Note: STELARA contains 0.02 mg of polysorbate 80 per dose unit. Polysorbates can cause allergic reactions in some individuals; inform your doctor if you have known allergies to polysorbates.
- Sucrose — a stabilizer that protects the protein during storage
- Water for injections — the solvent
Appearance
STELARA solution for injection is clear to slightly opalescent (having a pearlescent sheen), colorless to light yellow. The solution may contain a few small translucent or white protein particles. This is normal for biologic medicines and does not affect safety or efficacy. The medicine is supplied in a single-use 2 mL glass vial or prefilled syringe. Each vial contains 45 mg of ustekinumab in 0.5 mL; prefilled syringes are available in 45 mg and 90 mg strengths.
Marketing Authorization Holder and Manufacturer
STELARA is manufactured by Janssen Biologics B.V. (Leiden, Netherlands) and marketed by Janssen-Cilag International NV (Beerse, Belgium). It is approved by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and regulatory authorities in over 100 countries worldwide. Several biosimilar versions — Imuldosa, Yesintek, WEZENLA, STEQEYMA, and Usymro — have been approved or are in regulatory review, offering additional options for patients and healthcare systems.
Frequently Asked Questions About STELARA
STELARA (ustekinumab) is used to treat four inflammatory conditions: moderate to severe plaque psoriasis in adults and children aged 6 and older, active psoriatic arthritis in adults, moderate to severe Crohn's disease in adults and children weighing at least 40 kg, and moderate to severe ulcerative colitis in adults. It works by blocking IL-12 and IL-23, key cytokines that drive the inflammatory process in these conditions.
For psoriasis and psoriatic arthritis, STELARA is injected subcutaneously at weeks 0 and 4, then every 12 weeks. For Crohn's disease and ulcerative colitis, the first dose is an intravenous infusion, followed by a subcutaneous injection at week 8, then every 12 weeks (or every 8 weeks depending on your response). The 12-week dosing interval makes STELARA one of the most convenient biologic treatments available.
The most common side effects include upper respiratory infections (common cold, sore throat), headache, fatigue, diarrhea, nausea, injection site reactions (redness, pain), itching, back or joint pain, and sinusitis. These are generally mild and tend to improve over time. Serious side effects such as severe allergic reactions and serious infections are rare but require immediate medical attention.
There is no specific interaction between STELARA and alcohol. However, excessive alcohol consumption can worsen psoriasis and inflammatory bowel disease symptoms, and may affect liver function. Moderate alcohol intake is generally considered acceptable, but you should discuss your individual situation with your doctor, especially if you have liver disease or Crohn's disease.
Limited data suggests no increased risk of birth defects in children exposed to STELARA in the womb. However, due to limited experience, it is generally recommended to avoid STELARA during pregnancy as a precaution. Women of childbearing potential should use effective contraception during treatment and for at least 15 weeks after the last dose. If STELARA was received during pregnancy, live vaccines should be delayed for the infant's first 12 months unless otherwise advised by a doctor.
For psoriasis, many patients notice improvement within 2 to 4 weeks, with significant results typically visible by week 12 to 16. For Crohn's disease and ulcerative colitis, clinical response often begins within 6 to 8 weeks after the initial intravenous induction dose. The full therapeutic benefit may continue to develop over several months of continued treatment.
References
- European Medicines Agency (EMA). STELARA (ustekinumab) — Summary of Product Characteristics. Last updated 2025. Available at: ema.europa.eu/EPAR/stelara
- U.S. Food and Drug Administration (FDA). STELARA Prescribing Information. Janssen Biotech, Inc. Available at: FDA Drug Label
- Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665-1674. doi:10.1016/S0140-6736(08)60725-4
- Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease (UNITI-1, UNITI-2, IM-UNITI). N Engl J Med. 2016;375(20):1946-1960. doi:10.1056/NEJMoa1602773
- Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis (UNIFI). N Engl J Med. 2019;381(13):1201-1214. doi:10.1056/NEJMoa1900750
- National Institute for Health and Care Excellence (NICE). Ustekinumab for treating active psoriatic arthritis. Technology appraisal guidance [TA340]. 2015.
- British National Formulary (BNF). Ustekinumab. Available at: bnf.nice.org.uk/drugs/ustekinumab
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023.
Editorial Team
Written by the iMedic Medical Editorial Team — specialists in dermatology, gastroenterology, rheumatology, and clinical pharmacology.
Reviewed by the iMedic Medical Review Board according to international guidelines from EMA, FDA, NICE, and WHO. Evidence Level 1A.
Sources: European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), National Institute for Health and Care Excellence (NICE), British National Formulary (BNF), World Health Organization (WHO). All content follows the GRADE evidence framework and is free from commercial funding or pharmaceutical industry influence.