Who makes Stelara?
Stelara (ustekinumab) is a name‑brand prescription medication that is a treatment option for several inflammatory diseases. It is manufactured by Janssen Biotech, Inc., which along with Janssen Research & Development, LLC are two of the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen currently has treatments that are used in therapeutic areas such as cardiovascular and metabolism, immunology, infectious diseases and vaccines, oncology, and pulmonary hypertension.
The approval of Stelara by the U.S. Food and Drug Administration (FDA) was initially given in the treatment of adult patients with a moderate to severe form of psoriasis in September 2009. The approval was supported by the effectiveness and safety profile from two Phase 3 clinical studies. They showed improvement in signs and symptoms according to the American College of Rheumatology criteria, the primary endpoint for both studies.
Since 2009, Stelara has also been approved to treat other inflammatory conditions including psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Stelara FAQs
What is Stelara used for?
Stelara is a subcutaneous injection (under the skin) given in your upper arms, buttocks, thighs, or abdominal area. It is typically used when other treatments such as corticosteroids, immunomodulatory drugs, or other biologic medications such as TNF blockers have failed. Stelara is FDA‑approved to treat adults with:
- Moderate to severe plaque psoriasis. Plaque psoriasis appears as raised, red patches of skin covered by silvery‑white scales. On darker skin, patches can appear purplish with gray scales. Plaque psoriasis typically develops symmetrically, most commonly on the scalp, trunk, knees, and elbows.
- Active psoriatic arthritis. This inflammatory condition can cause pain and swelling in joints and at sites where ligaments and tendons attach to bones. Many people with psoriatic arthritis already have psoriasis, though some experience joint pain before any skin rash. Stelara may be used alone or with other medications such as methotrexate.
- Moderate to severe active Crohn’s disease. Crohn’s disease is an inflammatory bowel disease (IBD) causing inflammation anywhere in the digestive tract, leading to stomach pain, fatigue, diarrhea, weight loss, and malnutrition.
- Moderate to severe active ulcerative colitis. Ulcerative colitis is an IBD in which an overactive immune system causes inflammation and ulcers in the lining of the large intestine (colon).
Stelara is also approved for children aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for active psoriatic arthritis in pediatric patients.
What is the active ingredient in Stelara?
The active ingredient in Stelara is ustekinumab, a monoclonal antibody that targets human interleukin‑12 (IL‑12) and interleukin‑23 (IL‑23). By binding to these cytokines, Stelara lowers inflammation and calms the immune system.
How do you use Stelara?
Your healthcare provider will determine your dose. For adults with Crohn’s disease or ulcerative colitis, the first dose is given by intravenous (IV) infusion in a clinical setting. Subsequent doses are administered as a subcutaneous injection every eight weeks.
Adults and children (6 years and older) with psoriasis or psoriatic arthritis self‑inject Stelara subcutaneously in the buttocks, upper arms or thighs, or abdomen. You should be trained by a healthcare professional before administering your first dose. Rotate injection sites and avoid areas that are red, bruised, tender, or hardened.
What drug interactions are there with Stelara?
Stelara may interact with other medications, affecting their effectiveness or increasing side effects. Inform your healthcare provider about all prescription drugs, over‑the‑counter medicines, vitamins, and supplements you take. Notable interactions include live vaccines (e.g., BCG vaccine), warfarin, and cyclosporine.
What are the possible side effects of Stelara?
The most common side effects observed in clinical trials include:
- Runny nose, nasal congestion, or sore throat
- Upper respiratory tract infection
- Sinus infection
- Bronchitis
- Injection site reactions
- Tiredness
- Headache
- Vomiting
- Itchiness
- Vaginal yeast infections
- Urinary tract infections
- Nausea
Other potential side effects:
- Diarrhea
- Dizziness
- Back pain
- Depression
- Muscle pain
Rare but serious side effects may include:
- Severe allergic reactions (hives, facial or throat swelling, shortness of breath)
- Increased risk of serious infections (e.g., tuberculosis)
- Increased risk of certain cancers, including skin cancer
- Posterior reversible encephalopathy syndrome (PRES), with symptoms such as confusion, headaches, vision changes, or seizures
Contact your healthcare provider or report adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Are there any contraindications to taking Stelara?
Avoid Stelara if you have an allergy to ustekinumab or any inactive ingredients. Use caution if you have a latex allergy, as the syringe’s needle cover contains latex.
What should you tell your healthcare provider before using Stelara?
Inform your provider if you have or plan to receive any vaccines (especially live vaccines), a latex allergy, new or changing skin lesions, are receiving allergy shots, have had phototherapy, are pregnant or planning pregnancy, or are breastfeeding.
How can I get Stelara for free?
Janssen collaborates with non‑profit foundations and offers patient assistance programs via Janssen CarePath and Stelara withME. Eligibility requirements apply. Patients with private or commercial insurance may pay as little as $5 per injection. Federal or state program beneficiaries (Medicaid, Medicare, TRICARE, etc.) are not eligible. Visit the respective program websites for enrollment details.
Why is Stelara so expensive?
Stelara is a biologic drug made from living cells and currently has no generic equivalent. The FDA’s approval of the biosimilar Wezlana (ustekinumab‑auub) may lower costs, but prices will likely remain high. Check your insurance coverage and copay details.
How long does it take for Stelara to work?
Onset of symptom relief varies by condition:
- Crohn’s disease: improvement often by 6 weeks, some as early as 3 weeks
- Ulcerative colitis: relief typically by 8 weeks after first IV dose, with about 20% achieving complete relief
- Plaque psoriasis: 70% achieve 75% clearer skin by 12 weeks; 60% have minimal or no plaques by 12 weeks
- Psoriatic arthritis: 50% experience ≥20% improvement in joint pain and swelling by 24 weeks
Individual responses may vary.
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