FDA Approves STELARA® (Ustekinumab) for Treatment of Moderate-to-Severe Crohn’s Disease

First biologic therapy to target Interleukin-12 and Interleukin-23 cytokines for the treatment of Crohn’s disease 

NEW YORK, NY – The Crohn’s & Colitis Foundation released the following statement today after the U.S. Food & Drug Administration announced its approval of STELARA® (ustekinumab), a biologic therapy from Janssen Biotech, Inc., for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) earlier this week. STELARA will be available for use in adult patients with Crohn’s disease who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker. It has also been approved for use in patients who failed or were intolerant to treatment with one or more TNF blockers.

"Because of the individual nature of these diseases, what works for one patient may not work for another. That is why it is so critical that our Crohn’s patients have many different treatment options available to them,” said Michael Osso, President & CEO of the Crohn's & Colitis Foundation. "The approval of STELARA is extremely important for patients living with moderate-to-severe Crohn’s disease. Many of these patients have exhausted available treatments, and STELARA gives them another option to hopefully, induce remission, help manage their disease, and improve their quality of life.”

STELARA® is the first biologic therapy for Crohn’s disease targeting Interleukin-12 and Interleukin-23 cytokines, which play a key role in inflammatory and immune responses.

“The role of cytokines in regulating the immune system’s response to inflammation has been the subject of significant research. Through our robust grant-funding program, the Foundation has funded a number of preliminary research studies into the importance of cytokines in the treatment of IBD,” Osso said. “We will continue to fund research into cytokines and other potential therapeutic targets in order to yield additional discoveries and new treatments for IBD patients.”

STELARA® is the only treatment for Crohn’s disease that starts with a weight-based, one-time intravenous (IV) infusion induction dose (260 mg [55 kg or less], 390 mg [more than 55 kg to 85 kg], or 520 mg [more than 85 kg]) to help reduce symptoms, followed by 90 mg subcutaneous maintenance injections every 8 weeks to help keep the symptoms under control. The first dose of STELARA® is an induction dose, administered intravenously, under the supervision of a healthcare professional. Subsequent maintenance doses are administered as a subcutaneous injection every 8 weeks, either by a healthcare professional or self-injected by the patient after proper training.

About Crohn's Disease

Crohn’s disease is a painful, medically incurable disease that attacks the digestive system. Crohn's disease may attack anywhere along the digestive tract, from mouth to anus. Symptoms may include abdominal pain, persistent diarrhea, rectal bleeding, fever, and weight loss. Many patients require numerous hospitalizations and surgery. Most people develop the diseases between the ages of 15 and 35; however the incidence is increasing in children.

About STELARA® (ustekinumab) 

STELARA® is a prescription medicine used to treat moderately to severely active Crohn’s disease in adult patients (18 years and older) who have already taken other medicine that did not work well enough or they could not tolerate it.

Important Safety Information for STELARA®

STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

Serious Infections

STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®. If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®. You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA®, tell your doctor if you:

  • think you have an infection or have symptoms of an infection such as: 
    • fever, sweats, or chills 
    • muscle aches 
    • cough 
    • shortness of breath
    • blood in your phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinate more often than normal
    • feel very tired
    • are being treated for an infection
    • get a lot of infections or have infections that keep coming back
    • have TB, or have been in close contact with someone who has TB

After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above).

STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and interleukin 23 (IL‐23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections.


STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.

Reversible posterior leukoencephalopathy syndrome (RPLS)

RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions

Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Before receiving STELARA®, tell your doctor if you:

  • Have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS.
  • Ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure.
  • Are allergic to latex. The needle cover on the prefilled syringe contains latex.
  • Have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA® or one year after you stop taking STELARA®.
  • Have any new or changing lesions within psoriasis areas or on normal skin.
  • Are receiving or have received allergy shots, especially for serious allergic reactions.
  • Receive or have received phototherapy for your psoriasis.
  • Have any other medical conditions.
  • Are pregnant or plan to become pregnant. It is not known if STELARA® will harm your unborn baby. You and your doctor should decide if you will take STELARA®.
  • Are breast‐feeding or plan to breast‐feed. It is thought that STELARA® passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take STELARA®.

Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed STELARA®:

  • Use STELARA® exactly as prescribed by your doctor. 
  • If your doctor decides that you or a caregiver may give your injections of STELARA® at home, you should receive training on the right way to prepare and inject STELARA®. Do not try to inject STELARA® yourself until you or your caregiver has been shown how to inject STELARA® by your doctor or nurse.

Common side effects of STELARA® include: upper respiratory infections, headache, tiredness, joint pain, nausea, itching, vomiting, vaginal yeast infections, urinary tract infections, and redness at the injection site. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please read the full Prescribing Information and Medication Guide for STELARA®.

Crohn's & Colitis Foundation

The Crohn’s & Colitis Foundation is the leading nonprofit organization focused on both research and patient support for inflammatory bowel disease (IBD), with the mission of curing Crohn’s disease and ulcerative colitis and improving the quality of life for the millions of Americans living with IBD. The Foundation’s work is dramatically accelerating the research process, while also providing extensive educational and support resources for patients and their families, medical professionals, and the public.