5-Year STELARA Data Shows Impact on Patients with Crohn’s Disease


Recently, during the virtual 28th United European Gastroenterology Week Congress, the Janssen Pharmaceutical Companies of Johnson & Johnson announced 5-year results from a Phase 3 extension study on STELARA (ustekinumab). The data, sourced from the IM-UNITI extension, sought to understand the long-term impact of STELARA for patients with moderate-to-severe Crohn’s disease. Ultimately, the data showed that STELARA assists with long-term remission and maintained symptom reduction.


So what is STELARA (ustekinumab)? This monoclonal antibody is the first selective IL-12 and IL-23 inhibitor. It is approved to treat adult and pediatric patients with plaque psoriasis, adult patients with psoriatic arthritis, adult patients with ulcerative colitis (UC), and adult patients with Crohn’s disease.

During the IM-UNITI trial, patients with moderate-to-severe Crohn’s disease received subcutaneously-administered maintenance doses of 90 mg q8w or q12w STELARA. Compared to patients receiving a placebo, those taking STELARA saw significant reductions in symptoms. 55% of patients maintained remission through 5 years of treatment. Additionally, 93% of patients no longer required steroid use. STELARA was found to be relatively safe and well-tolerated.

However, there is some safety information to take into account. STELARA may lower patients’ ability to fight infections. Adverse reactions include congestion, fever, headaches, fatigue, itching (pruritus), nausea and diarrhea, vomiting, abdominal and joint pain, sore throat, running nose, and a variety of infections: sinus, yeast, urinary tract, lung. If you are taking STELARA and experiencing signs of an infection, please see your doctor.

Crohn’s Disease

Although doctors are not sure of the exact cause of Crohn’s disease, which exists under the umbrella of inflammatory bowel disease (IBD), many believe it results from genetics and your immune system. Crohn’s disease is characterized by digestive tract inflammation, most often in the ileum or colon. Often, symptoms appear before age 30. Caucasians, cigarette smokers, and Ashkenazi Jews are at higher risk of developing Crohn’s disease.

Generally, the condition occurs in symptomatic periods and periods of remission. Symptoms include:

  • Diarrhea
  • Fatigue
  • Unintended weight loss
  • Abdominal pain and cramping
  • Ulcers
  • Fever
  • Bloody stool
  • Mouth sores
  • Loss of appetite
  • Anal drainage or pain
  • Malnutrition
  • Liver, joint, skin, eye, and bile duct inflammation
  • Delayed growth and development
  • Bowel obstructions

Learn more about Crohn’s disease here.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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