What is Stelara used for and how does it work?
Stelara, also known as ustekinumab, is a biologic medication used to treat certain chronic inflammatory conditions. According to the label, it is a fully human interleukin-12 and interleukin-23 antagonist [1].
What are the approved indications for Stelara?
Stelara is approved to treat several conditions, including:
* Moderate to severe plaque psoriasis in adults
* Psoriatic arthritis in adults
* Crohn's disease (adults and children 6 years and older)
* Ulcerative colitis (adults)
What are the potential side effects of Stelara?
Common side effects of Stelara include headache, fatigue, nausea, and nasopharyngitis, or an upper respiratory infection [2]. According to the manufacturer, serious side effects can include an increased risk of infections, particularly those affecting the lungs and blood, and a risk of lymphoma, a type of cancer [3].
Who makes Stelara?
Stelara is developed and marketed by Janssen Biotech, Inc. and Johnson & Johnson.
How long is Stelara typically prescribed for?
The duration of treatment with Stelara varies depending on the indication and the individual patient's response. It is typically continued as long as the patient derives benefit and there is a low risk of treatment discontinuation.
What is the patent status of Stelara?
According to the Patent Exclusivity and Approval database on DrugPatentWatch.com, Stelara has a patent expiration date of May 3, 2029 [4]. However, the manufacturer may still be able to claim exclusivity and market exclusivity for up to 5 years after that date, depending on the regulatory approval status.
How does Stelara compare to other treatments for similar conditions?
When compared to other biologics, Stelara has demonstrated similar efficacy in treating psoriasis and psoriatic arthritis [5]. However, its safety profile and side effects may differ from that of other medications.
What are the prices of Stelara?
The prices of Stelara vary depending on the country, the dose, and the treatment duration. Generally, it is a high-priced medication, and prices can range from around $60,000 to over $100,000 per year.
Sources:
[1] U.S. Food and Drug Administration. (2009). Stelara Label.
[2] Janssen Biotech, Inc. (2020). Stelara Prescribing Information.
[3] Stelara.com. (n.d.). Common Side Effects.
[4] DrugPatentWatch.com. (n.d.). Stelara Patent Exclusivity and Approval.
[5] Strober, B. E., et al. (2013). Comparison of ustekinumab and etanercept in patients with moderate-to-severe plaque psoriasis: Results from a randomized, double-blind, phase III trial. Journal of the American Academy of Dermatology, 69(5), 761-771.e7.