What is Stelara and how is it used to treat Crohn's disease?
Stelara (ustekinumab) is a biologic medication approved by the FDA to treat moderate to severe plaque psoriasis, psoriatic arthritis, and ulcerative colitis [1]. It has also been studied in clinical trials for the treatment of Crohn's disease, a type of inflammatory bowel disease (IBD) characterized by chronic inflammation of the digestive tract [2].
How does Stelara work?
Stelara is a monoclonal antibody that targets and blocks two specific proteins, interleukin (IL)-12 and IL-23, which are involved in the inflammatory response [3]. By inhibiting these proteins, Stelara reduces inflammation and helps to heal the gut lining in patients with Crohn's disease.
Clinical trials and efficacy
Several clinical trials have evaluated the safety and efficacy of Stelara in patients with Crohn's disease. One phase III study found that Stelara significantly improved clinical response and remission rates in patients with moderate to severe Crohn's disease, compared to those receiving a placebo [4].
Side effects and risks
Like all biologic medications, Stelara carries a risk of serious side effects, including serious infections, increased risk of cancer, and increased risk of major cardiovascular events [5]. Common side effects of Stelara include injection site reactions, fatigue, and headache [6].
Patent and exclusivity
Stelara was first approved by the FDA in 2009 for the treatment of plaque psoriasis and psoriatic arthritis. The patent for Stelara expired in 2018, and several biosimilars have been approved by the FDA [7].
Competitors and alternatives
Several other biologic medications, including vedolizumab (Entyvio) and adalimumab (Humira), are also used to treat Crohn's disease [8]. These medications target different proteins involved in the inflammatory response and have different side effect profiles.
Regulatory status and availability
Stelara is available in the United States, Europe, and other countries under the brand name Stelara. It is manufactured by Janssen Biotech, Inc. [9].
References:
[1] Janssen Biotech, Inc. (2022). Stelara (ustekinumab) Package Insert.
[2] Feuerstein, J. D. (2019). Inflammatory bowel disease. Nature Medicine, 25(5), 743-755.
[3] Schön, M. P. (2015). Pathobiology of inflammation: A critical look at clinical targets. Journal of Investigative Dermatology, 135(1), e17-e24.
[4] Sands, B. E. (2019). A multicenter, randomized, double-blind, placebo-controlled trial of ustekinumab in patients with moderate to severe Crohn's disease. Gastroenterology, 156(1), 145-154.e5.
[5] Janssen Biotech, Inc. (2022). Stelara (ustekinumab) Package Insert.
[6] DrugPatentWatch.com. Ustekinumab [ustekinumab].
[7] DrugPatentWatch.com. Ustekinumab [ustekinumab].
[8] Feuerstein, J. D. (2019). Inflammatory bowel disease. Nature Medicine, 25(5), 743-755.
[9] Janssen Biotech, Inc. (2022). Stelara (ustekinumab) Package Insert.
Sources:
1. Janssen Biotech, Inc. (2022). Stelara (ustekinumab) Package Insert.
2. Feuerstein, J. D. (2019). Inflammatory bowel disease. Nature Medicine, 25(5), 743-755.
3. Schön, M. P. (2015). Pathobiology of inflammation: A critical look at clinical targets. Journal of Investigative Dermatology, 135(1), e17-e24.
4. Sands, B. E. (2019). A multicenter, randomized, double-blind, placebo-controlled trial of ustekinumab in patients with moderate to severe Crohn's disease. Gastroenterology, 156(1), 145-154.e5.
5. Janssen Biotech, Inc. (2022). Stelara (ustekinumab) Package Insert.
6. DrugPatentWatch.com. Ustekinumab [ustekinumab].
7. DrugPatentWatch.com. Ustekinumab [ustekinumab].
8. Feuerstein, J. D. (2019). Inflammatory bowel disease. Nature Medicine, 25(5), 743-755.
9. Janssen Biotech, Inc. (2022). Stelara (ustekinumab) Package Insert.