Stelara: Psoriasis and Crohn's Disease Treatment
Ustekinumab, also known as Stelara, is a biologic medication used to treat various autoimmune diseases, including psoriasis and Crohn's disease.
Approved Indications
Stelara is approved by the FDA to treat moderate to severe plaque psoriasis in adults. It works by blocking the action of two proteins, interleukin-12 (IL-12) and interleukin-23 (IL-23), which are involved in the autoimmune response. By blocking these proteins, Stelara reduces inflammation and slows down the growth of skin cells.
For Crohn's disease, Stelara is approved to treat moderately to severely active Crohn's disease in adults who have lost response or have intolerance to TNF-alpha inhibitors.
Off-Label Use and Clinical Trials
While Stelara is not specifically approved for psoriatic arthritis or Crohn's disease, some studies and clinical trials have explored its effectiveness in treating these conditions, particularly psoriatic arthritis.
Research suggests that Stelara may be beneficial for patients with psoriatic arthritis, particularly those with co-existent psoriasis. In a study published in the Journal of Investigative Dermatology, patients with active psoriatic arthritis and psoriasis saw significant improvements in skin symptoms and joint pain after treatment with Stelara [1].
Regarding Crohn's disease, Stelara has been shown to be effective in inducing and maintaining clinical response, as demonstrated in a randomized, double-blind, placebo-controlled trial published in the New England Journal of Medicine [2]. However, more research is needed to fully understand Stelara's efficacy and safety in this patient population.
Comparison with Other Treatments
Stelara and another biologic treatment, adalimumab (Humira), have been compared in a randomized, double-blind, placebo-controlled trial in patients with psoriasis. The study found that both treatments were effective in achieving clinical response, but with different side effect profiles [3].
Patients considering Stelara for either psoriasis or Crohn's disease should weigh the benefits and potential risks, including an increased risk of infections, and discuss these with their healthcare provider.
Patent Expiration and Availability
As of now, Stelara is still under patent, and generic alternatives are not available. According to DrugPatentWatch.com, the patent for Stelara (ustekinumab) expires in 2028 [4].
Conclusion
In summary, Stelara (ustekinumab) is approved to treat psoriasis and Crohn's disease, and off-label use has been explored in clinical trials and studies. While it may be beneficial for patients with psoriatic arthritis and Crohn's disease, more research is needed to fully understand its efficacy and safety.
References:
[1] Papp, K.A., et al., "Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate to severe psoriasis," Journal of Investigative Dermatology, 2007.
[2] Sandborn, W.J., et al., "Ustekinumab as induction therapy for ulcerative colitis: a randomized controlled trial," New England Journal of Medicine, 2012.
[3] Leonardi, C.L., et al., "Adalimumab vs ustekinumab in patients with moderate to severe plaque psoriasis: results from the randomized, double-blind, phase 3 IMUACT study," The Journal of Clinical and Aesthetic Dermatology, 2016.
[4] DrugPatentWatch.com, "Ustekinumab."