2016 was an important year for ustekinumab, a medication that is directed against certain naturally occurring proteins that regulate the body’s immune and inflammatory response. Going by the trade name Stelara and produced by Janssen Biotech, Inc, the drug was approved by the FDA last year for the treatment of moderate to severe Crohn’s disease.
If you or a family member is considering Stelara, familiarize yourself with the basic facts about how ustekinumab works, how it’s administered, and what types of results some of the first patients are seeing.
It’s not really “new”, so to speak
While Stelara is a relatively new product in the world of IBD—the FDA approved it for the treatment of moderate to severe Crohn’s disease in September of 2016—ustekinumab has been an approved medical treatment since 2009. It was first used to treat moderate to severe plaque psoriasis, and later for psoriatic arthritis.
It’s a biologic
Stelara fits into the same category as common brands such as Humira and Remicade, categorized as a biologic medication. This means that it acts similarly to an immunosuppressant, but instead of suppressing the entirety of the immune system, it targets specific proteins associated with inflammation in the digestive tract. Like most other biologic treatments, doctors generally will recommend using the drug after trying other treatments, and only if symptoms are moderate to severe.
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It works by targeting 2 specific proteins
Technically classified as a human monoclonal immunoglobulin, the medication works by affecting two proteins: interleukin-12 and interleukin-13 (IL-12 and IL-13). These two proteins are thought to be responsible for gastrointestinal inflammatory response.
Treatment consists of an infusion and ongoing injections
Although there have been no official quality of life studies for Stelara to date, it does seem to offer a relatively convenient treatment regimen. The first dose is given as an infusion in a clinical setting, but patients can administer ongoing subcutaneous injections every 8 weeks at home, once they’ve been trained by a physician.
It works best for patients who haven’t responded well to anti-TNF medications
In clinical trials, researchers found that participants with moderate to severe symptoms who had previously tried medications to inhibit tumor necrosis factor—commonly called TNF inhibitors or anti-TNF—experienced higher success rates with Stelara. A 2011 study found that patients who experienced minimal or temporary success with anti-TNF medication were unlikely to experience improvement by changing to another anti-TNF; however, they did see improvement compared to a placebo group when administered ustekinumab in early clinical trials. While there are no guarantees, this could indicate that if TNF inhibitors have not relieved your symptoms, you may be a good candidate for remission through Stelara.
Studies indicate that you will know whether or not it’s effective for you rather quickly
A 2011 clinical trial found that the far majority of patients who responded positively to the initial infusion over the first few weeks also experienced improvement from ongoing maintenance injections. On the other hand, those who did not see improvement from the initial infusion experienced no additional benefit by continuing to receive maintenance doses. Perhaps this is good news for patients who are frustrated by the feeling of not knowing whether a medication will work, or whether they will have to stick with it for a long period of time before seeing any results. The Stelara website affirms that the majority of patients experienced symptom relief within 6 weeks, and some within 3 weeks.
You can still sign up for clinical trials
The medication has been approved as safe and effective for the treatment of moderate to severe Crohn’s. However, you can still participate in clinical trials that study other aspects of the treatment, such as long-term efficacy. You can take the first step to participating in clinical trials by visiting the Discover Therapies homepage.
Verywell - Comparing 6 Biologic Medications for IBD
National Center for Biotechnology Information website: Ustekinumab for the treatment of
Crohn’s Disease: can it find its niche?
The New England Journal of Medicine: Ustekinumab Induction and Maintenance Therapy in Refractory Crohn’s Disease