Stelara Now Approved for the Treatment of UC

This week, Janssen Pharmaceutical Companies (a part of Johnson & Johnson) announced that the US FDA (Food and Drug Administration) has approved an expansion of the use of their drug Stelara. Previously, Stelara (ustekinumab) was approved for the treatment of adults with moderate to severe Crohn’s disease or psoriatic arthritis. Stelara has also been previously approved for the treatment of moderate to severe plaque psoriasis in individuals 12 years old and older who require systemic (whole body) treatment or phototherapy. This new expansion will allow Stelara to be used for the treatment of adults with moderate to severe ulcerative colitis moving forward. Stelara was also recently approved for the treatment of UC in the European Union.

What is Stelara?

Stelara is a biologic therapy, a type of genetically engineered treatment option that targets specific cells or proteins. Stelara is a type of biologic called a monoclonal antibody, and blocks the action of several chemical messengers in the body that play a role in inflammation. These chemical messengers, also called interleukins (ILs), include IL-12 and IL-23. When the actions of IL-12 and IL-23 are blocked, it may help reduce inflammation, including inflammation related to inflammatory bowel conditions like UC. Reducing this inflammation may help reduce symptoms and allow damaged or inflamed gastrointestinal tissue to heal.

Results of a recent clinical trial

The approval for Stelara’s expanded use in treating UC came after results from a recent clinical trial were reviewed. This trial was called the UNIFI clinical trial and included over 960 adults with moderate to severe UC. All participants were unable to be treated with currently available biologic treatment options. In the phase 3 UNIFI study, participants were given one infusion of Stelara as part of the induction phase of the trial. A maintenance part of the trial was started eight weeks later, where participants received a subcutaneous (under the skin) injection of Stelara every eight or twelve weeks for the next year. Those taking Stelara were compared to another group given a placebo.

Almost 20 percent of those given Stelara reported being in remission from their UC within the first eight weeks of the induction phase, and about 45 percent of those receiving Stelara injections every eight weeks reported being in remission at the end of the maintenance phase a year later. Just over 40 percent of those receiving Stelara who reported being in remission at the end of the maintenance phase were not taking any steroids to maintain their remission. Over half (58 percent) of those given Stelara during the induction phase reported a reduction in UC-related symptoms (also called a clinical response) by the end of the eight-week period after the first infusion. These results suggest that Stelara may improve the chances of achieving remission from UC and reduce symptoms in some individuals.

The researchers leading the study also looked at the intestinal lining to determine how Stelara impacted those taking it. Over 15 percent of individuals taking Stelara showed signs of improvement in their intestinal lining by the end of the first eight weeks (after only one infusion), and about 44 percent showed similar improvements at the end of the one-year maintenance phase. This suggests that Stelara may be beneficial in promoting gastrointestinal healing after UC-related inflammation and damage. Many participants are continuing to be followed for the next three years to learn more about the long-term outcomes of using Stelara to treat moderate to severe UC.

The researchers involved in the UNIFI study published their results in The New England Journal of Medicine last month.¹ There were no significant differences found in the safety and side effects of Stelara when compared to other conditions Stelara is used for. Common side effects of Stelara include upper respiratory infections, fever, runny or stuffy nose, sore throat, headache, nausea, vomiting, tiredness, urinary tract infections, sinus infections, diarrhea, and joint pain. Stelara may also impact the way the immune system works. A healthcare provider can help you determine if Stelara is appropriate for the treatment of your UC, and what side effects you may be at risk for.^1-3