Johnson & Johnson's Stelara posts positive 3-year data in ulcerative colitis as competition heats up

Johnson & Johnson presented data at the European Crohn’s and Colitis Organization Congress that showed Stelara's ability to sustain remission for three years for ulcerative colitis patients. (Johnson & Johnson)

Since hitting the market in 2009, Johnson & Johnson’s blockbuster drug Stelara has made a habit of exceeding analyst expectations.

There was no better example than last year when it overcame formidable competition, a sales-stunting global pandemic and price pressures to post $7.7 billion in revenue, a surprisingly hefty increase from its $6.6 billion figure from 2019.

Stelara’s remarkable durability isn’t limited to its sales performance. Results of a long-term extension of a clinical trial show that Stelara has exceptional staying power in ulcerative colitis.

In three-year data from the Unifi phase 3 trial, which led to Stelara’s FDA approval for ulcerative colitis, 55.2% of adults who responded to treatment sustained remission for 152 weeks, J&J said Friday. In addition, 96.4% of the patients in remission in week 152 were corticosteroid free.  

“This disease comes and goes," Bruce Sands, M.D., the study’s spokesperson and chief of gastroenterology at Mount Sinai, said in an interview. "It’s a chronic condition, so we thought long-term efficacy is important as well as long-term safety. The data shows really impressive long-term efficacy.” 

On the safety front, the study didn't flag any new risks.

Investigators designed the trial to evaluate the safety and efficacy of induction and maintenance doses for the treatment in moderate to severe active ulcerative colitis patients. The study enrolled adults who were unable to tolerate conventional treatments, such as corticosteroids and immunomodulators, or biologics, such as TNF blockers or vedolizumab.

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The team presented results from the long-term extension Friday at the European Crohn’s and Colitis Organization Congress.

One of the most encouraging aspects of the study was that many patients who were in symptomatic remission were also off steroids, Sands said.

“That’s important because we think steroids are very harmful over the long term,” Sands said.

As the first biologic treatment to selectively inhibit the IL-12 and IL-23 pathways, Stelara (ustekinumab) has always carried significant potential. J&J has realized it by winning approvals for the monoclonal antibody in plaque psoriasis (2009), psoriatic arthritis (2013), Crohn’s disease (2016) and ulcerative colitis (2019).

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Meanwhile, the immunology field has grown increasingly competitive in recent years, and that trend is likely to continue. Biosimilars to AbbVie's Humira are set to launch in the U.S. in 2023, upping pricing pressures to the class. And AbbVie's follow-up to that drug, Rinvoq, recently posted positive data in ulcerative colitis, meaning an FDA filing—and more competition—could follow.