Janssen has debuted the first safety and efficacy data on Tremfya in ulcerative colitis, and so far, prospects for a label expansion look good. The readout accompanies positive 48-week results in Crohn’s disease, further solidifying Tremfya’s case in inflammatory bowel disease (IBD).
In the phase 2b Quasar induction study in moderate to severe ulcerative colitis (UC), more than 60% of patients on Tremfya hit the primary endpoint of clinical response, compared with about 28% for placebo. Meanwhile, 30% of patients on the IL-23 inhibitor showed endoscopic improvement versus placebo, Johnson & Johnson said Friday.
"The improvement rates we saw in the Quasar study demonstrate the potential for Tremfya in addressing this important need for patients," Jan Wehkamp, M.D., Ph.D., VP, gastroenterology disease area leader at Janssen Research & Development, said in an interview.
Tremfya is currently approved for psoriasis and psoriatic arthritis, though J&J hopes to push the drug into Crohn’s and UC.
"We are in a race to innovate for patients with disease where considerable need remains," Wehkamp noted.
New indications would only add to the drug's growth prospects. In 2021, Tremfya generated worldwide sales of about $2.13 billion, a 58% increase from 2020.
In Quasar, investigators tested J&J's drug against placebo in 313 patients with moderate to severely active UC who previously had an inadequate response to conventional therapies and/or certain advanced therapies like Takeda's Entyvio or Pfizer's Xeljanz. Patients who weren’t assigned placebo received either a 200- or 400-mg IV dose of Tremfya.
On the trial's secondary endpoints, Tremfya also met the mark.
On one secondary endpoint, investigators found that 26% and 25% of patients on 200- and 400-mg Tremfya, respectively, hit clinical remission. That compared with 9.5% in the placebo group.
Meanwhile, 50.5% and 47.7% of patients in the 200-mg and 400-mg Tremfya groups, respectively, achieved symptomatic remission, compared to 20% in the control arm. And nearly 31% of patients in both the 200-mg and 400-mg Tremfya groups achieved endoscopic improvement, versus 12.4% in the placebo group.
Tremfya’s safety matched up with the drug’s known safety profile, J&J said. A Tremfya phase 3 in UC is ongoing and enrolling participants, the company said.
J&J estimates there are nearly 1 million people in the U.S. suffering from UC. Worldwide, only about 10% of patients are in full remission, representing "tremendous" unmet medical need for these patients, Wehkamp added.
Aside from the Quasar results, J&J on Friday also released long-term data on Tremfya in moderate to severely active Crohn’s disease. In that phase 2 study, dubbed Galaxi 1, 57.4% to 73% of patients on Tremfya (across three doses tested) achieved clinical remission.
That compared with 58.7% for patients on J&J's Stelara in the trial's reference arm. The study wasn’t designed to evaluate differences between treatment groups, J&J pointed out.
At the 48-week mark, the majority of the patients who hit clinical remission on Tremfya were also able to go corticosteroid-free, J&J said.
Tremfya’s phase 3 in Crohn’s—like its trial in UC—is ongoing and recruiting, J&J said.
Crohn’s disease affects an estimated 3 million Americans, J&J pointed out.