Tremfya nabs FDA approval for active ulcerative colitis, chasing competitor Skyrizi
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The FDA has approved Johnson & Johnson’s Tremfya, a dual acting interleukin-23 inhibitor, for the treatment of patients with moderately to severely active ulcerative colitis, according to a company release.
Tremfya (guselkumab) is now approved for three indications including plaque psoriasis, active psoriatic arthritis and UC, according to a company press release. With this approval, Tremfya is the latest contender in an increasingly crowded UC market alongside AbbVie and its rival IL-23 inhibitor, Skyrizi (risankizumab), which was approved for both Crohn’s disease and UC in June.
“Treatment with Tremfya resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining,” David T. Rubin, MD, director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, said in the release. “Today’s approval of Tremfya builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease.”
The agency based its decision on data from the ongoing phase 2b/3 QUASAR trial, which assessed efficacy and safety of Tremfya among adult patients with moderately to severely active UC who were either intolerant or nonresponsive to conventional therapy, other biologics or JAK inhibitors.
According to QUASAR study results, 50% of patients who received subcutaneous Tremfya 200 mg every 4 weeks achieved clinical remission at 44 weeks compared with 45% of patients who received Tremfya 100 mg every 8 weeks and just 19% of patients who received placebo.
Additionally, compared with placebo, at 1 year, 34% of patients who received Tremfya 200 mg achieved endoscopic remission vs. 35% of patients who received Tremfya 100 mg and 15% of those treated with placebo (P <.001).
“There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission,” Christopher Gasink, MD, vice president of medical affairs, gastroenterology and autoantibody at Johnson & Johnson Innovative Medicine, said in the release. “In the QUASAR clinical program, Tremfya demonstrated high reported rates of endoscopic remission at 1 year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease.”
The company noted that Tremfya is intended to be administered as an IV 200 mg dose during induction at weeks 0, 4 and 8 by a health care professional followed by maintenance dosing with either SC 100 mg at week 16 then every 8 weeks or SC 200 mg at week 12 and every 4 weeks after that. Maintenance Tremfya can be self-administered or administered by a properly trained caregiver, the release stated, using the “lowest effective recommended dosage to maintain therapeutic response.”
In June, Johnson & Johson submitted a supplemental biologics license application with the FDA to also obtain approval of Tremfya to treat patients with moderately to severely active Crohn’s disease.
Perspective
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Edward V. Loftus Jr., MD
It is a welcome addition to the UC market.
The maintenance data on Tremfya relative to placebo looks impressive.
I don't have any great insight on its position relevant to other UC therapies, but each physician should review phase 3 trial data of these therapies and draw their own conclusions from that.
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