Tremfya’s FDA win as fully subcutaneous option for Crohn’s may pave way to eclipse Stelara
Key takeaways:
- Tremfya is the first approved IL-23 inhibitor to offer both IV and fully subcutaneous induction regimens.
- This approval for Crohn’s disease may make Tremfya a direct competitor with Stelara.
The FDA has approved Tremfya as the “first and only” interleukin-23 inhibitor that offers both IV and fully subcutaneous induction options for the treatment of moderately to severely active Crohn’s disease, Johnson & Johnson reported.
Previously approved for ulcerative colitis in September 2024, Tremfya (guselkumab) is now the third IL-23p19 specific inhibitor approved for both major types of inflammatory bowel disease. Yet, unlike its IL-23p19 predecessors — Skyrizi (risankizumab, AbbVie) and Omvoh (mirikizumab, Eli Lilly & Co.) — Tremfya is the only one to demonstrate clinical superiority to the IL-12/23 heavyweight Stelara (ustekinumab, Janssen).
With more flexible induction options than its IL-23p19 rivals and a clinical edge on the resident blockbuster in the field, Tremfya may be well-positioned to supplant the defending champion, despite its late market entry.
“Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” Remo Panaccione, MD, FRCPC, professor of medicine and director of the Inflammatory Bowel Disease Unit at the University of Calgary in Canada, said in a Johnson & Johnson press release. “The approval of Tremfya offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.”
The FDA based its decision on data from the phase 3 GRAVITI trial, which assessed efficacy of Tremfya 400 mg as subcutaneous induction among adult patients with moderately to severely active Crohn’s who were either intolerant or nonresponsive to conventional therapy, other biologics or tumor necrosis factor inhibitors.
Additionally, the approval was supported by phase 3 data from the GALAXI 2/GALAXI 3 trials, which examined clinical, endoscopic and safety outcomes of Tremfya compared with conventional therapies and biologics for patients with Crohn’s disease; this included a double-blind head-to-head assessment of Tremfya against Stelara.
According to GRAVITI results, at week 48, the fully subcutaneous Tremfya 200 mg option demonstrated significant improvements compared with placebo, including clinical remission (65% vs. 17%), endoscopic response rate (48% vs. 5%), endoscopic remission rate (40% vs. 6%) and deep remission (34% vs. 4%).
Results from GALAXI 2/GALAXI 3 found that Tremfya 200 mg demonstrated statistically significant and clinically meaningful superiority to Stelara on all pooled endoscopic endpoints, including endoscopic response (52.7% vs. 37.1%), endoscopic remission (37.2% vs. 24.7%) clinical remission/endoscopic response (47.3% vs. 33.7%) and deep remission (33.8% vs. 22.3%).
“Tremfya is the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active Crohn’s disease,” Chris Gasink, MD, vice president of medical affairs in gastroenterology and autoantibody at Johnson & Johnson Innovative Medicine, said in the release. “With the approval of Tremfya, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start.”
He added: “Tremfya provides people living with Crohn’s disease and their health care providers a new treatment option that is supported by data from multiple phase 3 studies, including pooled analyses showing statistical superiority vs. Stelara across four endoscopic or combined clinical and endoscopic endpoints.”
Reference:
- Tremfya (guselkumab) demonstrates superiority versus Stelara (ustekinumab) in phase 3 Crohn’s disease program. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-demonstrates-superiority-versus-stelara-ustekinumab-in-phase-3-crohns-disease-program. Published March 21, 2025. Accessed March 21, 2025.
Perspective
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It’s great to have another option for our patients with Crohn’s disease, as it helps to partially meet our unmet need for these patients with a potentially debilitating disease. The subcutaneous induction option for this anti-IL-23 is unique (for now), and for the busy clinician this might save them and their staff some hassles in “on-boarding” the medication — theoretically, just one prior authorization request instead of two for IV induction/subcutaneous maintenance.
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