Guselkumab’s Promising Results as First Subcutaneous IL-23 Inhibitor to Treat Crohn’s
Johnson & Johnson announced results from its phase 3 GRAVITI trial exploring guselkumab’s results in subcutaneous (SC) induction and maintenance therapy for treating Crohn’s disease.
Based on results of Johnson & Johnson’s phase 3 GRAVITI (NCT05197049) clinical trial, guselkumab (Tremfya) showed significantly successful results for treating patients living with Crohn’s Disease (CD). Guselkumab now stands alone as the first and only subcutaneous interleukin-23 (IL-23) inhibitor recommended to treat CD. Data from the GRAVITI trial were presented at ACG 2024, the annual meeting of the American College of Gastroenterology.
“The GRAVITI results show that induction treatment with subcutaneous guselkumab is as rapid and robust as we have seen with the [intravenous] induction, which could offer a welcome new option for Crohn's disease treatment,” said Remo Panaccione, MD, FRCPC, Study Investigator and Professor of Medicine and the Director of the Inflammatory Bowel Disease Unit at the University of Calgary, according to a Johnson & Johnson news release.1 “The 1-year results of this study suggest that [subcutaneous] induction with guselkumab is a promising approach to help people with CD manage their symptoms and achieve meaningful endoscopic improvements.”
Guselkumab now stands alone as the first and only subcutaneous IL-23 inhibitor recommended to treat Crohn’s. | image credit: luchschenF / stock.adobe.com
Prior to Johnson & Johnson’s announcement, the company’s guselkumab medication was already approved for treating ulcerative colitis. It was also the first IL-23 inhibitor to show superiority compared with ustekinumab for addressing populations of people living with Crohn’s. According to a previous Johnson & Johnson press release published earlier this month, “90% of biologic-naïve patients and 3 times more biologic-refractory patients with ulcerative colitis achieved endoscopic remission with TREMFYA.”2
READ MORE: Guselkumab Shows Positive Results in Trials for Crohn’s Disease, Ulcerative Colitis
However, the manufacturer’s latest update on guselkumab was regarding the subcutaneous regimen in both induction and maintenance of treating patients with CD.1
The randomized, double-blind, placebo-controlled Phase 3 GRAVITI study examined the induction of subcutaneous guselkumab for treating patients with moderate-to-severe CD at 0, 4, and 8 weeks. Furthermore, only patients who had an inadequate response or failed to tolerate traditional therapies for treating their CD were included in the trial.
“These results show that TREMFYA has the potential to become the only IL-23 inhibitor to offer both [subcutaneous] and [intravenous] induction options for [CD], and, if approved, will offer choice and flexibility for people living with CD. The convenience of self-administration from the start of treatment is part of our commitment to delivering innovative therapeutic solutions to people with Crohn's disease,” said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead of Immunology at Johnson & Johnson Innovative Medicine.1
After receiving 400 milligram doses at weeks 0, 4, and 8, more than half (56.1%) of patients receiving guselkumab experienced CD remission by week 12, compared with the placebo group (21.4%). Furthermore, 41.3% of patients achieved endoscopic response compared with the placebo group (21.4%). Researchers also discovered a “rapid onset of action” in guselkumab due to its ability to achieve clinical remission by week 4.
Further successful results were identified at induction week 48, when remission was more than 3 times higher for both maintenance doses of guselkumab (60% for 100 mg every 8 weeks and 66.1% for 200 mg every 4 weeks) compared with placebo (17.1%). Endoscopic response was 44.3% and 51.3% for 100 mg and 200 mg doses respectively, while the placebo group’s was 6.8%. And finally, endoscopic remission was achieved for 30.4% for 100 mg and 38.3% for 200 mg compared with 6% in the placebo.
“The GRAVITI data reinforced the well-established safety profile of TREMFYA and add to J&J’s commitment to delivering innovative therapeutic solutions to people with [CD],” a Johnson & Johnson Innovative Medicine spokesperson told Drug Topics.
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