Guselkumab Shows Positive Results in Trials for Crohn’s Disease, Ulcerative Colitis
Guselkumab is currently approved by the FDA to treat adults with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, and adults with moderately to severely active ulcerative colitis.
Positive results have been announced from 2 clinical programs evaluating the efficacy and safety of guselkumab (Tremfya) in patients with Crohn's disease and moderate to severe active ulcerative colitis (UC), Johnson and Johnson announced in a release.1 Tremfya is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in patients with Crohn’s disease.
Guselkumab Shows Positive Results in Trials for Crohn’s Disease, Ulcerative Colitis / doucefleur - stock.adobe.com
Data from the GALAXI program (NCT03466411) and the QUASAR trial (NCT04033445) showed that guselkumab demonstrated high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients with Crohn's disease and UC. The data from the studies are being presented at the United European Gastroenterology Week 2024.
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“These results show the potential of TREMFYA to offer a differentiated treatment option for patients with Crohn's disease and UC, including those starting on a biologic for the first time, and those who have failed prior biologics and traditionally have been less likely to respond to other therapies," Esi Lamousé-Smith, MD, PhD, vice president, Gastroenterology Disease Area Lead, Immunology at Johnson & Johnson Innovative Medicine, said in a release.1
The GALAXI clinical program consists of 3 separate studies: the 48-week phase 2 dose-ranging study GALAXI 1, and 2 48-week phase 3 confirmatory studies, GALAXI 2 and GALAXI 3. The main purpose of the GALAXI program is to evaluate the clinical efficacy, clinical and endoscopic efficacy, and safety of guselkumab in participants with Crohn's disease. The 3 studies included 873 patients with moderate to severe active Crohn's disease with inadequate response or intolerance to conventional therapies and/or biologics.
In a pooled dataset from the clinical program, 44% of biologic-naïve patients who were treated with 100 mg guselkumab every 8 weeks and 46.1% treated with 200 mg every 4 weeks achieved endoscopic remission, compared to 29.8% of patients treated with ustekinumab. In biologic-refractory patients, 28.1% of patients treated with 100 mg every 8 weeks and 28.6% of patients treated with 200 mg every 4 weeks achieved endoscopic remission, compared to 20.5% of patients treated with ustekinumab.
QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, phase 2b/3 program evaluating the efficacy and safety of guselkumab in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics and/or JAK inhibitors. The program includes a phase 2b dose-ranging induction study, a confirmatory phase 3 induction study, and a phase 3 randomized withdrawal maintenance study.
In the program, 38.1% of biologic/JAK inhibitor-naïve patients treated with 100 mg guselkumab every 8 weeks and 41.7% treated with 200 mg every 4 weeks achieved endoscopic remission, compared to 20.4% of patients treated with placebo. In biologic/JAK inhibitor-refractory patients, 31.2% of patients treated with 100 mg every 8 weeks and 23.9% of patients treated with 200 mg every 4 weeks achieved endoscopic remission, compared to 8% of patients treated with placebo.
"TREMFYA builds upon our nearly 3 decades of leadership in irritable bowel disease therapy and focused innovation in the IL-23 pathway to address the needs of people living with ulcerative colitis and delivering meaningful improvements in symptoms and the potential for sustained remission,” Lamousé-Smith said in a release.1
Guselkumab is currently approved by the FDA to treat adults with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, and adults with moderately to severely active ulcerative colitis. An application is currently under review by the FDA for guselkumab to treat moderately to severely active Crohn's disease.
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References
1. TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn's disease and ulcerative colitis. News Release. Johnson and Johnson. October 10, 2024. Accessed October 10, 2024. https://www.investor.jnj.com/news/news-details/2024/TREMFYA-guselkumab-demonstrates-impressive-results-across-biologic-nave-and-biologic-refractory-patients-in-Crohns-disease-and-ulcerative-colitis/default.aspx
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