In a major advance for patients with Crohn’s disease, a new study led by researchers at Mount Sinai Health System found that guselkumab, a medication with a mechanism of action that is new to inflammatory bowel disease (IBD) treatment, outperformed an established standard of care in promoting intestinal healing and symptom relief.

These findings from two pivotal Phase III trials known as GALAXI 2 and 3, published in The Lancet, provided the basis for the recent Food and Drug Administration approval of guselkumab (brand name Tremfya) for the treatment of moderately to severely active Crohn’s disease.

Crohn’s disease affects roughly 780,000 people in the United States and often requires a lifetime of management. Despite numerous available biologic medications, many patients fail to achieve sustained remission. Guselkumab blocks the interleukin-23 (IL-23) pathway, a key driver of chronic intestinal inflammation.