Tremfya Outperforms Placebo, Stelara in Phase III Crohn's Study

Johnson & Johnson has announced that Phase III trial results for Tremfya (guselkumab) in adults with moderate-to-severe Crohn’s disease have demonstrated superior efficacy of subcutaneous maintenance doses compared to placebo and Stelara (ustekinumab). These findings, originating from the GALAXI 2 and GALAXI 3 studies, were presented at Digestive Disease Week (DDW).

Lead investigator Remo Panaccione stated, "The GALAXI programme demonstrates the potential of guselkumab and this targeted IL-23 approach for rapid and sustained efficacy in the treatment of Crohn’s disease." Both GALAXI 2 and GALAXI 3 trials included approximately 500 adults suffering from moderately to severely active Crohn’s disease. The trials assessed the efficacy of a subcutaneous dose of Tremfya at 200mg every four weeks or 100mg every eight weeks, in comparison with placebo and Stelara over a 48-week period.

The results showed that both maintenance doses of Tremfya achieved the composite co-primary endpoints compared to placebo in both studies. When pitted against Stelara, both doses of Tremfya exhibited statistically significant and clinically meaningful improvements across all predetermined pooled endoscopic endpoints, including endoscopic response, endoscopic remission, clinical remission, and deep remission. Johnson & Johnson highlighted that the safety profile of Tremfya remained consistent with its currently approved uses.

The company has already submitted a regulatory application in Europe to extend the approval of Tremfya to treat moderate-to-severe Crohn’s disease. Tremfya is currently approved in Europe for the treatment of plaque psoriasis and psoriatic arthritis.