J&J reveals Phase III Tremfya maintenance study data in ulcerative colitis

Johnson & Johnson announced significant findings from its Phase III QUASAR maintenance study on Monday. The trial assessed the efficacy of subcutaneous Tremfya (guselkumab) in adults with moderately to severely active ulcerative colitis (UC), achieving its primary endpoint and all major secondary endpoints. These findings were unveiled at the Digestive Disease Week (DDW) conference. The company has since filed for regulatory approval of Tremfya as a UC treatment in both the United States and Europe.

David Rubin, the lead investigator of the study, highlighted the potential of guselkumab to offer sustained clinical remission and achieve high-bar endpoints such as endoscopic remission and histologic remission. Such improvements represent significant progress in the treatment of this inflammatory bowel disease.

The study involved adults who showed a clinical response after 12 weeks of intravenous Tremfya during Phase II and Phase III induction studies. These participants were then randomized into three groups: one receiving 200mg of subcutaneous Tremfya every four weeks, another receiving 100mg of Tremfya every eight weeks, and a placebo group. At week 44, the primary endpoint of clinical remission was met by 50% of patients in the 200mg group, 45.2% in the 100mg group, and 18.9% in the placebo group.

In addition to the primary endpoint, both Tremfya groups reached all nine major secondary endpoints. These endpoints included endoscopic remission, endoscopic improvement, clinical response, and histo-endoscopic mucosal improvement, all showing significant benefits compared to placebo.

The safety profile of Tremfya was consistent with previous studies on its use for moderate to severe plaque psoriasis and active psoriatic arthritis. The incidence of patients experiencing more than one adverse event (AE) was comparable across all groups, with 70% in the 200mg group, 64.5% in the 100mg group, and 68.2% in the placebo group. The most frequently reported adverse events were COVID-19, ulcerative colitis, and joint pain.

These encouraging results from the QUASAR study suggest that Tremfya could become a valuable treatment option for patients with moderately to severely active ulcerative colitis. Johnson & Johnson’s regulatory submissions in the US and Europe indicate confidence in the drug's potential to meet the unmet needs in UC treatment.

In conclusion, the Phase III QUASAR maintenance study provides promising evidence that Tremfya (guselkumab) can deliver durable clinical remission and significant improvements for patients with ulcerative colitis. The consistency in its safety profile and successful achievement of both primary and secondary endpoints mark a noteworthy step forward in UC therapy.