Johnson & Johnson’s (NYSE:JNJ) Janssen unit announced new Phase 2 GALAXI 1 data at Digestive Disease Week (DDW), showing substantial rates of clinical-biomarker and endoscopic response and clinical remission through 48 weeks of Tremfya (guselkumab) therapy for Crohn’s disease.
The company also announced long-term pooled safety analyses for Stelara (ustekinumab) at the DDW event May 21-24 in San Diego, California.
In the GALAXI 1 study focused on adults with moderately severe Crohn’s disease who were poor candidates for traditional therapies or biologics, guselkumab recipients had a clinical biomarker response between 47.5% and 66.7% at week 48 across dose groups. About 45% of such patients had an endoscopic response. In addition, between 39.3% and 66.7% achieved remission based on C-reactive protein (CRP) or fecal calprotectin levels in the same time interval.
At present, Tremfya is not FDA approved for Crohn’s disease or ulcerative colitis. It first won FDA approval for plaque psoriasis in 2017 and active psoriatic arthritis in 2020.
In addition, Janssen announced that Stelara has a positive safety profile in patients with inflammatory bowel disease based on pooled analyses of long-term safety data in bio-naïve and bio-failure Crohn’s disease and ulcerative colitis patients.
FDA approved the use of Stelara for Crohn’s disease in 2016 and for ulcerative colitis in 2019.
Outside of gastroenterology, the drug is approved for psoriasis, psoriatic arthritis and plaque psoriasis.
In a pooled safety analysis involving 13 studies across all approved indications, Stelara recipients had no increased incidence of malignancy compared to placebo.
That analysis pooled long-term safety data from 2,501 placebo recipients and 6,701 Stelara recipients for up to five years.
“These data provide validation and underscore our commitment to continuing to innovate for patients with disease where considerable need remains,” said Dr. Jan Wehkamp, vice president, gastroenterology disease area leader at Janssen Research & Development.
Filed Under: Gastroenterology