Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA ® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022

SPRING HOUSE, PENNSYLVANIA, May 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA® (ustekinumab).1,2,3,4 These data are being presented as oral and poster presentations and are among 29 Janssen abstracts presented during the Digestive Disease Week® (DDW) meeting taking place in person and virtually in San Diego, California on May 21-24, 2022. The GALAXI 1 data showed study participants with an inadequate response or intolerance to conventional therapies and/or biologics treated with TREMFYA achieved high levels of clinical-biomarker responsea (47.5-66.7 percent), endoscopic responseb (44.3-46 percent), and clinical remissionc with C-reactive protein (CRP) ≤3 mg/L or fecal calprotectin ≤250 μg/g (39.3-66.7 percent) at 48 weeks across dose groups.1 TREMFYA is not approved to treat adult patients with CD or UC in the U.S.5The STELARA pooled analyses of long-term safety data in bio-naïve and bio-failure CD/UC patients treated with STELARA demonstrated a favorable safety profile consistent with analyses in the overall inflammatory bowel disease (IBD) population and the established safety profile across approved indications.2,3 In addition, a STELARA pooled saf...

Source: Johnson and Johnson - May 24, 2022 Category: Pharmaceuticals Source Type: news