Clinical Efficacy for Guselkumab, Long-Term Safety Profile for Ustekinumab Shown for Patients Living with Inflammatory Bowel Disease

New data from the phase 2 GALAXI 1 clinical trial of guselkumab (Tremfya) showed positive long-term efficacy and safety in adult patients with moderately to severely active Crohn disease (CD). These results from 3 separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with ustekinumab (Stelara) were presented at Digestive Disease Week meeting in San Diego, California.

In GALAXI 1, the data showed study participants with an inadequate response or intolerance to conventional therapies and/or biologics treated with guselkumab achieved high levels of clinical biomarker response (47.5%-66.7%), endoscopic response (44.3%-44.6%), and clinical remission with C-reactive protein ≤3 mg/L or fecal calprotectin ≤250 μg/g (39.3%-66.7%)at 48 weeks post dose.

The ustekinumab pooled analyses of long-term safety data in bio-naïve and bio-failure CD/UC patients treated with ustekinumab demonstrated a favorable safety profile consistent with analyses in the overall inflammatory bowel disease (IBD) population and the established safety profile across approved indications.

A long-term safety analysis of 4 phase 2/3 studies included 771 bio-naïve patients with IBD administered ustekinumab with 1511 patient-years of follow up and 425 bio-naïve patients administered placebo with 376 patient-years of follow up. The data showed that event rates adjusted per 100 patient-years for adverse events (AEs), serious AEs, infections, serious infections, major adverse cardiac events (MACE), and malignancies were similar among cohorts treated with ustekinumab and placebo through up to 1 year.

Further, rates per 100 patient-years for AEs, serious AEs, infections, serious infections, and MACE were similar and/or lower for patients administered ustekinumab compared with placebo through up to 5 years in bio-naïve patients with CD and up to 2 years in bio-naïve patients with UC.

A pooled long-term safety analysis of 5 phase 2/3 IBD studies included 1596 bio-failure patients with 1970 patient-years of follow up administered ustekinumab and 847 bio-failure patients with 473 patient-years of follow up administered placebo. The event rates per 100 patient-years for AEs, serious AEs, infections, serious infections, MACE, and malignancies were similar between patients administered ustekinumab and placebo through up to 5 years in bio-failure patients with CD and up to 2 years in bio-failure patients with UC. The safety profile of ustekinumab was consistent with previous observations of the safety profile in IBD and across approved indications.

An analysis of pooled long-term safety data from 13 studies across approved indications for ustekinumab, including CD and UC, in 2501 patients administered placebo with 1244 patient-years of follow up and 6710 patients administered ustekinumab with 13,807 patient-years of follow up, showed no increased malignancy incidence in patients administered ustekinumab versus those administered placebo through up to 5 years of follow up.

“These new data from the GALAXI 1 study are encouraging as we continue to investigate long-term treatment solutions to address the unmet needs for our patients who live with the burden of moderately to severely active Crohn’s disease,” said GALAXI 1 presenting study author Remo Panaccione, MD, professor of medicine and director of the Inflammatory Bowel Disease Unit at the University of Calgary, Alberta, Canada, in a press release. “The clinical-biomarker response and endoscopic response data from the phase 2 GALAXI 1 clinical trial build upon the study’s clinical remission outcomes and give us insight into the potential that Tremfya may provide sustained remission.”

REFERENCE

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. Johnson and Johnson. May 24, 2022. Accessed June 1, 2022. https://www.jnj.com/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