What Ustekinumab Provides in Long-Term IBD Care

Despite the bevy of biologics available for people struggling with Crohn’s disease and ulcerative colitis (UC), not all patients are able to respond to or tolerate a vast majority of approved therapies.

Fortunately, new data presented at Digestive Disease Week (DDW) 2022 suggests that ustekinumab (STELARA) could function as an alternative option to bio-failure and bio-naïve patients living with these inflammatory bowel diseases (IBD).

Pooled data from four long-term phase 2 and 3 studies of bio-naïve IBD patients found that event rate per 100 patient-years for adverse events (AE), serious AEs, infection, malignancies, and more were similar and/or numerically lower for patients who received ustekinumab compared to those on placebo.

Similar event rates were observed in five phase 2/3 IBD studies of bio-failure patients over a 5-year period.

Remo Panaccione, MD, FRCPC, Director of the Inflammatory Bowel Disease Clinic and Director of Gastroenterology Research at the University of Calgary in Alberta, Canada, spoke with Assistant Managing Editor Kenny Walter of the implications of the new long-term data on IBD care.

“Overall, I think it just builds on the safety history of STELARA; we know STELARA is a highly effective therapy in IBD, not only when it's used first-line, but in patients who've been previously exposed to other advanced therapy,” Panaccione said. “I think this data gives us confidence that in addition to its ability to be able to achieve efficacy across a multitude of endpoints, that it can be used safely in the long-term benefit are patients with inflammatory bowel disease.”

Similarly, new phase 2 data form the GALAXI 1 trial featured at DDW showed that participants treated with guselkumab who had inadequate responses to conventional therapies achieved high levels of clinical-biomarker response, endoscopic response, and clinical remissionC-reactive protein (CRP) ≤3 mg/L or fecal calprotectin ≤250 μg/g (39.3-66.7%) at 48 weeks across all dose groups.

Panaccione spoke noted that these therapuetic options could provide relief for patients affected by either Crohn’s disease and UC.

“When you have data that shows that it's approved in both indications, then you don’t need to- for lack of a better word-hedge your bets,” he said. “I think it's really important because, it gives (patients) a sense of comfort. In both Crohn's disease and ulcerative colitis, the dosing is the same. As physicians, we use drugs that we have a lot of experience with much better in clinical practice. So having that dual indication is extremely important.”