Despite the plethora of biologics available to 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 suggest that ustekinumab (STELARA) could act as an alternative option for biofailure and bionaive patients living with these inflammatory bowel disease (IBD).
Pooled data from four long-term Phase 2 and 3 studies of bio-naive IBD patients found that the event rate per 100 patient-years for adverse events (AE), serious adverse events, infection, malignancies, and more was comparable and/or numerically lower for patients who received ustekinumab compared to patients who received placebo.
Similar incident rates were observed in five Phase 2/3 IBD studies of patients with biofailure 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 editor-in-chief Kenny Walter about the implications of the new long-term data for IBD care.
“Overall, I think it just builds on STELARA’s security history; we know that STELARA is a very effective therapy in IBD, not only when used in primary care, but also in patients who have been previously exposed to other advanced therapies,” said Panaccione. “I think these data give us confidence that it is not only able to achieve efficacy on a wide range of endpoints, but also that it can be used safely in the long term for patients with inflammatory bowel disease.”
Similarly, new phase 2 data from the GALAXI 1 study at DDW showed that participants treated with guselkumab who responded inadequately to conventional therapies achieved high levels of clinical biomarker response, endoscopic response and clinical remission C-reactive protein (CRP) ≤3 mg/l or faecal calprotectin ≤ 250 g/g (39.3-66.7%) at 48 weeks for all dose groups.
Panaccione spoke noted that these therapeutic options may provide relief for patients suffering from Crohn’s disease or UC.
“If you have data showing it’s approved in both indications, you don’t have to hedge your bets, for lack of a better word,” he said. “I think it’s very important because it gives (patients) a sense of comfort. In both Crohn’s disease and ulcerative colitis, the dosage is the same. As doctors, we use drugs that we have a lot of experience with in clinical practice much better. So having that double indication is extremely important.”