Preston Klassen, MD, head of research and development at Arena Pharmaceuticals, discusses a post hoc analysis of biomarkers and clinical outcomes in patients with ulcerative colitis receving etrasimod.
A recent study has found that fecal calprotectin and c-reactive protein may be good surrogate markers of clinical and endoscopic response in patients with ulcerative colitis receiving etrasimod.
Investigators found that patients receiving etrasimod 2mg had a significant decrease in fecal calprotectin and c-reactive protein during treatment.
Preston Klassen, MD, MHS, head of research and development at Arena Pharmaceuticals, sat down with MD Magazine® at Digestive Disease Week 2019 in San Diego, CA to discuss the findings of the study and its implications on clinical practice.
MD Mag: What did you find when examining biomarkers and clinical outcomes in patients with ulcerative colitis receiving etrasimod?
Klassen: So, our second etrasimod poster at DDW was a presentation on fecal calprotectin and CRP changes over the course of the phase 2 OASIS trial. So, we looked at both of these biomarkers to understand across placebo, the 1mg, and the 2mg doses not only what happened in terms of improvements in these biomarkers but also whether improvements in the biomarkers were actually correlated with clinical outcome as analyzed by the complete remission of the disease using the Mayo Clinic definition. Finally, we did a correlation to see whether CRP and fecal calprotectin correlated together.
So, what we did see was significant reductions for both c-reactive protein or CRP and fecal calprotectin at the 2mg, particularly, dose of etrasimod over this 12-week period of time in the OASIS trial. Reductions in both CRP and fecal calprotectin were highly correlated among patients who achieve clinical remission, which makes sense. If you see significant reductions in these biomarkers, you're more likely to be a patient that is going into remission and we saw a moderate correlation between the two biomarkers. So, the clinical importance of secondary analyses like these are that they're helpful to continue to think about using biomarkers as opposed to more invasive measures like endoscopy when measuring the disease severity and, in particular, the response to therapy over time.