Sergio Schwartzman, MD: The C-axSpAnd study was also a pivotal study. This study resulted in the first therapy that actually was approved for non-radiographic axial spondyloarthritis. And the lessons that were learned from the previous studies were that you needed a longer term, in terms of determining efficacy. So, the primary outcome was at 1 year. You needed a uniform population of patients, so these were all patients who fulfill the categorization of non-radiographic axial spondyloarthritis from the classification criteria. And probably the most challenging component of this was that there was a liberal component in terms of patients escaping at an early point of the study.
So, I think with that as background, what we then saw was that in the primary outcome, not only was there a statistically significant, large delta difference between the treatment arm and the placebo arm, but number two—and I think importantly for me—was that the placebo arm response was very low. And I think that tells you that this was a well-constructed and well-populated study, with patients that fulfilled appropriate classification criteria, and importantly, had a dramatic response to the therapy certolizumab that was being tested.