Advances in The Management of Rheumatic Disease - Episode 8
Sergio Schwartzman, MD: In terms of the evolution of the studies in the management of axial spondyloarthritis, we have a number of therapies that have now been approved for the management of patients with radiographic axial spondyloarthritis or ankylosing spondylitis. In the United States, however, we have been slow to address patients with nonradiographic axial spondyloarthritis. Even though not everybody who has nonradiographic axial spondyloarthritis will evolve into radiographic disease or ankylosing spondylitis, most of us do believe that in the natural history of ankylosing spondylitis, there’s clearly a nonradiographic stage. Perhaps intervening at that point will prevent the progression of the disease into classic ankylosing spondylitis, which does have a number of effects not only on issues referable to the patient’s normal daily life but also comorbidities as well.
There’s been an effort to study therapies for nonradiographic axial spondyloarthritis, and the C-AXSPAND study did exactly that. It was a study that looked at over 300 patients with nonradiographic axial spondyloarthritis and had a placebo control over a 1-year period. It demonstrated that patients with nonradiographic axial spondyloarthritis managed with certolizumab did have a statistically significant better response than placebo patients over a 1-year period. This was the second study that has been done with that same therapy, and as a consequence of both of these studies—but predominantly the C-AXSPAND study—the FDA has granted an approval to certolizumab for the management of nonradiographic axial spondyloarthritis. This is the first therapy that we have available for this disease.
The other point that was very interesting to me about the C-AXSPAND study is that there has been controversy as to whether anti-TNF [tumor necrosis factor] agents prevent radiographic progression of disease. In this study, as well as a former study that was done, there was indeed evidence, particularly now in the C-AXSPAND study, that MRIs [magnetic resonance imaging] improved in patients who were managed with this therapy. I think that the concept of not only clinical response, but an imaging response, was addressed by C-AXSPAND and very appropriately did receive a label for the management of patients with nonradiographic axial spondyloarthritis.
Transcript edited for clarity.