In a new video from MedPage Today, esteemed rheumatologist and researcher, Atul Deodhar, M.D., M.R.C.P. discusses his new axial spondyloarthritis study, which concludes in supporting TNF inhibitor use in nonradiographic axial spondyloarthritis (axial spondyloarthritis without sacroiliitis evident on X-ray.) Watch the Video Now!
Excerpts from the video’s transcript:
The study looked at the efficacy and safety of certolizumab pegol [Cimzia], which is an anti-TNF drug, over four years in patients with the entire spectrum of axial spondyloarthritis (SpA)…
Ankylosing spondylitis has been followed for up to four or five years in clinical studies of this kind, but nonradiographic axial SpA has never been followed for this long. People had questions as to whether nonradiographic axial SpA patients have the same types of clinical responses — whether efficacy is the same — as in ankylosing spondylitis. The FDA in particular has had questions about this, and even clinical rheumatologists had questions whether patients with nonradiographic axial SpA would have the same types of responses as patients with ankylosing spondylitis when given TNF inhibitors.
What we found was that treatment with certolizumab pegol had very similar efficacy in both types of patients, nonradiographic SpA and ankylosing spondylitis. The responses were equally robust.
This was a multicenter, double-blind, randomized, placebo-controlled study that was done in multiple nations in North and South America, and Europe. There were over 200 patients in the study, and nearly half had nonradiographic axial SpA.
The results were that patients responded quite well to this particular drug. The primary endpoint was met by about 60% of patients with ankylosing spondylitis and nonradiographic axial SpA at week 12… Again, the interesting point was that there was no difference in response between ankylosing spondylitis and nonradiographic axial SpA, and the safety signal was not any different than what we already knew.
Further study details available on the abstract’s poster, here.
This distinction between ankylosing spondylitis and nonradiographic axial SpA is completely arbitrary, and totally depends on whether the x-rays, according to the reader, show enough sacroiliitis…. There are newer studies that are purely looking at this population of nonradiographic axial SpA, and will follow them for up to four years. That, hopefully, will convince the FDA that this entity is real and these patients have a similar disease severity and their limitations are real and similar to ankylosing spondylitis…
I would say the takeaway message from our study is that nonradiographic axial SpA patients have a similar disease burden to ankylosing spondylitis, their health-related quality of life is as low as the ankylosing spondylitis patients, and they require the same type of care as provided to our ankylosing spondylitis patients. And our study shows that the responses these patients get are very similar and as robust as ankylosing spondylitis patients get.
The next steps will be to look at whether we will be able to prevent structural damage, which is one of the unanswered questions in this field. We don’t know whether, if we treat these patients aggressively and early enough, does this prevent them from going from nonradiographic to radiographic axial SpA — which means can we prevent them from getting ankylosing spondylitis? Whether we can prevent the X-ray damage or structural progression? This is a huge unanswered question. And for that we probably need studies even longer than four years.
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