Schwartzman, MD: In terms of the last case, this brings up a point that was raised before, which is that we’re much more sensitive to fertility issues and the effects of our therapies on patients of childbearing age. I shouldn’t limit this to women because the effects of therapies on male fertility haven’t been addressed as much as they have in female fertility. I’ll give you an example: targeted synthetics, the JAK inhibitors, in preclinical they all are studied in male beagle dogs in preclinical studies. That’s the model for safety of a therapy before it goes out into clinical trials. What they found for filgotinib, which is not yet approved for the management of rheumatoid arthritis, was that there was an effect on spermatogenesis in the male beagle dogs. All of the other agents have been tested in beagle dogs, and they’re fine. My point about this is that fertility should not be unifocal and only applicable to women. It should be as important in men. To finish the filgotinib story for you, they actually mandated that before the drug gets approved to have studies in normal males with the drug. Those are ongoing.
Our woman is 21, an active athlete, and her pain improves. It’s inflammatory pain. She is being treated with nonsteroidal anti-inflammatory agents, and she’s having back pain. This is the whole issue of IBP (inflammatory back pain): How specific is inflammatory back pain for spondyloarthritis? It’s not as specific as you would want. Studies have demonstrated that, depending on which definition you use for inflammatory back pain, the percentage of patients who will have spondyloarthritis syndrome can vary anywhere from about 20% to 60%, depending on which study you look at. For me, a young person with inflammatory back pain that was not necessarily precipitated by a mechanical event, meaning an injury or a sport, is a red flag for spondyloarthritis.
After 4 weeks on ibuprofen at a reasonably high dose of 1,200 mg a day, the patient still has back pain, is now noticing decreased mobility and productivity, and she’s having GI adverse events to the nonsteroidal anti-inflammatory agents. As we commonly and unfortunately see in patients with spondyloarthritis, the x-rays, particularly early on, do not show any evidence of disease. She is HLA-B27 positive and does have elevated high markers of disease activity, with a CRP of 4.7 and a SED rate of 38.
Transcript Edited for Clarity