Medicine Matters rheumatology

These results are important because this-- tofacitinib is a Janus kinase 1 and 3 inhibitor, which is a different class of medications than what we have traditionally been used to using in patients with axial spondyloarthritis, like TNF alpha inhibitors. In the last few years, we have also been using IL-17A inhibitors like secukinumab and ixekizumab, but now is shifting the gear into a different class of medication, the Janus kinase inhibitors.

And this trial showed us that the drug is efficacious. It met both the primary and the secondary endpoints. It is kind of opening more like widening the armamentarium of the drugs we have available for treatment of patients with axial spondyloarthritis. And additionally, you know, what I found interesting in this study was that the improvement in the symptoms was seen as early as two weeks. At two weeks, it was an improvement in ASAS 20, which kept on improving. And at four weeks, there was also an improvement in the ASAS 40 in these patients, which is very kind of reassuring to both clinicians and patients to see that this medication will act early on.

The primary efficacy endpoints that were met in this study, the ASAS 20, at week 16, we showed about 56% improvement compared to the placebo, which was only 29. So it was a wide delta. It's comparable to the other class of agents that are available for treatment of axial spondyloarthritis.

And then it also showed-- this study was well-designed. It also looked at other secondary endpoints. And the first secondary endpoint they looked at was ASAS 40, and had a pretty ASAS 40 response too, of about 40%, and showed an improvement in AS test, in high sensitivity CRP, quality of life of the patient. So looking at that, the study has evaluated multiple endpoints to prove that it is efficacious compared to the placebo.

The biggest advantage is it's orally available. So patients like the ease of administering the medications. So patients like to take a pill rather than an injection. So that is what makes it very attractive to the patients.

One is that this was a study done predominantly-- 80% of the patients were males, and only 20% of them were females. So I always-- you know, we always try to generalize results. Whenever clinical trials are done, we generalize them to the females. So I think I would like to have them look at and design it in a way that there's equal number of females and see if it's equally efficacious in women as it is in men. That would be one.

Our target in this disease is to slow radiographic progression. So it needs to be seen in the long term data whether the study will halt radiographic progression. And then, they did present in this abstract 40 week safety data, which looked very promising. There weren't any alarms. But obviously, we still need to wait for long-term safety data.

We're just-- every time a new clinical trial in axial spondyloarthritis becomes available, as clinicians, we kind of-- makes us feel happy because we are always looking for more options for our patients.