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Medicine Matters rheumatology

The rationale behind SELECT-AXIS 1, the trial, was to investigate upadacitinib in patients with ankylosing spondylitis. We know from other JAK inhibitors, like tofacitinib and filgotinib, that there was, indeed, efficacy in patients with ankylosing spondylitis. So it was also a logical step to also test this with upadacitinib, as this also was efficacious in RA, as also, the other JAK inhibitors.

The primary endpoint of the study was the ASAS40, and this was achieved by 52% of the patients in the upadacitinib group and 26% of the patients in the placebo group. So the primary outcome was met. Except from the primary endpoint, we had, also, multiple secondary endpoints, which were multiplicity controlled. And they also reached a level of significance. most of them-- the adjusted level and the single-arm, also, the nominal p-value.

There was also a good effect on the MRI, which I think is very important, as the other outcomes are really subjective patient-reported outcomes. But MRI-- there was really a clear effect on both the inflammation in SI joints and in spine, and I think that's an important addition.

These results need to be confirmed in the phase III trial program. And if it also would sustain the same results, that would offer a new treatment option for patients with ankylosing spondylitis. And as we have not so many treatment options for patients with ankylosing spondylitis, that would really be an advantage.

What really needs to be done is a phase III trial program in patients with the full spectrum of axial SpA. So that would include the patients with radiographic axial SpA and nonradiographic axial SpA patients who are bDMARD naive, and also, patients who have already experienced biological DMARD. So that would need to be included in an entire phase III program.