Philip J. Mease, MD: These data are from the SELECT-PsA 1 and 2 trials using a drug known as upadacitinib, a relatively specific JAK1 inhibitor, in the treatment of psoriatic arthritis. In the SELECT-PsA 1, which was a larger trial involving bio-naïve patients and the primary end point, the ACR20 [American College of Rheumatology 20% improvement] response was seen in 71% of patients on the 15-mg dose of upadacitinib and 79% on the 30-mg dose. There was an adalimumab reference arm in which 65% of patients achieved an ACR20 response.
They’re very similar, and actually the 30 mg was superior to adalimumab, and all these were superior to placebo. These are very high rates of response, and we saw correspondingly high rates of ACR50 and ACR70 response as well. The resolution of enthesitis was 50% to 60%, and the resolution of dactylitis was 70% to 80%. These are for all the arms of the study. These are excitingly good results.
Also, in the skin we saw two-thirds of patients having a PASI 75 [Psoriasis Area and Severity Index decrease of 75%] response, which is very good. In terms of achievement of minimal disease activity, in this trial about a third of patients in the 15-mg arm and 45% in the 30-mg arm achieved this. Also, x-rays were assessed, and we saw inhibition of structural damage progression in the radiographs.
The adverse-effect profile was similar to what we’ve seen in rheumatoid arthritis. There was a bit more herpes zoster in the upadacitinib-treated patients with some dose effect, with more in the 30-mg dose, and this was true of the serious infection rate as well.
There was a single VTE, or venous thromboembolism event, in the placebo group, 1 in the upadacitinib 30-mg group, and 2 in the adalimumab 40-mg group. So it’s balanced between the different arms of the study.
A second trial, which I had the opportunity to present, was the SELECT-PsA 2 study, for patients who had had previous exposure to the biologic agents, such as TNF [tumor necrosis factor] inhibitors. In that trial we also saw good ACR responses. For example, in the 15-mg dose, 57% achieved an ACR20 with high rates of enthesitis and dactylitis resolution, good skin responses, and about a quarter patients achieving minimal disease activity criteria.
The safety profile in that trial was pretty similar to what I just mentioned, in SELECT-PsA 1. This drug is going forward with the FDA application for approval in psoriatic arthritis as well as axial spondylarthritis, so we’re excited to see additional entries into the JAK inhibitor class that we will be able to use as effective oral medications in psoriatic arthritis.
One of the things I find very exciting doing research and education in the fields of psoriatic arthritis and spondylarthritis is how much these conditions have come to the fore, with much more interesting research on pathophysiology, on clinical presentation, on how you measure the diseases. Or how we can develop biomarkers to try to identify the diseases earlier and develop measures that are targets of low disease activity or remission, which we try to achieve so we can practically use that in the clinic.
We saw a number of abstracts in all these areas, so I’m really proud that there are so many rheumatologists around the world who have a real interest in these diseases and are seeing that these patients get treated effectively. It’s become a substantial part of our meetings, so I’m happy to see them.
Transcript Edited for Clarity