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Another, new Janus kinase 1 (JAK1) inhibitor is out with impressive data - this time it’s filgotinib, demonstrating its efficacy and safety two separate clinical trials of patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS).
The EQUATOR trial was multicenter, phase 2 study oof 191 patients with active moderate-to-severe PsA. Patients continued their background csDMARDs and were randomized to filgotinib 200 mg or placebo orally once daily. The primary endpoint was the ACR20 response at 16 weeks.
Overall, an ACR20 response was seen in 80% of filgotinib patients but only 33% of the placebo patients (treatment difference 47% [95% CI 30·2–59·6], p<0·0001).
Safety signals were similar. The most common events were nasopharyngitis and headache.
The TORTUGA trial was a multicenter, phase 2 trial, wherein active AS patients were randomized to receive filgotinib 200 mg or placebo orally daily for 12 weeks. The primary endpoint was the change in the ankylosing spondylitis disease activity score (ASDAS) at week 12. (Citation source: https://buff.ly/2KwhxN6)
A total of 116 AS patients were treated. The mean ASDAS change was greater (−1·47) in the filgotinib group compared with placebo (−0·57) treated patients (least squares mean difference between groups of −0·85 (95% CI −1·17 to −0·53; p<0·0001).
There were no deaths reported during the study. Other adverse events were minor and balanced between groups.
These trials suggest that JAK 1 inhibition with filgotinib is efficacious and safe for the treatment ankylosing spondylitis and psoriatic arthritis patients not responding to conventional therapies.