AbbVie announced that its Janus Kinase (JAK) inhibitor was approved by the European Commission for non-radiographic axial spondyloarthritis and moderate to severe ulcerative colitis.
Rinvoq is approved for treating adult patients with moderately to severely active ulcerative colitis who have inadequate responses or are intolerant to conventional therapy or biologics.
The approval was based on two induction studies (U-ACHIEVE induction and U-ACCOMPLISH) and one maintenance study (U-ACHIEVE maintenance). In all the studies, clinical remission was the primary endpoint; Rinvoq achieved the primary endpoint at week 8 in induction studies and at week 52 in maintenance study. All the other secondary endpoints were met in the study.
In U-ACHIEVE and U-ACCOMPLISH induction trials, 26% and 33% of patients on Rinvoq 45 mg achieved the primary endpoint of clinical remission at week eight compared to 5% and 4% of patients who were on placebo. 73% and 74% of patients on Rinvoq 45 mg achieved clinical remission at week eight versus 27% and 25% of patients on placebo. 36% and 44% of patients on placebo had mucosal healing at week eight compared to 7% and 8% in patients on placebo.
In the U-ACHIEVE maintenance trial, 42% and 52% of patients on Rinvoq 15 mg and Rinvoq 30 mg achieved the primary endpoint of clinical remission versus 12% of patients on placebo.
Rinvoq was approved for patients with axial spondyloarthritis (nr-axSpA and ankylosing spondylitis). With this approval, Rinvoq became the first JAK inhibitor to receive authorization for axial spondyloarthritis. The approval was based on the Phase 3 SELECT-AXIS 2 clinical trial; Assessment of SpondyloArthritis international Society 40 (ASAS40) was the primary endpoint. At week 14, 45% of patients achieved ASAS40 versus 23% of patients on placebo.
Rinvoq can cause serious infections that might lead to hospitalization or death. Lymphoma and other malignancies were observed in patients who were treated with Rinvoq. Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis observed in patients treated with Rinvoq. Severe hypersensitivity reactions and gastrointestinal perforations were observed in clinical trials among patients treated with Rinvoq. Further, there is advice that it might cause fetal damage in pregnant women.
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