AbbVie’s Rinvoq (upadacitinib) Receives EC’s Approval as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis
- The approval was based on the P-III (SELECT-AXIS 2) trial to evaluate the safety and efficacy of Rinvoq vs PBO in adult patients with nr-axSpA who are bDMARD-naïve and had an inadequate response to two NSAIDs or intolerance to contraindication for NSAIDs
- The results showed that a greater proportion of patients with Rinvoq (15mg) achieved ASAS40 response @14wk. (45% vs 23%), statistical significance was also achieved in 12 of the 14 multiplicity-controlled 2EPs. The safety data were similar as previously reported to the known safety profile of Rinvoq with no new risks, AEs (48% vs 46%)
- Rinvoq has been approved in all member states of the EU, as well as Iceland, Liechtenstein, Northern Ireland & Norwa
Ref: AbbVie | Image: AbbVie
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