- The approval is based on P-III SELECT rheumatoid arthritis program which involves assessing of RINVOQ vs placebo, MTX or adalimumab in 4,400 patients in five pivotal studies i.e SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY
- P-III study results: SELECT COMPARE- RINVOQ + MTX
vs PBO + MTX (29% vs 6%) & Humira
+ MTX (29% vs 18%) @12wks; SELECT-MONOTHERAPY- RINVOQ vs MTX @monothx achieved remission (28% vs 8%) @14wks.; SELECT-EARLY (48% vs 18%) @24 wks.; inhibition of structural joint damage progression (0.1 vs 0.7) @24wks., (0.2 vs 0.9) @26 wks.
- RINVOQ (upadacitinib) is a once-daily selective and reversible JAK inhibitor and may be used as monotherapy or in combination with methotrexate (MTX)
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