AbbVie's Rinvoq (upadacitinib) Receives EC's Approval for the Treatment of Moderate to Severe Atopic Dermatitis
Shots:
- The approval is based on 3 P-III studies i.e.- Measure Up 1/2/AD Up evaluating the efficacy & safety of Rinvoq (15/30 mg- qd) as monothx. with TCS vs PBO in 2500+ adults & adolescents with AD
- The studies met its 1EPs & 2EPs @16wks. i.e.- improvement in skin clearance & itch reduction- patients achieved EASI 75 (70%/ 60%/65%) & (80%/ 73%/ 77%) vs (16%/13%/26%); vIGA-AD 0/1 (48%/39%/31%) & (62%/ 52%/ 59%) vs (8%/5%/11%)- improvement in Worst Pruritus NRS ≥4 (52%/ 42%/ 52%) & (60%/ 60%/ 64%) vs (12%/ 9%/ 15%). The results continued to be maintained for 52wks.
- The approval marks the 4th indication in the EU with previous approval in RA- PsA & AS and is approved in the US for RA
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