AbbVie’s Rinvoq (upadacitinib) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Atopic Dermatitis
Shots:
- The approval is based on P-III (Measure Up 1/2/ AD Up) studies to evaluate Rinvoq (15/30 mg, qd) with TCS vs PBO in 2500+ patients aged ≥12yrs.with AD
- The trial met 1EPs & 2EPs i.e., @16wk., improvement in higher levels of skin clearance (53%/66% vs 8%)/(42%/58% vs 5%)/(43%/63% vs 13%) in EASI 90 & (17%/27% vs 2%)/(14%/19% vs 1%)/(12%/23% vs 1%) in EASI 100; skin clearance (70%/80% vs 16%)/(60%/73% vs 17%)/65%/77% vs 23%) in EASI 75 & (48%/62% vs 8%)/(39%/52% vs 5%)/(40%/59% vs 11%) in vIGA-AD 0/1
- The therapy showed (52%/60% vs 12%)/(42%/60% vs 9%)/(52%/62% vs 15%) improvement in itch @1wk. & safety profile was similar to patients with RA. The therapy is also approved in the EU for AD
Ref: Abbvie | Image: abbvie
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