The P-II study evaluates upadacitinib (30mg) as monotx. & in combination with ABBV-599 high dose (elsubrutinib – 60mg & upadacitinib – 30mg) vs PBO in 341 patients
The trial met its 1EPs of SLE responder index (SRI-4) & steroid dose ≤10mg prednisone equivalent once per day @24wk. vs PBO (54.8% & 48.5% vs 37.3%) & evaluate reductions in disease activity & glucocorticoid use. The trial met 2EPs at 48wk. in both active treatment groups, incl. lupus flares showed greater treatment effects in upadacitinib & ABBV-599
Other measures of disease activity & treatment response were met, incl. BICLA response, SRI-4 & LLDAS with no new safety signals, rate of TEAEs (ABBV-599 at 86.8%, upadacitinib at 82.3%, PBO at 78.7%); SAEs (10.3% & 21.0% vs 17.3%)
Ref: PRNewswire | Image: AbbVie
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