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Thursday, March 23, 2023

AbbVie Advances Upadacitinib (RINVOQ®) to Phase 3 in Systemic Lupus Erythematosus

 

  • Results of the M19-130 (SLEek) Phase 2 trial of upadacitinib given alone or as a combination therapy (ABBV-599) met the primary endpoint of systemic lupus erythematosus (SLE) Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 in patients with moderately to severely active SLE1,2

  • No new safety signals were identified with upadacitinib, and a similar safety profile was observed for the combination therapy (ABBV-599) as for treatment with upadacitinib alone2,3,4,5,6,7

  • SLE is a complex autoimmune disorder in which the body's immune system attacks healthy tissue of the musculoskeletal system, skin, kidneys, lungs and other critical organs, leading to symptoms such as fatigue, joint pain and impaired function.8,9

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