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New England Journal of Medicine Publishes 24-Week Results from Phase 3 Study Evaluating RINVOQ™ (upadacitinib) in Psoriatic Arthritis

Published: 2021-04-01 12:31:00 ET
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- In SELECT-PsA 1, RINVOQ™ (upadacitinib, 15 mg and 30 mg) improved key joint and skin symptoms up to 24 weeks, including enthesitis[1]

- Both doses of upadacitinib significantly improved fatigue compared to placebo at week 12[1]

- Results build on previously announced topline results with safety data through week 24 that are generally similar to the known safety profile of upadacitinib in rheumatoid arthritis[1,2]

NORTH CHICAGO, Ill., April 1, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the New England Journal of Medicine has published 24-week results from the Phase 3 SELECT-PsA 1 trial evaluating RINVOQ (upadacitinib, 15 mg and 30 mg) in adults with active psoriatic arthritis who had responded inadequately or were intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).1 These data build on previously announced Phase 3 topline results showing that upadacitinib 15 mg and 30 mg met the primary endpoint of ACR20 response at week 12 versus placebo as well as key secondary endpoints.1 

"These data show upadacitinib's potential to improve clinical and radiographic outcomes for people with psoriatic arthritis, a complex and progressive autoimmune disease," said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie. "Ultimately, our goal is to help more patients achieve disease control and relief from their most bothersome joint and skin symptoms that can impact their daily lives."

Recently, the European Commission (EC) approved RINVOQ (15 mg) for use in adults with active psoriatic arthritis. Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy are under evaluation by regulatory authorities in the United States.

Efficacy results for ranked secondary endpoints not previously reported include:1*

  • A significantly higher percentage of patients taking upadacitinib 15 mg and 30 mg (54 and 58 percent, respectively) achieved resolution of enthesitis (Leeds Enthesitis Index (LEI)=0) compared to those taking placebo (32 percent) at week 24 (p