Rinvoq (upadacitinib) Effective in Phase 3 Psoriatic Arthritis Study
by Dr. C.H. Weaver M.D. 3/2020
Top line results of the SELECT-PSA trial of Rinvoq in psoriatic arthritis (PsA) results were published demonstrating that upadacitinib represents an effective treatment option.
About Rinvoq (upadacitinib)
The US Food and Drug Administration (FDA) approved the third JAK inhibitor for use in RA in August 2019. Rinvoq (upadacitinib) was approved for the treatment of adults with RA with moderately to severely active disease who either not responding to, or intolerant of, methotrexate (MTX).
Janus-associated kinase 1 (JAK1) inhibitors mediate the signaling of cytokines and growth factors important for blood cell production and immune function. Jakafi® (ruxolitinib) was the first JAK 1 inhibitor approved for the treatment of some Myleoproliferative Neoplasms. Blocking the JAK pathway also appears important for treating the immune response in PsA and investigators have begun to report results.
The SELECT-PsA 1 was a Phase 3, double-blind, randomized clinical trial performed in 1705 PsA patients, unresponsive to at least one non-biologic DMARD. Patients were treated with Rinvoq (15 or 30 mg) for 24 weeks or a placebo and directly compared. The primary endpoint was the ACR20 response at 12 weeks.
When analyzed at 12 weeks from initiation of therapy significantly more patients receiving either dose of Rinvoq achieved a superior reduction in symptoms compared to placebo.
Radiographic outcomes were also assessed; and after 24 weeks, both the 15 mg and 30 mg dose of Rinvoq significantly inhibited radiographic progression compared to placebo.
Rinvoq represents a new treatment option for patients with PsA who should discuss its potential role in the management of their disease.
RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis | AbbVie News Center
NORTH CHICAGO, Ill., Feb. 5, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-PsA 1 clinical trial. In this study, both doses of RINVOQTM (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who have responded inadequately or are intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).1 RINVOQ also demonstrated significant improvements in signs and symptoms of the disease across a variety of endpoints compared to placebo.1 RINVOQ, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily therapy in psoriatic arthritis and multiple immune-mediated inflammatory diseases.1,3-10