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by Dr. David Borenstein, Medically Reviewed by Dr. C.H. Weaver M.D. 11/2021

Rinvoq Promising for Ankylosing Spondylitis & Non-radiographic Axial Spondyloarthritis

Ankylosing spondylitis (AS) is an inflammatory spinal disease which is associated with varying degrees of spinal fusion along with prolonged back pain, and fatigue. The current treatment of AS includes NSAIDs, tumor necrosis factor inhibitors (TNFi), and interleukin-17 (Il-17) agents. Janus kinase (JAK) inhibitors, including Rinvoq (Upadacitinib) are indicated for the treatment of rheumatoid arthritis. The efficacy of Rinvoq for patients with AS has been studied in the Phase 3 Select-Axis 2 clinical trial. The trial demonstrated the benefit of Rinvoq compared to placebo.

About Rinvoq (upadacitinib)

Rinvoq (upadacitinib) is a Janus-associated kinase 1 (JAK1) inhibitor that mediates 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 some forms of inflammatory arthritis and spondylitis. The US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib) for the treatment of adults with RA with moderately to severely active disease who either not responding to, or intolerant of, methotrexate (MTX) and Psoriatic Arthritis.

About the Phase 3 Select-Axis 2 clinical trial

A total of 420 AS patients who had failed other biologic therapies were given Rinvoq 15 mg daily or placebo and directly compared. At week 14, Rinvoq patients were found to have met the primary endpoint of 40% improvement in a variety of clinical parameters associated with AS compared to placebo (44% versus10% respectively). The amount of back pain was significantly decreased with Rinvoq patients versus placebo. Also noted was a greater improvement measured on magnetic resonance imaging with fewer areas of inflammation. No Rinvoq treateed patient stopped the study because of drug related side effects and serious infections occurred in 2.4% in Rinvoq treated patients - the infections were Covid related.

The results of the Select-Axis 2 study suggest that Rinvoq is an effective therapy in AS patients who have failed other biologic therapies like anti-TNFs or anti-IL-17 agents. Rinvoq is awaiting approval by the Food and Drug Administration for treatment of AS.

Non-radiographic Axial Spondyloarthritis (nr-axSpA)

Non-radiographic Axial Spondyloarthritis is an inflammatory spinal disease similar to AS which is associated with varying degrees of spinal fusion along with prolonged back pain, and fatigue. The difference between these illnesses is the absence of signs of inflammation or damage in the sacroiliac joints on x-Ray. The current treatment of nr-axSpA includes NSAIDs, tumor necrosis factor inhibitors (TNFi), and interleukin-17 (Il-17) agents. The effectiveness of Rinvoq for patients with nr-axSpA has been studied in a clinical trial that demonstrated the benefit of Rinvoq compared to placebo.

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A total of 313 nr-axSpA patients who have failed other biologic therapies were given Rinvoq15 mg daily or placebo. At week 14, Rinvoq patients were found to have met the primary nr-axSpA endpoint of 40% improvement in a variety of clinical parameters associated with compared to 23% with placebo. The amount of back pain was significantly decreased with Rinvoq and there was a greater improvement measured on magnetic resonance imaging with fewer areas of inflammation.

The results of these clinical studies suggest that Rinvoq is an effective therapy in patients with both AS and nr-axSpa. Rinvoq is awaiting approval by the Food and Drug Administration for treatment of nr-SpA.

References: 

  1. Abbvie.com News Center 10/7/21 https://news.abbvie.com/user_pref.cfm /article_print.cfm?article_id=12347
  2. Abbvie.com News Center 10/7/21 https://news.abbvie.com/user_pref.cfm (/article_print.cfm?article_id=12346)