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by Dr. David Borenstein, Medically Reviewed by Dr. C.H. Weaver M.D. 6/2022

Rinvoq Approved 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 FDA has approved Rinvoq for AS based on two Phase 3, multicenter, randomized double-blind, placebo-controlled studies.3

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.

Select Axis Trials

The SELECT-AXIS 1 trial tested AS individuals who never had biologic therapies and had an inadequate response to two non-steroidal anti-inflammatory drugs. Rinvoq was compared to placebo in 93 and 94 patients with AS respectively. At 14 weeks, 40 % improvement was noted with Rinvoq compared to 26% for placebo group. Side effects were noted in 62% of the active treatment group versus 55% in the placebo group. No serious infections or deaths were reported.

The SELECT-AXIS 2 clinical trial tested AS patients who had failed up to two biologic therapies (tumor necrosis factor inhibitors for example). Rinvoq was administered to 156 individuals while 157 received placebo. At 14 weeks, 40% improvement was noted in 45% of the active treatment group and 23% of the placebo group. No serious infections or deaths were reported in either group.

Rinvoq is approved for those AS patients who have insufficient response or intolerance to one or more tumor necrosis factors. The dose is 15mg once a day by an oral route.

The JAK inhibitors are associated with significant side effects along with black box warnings. An increase in events is noted with cardiovascular events including myocardial infarction and stroke. Also noted is an increase in malignancies including lymphomas and solid tumors. Thrombosis is also increased including pulmonary embolism, deep venous thrombosis, and arterial clots. As noted with other biologic therapies, an increase of infections includes tuberculosis, invasive fungal infections, pneumonia, and herpes zoster. The relative frequency of toxicities is not the same for the JAK inhibitor class of agents. Further studies will quantify the frequency of toxicity of each agent in this class.

Updacitinib is the second biologic, oral therapy for AS. The is the second JAK inhibitor that is approved for AS. This is a significant advance for patients with AS who prefer oral therapy.

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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.

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)
  3. Spondylitis.org/research -new/oral-jak-inhibitor-upadacitinib-rinvoq-approved-for-ankylosing-spondylitis/