Upadacitinib Appears to Help Ankylosing Spondylitis Patients During Phase II Trial

Upadacitinib Appears Help Ankylosing Spondylitis Patients during Phase II Trial TrialsiteN

AbbVie’s Executive Medical Director, Dr. Aileen Lorenzo Pangan, recently discussed the American-biopharma company’s commitment to advancing the standard of care for patients with rheumatic diseases such as ankylosing spondylitis (AS). With thirty-eight abstracts presented at this year’s ACR/ARP Annual Meeting, they discussed the results from five clinical trials involving RINVOQ in rheumatoid arthritis (RS) and initial results from an ankylosing spondylitis (AS) study are published.

Ankylosing Spondylitis (AS)

AS represents a type of arthritis involving long-term inflammation of the joints and the spine. Often the joint interfacing the spine and pelvis are impacted. Other joints may be affected. Additionally, eye and bowel problems can occur as well as back pain. Stiffness in the impacted joints increases over time. Although the cause is unknown, it is believed to be involved with a combination of genetic and environmental factors. The standard of care depends on a number of factors.

What is RINVOQ?

Known as Upadacitinib, it is a drug for the treatment of rheumatoid arthritis approved by the U.S. FDA on August 16, 2019. The new JAK inhibitor was approved for adults with moderate to severe RA who cannot tolerate methotrexate or don’t sufficiently respond to that treatment.

SELECT-AXIS 1

The SELECT-AXIS 1 study is a Phase 2 multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS). Up to 187 patients were involved in the study that commenced during October 2017 and concludes in November 2020. The study has been conducted at up to 101 clinical investigational sites.

Dr. Pangan noted that the Phase 2/3 SELECT-AXIS 1 trial evidenced twice as many adult patients with active AS treated with RINVOQ (upadacitinib; 15 mg, once daily) achieved the desired primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 14 as against the placebo (52% vs. 26%; p<0.001)

Medical Rsearch.com reported that this was the first trial to assess the efficacy and safety of RINVOQ in adult patients with active AS who are naïve to biologic disease-modifying antirheumatic drugs (bDMARDs) and experienced adequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDS). These research findings to date were recently published in The Lancet. 

The investigators noted in the results summary that upadacitinib 15 mg was efficacious and well-tolerated in patients with active ankylosing spondylitis who had an inadequate response or contraindication to nonsteroidal anti-inflammatory drugs. The data reported the investigators in this industry-funded study support further investigation of upadacitinib for the treatment of axial spondylarthritis.

Lead Research/Investigators

  • Andrea Everding, MD
  • Yunxia Sui, PhD
  • Alvina D. Chu, MD
  • Professor Joachim Sieper, MD

Call to ActionTrialSite News will continue to monitor additional upadacitinib studies in indications such as.