Phase 3 Trial Data Shows Cosentyx Efficacy in nr-axSpA

According to Ankylosing Spondylitis News, data from the Phase 3 PREVENT clinical trial highlights Cosentyx (secukinumab) as an effective treatment for patients with non-radiographic axial spondyloarthritis (nr-axSpA), as well as ankylosing spondylitis. The PREVENT trial sought to understand whether Cosentyx could cause continued symptom reduction over a long-term period. Based on the positive data, Cosentyx was recently FDA-approved for patients with nr-axSpA. You can read the full study results in Arthritis & Rheumatology.

Study Findings

In chronic inflammatory diseases, pro-inflammatory immune proteins (interleukins) often play a role. In this case, researchers wondered if inhibiting interleukin-17a (IL-17a) would reduce inflammation in patients with nr-axSpA.

Prior to the PREVENT trial, researchers examined the efficacy of Cosentyx for patients with ankylosing spondylitis in the MEASURE 1 and MEASURE 2 clinical trials. However, researchers wanted to officially determine the therapeutic value for patients with nr-axSpA.

The PREVENT trial enrolled 555 participants, a majority of which were male. The average participant age was 39. Prior to enrollment, patients tried at least 2 NSAIDs for at least one month. However, most patients previously did not try any TNF inhibitors. Ultimately, researchers wanted to see whether Cosentyx provided a significant benefit to patients as compared to a placebo. To determine this, they utilized the Assessment of Spondyloarthritis International Society (ASAS) 40 response criteria after 4 months and 1 year. These criteria measure inflammation, pain, function, and quality of life (QOL).

Cosentyx significantly improved symptom reduction (fatigue, spine and joint pain, swelling, and stiffness) in patients when compared to a placebo. Additionally, Cosentyx significantly improved quality of life. The therapy was generally well-tolerated. Side effects included uveitis (eye inflammation) and inflammatory bowel disease.

Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

Both non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis exist under the umbrella of spondyloarthritis, a group of conditions characterized by inflammatory arthritis, particularly in the spine. According to Creaky Joints:

Non-radiographic means the disease causes symptoms, but there’s no visible damage on X-rays, the way there is with Ankylosing Spondylitis. Axial refers to joints that the disease primarily affects: the spine, chest, and hip bone; and spondyloarthritis is a family of inflammatory arthritis that affects the joints and entheses, which are tissues between the bone and ligament or tendons.

Patients with nr-axSpA usually experience symptoms before the age of 40. These include:

  • Back pain and stiffness, especially in the morning. However, the back pain may be intense enough to wake you up in the middle of the night.
  • Pain reduction when moving around or becoming active
  • Psoriatic arthritis and plaques
  • Diarrhea
  • Joint pain and inflammation
  • Uveitis (eye inflammation)

Learn more about nr-axSpA.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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