Cosentyx’s benefits seen in adults with axSpA for up to 2 years
Phase 3 study show sustained reduction in inflammation at sacroiliac joints
A chronic inflammatory condition known as non-radiographic axial spondyloarthritis (axSpA) remained undetectable on X-ray for most people with active disease who were on treatment with Cosentyx (secukinumab) for up to two years.
That’s according to new data from PREVENT (NCT02696031), a Phase 3 clinical study that also showed sustained reduction in inflammation at the sacroiliac joints, which link the spine (sacrum) and the pelvis (iliac bone).
The study, “Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis,” was published in the journal Arthritis Research & Therapy.
AxSpA is a type of arthritis in which the spine becomes inflamed, causing back pain, morning stiffness, and trouble moving. When damage caused by inflammation cannot be seen on an X-ray, it’s called non-radiographic axSpA.
People with active non-radiographic axSpA can show signs of disease on blood biomarkers and MRI scans. Many (up to 40%) progress to ankylosing spondylitis, which means that damage also becomes visible on an X-ray.
Cosentyx reduces immune system activity by blocking interleukin-17A
Novartis’ Cosentyx is an antibody that binds to and blocks interleukin-17A, a molecule that signals immune cells to rev up inflammation. By blocking interleukin-17A, Cosentyx reduces the activity of the immune system and eases inflammation.
The medication is approved in the U.S. and Europe for non-radiographic axSpA and ankylosing spondylitis. Doctors can also use it to treat plaque psoriasis and psoriatic arthritis.
PREVENT, sponsored by Novartis, was designed to test how safe and well-tolerated Cosentyx is versus a placebo, and how well it works in 555 adults with active non-radiographic axSpA who failed to respond well to at least two different non-steroidal anti-inflammatory drugs.
At entry to the study (baseline), all patients were randomly assigned to 150 mg Cosentyx (with or without induction phase) or a placebo. After 20 weeks, those with inadequate response (based on assessments of disease activity) were allowed to switch to Cosentyx or standard of care.
At this point, one of the study’s primary outcome measure had been met: after 16 weeks, 41.5% of patients given Cosentyx versus 29.2% of those on a placebo had seen at least a 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS) 40 response criteria. ASAS40 is defined as an improvement or reduction of at least 40% in a minimum of three of the following domains: inflammation, global patient assessment, pain, and function.
At one year (52 weeks), all but three patients who had switched to standard of care received open-label Cosentyx for another year. A total of 438 (78.9%) patients completed the two years (104 weeks) of the study.
Most patients did not show disease worsening, based on radiographic scores
Over the course of the two years, there were minimal changes to the mean radiographic scores of damage to the spine and the sacroiliac joints, regardless of whether the patients had been assigned initially to the Cosentyx or the placebo group.
This means that there was little progression of damage to these areas, and the majority of patients did not show any worsening of the disease based on the radiographic scores for the sacroiliac joints (up to 87.7%) and the spine (up to 97.5%).
Seven patients (3.3%) in the Cosentyx group and three patients (2.9%) in the placebo group with undetectable damage on a baseline X-ray had radiographic changes indicating disease progression after two years.
“The overall radiographic changes, along with any changes in spinal inflammation, in a population of patients on an effective biologic therapy were minimal over time,” the researchers wrote.
Bone marrow edema, which refers to swelling in the soft tissue inside the bones, was reduced by a mean 1.23 points in the sacroiliac joints of patients in the Cosentyx group after 16 weeks versus 0.67 points in the placebo group.
The reduction in inflammation was maintained throughout the study for up to two years, at which point all patients were receiving Cosentyx, and bone marrow edema was reduced by a mean 1.73 points from baseline.
The inflammation in the spine, as observed on MRI scans, was low both at the beginning of the study and at the end of the two-year period.