A Phase 3 trial of Cimzia (certolizumab pegol [CZP]; UCB) in patients with non-radiographic axial spondyloarthritis (nr-axSpA) has demonstrated major improvement in disease activity after 52-weeks of treatment.
Cimzia, an Fc-free, PEGylated tumor necrosis factor (TNF) antagonist, is currently approved to treat adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). Patients with nr-axSpA share similar symptoms to those with AS but have no definitive radiographic sacroiliitis. Currently, there are no approved biological treatments in the US for nr-axSpA.
To examine the efficacy of CZP in nr-axSpA, the C-AXSPAND Phase 3 trial randomized 317 adult patients with nr-axSpA to receive either CZP or placebo. During the 52-week trial period, the treatment group received a 400mg dose of CZP subcutaneously at weeks 0, 2, and 4, followed by 200mg of CZP every 2 weeks starting at week 6; or placebo.
At week 52, 47.2% of patients who received CZP demonstrated major improvement response in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) vs 7% who received placebo (the primary endpoint). ASDAS-MI is a composite index endorsed by the Assessment of SpondyloArthritis International Society (ASAS) and Outcome Measures in Rheumatology (OMERACT). The index measures C-reactive protein, and patient-reported outcomes, such as back pain, duration of morning stiffness, patient global assessment of the disease, and peripheral pain/swelling.
The study also met the secondary endpoint of Assessment of Spondyloarthritis International Society 40% (ASAS40%) response at week 12. The C-AXSPAND trial is ongoing, with a 2-year safety follow-up and an 8-week follow-up period after treatment is stopped. Full results are expected sometime in 2020.
“People with nr-axSpA face a significant disease burden, similar to people with ankylosing spondylitis, and are in need of effective treatment options,” said Emmanuel Caeymaex, Head of Immunology and EVP at UCB. “We look forward to quickly submitting this data to the FDA for review.”
For more information visit UCB.com.