UCB Canada has announced that CIMZIA (certolizumab pegol) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-axSpA), has been approved for use by Health Canada.
The treatment is targeted at adults with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Health Canada’s approval is based on data from C-AXSPAND5, a Phase 3, multicentre, double-blind, placebo-controlled 52-week study that randomised 317 adult patients to receive either CIMZIA or placebo plus common background medications, which included NSAIDs, corticosteroids, analgesics and slow-acting anti-rheumatic drugs. The study met its primary endpoint, with 47.2% of patients treated with CIMZIA demonstrating major improvement response in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) at week 52, compared to 7.0% of patients treated with placebo. Detailed findings from the study were published online in Arthritis & Rheumatology in March 2019.
“We’re pleased to see this important advance for the spondyloarthritis community. Greater awareness, earlier diagnosis and more treatment options will help deliver better outcomes for Canadians living with this painful disease which often falls through the cracks, and carries with it a significant burden,” said Gerald Major, president, Canadian Spondylitis Association.
The approval marks the fifth indication for CIMZIA, which is the only Fc-free, PEGylated anti-TNF option available for the treatment of the disease where significant unmet need currently exists, UCB said in a press release.
“The journey patients face from symptom onset to diagnosis and receiving appropriate treatment can be extremely lengthy—sometimes up to 10 years. So having a new and effective option for nr-axSpA is welcome news, both for those suffering and their physicians who are seeking a proven treatment to reduce the severe pain, stiffness, and other burdensome symptoms of the disease,” said Walter Maksymowych, professor and medical scientist in the Department of Medicine, Division of Rheumatology at the University of Alberta (Edmonton, Canada).
“The approval of CIMZIA for nr-axSpA is an important treatment advance which builds on more than a decade of market experience and proven efficacy and safety,” said Lionel Houle, head of immunology, UCB Canada.