Health Canada Approves Cimzia for Non-radiographic Axial Spondyloarthritis

Health Canada has approved Cimzia (certolizumab pegol) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-axSpA).

The medication is used to treat nr-axSpA patients with evidence of active inflammation, as indicated by magnetic resonance imaging and/or levels of the blood marker C-reactive protein, and who have failed or are intolerant to treatment with nonsteroidal anti-inflammatory drugs.

Axial spondyloarthritis is a type of arthritis that mainly affects the joints of the spine, causing chronic back pain. It is classified as ankylosing spondylitis if joint damage is visible through radiographs (X-rays) or nr-axSpA when no such changes can be seen with this approach.

“We’re pleased to see this important advance for the spondyloarthritis community,” Gerald Major, the president of the Canadian Spondylitis Association, said in a press release.

Cimzia is an antibody fragment developed by Belgium-based UCB. It works by blocking the activity of tumor necrosis factor alpha, a signaling molecule that acts as a potent driver of inflammation.

The therapy does not have the Fc region of antibodies, which allows them to easily move across the placenta during pregnancy. Based on results of two Phase 1 studies, the U.S. Food and Drug Administration has deemed the risk to be negligible of Cimzia being transferred to the placenta and breast milk.

Health Canada’s decision was based largely on data from the Phase 3 C-AXSPAND trial (NCT02552212), in which 317 people with active nr-axSpA were treated with subcutaneous (under-the-skin) injections of either Cimzia or a placebo for a year. The group on Cimzia took 400 mg every two weeks for three cycles, and 200 mg every two weeks thereafter.

Results showed that a greater percentage of participants on Cimzia (47.2% vs. 7% of those receiving the placebo) experienced a significant reduction in disease activity by the end of treatment, as assessed with the Ankylosing Spondylitis Disease Activity Score.

Another measure of disease activity, the Assessment of SpondyloArthritis International Society 40% (ASAS 40) response, also supported Cimzia’s benefits at week 12. ASAS 40 refers to an improvement of at least 40% in three of the following: patient global assessment, pain assessment, function, and inflammation.

“[H]aving a new and effective option for nr-axSpA is welcome news, both for those suffering and their physicians,” said Walter Maksymowych, MD, professor of rheumatology at the University of Alberta.

Added Louis Bessette, MD, rheumatologist and professor at Laval University: “Non-Radiographic Axial Spondyloarthritis can often be misdiagnosed or there is a delay in diagnosis … Given the tremendous burden to patients who are often struck at the prime of their lives, having a new treatment option can help prompt improved awareness, diagnosis and, ultimately, outcomes.”