Cimzia (certolizumab pegol) appears to effectively reduce disease activity and manage disease symptoms in patients with axial spondyloarthritis (axSpA) without X-ray evidence of ankylosing spondylitis, according to Phase 3 trial results.
The trial also highlights the limitations of current standard-of-care therapies to deliver adequate disease control.
The Phase 3 C-AXSPAND trial (NCT02552212) compared the effectiveness and safety of Cimzia to placebo in 317 patients with active, non-radiographic axSpA (nr-axSpa) — those who do not exhibit radiographic inflammation of the sacroiliac joints in the spine.
All patients showed active inflammatory status, confirmed by magnetic resonance imaging (MRI) or elevated C-reactive protein, and did not respond or were intolerant to standard therapy with non-steroidal anti-inflammatory drugs (NSAIDs).
The participants were randomized to receive 400 mg of Cimzia or placebo injected subcutaneously every two weeks for three cycles, followed by a 200 mg dose every two weeks up to the total treatment duration of 52 weeks.
“People with nr-axSpA face a significant disease burden, similar to people with ankylosing spondylitis, and are in need of effective treatment options,” Emmanuel Caeymaex, head of immunology and executive vice president of UCB, said in a press release.
“The positive topline results of the C-AXSPAND study show the significant value that Cimzia may provide to people living with nr-axSpA,” he said. “The study also reinforces UCB’s leadership in this disease area and our commitment to connecting science to unmet patient needs and ultimately providing valuable solutions.”
The results revealed that 47.2% of patients treated with Cimzia experienced major improvement in disease activity by the end of treatment, defined by at least a two point improvement in the Ankylosing Spondylitis Disease Activity Score (ASDAS-MI), compared to only 7% in the placebo-treated group.
Also, Cimzia-treated patients saw significant improvement in the Assessment of SpondyloArthritis International Society 40% (ASAS40) response at week 12, another index to determine disease activity.
“People living with nr-axSpA frequently face delayed or incorrect diagnosis, and currently, in the U.S., there are no FDA approved options to treat this condition,” said Atul Deodhar, MD, professor of medicine at OHSU (Oregon Health & Science University), and a lead investigator for the study.
“The C-AXSPAND study results provide important insights into the potential of Cimzia as an effective and durable treatment option for these patients,” Deodhar said.
“We look forward to quickly submitting this data to the FDA for review,” Caeymaex added.
Cimzia was approved by the U.S. Food and Drug Administration to treat adults with active ankylosing spondylitis (but not for nr-axSpA), rheumatoid arthritis, and psoriatic arthritis.
Recently, the European Medicines Agency approved a label update, stating that Cimzia can be used by pregnant and breastfeeding women.