Successful Phase III C-AXSPAND study of Cimzia to treat axial spondyloarthritis.- UCB.

UCB has announced positive topline results from C-AXSPAND, a Phase III placebo controlled study to investigate the efficacy of Cimzia (certolizumab pegol) on the signs and symptoms of active axSpA (Axial Spondyloarthritis) in patients without x-ray evidence of ankylosing spondylitis (AS). The study met the primary objective of achieving a major improvement, or ASDAS-MI, defined as a two-point improvement on the ASDAS at week 52 for Cimzia-treated patients compared to placebo. The study also met Assessment of SpondyloArthritis International Society 40% (ASAS40) response at week 12, a key secondary objective.

“People living with nr-axSpA frequently face delayed or incorrect diagnosis, and currently, in the US, there are no FDA approved options to treat this condition. The C-AXSPAND study results provide important insights into the potential of Cimzia as an effective and durable treatment option for these patients. Additionally, the study is unique in that it used ASDAS-MI, a rigorous response threshold, and assessed the long-term efficacy of Cimzia in a one-year, placebo-controlled trial. The study included nr-axSpA patients with objective signs of inflammation, an extended placebo phase, and allowed for modification of background medications to help gain a deeper understanding of the natural history of axSpA and to demonstrate the need for biologic treatment for this disease,” said Atul Deodhar, MD, MRCP, FACP, FACR, Professor of Medicine, OHSU, and a plead investigator for the study.

Axial spondyloarthritis is a painful, chronic inflammatory disease that starts in the sacroiliac joints and progresses to the spine, ultimately causing spinal fusion over time in many patients. People with nr-axSpA face a significant disease burden, similar to people with ankylosing spondylitis, and are in need of effective treatment options. The positive topline results of the C-XSPAND study show the significant value that Cimzia may provide to people living with nr-axSpA. . UCB plans to quickly submit this data to the FDA for review. Axial Spondyloarthritis, or axSpA, is a spectrum of disease which comprises both non-radiographic axSpA and radiographic axSpA, also known as ankylosing spondylitis (AS). nr-axSpA and AS share similar symptomology and burden of disease. However, in AS there is a definitive structural change of the sacroiliac joints detectable by x-ray; while in nr-axSpA there is no definitive radiographic sacroiliitis, though there may be MRI evidence of sacroiliitis.

The primary efficacy variable assessed in C-AXSPAND was ASDAS-MI response at Week 52. The ASDAS is a composite index to assess patient disease activity. It is comprised of objective evidence of systemic inflammation, such as 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 ASDAS is a validated, highly discriminatory instrument for assessing disease activity in axSpA. In the C-AXSPAND study, the primary outcome was defined as a composite endpoint that was achieved if a patient remained on study treatment through 52 weeks and achieved ASDAS-MI response at week 52. Patients in both the treatment and placebo groups remained on their background therapy for the duration of the study. No new safety signals were observed in the study. Cimzia is approved by the FDA for adults with active AS, but not for nr-axSpA.