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CIMZIA® (certolizumab pegol) is Now the First and Only U.S. FDA-Approved Treatment for Non-Radiographic Axial Spondyloarthritis

  • Patients living with non-radiographic axial spondyloarthritis, an often undiagnosed, chronic, painful and debilitating disease, now have an approved, clinically validated treatment
  • FDA approval was based on the C-AXSPAND Phase 3 study in adults with non-radiographic axial spondyloarthritis, which demonstrated rapid and major improvement response with CIMZIA compared to placebo. Patients remained on common background medications, which could be adjusted at any point during the study.

Brussels, Belgium – 28 March 2019 – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for CIMZIA® (certolizumab pegol) to include a new indication for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. The approval makes CIMZIA the first and only FDA-approved treatment for nr-axSpA.

A chronic inflammatory condition, nr-axSpA mainly affects the spine and sacroiliac joints and is often undiagnosed and not appropriately treated. In nr-axSpA, definitive evidence of the disease is not evident on an x-ray. Disease onset typically begins in early adulthood and causes chronic and debilitating back pain, stiffness and fatigue, often having a profound impact on patients’ lives.

“This is such an important advancement for the spondyloarthritis community. More treatment options, earlier diagnosis, and awareness building will lead to better outcomes for people living with the disease,” said Cassie Shafer, Chief Executive Officer, Spondylitis Association of America.

“The FDA approval of CIMZIA for adults with non-radiographic axial spondyloarthritis will be transformative for the many patients living with this disease,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB. “We are proud to be at the forefront of discovering and delivering valuable treatment options for patients with significant disease burden and high unmet need. We are committed to improving care and outcomes for patients across the axial spondyloarthritis spectrum of disease.”

“Non-radiographic axial spondyloarthritis requires early diagnosis, followed by appropriate treatment. Yet for some patients, the journey to diagnosis can take nearly a decade from symptom onset. This FDA indication will make it easier for patients to receive another avenue of treatment in reducing the severe pain, stiffness, and other burdensome symptoms associated with this disease, to help ultimately improve their quality of life,” said Dr. Atul Deodhar, MD, MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University, and a lead author for the pivotal C-AXSPAND study.

This FDA approval is based on data from C-AXSPAND, a Phase 3, multi-center, double-blind, placebo-controlled 52-week study that randomized 317 adult patients to receive either CIMZIA or placebo plus common background medications, which included NSAIDs, corticosteroids, analgesics and slow-acting anti-rheumatic drugs.i 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.i ASDAS-MI is a validated, rigorous response threshold, defined as an ASDAS decrease of at least two points from baseline or reaching the lowest possible value.i C-AXSPAND is the first study to adopt this stringent threshold as a primary outcome measure. Detailed findings from the study were published online in Arthritis & Rheumatology on March 8, 2019.

The study also met ASAS40, an important secondary endpoint, with 47.8% of CIMZIA-treated patients achieving a 40% improvement in Ankylosing Spondylitis Assessment Score (ASAS40) compared to 11.4% of placebo-treated patients at week 12.

The safety profile for patients with nr-axSpA treated with CIMZIA was similar to the safety profile seen in patients with RA and previous experience with CIMZIA.

According to the updated label, the recommended dose of CIMZIA for adult patients with nr-axSpA is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every 2 weeks or 400 mg every 4 weeks. For full prescribing information, please visit www.ucb-usa.com.

CIMZIA is also FDA-approved for ankylosing spondylitis (AS), as well as rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and Crohn’s disease.

Learn more about UCB >>>

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