Certolizumab Pegol Demonstrates Positive Results in Phase 3 Trial for Nonradiographic Axial Spondyloarthritis

Results from a phase 3 placebo-controlled study show that CIMZIA® (certolizumab pegol) improves the signs and symptoms of nonradiographic axial spondyloarthritis (nr-axSpA) compared with placebo at 52 weeks. The data highlight the potential of CIMZIA for the treatment of nr-axSpA and provide evidence for the high burden of the disease.

The C-AXSPAND study (ClinicalTrials.gov identifier: NCT02552212) is a multicenter, randomized, double-blind, placebo controlled study including 317 adult patients with active axSpA without radiographic evidence of ankylosing spondylitis (AS). Participants received a 400 mg dose of subcutaneous CIMZIA or placebo at baseline and at 2 and 4 weeks, followed by 200 mg of CIMZIA every 2 weeks thereafter.

The primary efficacy variable was the Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) response at 52 weeks. Secondary efficacy variables at 12 and 52 weeks included the Assessment of Spondyloarthritis International Society 40% response (ASAS40), change from baseline in Bath Ankylosing Spondylitis Functional Index, change from baseline in Bath Ankylosing Spondylitis Disease Activity Index, change from Baseline in SI joint Spondyloarthritis Research Consortium of Canada score (at 12 weeks only), and the number of patients without relevant changes to background medication.

“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,” stated Atul Deodhar, MD, MRCP, FACP, FACR, Professor of Medicine, OHSU, 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. 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 1-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.”

C-AXSPAND met the primary objective, with 47.2% of CIMZIA-treated patients demonstrating major improvement response on the ASDAS-MI at 52 weeks compared with 7% of patients treated with placebo. The study also met the ASAS40 response secondary objective at 12 weeks.

“These findings will hopefully lead to the first FDA-approved treatment for nr-axSpA,” Dr Deodhar told Rheumatology Advisor. “Availability of this treatment could have large repercussions in the management of these patients — from improving the awareness of nr-axSpA, to early identification and appropriate treatment that improves the quality of life.”

Reference

CIMZIA® (certolizumab pegol) is The First Therapy to Demonstrate Positive Results in a 52-week, Placebo Controlled Non-Radiographic Axial Spondyloarthritis Study [press release]. Brussels, Belgium: UCB. https://www.ucb.com/stories-media/Press-Releases/article/CIMZIA-certolizumab-pegol-is-The-First-Therapy-to-Demonstrate-Positive-Results-in-a-52-week-Placebo-Controlled-Non-Radiographic-Axial-Spondyloarthritis-Study. Published May 16, 2018. Accessed May 17, 2018.