Certolizumab pegol in the treatment of axial spondyloarthritis.

ABSTRACT

Axial spondyloarthritis is a chronic, immune-mediated systemic inflammatory disease encompassing ankylosing spondylitis and nonradiographic axial spondyloarthritis. TNF inhibitors are the preferred second line therapy for patients with active axial spondyloarthritis. Certolizumab pegol is a TNF inhibitor approved for treatment of both. Three large phase III trials (RAPID-axSpA, C-axSpAnd and C-OPTIMISE) and one large phase IV trial (CIMAX) establish its clinical efficacy in treatment of active disease and maintenance of remission for both diseases. Real world evidence demonstrates clinical efficacy and benefits including reduced bone loss, reduced risk of uveitis, safety in pregnancy and lactation and index drug survival of 10 years. It is generally well tolerated, though can be associated with increased risk of serious infections.

Axial spondyloarthritis is a chronic (long-lasting) autoimmune disease encompassing two other inflammatory conditions called ankylosing spondylitis and nonradiographic axial spondyloarthritis. A type of medicines, called tumor necrosis factor inhibitors, are the preferred second-line medicines for patients with active axial spondyloarthritis. Second line is treatment for a condition after the initial treatment has failed. Certolizumab pegol is one of these medicines approved for the treatment of both. Four large phase III or IV studies (RAPID-axSpA, C-axSpAnd, C-OPTIMISE and CIMAX) establish its effectiveness in the treatment of active disease and maintenance of remission (a period where disease symptoms have become less severe) for both diseases. Studies of its use in routine healthcare delivery show clinical efficacy (or effectiveness) and benefits including reduced bone loss, reduced risk of certain eye disease (uveitis), safety in pregnancy and lactation and 10-year effectiveness before the need for a medication change. It is generally well tolerated, though can be associated with increased risk of serious infections.