UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia® (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA). The regulatory filings for two new indications for certolizumab pegol are now under review by the US FDA and EMA.
"We are committed to providing treatments for patients with severe diseases such as PsA and axSpA which can affect adults at a very productive and active time of their lives. These new regulatory filings bring us one step closer to supporting more people living with immunological conditions and to building UCB's immunology franchise," said Professor Dr. Iris Loew-Friedrich , Chief Medical Officer and Executive Vice President UCB. "The clinical study supporting the axSpA filing represents the first Phase 3 study with an anti-TNF to include axSpA patients with and without definitive radiographic evidence of structural damage to the spine. Similarly the study supporting the PsA filing was the first randomized, controlled study of an anti-TNF in PsA to include patients with and without prior anti-TNF exposure."
Certolizumab pegol is a Fc-free, PEGylated anti-TNF. In the US, certolizumab pegol is approved for the treatment of adults with moderately to severely active rheumatoid arthritis. It is also approved for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. Certolizumab pegol is marketed under the trade name Cimzia®.
In the EU, certolizumab pegol in combination with methotrexate (MTX) is approved for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs including MTX. Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
PsA is a chronic inflammatory condition which affects both the skin and joints. It can cause skin and nail abnormalities and can lead to significant joint damage and disability over time.
The RAPID-PsA study was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of certolizumab pegol in patients with adult onset active and progressive PsA. Patients (n=409) received certolizumab pegol 400 mg on weeks 0, 2 and 4 and were then randomized (1:1:1) to receive either certolizumab pegol 200 mg every 2 weeks, 400 mg every 4 weeks or placebo. One clinical primary endpoint of the study was the ACR20 response at week 12. The second clinical primary endpoint was the difference from baseline to week 24 in the van der Heijde modified Total Sharp Score (mTSS) of radiographic changes.
AxSpA is a form of spondyloarthritis that affects mainly the spine and sacroiliac joints, and includes ankylosing spondylitis (AS) and axSpA without definitive radiographic evidence of AS (nr-axSpA). The symptoms of AS can vary, but most people experience back pain and stiffness due to inflammation. People with nr-axSpA can have similar signs and symptoms to AS, but do not have definitive X-ray evidence of structural damage.
The RAPID -axSpA study was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of certolizumab pegol in patients with active axSpA. Patients (n=325) received certolizumab pegol 400 mg on weeks 0, 2 and 4 and were then randomized (1:1:1) to receive certolizumab pegol 200 mg every two weeks, 400 mg every four weeks or placebo. The primary endpoint of the study was the ASAS20 response rate at week 12.