Results of a phase 3 study evaluating the efficacy and safety of Cimzia® (certolizumab pegol) in the treatment of Japanese patients with early rheumatoid arthritis (RA) are presented this week at the European League Against Rheumatism (EULAR) 2014 Annual Congress in Paris, France (11th-14th June 2014).1 The study showed that combination treatment of certolizumab pegol with methotrexate (MTX) was significantly more effective than placebo with MTX in inhibiting structural disease progression, as well as achieving clinical remission in MTX-naïve Japanese patients with early RA and poor prognostic factors.1
In Japan, Astellas Pharma Inc. (TSE:4503) and UCB Japan are jointly developing and commercializing certolizumab pegol. Cimzia® (certolizumab pegol) 200 mg Syringe for s.c. injection is currently approved in Japan for the treatment of adult patients with RA who have had an inadequate response to conventional treatment.
"We are committed to improving the lives of patients at all stages of RA and are encouraged by the first Phase 3 study evaluating certolizumab pegol in the treatment of early RA. Data from this study suggested that Japanese patients with early RA and poor prognostic factors experienced meaningful clinical improvement when treated with a combination of certolizumab pegol with MTX. " said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.
In the study reported at EULAR 2014, 316 Japanese patients with early RA (<12 months from onset of persistent RA symptoms), who fulfilled the 2010 ACR/EULAR Classification Criteria, had at least moderate disease activity (DAS28[ESR]≥3.2), poor prognostic factors,* and who were MTX-naïve, were randomized either to certolizumab pegol and MTX or to MTX and placebo.1,2 The primary endpoint of the study was inhibition of radiographic progression (change from baseline in modified Total Sharp Score) at week 52. Secondary endpoints were inhibition of radiographic progression at week 24, and clinical remission rates (DAS28[ESR], ACR/EULAR [SDAI], and ACR/EULAR [Boolean]) at weeks 24 and 52.1
Patients in the certolizumab pegol with MTX group (n=159) showed significantly greater inhibition of radiographic progression relative to the placebo with MTX group (n=157) at week 52 (p<0.001) and week 24 (p=0.003). Clinical remission rates for the certolizumab pegol with MTX group were higher than those in the placebo with MTX group, across all parameters, at week 24 and at week 52. For example, at week 52, 45.3% of patients taking certolizumab pegol with MTX achieved ACR/EULAR [Boolean] remission compared to 28.0% of patients taking placebo with MTX (p=0.002). The ACR/EULAR [Boolean] definition of remission requires that a patient has little, if any, active disease.3 Almost half (45.3%) of the early RA patients receiving certolizumab pegol with MTX in this study achieved clinical remission using the stringent Boolean-based definition.1 No new or unexpected safety signals were observed.1
An additional multi-center, randomized, double-blind, placebo-controlled study is currently evaluating certolizumab pegol in combination with methotrexate in the treatment of disease modifying antirheumatic Drugs (DMARD)-naïve adults with early active rheumatoid arthritis. Top-line results of this global study are expected in 2016.4
In the European Union, Cimzia®, in combination with MTX, is approved for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. Cimzia®, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. Cimzia® is also approved in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:5
- Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs [NSAIDs])
- Axial spondyloarthritis without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to NSAIDs.5