New Data Showed Cimzia(R) Provided Rapid And Sustained Clinical Response, And Reinforces Need For Rapid-acting Treatments For RA

UCB today announced data that showed rapid and sustained improvements in symptoms of RA, as early as the first week, and inhibition of progression of structural joint damage (seen at week 24) following treatment with certolizumab pegol, together with methotrexate (MTX), was sustained for two years. The results from an open-label extension study*** to RAPID 1*, were presented at the European League Against Rheumatism (EULAR) meeting in Copenhagen.



New data from a post hoc** analysis, also presented at EULAR, showed the speed of developing a clinical response to treatment with 200 mg certolizumab pegol and MTX, is important in improving long-term outcomes for patients living with active RA. The analysis found most patients responded by Week 6. Patients who achieved control early at Week 6 had significantly better control of symptoms and quality of life at one year, compared to patients who achieved a later response at Week 12.



"These data confirm the rapid and sustained effect of Cimzia® in providing effective and clinically meaningful relief of rheumatoid arthritis, and reducing disease progression," said lead investigator Edward Keystone, M.D., The Rebecca MacDonald Center for Arthritis, Mount Sinai Hospital, The University of Toronto. "Recently published clinical data have shown Cimzia® to work rapidly, demonstrating an early response to treatment is associated with greater improvements in long-term outcomes, such as pain relief and physical function. This highlights the importance of using rapid-acting treatments to control inflammation in this debilitating condition."



The RAPID 1 extension study*** showed that rapid improvements in ACR[a] scores were sustained for two years in patients maintained on open-label treatment with 400 mg certolizumab pegol every 2 weeks and MTX. In the study, ACR20 response rates at Week 100, in patients who completed treatment with certolizumab pegol for two years, were 68.2% and 69.5% for patients who originally received certolizumab pegol 200 mg or 400 mg every 2 weeks plus MTX, respectively. ACR50 response rates were 55.2% and 51.5% respectively. Additionally, similar results were observed for Disease Activity Score (DAS28), and patient reported outcomes such as physical function and health-related quality of life.



Radiographic data presented in the same study, found the inhibition of progression of structural joint damage observed in RAPID 1* at 24 and 52 weeks in patients who completed treatment with certolizumab pegol and MTX, compared to MTX alone (p








The separate post hoc analysis** presented at the meeting investigated the relationship between the kinetics of response and long-term outcomes in patients who responded to treatment with 200 mg certolizumab pegol every 2 weeks and MTX, as measured by ACR20 response or change in DAS28 of >=1.2 from baseline.



Patients who had a rapid clinical response to certolizumab pegol early at Week 6 had a higher probability of improved quality of life and significantly better symptom control compared to the later responders at Week 12.



Early Week 6 responders had significantly higher ACR20, ACR50 and ACR70 responses at Week 52, compared to the later Week 12 responders (ACR20 83.1% versus 66.7%; ACR50 66.7% versus 34.5%; and ACR70 39.0% versus 16.1%, respectively (p