Belgian drugmaker UCB has reported pivotal study results showing Cimzia (certolizumab pegol), the only PEGylated anti-tumor necrosis factor, together with methotrexate rapidly reduced symptoms of disease and inhibited progression of joint damage in adult patients with active rheumatoid arthritis, with sustained results for up to one year.
The RAPID 1 study data, published in Arthritis and Rheumatism, showed that both co-primary endpoints, which included the ACR20 responder rate at week 24 and the change from baseline in the modified total sharp score at week 52, were met in the one-year study. Patients in both Cimzia plus MTX arms had a significantly-higher ACR20 response at 24 weeks (p<0.001) compared those on placebo plus MTX.
In addition, radiographic data showed Cimzia together with MTX inhibited progression of RA, with a significantly-smaller change from baseline in mTSS at 24 and 52 weeks of treatment, compared with MTX alone (p<0.001). The RAPID 1 trial "demonstrated a clear therapeutic benefit for patients with a reduction in swollen and tender joints, pain and fatigue as early as one week after treatment, and signs of preventing long-term structural damage by 16 weeks," said lead investigator Edward Keystone.
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