Cimzia is a PEGylated anti-TNF (Tumor Necrosis Factor), which has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia showed rapid and sustained clinical response in patients unresponsive to standard methotrexate (MTX) therapy (J-RAPID) or either unable to take or unresponsive to MTX (HIKARI).
In the J-RAPID study, RA patients were randomised to either certolizumab pegol 100mg, 200mg, 400mg or placebo once every two weeks, plus MTX.
Certolizumab pegol plus MTX was associated with a rapid and sustained reduction in RA signs and symptoms compared to placebo plus MTX.
In a second study (HIKARI) of Japanese patients in whom MTX was not tolerated, treatment with certolizumab pegol demonstrated an improved clinical response compared to placebo.
In the HIKARI study, the positive clinical response was observed both in patients receiving certolizumab pegol as monotherapy and in those receiving concomitant disease modifying antirheumatic drugs (DMARDs) other than MTX.