CIMZIA (certolizumab pegol), anti-TNFα

Substantial actual benefit in the treatment of active psoriatic arthritis when the response to disease-modifying antirheumatic drugs is inadequate.

• CIMZIA, in combination with methotrexate, has Marketing Authorisation in the treatment of active psoriatic arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) is inadequate. It can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate
• The level of evidence of the initial demonstration of the structural effect of CIMZIA (slowing of radiographic progression of joint damage) had been considered low by the Committee.
• The new follow-up data (after 96 weeks of treatment) indicate that maintenance of the absence of radiological progression and the benefit of the medicinal product can be reappraised on the basis of these results. This trend will need to be confirmed when the final data become available.