Cimzia (certolizumab pegol)
Cimzia (certolizumab pegol) is a recombinant Fab’-fragment of a humanized antibody for TNF-α. It is approved for treatment of moderate to severe rheumatoid arthritis (in combination with methotrexate), where treatment with methotrexate alone has insufficient effect. Cimzia can be used in monotherapy, when continued treatment with methotrexate is unsuitable.
Cimzia is dosed as a subcutaneous injection of 400mg at weeks 0, 2 and 4, and hereafter 200mg every second week.
Cimzia has been compared with placebo, in treatment of active rheumatoid arthritis (RA) in patients who have not experienced any beneficial effects, when being treated with MTX or other DMARD. Patients treated with Cimzia experience a minimal response (ACR20) significantly more often than those treated with placebo, after 24 weeks of treatment. After 52 weeks of treatment, a significant decrease of progression of structural changes in the joints (mTSS) is seen in patients treated with Cimzia compared with placebo.
Cimzia has not been studied for patients whose treatment with other TNFα-inhibitors have failed, and it has neither been compared to other TNFα-inhibitors nor other biological antirheumatics.
The most commonly occurring side effects are infections and infestations.
The price for a year of treatment with Cimzia is about 117.000 D.kr. (AIP).
IRF finds that TNFα-inhibitors still are the top choice among the biological antirheumatics. The choice of TNFα-inhibitor should be made with a background knowledge and experience with the products, especially concerning long-term effects and long-term side effects. Because of this, Enbrel, Humira and Remicade must still be considered the most obvious choices for a first line agent. Cimzia is a new TNFα-inhibitor, and could – with background in an advantageous comparison with one of the old TNFα-inhibitors – have secured a foothold in the row of first line agents. This comparison, however, has not been made, which is why Cimzia’s potential advantages in respect to other TNFα-inhibitors are hard to identify. As a result of this, Cimzia is not an obvious choice of first line agent in biological treatment of RA. Given that Cimzia has not been tested on patients whose treatment with other TNFα-inhibitors have failed, either, we cannot recommend using it in in this situation.
Cimzia was marketed on the 16th of November 2009.