ABSTRACT

The development of tumour necrosis factor-alpha (TNF-alpha) inhibitors is an important progress in the treatment of rheumatoid arthritis (RA). As a new anti-TNF alpha treatment drug, certolizumab pegol (CZP) is a recombinant, polyethylene glycolylated, antigen-binding fragment of a humanized monoclonal antibody that neutralizes TNF- alpha. In randomized, controlled trials, CZP was evaluated either as mono-therapy or combination with MTX or other DMARDs in mild to severely active RA. Data from these trials showed that with rapid onset of action CZP is effective in reducing the disease activity, disability and also inhibiting the radiographic progression. The beneficial effect of CZP was also demonstrated even in higher response rate than the previous studies in RA patients failed to other anti-TNF drugs. The meta-analysis and comparison trials indicated that CZP was effective for the improvement of disease activity scores, physical function, pain and fatigue relative to other biologic drugs. The randomized, controlled clinical trials and long term extension phases of these studies strengthen the use of CZP in patients with moderate to severely active RA as either mono therapy or preferably in combination with DMARDs after a loading regime (0-2-4 weeks 400 mg) to continue with 200 mg CZP every 2 weeks.