UCB's Cimzia is first anti-TNF agent to show significant early joint protection

UCB's Cimzia (certolizumab pegol), the first PEGylated, Fc-free, anti- tumor necrosis factor alpha agent in development for rheumatoid arthritis, has demonstrated significant radiographic evidence of ability to protect joints from the ravages of the disease at an unprecedented early stage. Importantly, the effect was demonstrated in a subset of patients who appeared not to be responding clinically to the drug, noted the Belgian drugmaker.

Data presented in oral session at the European League against Rheumatism meeting in Paris, France, show that, compared to placebo, Cimzia significantly reduced the modified Total Sharp Score - a measure of bone erosion and joint space narrowing evaluating whether joint destruction is progressing as early as 16 weeks after commencing treatment. Findings emerged in patients withdrawing from treatment because of an apparent lack of response according to the ACR20 criterion measuring symptoms and signs of active inflammatory disease.

Patients were participating in UCB's pivotal, randomized double-blind Phase III trials, RAPID 1 and RAPID 2, designed to evaluate safety and efficacy of 200mg and 400mg doses of Cimzia as add-on therapy to standard methotrexate treatment, compared against placebo and MTX, at 52 and 24 weeks, respectively. Patients not meeting the usual ACR20 criteria for clinical response to either of the two Cimzia doses added to MTX or placebo, were regarded as treatment failures and were withdrawn at week 16. Around 20% of Cimzia/MTX-treated subjects withdrew from each trial compared to 61% of placebo/MTX patients in RAPID 1 and 80% in RAPID 2. Radiographic assessments were then compared against baseline X rays.