UCB has announced the results of two late-stage studies of its anti-tumour necrosis factor agent Cimzia which show that the drug demonstrates significant clinical benefits for mono- and combination therapy in patients with rheumatoid arthritis.

The first of the Phase III trials, which are published in the online version of the Annals of the Rheumatic Diseases, involves the six-month FAST 4WARD study, The data showed that 400mg of Cimzia (certolizumab pegol), given every four weeks as subcutaneous monotherapy, significantly reduced signs, symptoms and pain associated with RA, and improved physical function, compared to patients treated with placebo.

Specifically, patients treated with Cimzia demonstrated significantly superior ACR20 response rates at week 24 versus those on placebo (45.5% versus 9.3%). The Belgian firm noted that response to treatment was rapid and significant with more than one-third of patients achieving an ACR20 response as early as week 1 of treatment, compared to less than 10% on placebo.

A second six-month study called RAPID 2, showed that treatment with Cimzia, together with methotrexate, significantly improved the clinical signs and symptoms of RA, inhibited progression of disease, and improved physical function in adult patients with active disease.

UCB cited Roy Fleischmann at the University of Texas Southwestern Medical Centre in Dallas, as saying that the positive outcomes of the FAST 4WARD study “are exciting and demonstrate the potential for certolizumab pegol as a future therapy dosed every four weeks for patients with rheumatoid arthritis”. It is the first Phase III trial to show a clinical benefit as monotherapy, “which becomes important when patients must discontinue treatment due to tolerability issues with conventional treatments, or have contraindications," he added.

The US Food and Drug Administration accepted a Biologics License Application for Cimzia for the treatment of adults with active RA in February and UCB submitted a marketing authorisation application to the European Medicines Agency in June. The drug was approved for Crohn’s disease in the USA in April but the the RA indication would be much more lucrative and help UCB plug the gap in sales resulting from the loss of patent protection on its biggest earners – the allergy drug Zyrtec (cetirizine) and the antiepileptic Keppra (levetiracetam).