UCB (UCBJF) recently presented data from a phase III study evaluating two dosing regimens of Cimzia (certolizumab pegol). The study evaluated 200mg (two-weekly dosing) and 400mg (four-weekly dosing) of Cimzia, in combination with methotrexate for the treatment of moderate-to-severe rheumatoid arthritis patients above 18 years. The data was presented at the 2012 Congress of the European League Against Rheumatism (EULAR).
In the DOSEFLEX phase IIIb study, 333 rheumatoid arthritis patients were enrolled. Comparable efficacy and maintenance of response was observed in both 200mg and 400mg dosing of Cimzia. Cimzia 200mg in combination with methotrexate is approved in both the US and the EU as rheumatoid arthritis maintenance therapy.
While the 400mg dosing is also approved for this indication in the US, it is not approved in the EU. Approval of 400mg dosage in European Union (EU) will decrease the burden on patients and increase their convenience.
Earlier this month, UCB presented positive data on Cimzia from a late-stage trial (RAPID-PsA) in patients suffering from psoriatic arthritis.
In the RAPID-PsA phase III study, 409 psoriatic arthritis patients were enrolled. It was observed that after 12 weeks of treatment with Cimzia, patients experienced statistically significant improvement in the signs and symptoms of psoriatic arthritis as compared to placebo.
On the basis of these results, UCB plans to make regulatory filings by the end of 2012 for the approval of Cimzia as a treatment for psoriatic arthritis.
We note that Cimzia is currently approved in the US for the treatment of moderate-to-severe rheumatoid arthritis patients above 18 years and for reducing the signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in moderate-to-severe CD patients above 18 years, who have failed prior therapy.
The drug is also approved in the EU in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults who have responded inadequately to disease-modifying antirheumatic drugs (DMARDs), including methotrexate.
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