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UCB have announced that the European Commission (EC) approved Cimzia, in combination with MTX, for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX.
Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
Cimzia has been approved to be administered as a subcutaneous injection using the new prefilled syringe designed in partnership with OXO Good Grips, a brand dedicated to providing innovative consumer products that make everyday living easier. The UCB and OXO Good Grips partnership resulted in a redesign of the traditional syringe with the aim of making self-administration easy for people living with RA. The syringe is designed for use by patients with different grip styles and strengths and it provides measurable improvements in the patient experience.
“Cimzia has been shown to rapidly reduce the rate of progression of joint damage and to improve measurements of patients’ physical function,” said Dr Prof Dr Iris Loew-Friedrich, Chief Medical Officer of UCB.
“These are areas of a key concern for rheumatologists when treating patients with active RA, and we therefore believe Cimzia provides an important new treatment option.”
In the RAPID 1 and RAPID 2 clinical trials statistically significantly greater ACR20 and ACR50 responses were achieved from Week 1 and Week 2, respectively, in both clinical trials compared to placebo. Responses were maintained through Weeks 52 (RAPID 1) and 24 (RAPID 2). Additionally, the RAPID 1 open label extension study, in patients who responded to treatment with Cimzia, showed that the improvements gained in ACR20/50/70 scores were sustained for two years in patients receiving Cimzia, in combination with MTX.
Radiographic data showed inhibition of the progression of structural joint damage, was observed at 24 weeks of treatment, in RA patients treated with Cimzia in combination with MTX and sustained for 100 weeks (100 week data are results from the open-label extension study of RAPID 1).
The recommended starting dose of Cimzia for adult patients with RA is 400mg (as 2 injections of 200mg each on one day) at weeks 0, 2 and 4, followed by a maintenance dose of 200mg every 2 weeks. MTX should be continued during treatment with Cimzia where appropriate.
The European approval is supported by data from a comprehensive clinical development programme, involving more than 2,300 patients with RA and over 4,000 patient-years experience.
As observed with other anti-TNF’s in the pivotal clinical trials reported serious adverse reactions included infections (including tuberculosis) and malignancies (including lymphoma). The most common adverse reactions belonged to the system organ classes Infections and Infestations, reported in 15.5% of patients on Cimzia and 7.6% of patients on placebo, and General disorders and administration site conditions, reported in 10.0% of patients on Cimzia and 9.7% of patients on placebo.
A pooled analysis of the safety data showed there was a low incidence of injection site pain (1.5%) and a low level of discontinuations due to adverse events (5%). Cimzia demonstrated a favorable risk-benefit profile in patients with at least up to two years of drug exposure.
The US Food and Drug Administration (FDA) recently approved Cimzia, together with MTX, for the treatment of adult patients with moderately to severely active RA.
