Cimzia approved for treating adult patients with rheumatoid arthritis

Sep 1 2009

UCB Canada Inc. announced today that Health Canada has approved Cimzia(TM), the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia(TM) can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered. Cimzia(TM) is available in Canada as of today.

"Canadians with RA endure severe inflammation and swelling of joints with stiffness and fatigue which makes it difficult for them to perform many activities of daily living." "said Dr. Denis Choquette, rheumatologist, Notre-Dame Hospital, CHUM, University of Montreal. "To inhibit structural damage, it is essential to treat patients with moderate to severe RA with treatments that provide a rapid onset and significant sustainable improvements for signs and symptoms of RA. Additionally, Certolizumab pegol (Cimzia(TM)) has been shown to have a low incidence of injection site pain reactions, which is an important quality of life indicator for many patients."

In clinical trials with Cimzia(TM), together with methotrexate (MTX), patients experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within one to two weeks, compared with MTX alone. Additionally, radiographic data showed Cimzia(TM), together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared with MTX alone (p(less than)0.001).

"The approval of Cimzia(TM) for moderate to severe rheumatoid arthritis in Canada is a major milestone for UCB, and more importantly, for Canadian patients seeking a new treatment option to manage this debilitating condition," said Anne de Cassini, General Manager, UCB Canada Inc. "UCB is committed to developing new therapies, such as Cimzia(TM), to help meet the needs of patients living with rheumatoid arthritis and other immune diseases. UCB is also proud of its partnership with OXO(R) Good Grips and of the fact that RA patients were directly involved in the design and development of our new prefilled syringe, which is designed to make self-administration easy for people living with rheumatoid arthritis."

"Rheumatoid arthritis is a complex chronic condition, and it is a good day for the 300,000 Canadians affected by this disease when there are new treatment options made available to them." said Steven McNair, Chief Executive Officer & President of The Arthritis Society.

The Health Canada approval was based on UCB's comprehensive clinical program, including data from four multi-center placebo-controlled phase III trials, involving more than 2 300 patients with RA and over 4 000 patient-years experience. Cimzia(TM) has been studied at dosing intervals of two or four weeks, and administered together with MTX or as monotherapy.

In the pivotal clinical trials, reported serious adverse reactions were infections including tuberculosis and malignancies including lymphoma. The most commonly occurring adverse events were upper respiratory tract infections, rash and urinary tract infections. A pooled analysis of the safety data show there was a low incidence of injection site pain ((less than)2%) and a low level of discontinuations due to adverse events (5%).

It is estimated that 5 million people suffer from RA globally. Approximately one per cent of Canadians of all ages are currently affected by RA(1). Prevalence is not split evenly between genders, since women are three times more likely to be affected than men. Although RA can affect people of all ages, the onset of the disease usually occurs between 35-55 years of age.