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Cimzia, the first PEGylated anti-TNF, receives recommendation for approval from NICE for the treatment of severe, active RA in adults
Under the Patient Access Scheme the new drug will be available free of charge to every eligible NHS RA patient in England and Wales for the first 12 weeks of therapy
UCB partners with U.S. consumer products company OXO, makers of Good Grips, to produce a new prefilled syringe, designed to overcome challenges many people with RA face when self-injecting
Slough, UK, Thursday 21 Jan 2010 ” UCB announced today that the National Institute for Health and Clinical Excellence (NICE) has issued a recommendation for approval1 to the NHS for the use of Cimzia, certolizumab pegol as an option for the treatment of adults with severe active RA on the condition that the Patient Access Scheme is implemented and the drug is prescribed in accordance with NICE TAG1302.
The registered UK indication for the drug Cimzia is for use in combination with methotrexate (MTX), for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.7
The NICE guidance also mentions a first of its kind Patient Access Scheme in RA, which will make certolizumab pegol available free of charge to all eligible NHS patients for the first 12 weeks of therapy,3 at which point clinical response is usually achieved.
RA is a debilitating, chronic disease which causes joint inflammation and which can lead to long-term joint damage, resulting in pain, disability and disfigurement4. Women are two to three times more likely to suffer from RA than men5 and the disease strikes people in the prime of their lives between the ages of 30-505. There are an estimated 580,000 adults living with RA in England alone.6
Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society, comments: “This is the first time a new NICE recommended RA treatment has been made available for almost two years – and could make a big difference to patients “day to day lives.”
Certolizumab pegol is the first PEGylated anti-TNF (Tumour Necrosis Factor alpha) to be launched in the U.K. for the treatment of moderate to severe active RA (recommended for approval by NICE for the treatment of severe active RA in England and Wales), in combination with methotrexate (MTX), in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX, has been inadequate (for full indication see SPC¥).7 In clinical trials with certolizumab pegol together with MTX, significant improvement in ACR± scores (20, 50 and 70) was evident at Week 1. These improvements continued rapidly over the first 4—12 weeks of treatment and remained significant relative to the placebo treatment group at Weeks 24 and 52.8
“Certolizumab pegol is an important new treatment option for people with rheumatoid arthritis, and it’s exciting that it is now available on the NHS ,” commented Professor Peter Taylor, investigator and Professor in Experimental Rheumatology, Imperial College London NHS Trust. “Certolizumab pegol has been shown to rapidly improve patients” symptoms and to significantly reduce the rate of progression of joint damage associated with rheumatoid arthritis. This fast and lasting effect is important as it quickly improves function, reduces work disability and leads to a better quality of life for patient.
UCB has also teamed up with the U.S. consumer products company OXO, maker of Good Grips, to design a new syringe and packaging components for certolizumab pegol that take into account the challenges many people with RA face when self-injecting, since painful or inflamed joints can limit their dexterity. The new prefilled syringe was designed with the help of RA patients for use by patients with different grip styles and strengths.
compared to placebo plus MTX treatment in RA patients with an incomplete response to MTX in clinical trials.
± ACR (American College of Rheumatology) response scores measure improvement in the tender and swollen joint count and also include assessment of the following five parameters: patient’s global assessment, physician’s global assessment, patient’s assessment of pain, degree of disability, and level of acute-phase reactant. ACR20 is achieved when there is 20% improvement in the tender and swollen joint count as well as a 20% improvement in at least three of the five parameters. ACR50 and ACR70 are an extension of these criteria corresponding to a 50% and 70% improvement respectively.
