Drugs Xagena
The European Medicines Agency’s ( EMA’s ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending extending the European Union marketing authorization for the use of Cimzia ( Certolizumab pegol ) in the treatment of adult patients with active psoriatic arthritis ( PsA ).
Psoriatic arthritis is a chronic, inflammatory condition that causes pain, swelling and stiffness in and around the joints and tendons and usually occurs in combination with psoriasis. In most people with psoriatic arthritis, psoriasis develops before joint problems. When hands and feet are affected in psoriatic arthritis, nail changes can occur as well as swelling in the fingers and toes ( dactylitis ).
Psoriatic arthritis affects an estimated 24 in 10,000 people and affects up to 30% of psoriasis patients. It usually occurs between the ages of 30 and 50.
The long-term burden of psoriatic arthritis is substantial with over half of patients developing progressive, erosive disease with functional impairment.
The positive opinion follows the EMA’s review of data from the RAPID-PsA study, an on-going, Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Certolizumab pegol in patients with adult onset active and progressive PsA.
In the European Union, Cimzia is approved in combination with Methotrexate ( MTX ) for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs, including Methotrexate.
Cimzia can be given as monotherapy in case of intolerance to Methotrexate or when continued treatment with Methotrexate is inappropriate.
In addition the European Commission has recently approved Cimzia for the treatment of adult patients with severe active axial spondyloarthritis ( axSpA ) comprising: a) ankylosing spondylitis ( AS ) - adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs ( NSAIDs ); b) axial spondyloarthritis without radiographic evidence of ankylosing spondylitis - adults with severe active axial spondyloarthritis without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to NSAIDs.
The RAPID-PsA study is an ongoing Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Certolizumab pegol in patients with adult onset active and progressive psoriatic arthritis. Patients ( n=409 ) were randomized 1:1:1 to placebo, or 400 mg Certolizumab pegol at week 0, 2 and 4 loading dose followed by either 200 mg Certolizumab pegol every two weeks or 400 mg Certolizumab pegol every four weeks. Patients could have had exposure to one previous tumour necrosis factor ( TNF ) inhibitor therapy.
Cimzia is the only Fc-free, PEGylated anti-TNF. Cimzia has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. ( Xagena )
Source: UCB, 2013
XagenaMedicine_2013
