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CIMZIATM (certolizumab Pegol) Demonstrates Efficacy In Psoriasis Patients Previously Treated With Biologics
06/04/07
Results from the first study to evaluate the efficacy and safety of CIMZIATM (certolizumab pegol), the first PEGylated, Fc-free anti-TNF, in patients with moderate to severe Psoriasis Treatment previously treated with other biological drugs ('biologics') were presented today at the European Academy of Dermatology and Venereology (EADV) Annual Meeting. This study demonstrated that regimens of both the 200mg and 400mg liquid formulations of CIMZIATM (certolizumab pegol), given every two weeks over a period of 12 weeks to patients with moderate to severe chronic plaque psoriasis previously treated with other biologics (including anti-TNFs), significantly reduced the redness, thickness and scaliness of lesions compared with placebo. "The results from the first study involving patients treated with certolizumab pegol who had previously been treated with other biologics suggest that it has the potential for further development into a valuable new treatment option for this difficult-to-treat disease," commented Professor Jean-Paul Ortonne, Department of Dermatology, Hospital LÀrchet, Nice, France. The phase II, randomized, double-blind placebo-controlled dose-ranging study involved 176 patients with moderate to severe chronic plaque psoriasis who were candidates for systemic therapy and/or phototherapy or photochemotherapy. 60 patients (34.1%) had previously used biologics, including 41 (23.3%) with prior anti-TNF use. The patients were randomized to receive subcutaneous liquid CIMZIATM (certolizumab pegol) 200mg (59 patients) or 400mg (58 patients) or placebo (59 patients) every two weeks for 12 weeks. The first dose of CIMZIATM (certolizumab pegol) was 400mg for both active treatment groups. In the sub-group of patients treated with a prior biologic (either anti-TNF or T-cell modulator), the difference in PASI 75 response between the active and placebo groups was 80% and 86% in the 200mg and 400mg arms respectively (p Similar results were observed in the subgroup of patients who had received prior anti-TNF therapy, with a difference of 77% and 86% in the number of patients achieving PASI 75 in the 200mg and 400mg arms respectively compared with placebo (p Results showed CIMZIATM (certolizumab pegol) was well tolerated. 66.7% of patients in the CIMZIATM (certolizumab pegol) 200mg arm, 61.4% of patients in the CIMZIATM (certolizumab pegol) 400mg arm and 67.2% of patients in the placebo arm reported an adverse event, the majority of which were of mild or moderate intensity.1 "These results suggest that patients with moderate to severe psoriasis treated with CIMZIATM may achieve high levels of response, irrespective of prior biologic use," remarked Olav Hellebo, Senior Vice President and President of Inflammation Operations, UCB. "It is important to note that all responders in this 12 week study are currently being followed-up until relapse or for a maximum of 24 weeks." About Psoriasis Psoriasis is a chronic skin disease of scaling and inflammation that affects around 125 million people worldwide, including 2% of the European population (one in 50 people). Although the disease occurs in all age groups, it primarily affects adults. Psoriasis occurs when skin cells quickly rise from their origin below the surface of the skin and pile up on the surface before they have a chance to mature. Usually this movement (also called turnover) takes about a month, but in psoriasis it may occur in only a few days. In its typical form, psoriasis results in patches of thick, red (inflamed) skin covered with silvery scales. These patches, which are sometimes referred to as plaques, usually itch or feel sore. They most often occur on the elbows, knees, other parts of the legs, scalp, lower back, face, palms, and soles of the feet, but they can occur on skin anywhere on the body. The cause of psoriasis is unknown, but it is thought to result from a deficiency in the body's immune system. There is no 'cure' for the disease, which is characterized by outbreaks interspersed by varying periods of remission. Psoriasis can have a markedly negative effect on quality of life, affecting a sufferer's physical, social, and psychological functioning.2 PASI 75 The 'Gold Standard' for the assessment of extensive psoriasis is the Psoriasis Area and Severity Index (PASI). This measures the average redness, thickness and scaliness of the lesions (each graded on a 0-4 scale), weighted by the area of involvement. PASI 75, a 75% improvement in PASI, is well established as a clinically meaningful endpoint for clinical trials in psoriasis.3 About CIMZIATM (certolizumab pegol) CIMZIATM (certolizumab pegol) is an investigational drug product. CIMZIA™ (certolizumab pegol) is the first and only PEGylated, Fc-free anti-TNF, and is currently being evaluated in the treatment of psoriasis, via subcutaneous administration. CIMZIATM (certolizumab pegol) is Fc-free and thus avoids potential cellular cytotoxicity. CIMZIATM (certolizumab pegol) 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. UCB filed a BLA with the Food and Drug Administration (FDA) for CIMZIATM (certolizumab pegol) in the treatment of Crohn's disease on February 28, 2006 and on April 28, 2006 submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the same indication. In February 2007, UCB announced positive results for two pivotal Phase III studies (RAPID 1 and RAPID 2) investigating the efficacy and tolerability of CIMZIATM (certolizumab pegol) in the treatment of rheumatoid arthritis. Further data from both RAPID 1 and RAPID 2 will be presented at major international rheumatology congresses later this year. Preparation for a license submission in the treatment of rheumatoid arthritis is ongoing, with filing planned later this year. About UCB UCB is a leading global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and Oncology - UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in 40 countries, UCB achieved revenues of € 2.3 billion in 2005. With worldwide headquarters located in Brussels, Belgium, UCB is listed on the Euronext Brussels Exchange.

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