Certolizumab pegol shows a rapid and effective treatment in patients with rheumatoid arthritis both as monotherapy and in combination therapy.

• The FAST4WARD study shows that certolizumab pegol administered as monotherapy is the first anti-TNF-α subcutaneous showing actual clinical benefit at four weeks of treatment • The RAPID 2 study shows a greater reduction of signs and symptoms and progression of rheumatoid arthritis Two pivotal studies published online in Annals of the Rheumatic Diseases, show that certolizumab pegol, the only anti-TNF pegylated Fc region with the company UCB Pharma, is effective and well tolerated both as monotherapy and in combination with methotrexate (MTX) in adults with active rheumatoid arthritis. The Study FAST4WARD The Study FAST4WARD of six months' duration, achieved its primary and secondary objectives and demonstrated that certolizumab pegol administered subcutaneously in doses of 400mg every four weeks as monotherapy, significantly reduced the signs and symptoms and pain associated with arthritis arthritis. In addition, improved physical function compared with patients treated with placebo (sorbitol). In the words of Professor Roy Fleischamm, Southwestern Medical Center at the University of Texas, Dallas "The positive results of the survey FAST4WARD are encouraging and demonstrate the potential of certolizumab pegol as a future treatment for patients with rheumatoid arthritis." Also stressed, "While the RAPID studies have shown the benefits of rapid certolizumab pegol in combination therapy, this is the first Phase III clinical trial demonstrating its effectiveness in monotherapy. This may become important when patients need to discontinue conventional treatments, due to poor tolerability or because they have contraindications to these treatments. " FAST4WARD: Main results of the clinical trial Upon reaching the main goal, patients treated with certolizumab pegol showed rates significantly higher ACR20 response at week 24 versus those who were in the placebo group (p <0001:45,5% versus 9.3%). Response to treatment was rapid, with more than one third of patients (36.7%) treated with certolizumab pegol, and reaching ACR20 response at week 1 of treatment. Patients treated with certolizumab pegol also experienced clinically significant improvement in physical function (HAQ-DI) from week 1 to week 24, relative to placebo (p <0.001). This is consistent with the significant reduction of levels of pain (VAS) and disease activity (DAS 28-3) (p <0001). Certolizumab pegol was generally well tolerated with a low incidence of pain in the area of injection (n = <3 new casos/100 patient years) and discontinued due to adverse events. Most adverse events reported in both treatment groups were mild to moderate. The most common adverse events were headache, nasopharyngitis, infections of the upper airways, sinusitis and diarrhea. Adverse events were serious infections and cancer, which is consistent with the findings of other trials in the class of anti-TNF. RAPID 2 The RAPID 2 study, conducted over six months, showed that treatment with certolizumab pegol, together with MTX, significantly improves the clinical signs and symptoms of rheumatoid arthritis, and inhibits disease progression and improving physical function in adult patients with active rheumatoid arthritis. According to principal investigator, Professor Josef Smol, Division of Rheumatology, Medical University of Vienna, "this study is important to reaffirm the benefits of certolizumab pegol in reducing pain and symptoms of rheumatoid arthritis, and the ability to prevent structural damage associated with early this debilitating condition. " Similarly, Professor Smol stressed, "These findings are consistent with data from the RAPID 1 study extension presented last week at the Annual Scientific Congress of the American College of Rheumtaology. The results showed long-term benefits of certolizumab pegol providing symptom relief, improving productivity and quality of life and reducing fatigue. RAPID 2: Main results of the clinical trial In the RAPID 2 study, patients with severe disease treated with certolizumab pegol (200mg or 400 mg), together with MTX, ACR20 responses were significantly higher from week 1, compared with patients treated with placebo plus MTX (p <0 , 01). The results were maintained throughout the study. Patients in both treatment groups had significant clinical improvements in physical function (HAQ-DI) from week 1, compared with group treated with placebo and MTX, the improvements in quality of life of patients were maintained through week 24 (0001). In addition, certolizumab pegol inhibited progression of structural joint damage, with minimal changes since the baseline in modified Total Sharp (MTSS) at week 24, compared with MTX alone (p <0001). There were no statistically significant differences in the clinical efficacy of primary and secondary variables between treatment arms 400mg or 200 mg of certolizumab pegol. Concurrent studies, RAPID 1 and RAPID 2, are the first clinical trials in Phase III, placebo-controlled trials, to demonstrate the efficacy and tolerability of certolizumab pegol in the treatment of rheumatoid arthritis. In addition, part of the clinical trials program involving more than 2,300 patients. The group of safety data from both studies show that certolizumab pegol was, in general, well tolerated, with a low incidence of pain in the area of injection (n = <3 new casos/100 patient years) and discontinued due to adverse events. The most common adverse events were headache, nasopharyngitis, and infections of the upper respiratory tract (including tuberculosis) and tumors (including lymphoma). The FDA accepted for processing the Biological License Application for certolizumab pegol for the treatment of adult patients with active rheumatoid arthritis in February 2008. UCB submitted the Request for Authorization to Trade the European Medicines Agency in June 2008, requesting approval of certolizumab pegol as a subcutaneous treatment for adults with rheumatoid arthritis, moderate to severe. About FAST4WARD (Study O11) The 24 weeks FAST4WARD study (Efficacy and Safety of cerTolizumab pegol - 4 Weekly dosage in rheumatoid arthritis) was designed to evaluate the efficacy and tolerability of certolizumab pegol 400mg monotherapy. The clinical trial phase III, randomized, double-blind, placebo-controlled trial involving 220 adults with active rheumatoid arthritis who had previously failed at least one of the disease modifying drugs (FAMEs). Patients were randomized to receive certolizumab pegol subcutaneous 400 mg every four weeks (n = 111) or placebo-sorbitol (n = 109). Patients were evaluated based on improvements in the signs and symptoms of rheumatoid arthritis. FAST4WARD The study achieved its main objective, l ACR20 response rate at week 24, as well as its secondary targets including the rates of ACR50 and ACR70 response. The patients who received certolizumab pegol experienced statistically significant clinical improvements in all ACR components at week 24 compared with those who were in the placebo group (p <0.5). About RAPID 2 The pivotal RAPID 2, double-blind, placebo-controlled trial, involving 619 patients with active rheumatoid arthritis in adults. The study was designed to evaluate the efficacy and tolerability of subcutaneous certolizumab pegol (200 and 400 mg), together with MTX every two weeks, compared with placebo plus MTX in patients with active rheumatoid arthritis. Patients were randomized to receive one of three treatment regimens: 246 patients received certolizumab pegol 400 mg at weeks 0, 2 and 4, then 200 mg of certolizumab pegol every two weeks, 246 patients received certolizumab pegol 400mg every two weeks; 127 patients received placebo every two weeks. Rapid 2 The study achieved its primary objective of ACR20 response at week 24, as well as secondary objectives: change from baseline in the MTSS and 50 and ACR 70 responses at week 24. Significantly more patients in the certolizumab pegol groups of 200 and 400mg achieved ACR20 response compared with placebo (p <0.001) rates were 57.3%, 57.6% and 8.7% respectively. Certolizumab pegol (200 and 400 mg) also significantly inhibited radiographic progression, the mean changes from baseline at week 24 MTSS were 0.2 and -0.4, repectivamente, versus 1.2 with placebo (analysis of rank p <, 01). Patients treated with certolizumab pegol was swift and significant improvements in physical function versus those treated with placebo (p <0.001). About UCB UCB Pharma (www.ucb-group.com), based in Brussels, Belgium, is a leading biopharmaceutical company, global in nature, and devoted to research, development and commercialization of innovative pharmaceutical products that focus on areas of the central nervous system and immunological diseases. With around 12,000 employees in over 40 countries, UCB Pharma achieved revenues of 3.6 billion euros in 2007. UCB Pharma is listed on Euronext Brussels (with the symbol: UCB).

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