最新数据显示美罗华可显著而持久地减轻风湿性关节炎症状
患者在接受连续几个疗程治疗后可体验到稳定的安全性
西班牙巴塞罗那6月13日讯：在欧洲抗风湿联盟（EULAR）会议上提交的最新数据显示，美罗华（MabThera）利妥昔单抗（rituximab）在减轻风湿性关节炎令人苦恼的症状方面有着持续的疗效，并且如果继续接受连续几个疗程的治疗还可以获得更好的效果，同时症状消失的患者数量也有所增加。重要的是，美罗华的安全性在已经接受了长达7个疗程治疗（间隔6至12个月）的患者身上仍然保持不变。
加拿大多伦多大学（University of Toronto）风湿病系教授凯斯通（Keystone）在评论这些发现时表示：“由于医生获得了有关美罗华治疗的经验，并且长期的疗效和安全性数据也在不断积累，我们能够为我们患者的最终利益而做出信心十足的治疗决策。”
接受连续疗程治疗后的结果
共有1053名风湿性关节炎患者接受了美罗华治疗，其中有近70%的患者接受了2年以上的跟踪调查，11%接受了3年以上的跟踪调查。该研究在一些对肿瘤坏死因子（TNF）抑制剂或改善病情抗风湿药没有充分响应的患者中展开，这两种药均是常用的风湿性关节炎类药物。所有参与研究的患者都根据病情接受了多个疗程的美罗华（2×1000毫克注射，间隔两周）治疗。
数据显示在对肿瘤坏死因子抑制剂没有充分响应的患者接受了3个疗程的美罗华治疗之后：
·实现难以实现的目标（ACR70响应，即病症改善了70%）的患者数量几乎增长了两倍，从11%增至25%
·症状消失的患者数量从6%增至12%
同样，在对改善病情抗风湿药没有充分响应或不耐受的患者中，症状消失率增长了近两倍，从5%增至14%，这证实了为有响应患者提供后续疗程的益处。
美罗华的长期安全性
检验美罗华长期安全性的进一步的综合数据显示，美罗华具有持续稳定的安全性，接受长达7个疗程治疗的1053名患者中严重感染的比率非常低，并且保持不变。这些结果对大量的美罗华安全性数据形成了补充，这些数据是对2438名患者进行数年的跟踪调查收集到的。
关于风湿性关节炎和美罗华
风湿性关节炎是一种自体免疫疾病，表现为能够导致行动迟缓、肿胀以及关节疼痛的炎症。现有的疗法包括改善病情类药物以及诸如肿瘤坏死因子抑制剂这样的生物药物。
美罗华是业界首个在风湿性关节炎炎症级联反应初期有选择性地杀死B细胞的疗法。B细胞在引起与风湿性关节炎有关的炎症上起着重要的作用，而美罗华可以破坏风湿性关节炎炎症级联反应。风湿性关节炎炎症级联反应是能够使关节骨液发炎的一系列反应，并可导致软骨损失和骨骼侵蚀，而这也正是风湿性关节炎的症状。美罗华有可能提供一种创新型新疗法，甚至可以治疗那些顽固性长期风湿性关节炎。长期以来，美罗华在治疗一种名为非何杰金瘤（NHL）的淋巴腺癌方面有着良好的疗效。美罗华的安全性目前已经在过去9年中于960,000多名患者身上得到了印证，这些患者患有肿瘤和自体免疫疾病。
关于罗氏的风湿性关节炎领域
罗氏未来几年增长的最重要推动力之一预计将是该公司在自身免疫类疾病领域的新兴特许权，而首当其冲的则是其中的风湿性关节炎领域。在推出美罗华之后，又有大量项目进入了开发阶段，这为罗氏进一步增大机遇提供了潜在的动力。美罗华是首类也是唯一一种风湿性关节炎选择性B细胞疗法，它通过杀死B细胞而提供了一种截然不同的疗法，B细胞在风湿性关节炎的发病机理中起着关键作用。Actemra是罗氏的第二种创新型药物，它是白介素-6（IL-6）受体的人源化单克隆抗体，白介素-6受体能够抑制白介素-6的活动，而白介素-6是一种在风湿性关节炎的炎症形成过程中起着主要作用的蛋白质。Actemra是中外制药株式会社（Chugai）同心协力研究的结果，目前正在同中外制药株式会社的合作下在全球进行共同开发。建立了丰富的产品线的其他项目包括一些正处于Ⅰ期、Ⅱ期以及Ⅲ期临床试验的药物。值得注意的是，一种用于治疗风湿性关节炎的完全人源化的抗CD20抗体ocrelizumab已经进入Ⅲ期开发阶段。
关于罗氏
罗氏总部位于瑞士巴塞尔，是致力于医药品和诊断学研究领域的全球领先的医疗保健集团之一。作为全球最大生物技术公司以及用于疾病早期探测、预防、诊断和治疗的创新产品和服务的供应商，罗氏对人们的健康和生活质量的改善做出了多方面的贡献。罗氏是体外诊断学领域的全球领导者、领先的癌症和移植药物供应商以及病毒学（virology）领域的市场领导者，并积极涉足其他治疗领域，如自身免疫性疾病、炎症、新陈代谢和中枢神经系统。2006年，罗氏药品部（Pharmaceuticals Division）销售额总计为333亿瑞士法郎，而诊断部（Diagnostics Division）销售额为87亿瑞士法郎。罗氏在全球拥有约75,000名员工，并与众多合作伙伴签订了研发协议并结成了战略联盟，其中包括在基因技术公司（Genentech）和中外制药株式会社拥有多数股权。垂询详情，请访问：www.oneyao.net
参考文献
1、疾病活动通过疾病活动积分（Disease Activity Score，DAS）来衡量，DAS28值低于或等于3.2的为低疾病活动度，DAS28值低于或等于2.6的表示症状已经消失。
2、ACR响应是一种标准的评估，用来衡量患者对抗风湿疗法的反应，由美国风湿病学学会（American college of Rheumatology）设计。它要求患者的众多症状能够出现指定程度的减轻。例如，20%，50%或70%的减轻度表示为ACR20，ACR50或ACR70。ACR70响应对于现有的治疗来说是非常突出的效果，表示患者的病情有了显著的改善。
Wednesday, 13 June 2007
Latest data show MabThera provides significant and sustained relief from signs and symptoms of rheumatoid arthritis
Patients experience consistent safety profile with subsequent courses of therapy
Barcelona, Spain. New data presented at the EULAR meeting (European League Against Rheumatism) demonstrate that MabThera's (rituximab) effectiveness in relieving patients of the distressing symptoms of rheumatoid arthritis (RA) is sustained or further improved with subsequent courses of treatment, as is the number of patients achieving remission1. Importantly, the safety profile of MabThera remained unchanged in patients who had received as many as seven courses of treatment at 6-12 month intervals.
Commenting on the findings, Professor Keystone, Rheumatology Department at the University of Toronto, Canada, said: "As physicians gain experience with MabThera and the long-term efficacy and safety data are collected, we are able to make treatment decisions with confidence for the ultimate benefit of our patients".
Results following subsequent courses of therapy
A total of 1053 RA patients was treated with MabThera with almost 70% of patients followed up for more than two years and 11% for more than three years. The study was conducted in patients who had an inadequate response to treatment with either tumour necrosis factor (TNF) inhibitors or disease-modifying anti-rheumatic drugs (DMARDs), both of which are commonly used classes of RA drugs. All study patients received multiple courses of MabThera (2 x1000mg infusion, 2 weeks apart) based on disease activity.
The data showed that after three courses of MabThera in patients who had an inadequate response to TNF inhibitors:
The number of patients achieving the hard-to-reach goal of a 70% improvement in disease signs and symptoms (ACR70 response2) almost tripled from 11% to 25%
The number of patients achieving remission improved from 6% to 12%
Equally, in patients with an inadequate response or intolerance to DMARDs, the remission rate increased almost threefold from 5% to 14% confirming the benefit of providing subsequent courses to responding patients.
Long-term safety of MabThera
Further pooled data examining the safety of MabThera when used long-term revealed that the safety profile of MabThera remained consistent with a low, unchanging rate of serious infections in 1053 patients, receiving up to seven treatment courses. These results add to the wealth of data contributing to MabThera's safety profile with 2438 patient-years of follow-up now collected.
About Rheumatoid Arthritis and MabThera
Rheumatoid arthritis is an autoimmune disease characterised by inflammation that leads to stiff, swollen and painful joints. Current treatments include disease-modifying drugs (DMARDS) and biologic therapy such as the TNF inhibitor drugs.
MabThera is a first-in-class therapy that selectively targets B cells early in the inflammatory cascade of rheumatoid arthritis. B cells are known to play a key role in the inflammation associated with rheumatoid arthritis and MabThera breaks the inflammatory cascade of RA – a series of reactions inflaming the synovia and leading to the cartilage loss and bone erosion that is characteristic of the disease, and may provide an innovative new treatment even in patients with severe and long-standing disease. MabThera has a strong heritage in the treatment of a form of lymphatic cancer called non-Hodgkin's lymphoma (NHL) and the safety profile of MabThera has now been established in more than 960,000 patient exposures over the last nine years in oncology and autoimmune disease.
About Roche in Rheumatoid Arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera, there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche's second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6, a protein that plays a major role in the RA inflammation process. Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a fully humanised anti-CD20 antibody, is just entering phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs approximately 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at
All trademarks used or mentioned in this release are protected by law.
For a selection of broadcast footage clips relating to MabThera and rheumatoid arthritis please visit
To view and download high resolution stills and media materials please visit the MabThera Virtual Press Office at
References
1 Disease activity is measured by a Disease Activity Score (DAS), where low disease activity is defined as DAS 28 ≤ 3.2 and remission is defined as DAS 28 ≤ 2.6
2 The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20%, 50% or 70% level of reduction is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition.