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2012年6月12日 星期二

新藥資訊更新


諾華公司的MS藥物Gilenya顯示長期療效和安全性,延長第三階段的研究頭

巴塞爾
,2012年6月12日,星期二,10:00 [北京時間]
諾華公司日前宣布新的長期數據Gilenya(芬戈莫德),唯一的口服療法批准用於治療復發的多發性硬化症(MS),顯示高達4.5連續多年的持續療效的利益和一致的安全性的人治療。這些結果,從第三階段擴展頭變換的研究,也表明為切換到Gilenya AVONEX(β-干擾素-1A IM),常用的治療多發性硬化症的患者提高療效。這些數據在第22屆歐洲神經學會(ENS),從6月9-12 2012年度會議在布拉格,捷克共和國。“這些數據進一步鞏固我們在Gilenya的長期有效性和安全性的信心。轉換擴展的研究表明,治療多發性硬化症患者不斷與Gilenya為多達四個半的時間裡表現出持續的臨床和MRI活動水平低,諾華製藥全球發展主管蒂姆·懷特說。“ “此外,患者誰干擾素β-1A IM Gilenya顯示為核心的研究相比,減少復發和擴展MRI措施改善。” 為核心的變換研究,Gilenya證明療效優於干擾素-β-1A即時通訊,減少在一年的年復發率(ARR)= 52%(Gilenya 0.5毫克,房租= 0.16;干擾素-β-1A IM,房租= 0.33,P <0.001)。擴展研究表明,這樣低的復發率,患者接受連續治療長達4.5年(Gilenya 0.5毫克,ARR的核心研究= 0.16; ARR的擴展研究= 0.16)Gilenya(N = 356)持續。從擴展研究的數據也表明,Gilenya治療的患者繼續保持低腦萎縮率在整個評估腦容量損失,這是作為一個長期殘疾的預測價值計量的研究。患者轉換為Gilenya開放標籤擴展研究(N = 167),他們的平均房租為0.33時,在核心研究治療干擾素-β-1A IM和0.20 Gilenya(NS)治療時,在推廣階段。在開關組患者還顯示,Gilenya開關後的腦萎縮放緩。從4.5年,這些擴展數據還表明Gilenya長期治療一般耐受性與安全性具有舉足輕重的試驗一致。與以往的研究,包括變換研究的核心,最常見的副作用是鼻咽炎,頭痛,上呼吸道感染。干擾素β-1A開關從治療Gilenya沒有透露任何新的或意外的安全關切。在開始治療,無症狀性短暫性心動過緩的發病率較低,觀察患者干擾素-β-1A IM切換到Gilenya(IFN-0.5毫克[0.6%]),未經處理解決。整體心臟事件的所有病人組相似。此外,所有患者治療Gilenya在擴展階段,無論在原治療的核心研究,發現相當比例的患者MRI疾病活動的自由,研究結束。(钆增強T1病變:在開關組的77.4%與74.7%Gilenya 0.5毫克;新/新擴大的T2病灶:開關組的45.0%與42.0%Gilenya 0.5毫克)。澤維爾蒙塔爾班,博士說:“ 連續和開關組沒有顯著性差異在研究結束時殘疾進展。“此擴展研究數據提供了深入了解芬戈莫德療效和安全性,多發性硬化症中心主任加泰羅尼亞,西班牙,巴塞羅那瓦爾德希伯倫大學附屬醫院臨床免疫學,單位。“結果,這是關鍵的第三階段研究是一致的,證實芬戈莫德治療MS的復發形式是非常有效的,作為第一個可用的口服治療多發性硬化症的,仍然是一個合適的患者有價值的治療方案。” 變換,大型III期雙盲,雙模擬,頭對頭研究,涉及1292與復發型多發性硬化症患者進行了一年多,比較Gilenya的療效和安全性,干擾素-β-1A IM。在12個月的核心研究結束時,符合條件的患者可以參加的擴展研究,跑了一個額外的3.5年。患者每日一次口服Gilenya仍然藥物和那些已與干擾素-β-1A(IM)治療轉換為擴展研究期間Gilenya。截至2012年2月,約36,000名病人已經與芬戈莫德治療臨床試驗和上市後的設置,有的高達7年,目前有大約34,000暴露患者年。Gilenya,從三菱田邊製藥公司的許可,是在第一類新的化合物稱為鞘氨醇1 -磷酸受體(S1PR)調製器。它已經證明療效優於Avonex的,常用的治療相比,相對減少了52%,年復發率(主要終點),相對減少了40%,腦萎縮的速度在一年(次要終點)復發型多發性硬化症患者中舉足輕重的頭頭試用。在最近的一個子分析,Gilenya表明在年復發率相對減少61%在一年相比,干擾素-β-1A(IM)與高活性復發-緩解型MS沒有響應干擾素治療的患者群。,Gilenya一般是一個非常有效的,每日一次口服治療多發性硬化症。在臨床試驗中,它被普遍良好的耐受性,可管理的安全性,並有越來越多的約36,000名患者已在臨床試驗治療Gilenya的長期有效性和安全性的經驗,並在上市後的設置。目前,還有約34000病人年曝光。

在臨床試驗中,最常見的副作用頭痛,肝酶升高,流感,腹瀉,腰痛,咳嗽Gilenya相關的其他副作用包括短暫的,一般無症狀,心率減少後開始治療和房室傳導阻滯,輕度血壓升高,黃斑水腫,輕度支氣管感染的整體,包括嚴重的感染,發生率治療組之間的可比性,雖然被視為下呼吸道感染(主要是支氣管炎)略有增加Gilenya治療的患者。整個臨床試驗方案的報告惡性腫瘤的人數為少,可比費率之間的的Gilenya和控制組。諾華公司提供創新的醫療解決方案,滿足患者和社會的不斷變化的需求。它提供了一個多元化的投資組合,以更好地滿足這些需求的創新藥物,眼部護理,成本節約型非專利藥品,預防性疫苗和診斷工具,過度的櫃檯和動物保健品。

以上為諾華公司的報告
原文如下:

Novartis MS drug Gilenya shows long-term efficacy and safety in extended phase III head-to-head study

Basel
Tuesday, June 12, 2012, 10:00 Hrs  [IST]
Novartis has announced that  new long-term data for Gilenya (fingolimod), the only oral therapy approved to treat people with relapsing forms of multiple sclerosis (MS), show a sustained efficacy benefit and a consistent safety profile with up to 4.5 years of continuous treatment. These results, from an extension of the phase III head-to-head TRANSFORMS study, also showed improved efficacy for patients switched to Gilenya from Avonex (interferon-beta-1a IM), a commonly prescribed MS treatment.

These data were presented at the 22nd Annual Meeting of the European Neurological Society (ENS), from June 9-12 2012 at Prague, Czech Republic.

“These data further reinforce our confidence in Gilenya's long-term effectiveness and safety profile. The TRANSFORMS extension study shows that MS patients treated continuously with Gilenya for up to four and a half years demonstrated sustained low levels of clinical and MRI activity,” said Tim Wright, Global Head of Development, Novartis Pharma. “Furthermore, patients who switched to Gilenya from interferon beta-1a IM showed a reduction in relapses and improvements in MRI measures in the extension compared to the core study.”

In the core TRANSFORMS study, Gilenya demonstrated superior efficacy to interferon-beta- 1a IM, reducing the annualized relapse rate (ARR) by 52 per cent at one year (Gilenya 0.5 mg, ARR = 0.16; interferon-beta- 1a IM, ARR = 0.33; p<0.001). The extension study showed that this low relapse rate was sustained in patients receiving continuous treatment with Gilenya (n=356) for up to 4.5 years (Gilenya 0.5 mg, ARR core study = 0.16; ARR extension study = 0.16). The data from the extension study also showed that patients treated with Gilenya continuously maintained a low brain atrophy rate throughout the study as measured by assessing brain volume loss, which is valued as a predictor of long-term disability.

For patients who switched to Gilenya for the open-label extension study (n=167), their ARR was 0.33 in the core study when treated with interferon-beta-1a IM and 0.20 in the extension phase when treated with Gilenya (n.s.). Patients in the switch group also displayed a slowing of brain atrophy following the switch to Gilenya.

These extension data from up to 4.5 years also showed long-term treatment with Gilenya was generally well tolerated with a safety profile consistent with pivotal trials. In line with previous studies, including the core TRANSFORMS study, the most common adverse events were nasopharyngitis, headache, and upper respiratory tract infections. Switching therapy from IFN beta-1a to Gilenya did not reveal any new or unexpected safety concerns. On treatment initiation, a low incidence of asymptomatic transient bradycardia was observed in patients who switched from interferon-beta-1a IM to Gilenya (IFN-0.5 mg [0.6 per cent]), which resolved without treatment. Overall cardiac events were similar across all patient groups.

In addition, all patients treated with Gilenya in the extension phase, regardless of original treatment in the core study, showed comparable percentage of patients free from MRI disease activity by the end of the study. (Free from Gd enhanced T1 lesions: 77.4 per cent in switch group vs. 74.7 per cent Gilenya 0.5mg; Free from new/newly enlarged T2 lesions: 45.0 per cent in switch group vs. 42.0 per cent Gilenya 0.5mg). The continuous and switch groups did not significantly differ with respect to disability progression at the end of the study.

“This extension study data provide deeper insight into the efficacy and safety profile of fingolimod,” said Dr Xavier Montalban, director of the Multiple Sclerosis Centre of Catalonia and of the Unit of Clinical Neuroimmunology, Vall d'Hebron University Hospital, Barcelona, Spain. “The results, which are consistent with the pivotal phase III studies, confirm that fingolimod is highly effective in treating relapsing forms of MS, and as the first available oral MS treatment, continues to be a valuable treatment option for appropriate patients.”

TRANSFORMS was a large phase III double-blind, double-dummy, head-to-head study that involved 1,292 patients with relapsing-remitting MS that was conducted over one year, comparing the efficacy and safety of Gilenya to interferon-beta-1a IM. At the end of the 12-month core study, eligible patients could enroll in the extension study, which ran for an additional 3.5 years. Patients on once-daily oral Gilenya remained on drug and those who had been treated with interferon-beta-1a (IM) switched to Gilenya for the duration of the extension study.

As of February 2012, approximately 36,000 patients have been treated with fingolimod in clinical trials and in the post-marketing setting, some up to seven years, and currently there is approximately 34,000 patient years of exposure.

Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators. It has demonstrated superior efficacy compared to Avonex, a commonly prescribed treatment, showing a 52 per cent relative reduction in annualized relapse rate (primary endpoint) and a 40 per cent relative reduction in the rate of brain atrophy (secondary endpoint) at one year in a pivotal head-to-head trial in patients with relapsing-remitting multiple sclerosis. In a recent sub-analysis, Gilenya showed a 61 per cent relative reduction in annualized relapse rate compared to interferon-beta-1a (IM) at one year in subgroups of patients with highly active relapsing-remitting MS not responding to interferon treatment.

Gilenya is generally a highly effective once-daily oral MS treatment. In clinical trials it was generally well tolerated with a manageable safety profile, and there is increasing experience of Gilenya's long-term effectiveness and safety profile, with approximately 36,000 patients having been treated in clinical trials and in a post-marketing setting. Currently, there is approximately 34,000 patient years of exposure. In clinical trials, the most common side effects were headache, liver enzyme elevations, influenza, diarrhoea, back pain, and cough. Other Gilenya-related side effects included transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular edema, and mild bronchoconstriction.

The rates of infections overall, including serious infections, were comparable among treatment groups, although a slight increase in lower respiratory tract infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups.

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. It offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products.



更多延伸閱讀:
2012 2 月 28



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