新藥資訊：Lemtrada 蘭特拉達

多發性硬化症 有新藥救了

【休士頓訊  聖安東尼奧】

 

藥物Lemtrada最初被美國FDA拒絕，但幾個月前該決定被推翻，已經批准局批准。

 

麗莎卡普斯（Lisa Capps）一年前生下一名女兒後，被診斷出患了多發性硬化症，由於這種疾病逐漸發展，最終會造成失明、無法行走、大小便失禁、失去平衡感等嚴重問題，令她對未來相當恐懼。 麗莎卡普斯不久之後將在聖安東尼奧神經中心（Neurology Center of San Antonio）開始接受蘭特拉達療法，該中心的多發性硬化症專家安巴斯醫師（Dr. Ann Bass）表示，在先前的臨床實驗中，有些病人在接受過兩年的蘭特拉達療程以後，接下來的十年中，症狀不斷減輕，令醫學界非常興奮。
在接受療程的頭兩年，病人每年住院一個星期，每天花七個小時以靜脈注射（intravenous injection）的方式，讓蘭特拉達把身體免疫系統的各種細胞摧毀，然後讓免疫系統重新開機，把免疫系統再一次建立起來。
由於在這段期間病人的免疫功能欠缺，所以需要醫師仔細觀察，特別是要注意腎臟（kidneys）和甲狀腺（thyroid）的功能。頭兩年之後，病人每天需要吃藥，每個星期需要打針。如果新建立的免疫系統不再去攻擊自身的組織與器官，病人可望不會再受多發性硬化症的困擾。
 

 附上Lemtrada 蘭特拉達 藥物經過美國FDA的核准以及藥物使用說明
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM426512.pdf
 附上Lemtrada 蘭特拉達 藥物相關資訊以及說明
http://www.rxlist.com/lemtrada-side-effects-drug-center.htm
以上為重要的連結。


常見的副作用包括：
 皮疹，頭痛，發熱，鼻咽炎，噁心，尿路感染，疲勞，失眠，上呼吸道感染，皰疹病毒感染，蕁麻疹，瘙癢，甲狀腺疾病，真菌感染，關節痛，痛在四肢，背部腹痛，腹瀉，鼻竇炎，口腔疼痛，麻木或刺痛，頭暈，腹痛，面色潮紅，嘔吐。

藥物使用：
Lemtrada蘭特拉達的推薦劑量為12毫克/天，2個療程給予靜脈滴注：第一療程：12毫克/天 連續5天（60毫克總劑量;二療程：12毫克/日 連續3天（36毫克總劑量）的第一個療程12個月後執行。Lemtrada可以與其他藥物發生相互作用。

臨床試驗

在對照臨床試驗（研究1和研究2），一共有811例的MS的接收LEMTRADA復發的形式。共有811名患者接受第1個療程的治療，789例患者接受治療的第二個療程12個月。65％為女性，92％是白人。

附上原文報導：

SAN ANTONIO - A groundbreaking new treatment for multiple sclerosis is now available in the United States and is being used to treat patients in San Antonio.

The drug Lemtrada was initially denied approval by the U.S. Food and Drug Administration but the decision was reversed several months ago, after a big outcry from the MS patient community.
Lisa Capps was excited to try the new treatment. She'll spend the week hooked up to an intravenous treatment of Lemtrada for about seven hours a day for five days.
However, she believes the time spent will be worth it. Other treatments for MS haven't worked for her and said she believes the new treatment could give a fighting chance.
"This was the newest thing out there and what they call the closest to a cure that we can get to MS right now," said Capps.
Capps was first diagnosed about a year ago, shortly after he daughter was born.
"I have to walk with a cane now and I also have cognitive problems, so I have difficulty thinking, focusing, holding attention," she said.
As the disease progresses, it could lead to vision loss, complete inability to walk, urinary and bowel disfunction, the inability to sense arms and legs, dizziness, loss of balance, and other disabilities.
Treatment with Lemtrada is expected to slow progression of the disease and reduce relapses.
Capp's physician, Dr. Ann Bass, a neurologist and multiple sclerosis specialist at Neurology Center of San Antonio, said Lemtrada works by rebooting the immune system and is similar to rebooting a computer.
She said it wipes out the immune system, then allows it to rebuild over time.
"The immune system kind of rebalance itself and it can last for several years," Bass said.
At first, patients need close monitoring, especially for kidney and thyroid function. During the time the immune system is low, patients require frequent health checks.
However, according to Bass, clinical trials have had ground breaking results
"I have patients in 10 years remission after two years of treatment," she said. " It improves their prognosis and really, most importantly, it just really improves their quality of life."
"It gives me lots of hope because I have a daughter who is 15 months old and I want to be able to keep up with her," said Capps.
Lemtrada is also unique because of the dosing.
According to Bass, other treatments include daily pills or injections several times a week, while Lemtrada is given intravenously for a five-day period the first year and then a three-day period for the second year.

新藥資訊：Lemtrada 蘭特拉達

新藥和醫療發展更新

新藥(諾華藥廠)Gilenya 口服藥物的回顧檢驗

Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths.

加拿大衛生局正在檢視和Gilenya代號FTY720 (fingolimod) 口服藥物是否上市,因為此醫藥物目前造成11位MS患者的死亡

There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya.

Gilenya, also called fingolimod, is taken once a day for people with the relapsing-remitting form of MS. (Novartis)

Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role.

Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya.

包含美國FDA和歐洲藥品局早先都宣布再次檢視此藥物的情形

Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated.

At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect.

But Health Canada says it felt the drug's benefits outweighed its risks.

Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks and another a disturbance of the heart rhythm. The seven other deaths are unexplained, including one from the United States involving a person who died within 24 hours of his or her first dose of Gilenya.

這11位死亡的案例中有4位和心臟相關 (3位心臟病1位心率不整) 其他7位未明(其中一位第一次服用後24小時內就死亡)

Health Canada says people taking the drug should not discontinue it without consulting their doctor. But anyone on the drug who is feeling symptoms of heart disease — including chest pain, slow or irregular heartbeat, or dizziness — should seek medical care.

The department says doctors should monitor patients on the drug closely. Blood pressure should be checked regularly as the drug is known to increase blood pressure.

看來目前只有Ampyra還較為安全（通用名稱dalfampridine，以前稱為fampridine），是第一個臨床治療是口服和第一個同類接受FDA的批准。其目的是幫助人們與任何類型的MS提高步行速度。該藥物的研製藥廠為 : Biogen Idec

更多閱讀:

美國FDA 批准第一個多發性硬化症的口服新藥

給不想手術，想服藥的病友

醫療發展更新

Application closes for MS Liberation treatment study in New York

日前有關於加拿大Saskatchewan和美國共同進行靜脈擴張術研究的申請名額已經額滿,加拿大共接到682患者参與實驗研究

For hundreds Multiple Sclerosis patients in Saskatchewan the next few months will be spent waiting.

On Friday, February 24 the deadline closed for the provincially funded MS Liberation Treatment trial in Albany, New York. The government received 682 applications to be part of the trial

Lori Lumax is one of the many people hoping to be chosen for the double-blind study and she is happy to see the government taking a step in the right direction.

“I’m really happy that this is going and there’s more studies coming out all the time so Canada is getting on top of it finally,” Lumax said.

The 46-year-old from Regina was diagnosed in 2003 and most of the time she only feels tired and dizzy. About once a year she has a relapse of symptoms which affect her cognitive functions causing her to lose feeling in her hands and feet and her balance.

Lumax said she is very excited for the study because all of the data will be documented to see if the controversial liberation treatment really works.

“If I’m not chosen for this trial – well, I’ll be looking at other trials coming up,” she said, explaining that she doesn’t want to wait for two years to see if the treatment will be offered here.

Lumax added that she is not willing to go overseas for treatment because she wants to know that there will be after-care in place.

Saskatchewan has one of the highest rates of MS with 3,500 people suffering from the disease. Starting in March the provincial government will send 86 patients to participate in the study in New York.

3月開始將會有86名Ms患者至紐約進行實驗手術研究

新藥和醫療發展更新