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DMD Research Update
by sllowe, Nov 28, 2008 09:00AM
, Nov 28, 2008 09:00AM
I know Sherry is doing her research and has to make a DMD decision, so here is a little more if you've not seen the results of these studies (from MSAA site)
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Spring 2008 Research Update
May 19, 2008
A one-year study in Germany found that 1157 patients with relapsing-remitting multiple sclerosis (RRMS) who began and continued on Avonex® for one year, benefited from nursing support. They also experienced a modest improvement in quality of life during this treatment period, as measured through the EuroQol questionnaire (EQ-5D).
In the BENEFIT trial, 468 patients experiencing a first event suggestive of MS (also known as a "clinically isolated syndrome") were randomized to receive immediate treatment with
Betaseron®,or delayed treatment with Betaseron following two years on a placebo (or earlier if a second event occurred). A three-year follow-up showed that patients who received immediate treatment had a 40-percent less risk of sustained disability progression compared to those with delayed treatment. Those receiving immediate treatment also had a 41-percent reduced risk of advancing to clinically definite MS (CDMS) within the three-year time period.
The BEYOND trial compared the effectiveness of three treatment arms (regular-dose Betaseron, double-dose Betaseron, and Copaxone®) in 2244 patients with RRMS. The primary endpoint was relapse risk, and all three treatments showed a robust, equal effectiveness (average follow-up time was just over two years). The annualized relapse rate fell by almost 80 percent, compared to the year prior to entry. Dropout rates showed that all drugs were well tolerated, with the lowest dropout rate in the regular-dose Betaseron group.
Early treatment with Copaxone was compared to placebo in the PRECISE trial, to determine Copaxone's effectiveness in delaying the development of CDMS, for individuals with a first event suggestive of MS. An interim analysis of the study's 481 participants showed a 45-percent risk reduction in the treated group compared to the placebo group. Due to the effectiveness of the treatment, the researchers recommended that the placebo portion of the study be discontinued early, and all patients be switched to active treatment.
The REGARD trial was conducted to compare the effectiveness of Copaxone versus Rebif® in 764 patients with RRMS. The primary endpoint was time to first relapse during a treatment period of nearly two years. The entire study group's population had much less disease activity (based on the pivotal studies conducted earlier) with 45-percent fewer relapses than expected and an annualized relapse rate of just 0.3, which is less than one relapse every three years. No significant difference was seen between the two groups for the primary outcome (time to first relapse).
In a small study in Italy, nine women patients with worsening RRMS (who were not responding to interferon treatment and had no neutralizing antibodies), were given low-dose Novantrone® (mitoxantone) via IV every three months, in addition to their interferon treatment. The Novantrone dose was adjusted for each patient, according to lymphocyte counts. After six months, total relapses dropped from 17 to 1; disability scores improved; and enhancing lesions decreased from 27 to 4. No serious side effects occurred during the treatment period. This reinforces the use of low-dose Novantrone as an add-on rescue therapy in RRMS patients not responding to interferon treatment. The combination therapy may also reduce the risk of adverse events due to the accumulation of high doses of Novantrone. In Turkey, another small study with 23 secondary-progressive MS (SPMS) patients and four individuals with worsening RRMS showed that Novantrone not only improved physical disability, but also improved cognition. With both of these studies, larger, placebo-controlled trials are needed to determine the actual benefits and risks.
As of March 2008, more than 26,000 patients were on Tysabri® worldwide. Since the re-launch of Tysabri in July 2006, no new cases of progressive multifocal leukoencephalopathy (PML) have been reported. PML is an often-fatal viral infection of the brain. Data from the PLEX study suggest that plasma exchange may be an effective procedure for accelerating the removal of Tysabri from the blood if PML infection is suspected. A new warning has been added to Tysabri's label about possible liver injury, and two cases of melanoma (skin cancer) have also been reported in women taking Tysabri, but a connection has not yet been confirmed.
Disappointing results from the OLYMPUS trial show that Rituxan® (rituximab) did not meet its primary endpoint for individuals with primary-progressive MS (PPMS), as measured by the time to confirmed disease progression. Rituxan continues to show encouraging results in reducing disease activity in individuals with RRMS.
The oral drug FTY720 is also showing encouraging results. A phase II study extension shows that 68 to 73 percent of the participating MS patients remain relapse-free, and 89 percent are free from active brain lesions, after three years of treatment.
***************************
Spring 2008 Research Update
May 19, 2008
A one-year study in Germany found that 1157 patients with relapsing-remitting multiple sclerosis (RRMS) who began and continued on Avonex® for one year, benefited from nursing support. They also experienced a modest improvement in quality of life during this treatment period, as measured through the EuroQol questionnaire (EQ-5D).
In the BENEFIT trial, 468 patients experiencing a first event suggestive of MS (also known as a "clinically isolated syndrome") were randomized to receive immediate treatment with
Betaseron®,or delayed treatment with Betaseron following two years on a placebo (or earlier if a second event occurred). A three-year follow-up showed that patients who received immediate treatment had a 40-percent less risk of sustained disability progression compared to those with delayed treatment. Those receiving immediate treatment also had a 41-percent reduced risk of advancing to clinically definite MS (CDMS) within the three-year time period.
The BEYOND trial compared the effectiveness of three treatment arms (regular-dose Betaseron, double-dose Betaseron, and Copaxone®) in 2244 patients with RRMS. The primary endpoint was relapse risk, and all three treatments showed a robust, equal effectiveness (average follow-up time was just over two years). The annualized relapse rate fell by almost 80 percent, compared to the year prior to entry. Dropout rates showed that all drugs were well tolerated, with the lowest dropout rate in the regular-dose Betaseron group.
Early treatment with Copaxone was compared to placebo in the PRECISE trial, to determine Copaxone's effectiveness in delaying the development of CDMS, for individuals with a first event suggestive of MS. An interim analysis of the study's 481 participants showed a 45-percent risk reduction in the treated group compared to the placebo group. Due to the effectiveness of the treatment, the researchers recommended that the placebo portion of the study be discontinued early, and all patients be switched to active treatment.
The REGARD trial was conducted to compare the effectiveness of Copaxone versus Rebif® in 764 patients with RRMS. The primary endpoint was time to first relapse during a treatment period of nearly two years. The entire study group's population had much less disease activity (based on the pivotal studies conducted earlier) with 45-percent fewer relapses than expected and an annualized relapse rate of just 0.3, which is less than one relapse every three years. No significant difference was seen between the two groups for the primary outcome (time to first relapse).
In a small study in Italy, nine women patients with worsening RRMS (who were not responding to interferon treatment and had no neutralizing antibodies), were given low-dose Novantrone® (mitoxantone) via IV every three months, in addition to their interferon treatment. The Novantrone dose was adjusted for each patient, according to lymphocyte counts. After six months, total relapses dropped from 17 to 1; disability scores improved; and enhancing lesions decreased from 27 to 4. No serious side effects occurred during the treatment period. This reinforces the use of low-dose Novantrone as an add-on rescue therapy in RRMS patients not responding to interferon treatment. The combination therapy may also reduce the risk of adverse events due to the accumulation of high doses of Novantrone. In Turkey, another small study with 23 secondary-progressive MS (SPMS) patients and four individuals with worsening RRMS showed that Novantrone not only improved physical disability, but also improved cognition. With both of these studies, larger, placebo-controlled trials are needed to determine the actual benefits and risks.
As of March 2008, more than 26,000 patients were on Tysabri® worldwide. Since the re-launch of Tysabri in July 2006, no new cases of progressive multifocal leukoencephalopathy (PML) have been reported. PML is an often-fatal viral infection of the brain. Data from the PLEX study suggest that plasma exchange may be an effective procedure for accelerating the removal of Tysabri from the blood if PML infection is suspected. A new warning has been added to Tysabri's label about possible liver injury, and two cases of melanoma (skin cancer) have also been reported in women taking Tysabri, but a connection has not yet been confirmed.
Disappointing results from the OLYMPUS trial show that Rituxan® (rituximab) did not meet its primary endpoint for individuals with primary-progressive MS (PPMS), as measured by the time to confirmed disease progression. Rituxan continues to show encouraging results in reducing disease activity in individuals with RRMS.
The oral drug FTY720 is also showing encouraging results. A phase II study extension shows that 68 to 73 percent of the participating MS patients remain relapse-free, and 89 percent are free from active brain lesions, after three years of treatment.
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Is there much known about long term side effects?
Can you post this as a health page? This would be great to have easily accessible all the time when the DMD question comes up... it can be an overwhelming choice to make.
Lu