Alemtuzumab
Posted: Tue May 01, 2007 3:57 pm
Hi all,
It is possible to access the abstracts from the AAN meeting...Below is an example of one that I located (I'm not sure if it has been mentioned yet...if it has, I apologize ahead of time)...there are more articles on prospective meds as well as a host of other important info...
the link is
http://www.abstracts2view.com/aan2007bo ... 2007-05-01
best,
TOL
[S12.004] Efficacy of Alemtuzumab in Treatment-Naive Relapsing-Remitting Multiple Sclerosis: Analysis after Two Years of Study CAMMS223
Alasdair J. Coles, Cambridge, United Kingdom, The CAMMS223 Study Group, San Antonio, TX
OBJECTIVE: Report superior efficacy of alemtuzumab over high-dose interferon beta-1a (IFN-beta-1a) in CAMMS223, a multicenter, rater-blinded clinical trial comparing two alemtuzumab dose levels with IFN-beta-1a in treatment-nave relapsing-remitting multiple sclerosis (RRMS) patients. BACKGROUND: Preliminary studies suggest that alemtuzumab (humanized anti-CD52) suppresses RRMS disease activity. DESIGN/METHODS: 334 treatment-nave RRMS patients were randomized 1:1:1 to IFN-beta-1a (44mcg subcutaneously thrice weekly), or alemtuzumab high-dose (24mg/day) or low-dose (12mg/day). Key entry criteria included onset of MS within 3 years of screening, EDSS 0.0 to 3.0 (inclusive), 2 attacks in the previous 2 years, and 1 enhancing lesion on a screening MRI brain scan. Alemtuzumab was given intravenously daily 5 at Month 0, 3 at Month 12, and (for some patients) again at Month 24. Co-primary efficacy endpoints were 6-month sustained accumulation of disability (SAD) and relapse rate, scored by a neurologist masked to treatment. Pre-specified interim analyses of efficacy and safety data were reviewed by an independent Data Safety Monitoring Board. RESULTS: After 2.2 years median follow-up (1st quartile=2.0; 3rd=2.5), the pre-specified Year 2 interim analysis showed that, compared to IFN-beta-1a-treated patients, alemtuzumab-treated patients (at high and low doses) had 75% reduction in the risk for relapse (p=0.00328), and 65% reduction in the risk for SAD (p=0.01194). These differences were statistically significant. Results of secondary/tertiary efficacy endpoints, including MRI data, functional assessments, and quality-of-life measures, support the conclusions from analysis of the co-primary endpoints. Trial safety data are presented in separate abstracts; immune thrombocytopenic purpura, thyroid adverse events, and infections occurred more frequently in alemtuzumab-treated patients than in IFN-beta-1a-treated patients. CONCLUSIONS/RELEVANCE: CAMMS223 data suggest that alemtuzumab was substantially more effective at suppressing relapses and accumulation of disability than high-dose IFN-beta-1a in treatment-nave RRMS patients through 2 years of follow-up. This increased efficacy comes with additional benefits of infrequent, convenient administration. Side effects are treatable and manageable.
It is possible to access the abstracts from the AAN meeting...Below is an example of one that I located (I'm not sure if it has been mentioned yet...if it has, I apologize ahead of time)...there are more articles on prospective meds as well as a host of other important info...
the link is
http://www.abstracts2view.com/aan2007bo ... 2007-05-01
best,
TOL
[S12.004] Efficacy of Alemtuzumab in Treatment-Naive Relapsing-Remitting Multiple Sclerosis: Analysis after Two Years of Study CAMMS223
Alasdair J. Coles, Cambridge, United Kingdom, The CAMMS223 Study Group, San Antonio, TX
OBJECTIVE: Report superior efficacy of alemtuzumab over high-dose interferon beta-1a (IFN-beta-1a) in CAMMS223, a multicenter, rater-blinded clinical trial comparing two alemtuzumab dose levels with IFN-beta-1a in treatment-nave relapsing-remitting multiple sclerosis (RRMS) patients. BACKGROUND: Preliminary studies suggest that alemtuzumab (humanized anti-CD52) suppresses RRMS disease activity. DESIGN/METHODS: 334 treatment-nave RRMS patients were randomized 1:1:1 to IFN-beta-1a (44mcg subcutaneously thrice weekly), or alemtuzumab high-dose (24mg/day) or low-dose (12mg/day). Key entry criteria included onset of MS within 3 years of screening, EDSS 0.0 to 3.0 (inclusive), 2 attacks in the previous 2 years, and 1 enhancing lesion on a screening MRI brain scan. Alemtuzumab was given intravenously daily 5 at Month 0, 3 at Month 12, and (for some patients) again at Month 24. Co-primary efficacy endpoints were 6-month sustained accumulation of disability (SAD) and relapse rate, scored by a neurologist masked to treatment. Pre-specified interim analyses of efficacy and safety data were reviewed by an independent Data Safety Monitoring Board. RESULTS: After 2.2 years median follow-up (1st quartile=2.0; 3rd=2.5), the pre-specified Year 2 interim analysis showed that, compared to IFN-beta-1a-treated patients, alemtuzumab-treated patients (at high and low doses) had 75% reduction in the risk for relapse (p=0.00328), and 65% reduction in the risk for SAD (p=0.01194). These differences were statistically significant. Results of secondary/tertiary efficacy endpoints, including MRI data, functional assessments, and quality-of-life measures, support the conclusions from analysis of the co-primary endpoints. Trial safety data are presented in separate abstracts; immune thrombocytopenic purpura, thyroid adverse events, and infections occurred more frequently in alemtuzumab-treated patients than in IFN-beta-1a-treated patients. CONCLUSIONS/RELEVANCE: CAMMS223 data suggest that alemtuzumab was substantially more effective at suppressing relapses and accumulation of disability than high-dose IFN-beta-1a in treatment-nave RRMS patients through 2 years of follow-up. This increased efficacy comes with additional benefits of infrequent, convenient administration. Side effects are treatable and manageable.