Alemtuzumab

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Alemtuzumab

Postby thinkingoutloud86 » 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.
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Re: Alemtuzumab

Postby mjs » Tue May 01, 2007 8:59 pm

thinkingoutloud86 wrote:Side effects are treatable and manageable.


Hmm, I wish it were that straightforward. Campath is ridiculously toxic - it lasts in your system for years on end, and causes other auto-immune diseases (in up to 20% of people). Efficacy seems great, but only for RRMS.

Tysabri seems more palatable.
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