Wednesday, 22 April 2015

AAN 2015: alemtuzumab brain atrophy data

Alemtuzumab has a major impact on reducing end-organ brain damage. #AAN2015 #MSResearch #MSBlog

"Do the results below show you how good alemtuzumab is in preventing end-organ damage and normalising the rate of brain atrophy? No. As good as they are they don't take into account the the possible reversal of pseudoatrophy in a the subset of MSers with recurrence of disease activity and hence reswelling of their brains from MS-related inflammation."


"The brain atrophy rates in these alemtuzumab-treated MSers seem remarkable and the best to date. Any annualised brain volume loss less than 0.4% is getting into the so called 'normal range' and figures of -0,15% and -0.19% are the best reported to date for a MS DMT.  However, what is the figure in  the group of MSers who are persistently NEDA beyond the 2nd course and what is the level in the groups requiring additional courses of treatment? I will need to get to the poster to see if this is disclosed."

"Despite this lack of subgroup analysis this data supports the long-term remission data and gives MSers some confidence that this therapy is optimising their brain health at least from a MS perspective. These results are not too dissimilar to the bone marrow transplant atrophy data from Canada."

What MS can do to your brain over 18 months!

Coles et al. Alemtuzumab Slows Brain Volume Loss Over 4 Years Despite Most Relapsing-Remitting Multiple Sclerosis Patients Not Receiving Treatment for 3 Years (P7.263). Neurology April 6, 2015 vol. 84 no. 14 Supplement P7.263

OBJECTIVE: Examine alemtuzumab’s effect on brain volume change over 4 years in patients who participated in the CARE-MS studies and ongoing extension. 


BACKGROUND: In 2 phase 3, head-to-head trials in active relapsing-remitting multiple sclerosis (RRMS) patients, alemtuzumab had superior efficacy versus subcutaneous interferon beta-1a (SC IFNB-1a), including a 42% greater reduction in brain volume loss than SC IFNB-1a over 2 years in treatment-naive patients (CARE-MS I; NCT00530348) and 24% greater reduction than SC IFNB-1a in patients who relapsed on prior therapy (CARE-MS II; NCT00548405). 

DESIGN/METHODS: Core study patients randomized to alemtuzumab received 12 mg/day intravenously on 5 consecutive days and on 3 consecutive days 12 months later. In the extension (NCT00930553), alemtuzumab-treated patients could receive as-needed retreatment >1 year after previous course. Magnetic resonance imaging scans were acquired at baseline and yearly thereafter. Brain volume loss was measured by brain parenchymal fraction (BPF) change. 

RESULTS: 349 (95.1%) CARE-MS I and 393 (92.9%) CARE-MS II alemtuzumab patients entered the extension phase; data are available through 4 years from first treatment with ongoing follow-up. Among CARE-MS I patients, 20.9% received 1 and 4.6% received 2 additional courses during the extension. Median rate of BPF loss decreased progressively over time in CARE-MS I (Year 1: -0.59%, Year 2: -0.25%, Year 3: -0.19%, Year 4: -0.15%). Among CARE-MS II patients, 24% received 1 and 7% received 2 additional courses during the extension. Median rate of BPF loss progressively slowed over 3 years in CARE-MS II and remained low in Year 4 (Year 1: -0.48%, Year 2: -0.22%, Year 3: -0.10%, Year 4: -0.19%). 

CONCLUSIONS: Slowing of brain volume loss with alemtuzumab was maintained over 4 years despite most patients receiving last treatment 3 years prior. These findings support alemtuzumab’s durable efficacy in RRMS. 

Study Supported by: Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals

CoI: multiple

8 comments:

  1. So what's the worst you can say about alemtuzumab right now? That it screws up people's thyroids? It's seeming like a better and better risk-reward ratio all the time.

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    1. it can do the ultimate worse and this is one reason that people much be tested every month for 4 years after the last dose

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    2. So does Tysabri, though obviously no one thinks that's a good situation either.

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    3. Also autoimmune thrombocytopaenia and Goodpasture's syndrome both potentially fatal but at a much lower level than Grave's.

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  2. Have you read the inset?? Melanoma, basement membrane disease, goodpastures, lymphoma, leukemia, thyroid cancer, hypothyroidism, hyperthyroidism, thyroid storm, anaphylaxis, hives, lymphedema. . .

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    1. Has a definite cancer risk been proven?

      http://www.ncbi.nlm.nih.gov/pubmed/23480032

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    2. Have you read the insert for paracetamol?! lol All potential side effects are listed. Anyone seriously considering taking the drug should be looking at the incidence of specific side effects in large scale clinical trials.

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  3. Those MRIs are a bit worrying. What type of MS did this poor soul have, and when in the disease course did this happen?

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