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Posted by on Oct 1, 2008 in Neurology, Pharma

Campath Efficacy in MS Holds Up

Campath Efficacy in MS Holds Up

Alemtuzumab_Fab.jpg

The mAb alemtuzumab (Campath; Genzyme/Bayer Healthcare) appears to provide the same kind of robust efficacy in multiple sclerosis as natalizumab (Tysabri; Elan/Biogen Idec). But like natalizumab, alemtuzumab is not without its risks.

Extension data from the ongoing phase 2 trial of alemtuzumab (CAMMS223) in patients with early, relapsing MS were presented last week at the World Congress on Treatment and Research in MS. Impressive efficacy outcomes with the drug in previous reports appear to be sustained at 36 months.

Specifically alemtuzumab significantly reduced the cumulative number of relapses and the time to sustained disability by more than 70%, when compared with interferon beta-1a (Rebif; EMD Serono/Pfizer). The percentage of relapse-free patients was also significantly higher with alemtuzumab (80% vs 50%), and the EDSS score actually dropped by 0.39 points with alemtuzumab treatment. (The EDSS score with interferon beta increased by 0.38 points.)

Adverse events of note are shown.

36-Month Outcome

Alemtuzumab

Interferon Beta-1a

No. patients with grade 3 infections

13

1

No. patients with grade 4/5 infections

0

0

Autoimmune thyroid dysfunction, %

23

3

ITP, %

2.8

0.5

Of acute concern is the rate of ITP with alemtuzumab treatment, an event which may be anticipated by platelet monitoring. Two, industry-supported, phase 3 studies (here and here) of alemtuzumab and interferon beta-1a in relapsing MS are currently recruiting patients. Primary outcome measures are the relapse rate and the time to sustained disability at 2 years. Blood monitoring will be performed monthly.

Alemtuzumab, a humanized anti-CD52 mAb, is FDA approved for the treatment of B-cell CLL. Interferon beta-1a is approved for the treatment of relapsing MS and has been shown (like other available interferon betas) to reduce the relapse rate in MS by approximately one third, when compared with placebo.

CLL = chronic lymphocytic leukemia; EDSS = Expanded Disability Status Scale; ITP = idiopathic thrombocytopenic purpura; mAb = monoclonal antibody. 

Fab fragment of alemtuzumab linked to antigen (yellow) from Wikipedia.

HT: Medscape Medical News

bmartin (1129 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.