In the CARE-MS I study, alemtuzumab was given at an initial intravenous dose of 12 mg/day once daily for 5 consecutive days, followed by 12 mg/day for 3 consecutive days 1 year later. INFB-1a was administered as a 44-mcg subcutaneous injection given three times per week for 2 years.
Other research, presented by Dr. Joanne Jones of the University of Cambridge, suggests that a predictive test could perhaps be developed to identify the 20% to 30% of patients who may develop autoimmunity following treatment with alemtuzumab.
The experimental test is based on detecting pretreatment levels of interleukin (IL)-21 and IL-7 in the blood. People who experience autoimmune side effects with alemtuzumab have increased IL-21 levels and decreased IL-7 levels.
"It appears that we can ‘pull out’ a group of patients who are [at] very low risk of developing autoimmunity," Dr. Jones said. These results are of course preliminary, but "may be helpful in counseling patients considering treatment with alemtuzumab," Dr. Jones suggested.
The CARE-MS I study was funded by Genzyme (a subsidiary of Sanofi-Aventis) and Bayer HealthCare. Dr. Coles disclosed receiving consulting fees, lecture fees, and institutional grant support from Genzyme, Merck Serono, and UCB-Celltech. Dr. Jones said she had no disclosures. Dr. Kantor has acted as an investigator or had commercial relationships with Acorda, Avanir, Biogen Idec, Genzyme, Novartis, and Teva Neuroscience.