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Perhaps most noteworthy in this study is that after two years, most people scored better on their EDSS disability scores than when they entered the study. That's a big deal. - Dave
Alemtuzumab Reduces MS Attacks by 49% in Treatment-Experienced Patients
Presented at AAN
By Alex Morrisson
NEW ORLEANS -- April 28, 2012 -- Multiple sclerosis (MS) exacerbations were reduced by nearly one-half among treatment-experienced patients on alemtuzumab compared with interferon (IFN) beta-1a, researchers said here at the 64th Annual Meeting of the American Academy of Neurology (AAN).
The achievement was accomplished without an increase in adverse side effects, said Jeffrey Cohen, MD, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio, on April 24.
Dr. Cohen reported that the primary endpoint -- the annualised relapse rate among the patients -- was reduced by 49%. Patients receiving alemtuzumab were giving the drug once per year compared with patients who received subcutaneous IFN beta-1a 44 µg 3 times a week.
The researchers enrolled 202 patients to receive IFN therapy and 426 patients to receive alemtuzumab 12 mg. A third arm that was supposed to receive alemtuzumab 24 mg was discontinued early to speed enrolment to the trial.
The annualized relapse rate was 0.52 per year among those on IFN compared with 0.26 per year among the patents receiving a 5-day infusion of alemtuzumab the first year and a 3-day infusion in the second year (P <.0001). Methylprednisolone was coadministered with alemtuzumab.
After 2 years of therapy, 65% of the patients assigned to receive alemtuzumab were free of relapses compared with 47% of the patients taking IFN -- a 47% reduction in the risk of experiencing a relapse (P <.0001).
In the coprimary endpoint, the time to sustained accumulation of disability was experienced by 12.7% of patients on alemtuzumab after 2 years compared with 21.1% of those on IFN -- a reduction of 42% (P =.0084).
When researchers scrutinised results based on the Expanded Disability Status Scale, they determined that patients assigned to alemtuzumab had achieved a 0.17-point reduction in scores, while those on IFN had experienced a 0.26-point increased in the scale (P <.0001).
Imaging studies also significantly favoured treatment with alemtuzumab, Dr. Cohen reported.
“Alemtuzumab provides a favourable benefit/risk balance in patients who have relapsed on prior therapy, a group with high unmet need,” he said.
The researchers suggested that alemtuzumab targets CD52 cells, causing depletion of B-cell and T-cell lymphocytes, which are believed to impact factors involved in MS pathology.
All patients in the study were diagnosed with remitting-relapsing MS and had experienced symptoms of the disease within the previous 10 years. For entry into the study, patients had to have experienced at least 2 relapses in the previous year, including 1 relapse while being treated with IFN beta or glatiramer acetate.
Two malignancies were observed among those on IFN and on alemtuzumab 12 mg alemtuzumab; 3 malignancies were seen in patients on the 24 mg dose of alemtuzumab.
Autoimmune thyroid adverse events where observed in about 15% of patients receiving alemtuzumab, most of which were detected through clinical and laboratory monitoring. Serious adverse events were rare.
[Presentation title: Efficacy and Safety Results From Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II (CARE-MS II): A Phase 3 Study in Relapsing-Remitting Multiple Sclerosis Patients Who Relapsed on Prior Therapy. Abstract S01.004]
Alemtuzumab Reduces MS Attacks by 49% in Treatment-Experienced Patients
Presented at AAN
By Alex Morrisson
NEW ORLEANS -- April 28, 2012 -- Multiple sclerosis (MS) exacerbations were reduced by nearly one-half among treatment-experienced patients on alemtuzumab compared with interferon (IFN) beta-1a, researchers said here at the 64th Annual Meeting of the American Academy of Neurology (AAN).
The achievement was accomplished without an increase in adverse side effects, said Jeffrey Cohen, MD, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio, on April 24.
Dr. Cohen reported that the primary endpoint -- the annualised relapse rate among the patients -- was reduced by 49%. Patients receiving alemtuzumab were giving the drug once per year compared with patients who received subcutaneous IFN beta-1a 44 µg 3 times a week.
The researchers enrolled 202 patients to receive IFN therapy and 426 patients to receive alemtuzumab 12 mg. A third arm that was supposed to receive alemtuzumab 24 mg was discontinued early to speed enrolment to the trial.
The annualized relapse rate was 0.52 per year among those on IFN compared with 0.26 per year among the patents receiving a 5-day infusion of alemtuzumab the first year and a 3-day infusion in the second year (P <.0001). Methylprednisolone was coadministered with alemtuzumab.
After 2 years of therapy, 65% of the patients assigned to receive alemtuzumab were free of relapses compared with 47% of the patients taking IFN -- a 47% reduction in the risk of experiencing a relapse (P <.0001).
In the coprimary endpoint, the time to sustained accumulation of disability was experienced by 12.7% of patients on alemtuzumab after 2 years compared with 21.1% of those on IFN -- a reduction of 42% (P =.0084).
When researchers scrutinised results based on the Expanded Disability Status Scale, they determined that patients assigned to alemtuzumab had achieved a 0.17-point reduction in scores, while those on IFN had experienced a 0.26-point increased in the scale (P <.0001).
Imaging studies also significantly favoured treatment with alemtuzumab, Dr. Cohen reported.
“Alemtuzumab provides a favourable benefit/risk balance in patients who have relapsed on prior therapy, a group with high unmet need,” he said.
The researchers suggested that alemtuzumab targets CD52 cells, causing depletion of B-cell and T-cell lymphocytes, which are believed to impact factors involved in MS pathology.
All patients in the study were diagnosed with remitting-relapsing MS and had experienced symptoms of the disease within the previous 10 years. For entry into the study, patients had to have experienced at least 2 relapses in the previous year, including 1 relapse while being treated with IFN beta or glatiramer acetate.
Two malignancies were observed among those on IFN and on alemtuzumab 12 mg alemtuzumab; 3 malignancies were seen in patients on the 24 mg dose of alemtuzumab.
Autoimmune thyroid adverse events where observed in about 15% of patients receiving alemtuzumab, most of which were detected through clinical and laboratory monitoring. Serious adverse events were rare.
[Presentation title: Efficacy and Safety Results From Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II (CARE-MS II): A Phase 3 Study in Relapsing-Remitting Multiple Sclerosis Patients Who Relapsed on Prior Therapy. Abstract S01.004]