COPENHAGEN, Denmark. — Latest data from the CARE-MS II extension study show that alemtuzumab (Lemtrada, Genzyme/Sanofi) has a durable effect on disability in multiple sclerosis (MS), with the mean Expanded Disability Status Scale (EDSS) score at 3 years still below that at baseline.

These new data were presented in a poster at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) last week.

Summing up the highlights of the meeting, Bernd Kieseier, MD, Heinrich Heine University, Düsseldorf, Germany, commented on these latest alemtuzumab results: "Of those patients stable at 2 years, almost 50% are stable in the third year without any further treatment and 20% have better disability scores. And of those who improved in the core study 10% improve more in the third year and 42% remain stable."

"Potent Drug"

Dr. Kieseier added: "These data clearly support the view that we have a potent drug here. It has a dramatic effect on EDSS, with some patients actually improving, and this is maintained in third year even without further treatment."

Commenting for Medscape Medical News, Jeffrey Cohen, MD, Cleveland Clinic, Ohio, who was not involved in this analysis, said, "These results tell me that the short-term benefit seen in the trial is maintained after the trial has ended. The drug continues to be beneficial for years after dosing. We have already seen this to be the case in phase 2 trials, where there has been up to 5 years' benefit. So this is no big surprise."

Noting that the mean EDSS score did increase slightly between year 2 and year 3, Dr. Cohen said the change was very small and "the score looks quite stable to me."

The CARE-MS II (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II) trial randomly assigned patients with active relapsing/remitting MS to treatment with alemtuzumab or interferon β. Alemtuzumab was given as a 12 g/d intravenous infusion on 5 consecutive days at baseline and 3 consecutive days 1 year later.

More than 90% (393 of 423) of patients who had received alemtuzumab, 12 mg, in CARE-MS II and completed the core study entered the extension. Of these, 20% received a further dose during the third year. Fewer than 3% of patients received another disease-modifying therapy in year 3.

In these patients, mean EDSS score increased slightly from year 2 to year 3 but still remained below the baseline score.

Table 1. Mean EDSS Score

Year Mean EDSS Score Change from Baseline
0 2.7  
2 2.5 –0.21
3 2.6 –0.06


At year 3, 70% of alemtuzumab-treated patients had stable or improved EDSS scores from baseline. Results were similar to those seen at year 2.

Table 2. Mean Change in EDSS Score From Baseline

Variable Years 0 to 2 (%) Years 0 to 3 (%)
Improved 46 45
Remained stable 30 25
Worsened 24 30


In addition, 66% of patients had stable or improved EDSS scores from the start of the extension study (end of year 2).

Among patients whose EDSS scores remained stable from baseline to year 2, 67% continued to remain stable or improved from year 2 to year 3. And among patients whose EDSS score improved from baseline to year 2, 53% remained stably improved or improved further from year 2 to year 3.

Table 3. EDSS Shift in Years 2 to 3 in Patients Who Were Stable/Improved at Year 2

Shift Patients Stable Baseline to Year 2 (%) Patients Improved Baseline to Year 2 (%)
Improved year 2 to 3 46 45
Stable year 2 to 3 30 25


At year 3, more than one third of patients who had received alemtuzumab in the core study attained improvement in pre-existing disability that was sustained for 6 months, and more than a quarter achieved improvement in pre-existing disability that was sustained for 12 months.

Table 4. Percentage of Patients with 3-, 6-, and 12-Month Sustained Reduction in Disability

Time Point At 2 Years (%) At 3 Years (%)
3-month SRD 36 43
6-month SRD 29 35
12-month SRD 22 27

SRD = sustained reduction in disability.


The CARE-MS trials were funded by Genzyme/sanofi aventis. Dr. Kieseier has received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Bayer Health Care, Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, sanofi aventis, and TEVA Pharmaceuticals. Dr. Cohen reports personal compensation for serving as a consultant or speaker from Biogen Idec, Elan, Novartis, Teva, and Vaccinex and research support paid to his institution from Biogen Idec, Consortium of MS Centers, US Department of Defense, Genzyme, National Institutes of Health, National MS Society, Novartis, Receptos, Synthon, and Teva.

29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Poster presentation #P592. Presented October 3, 2013.


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