A Cochrane review «»1 «Riera R, Porfírio GJ, Torloni MR. Alemtuzumab for ...»1 included 3 studies with a total of 1713 subjects with multiple sclerosis (MS).
The trials compared alemtuzumab vs. s.c. interferon beta-1a (IFN) for patients with
relapsing–remitting MS. Patients were treatment-naive in two studies, the third
study included patients with at least one relapse while being treated with IFN beta
or glatiramer acetate. Alemtuzumab was given for 12 or 24 months; for some outcomes,
the follow-up period reached 36 months. The regimens were (a) 12 mg or 24 mg per day
administered iv., once a day for 5 days at month 0 and 12 or (b) 24 mg per day, iv.,
once a day for 3 consecutive days at month 12 and 24. The patients in the other arm
of the trials received sc. IFN beta.
- At 24 months: alemtuzumab 12 mg was associated with: (a) higher relapse-free survival (HR 0.50,
95% CI 0.41 to 0.60; 2 studies, n=1248); (b) higher sustained disease progression-free
survival (HR 0.62, 95% CI 0.44 to 0.87; 2 studies, n= 1191); (c) a slightly higher
number of participants with at least one adverse event (RR 1.04, 95% CI 1.01 to 1.06;
2 studies, n=1248); (d) a lower number of participants with new or enlarging T2-hyperintense
lesions on MRI (RR 0.74, 95% CI 0.59 to 0.91; 2 studies, n= 1238); and (e) a lower
number of dropouts (RR 0.31, 95% CI 0.23 to 0.41; 2 studies, n=1248).
- At 36 months: alemtuzumab 24 mg was associated with: (a) higher relapse-free survival (45 vs. 17;
HR 0.21, 95% CI 0.11 to 0.40; one study, n=221); (b) a higher sustained disease progression-free
survival (HR 0.33, 95% CI 0.16 to 0.69; one study, n=221); and (c) no statistical
difference in the rate of participants with at least one adverse event. No studies
reported rate of participants free of clinical disease activity, quality of life,
fatigue or change in the numbers of MRI T2- and T1-weighted lesions after treatment.