Welcome to the healthcare professional section of the CARE-MSSM
Web site. Here you will find information on the Comparison of
Alemtuzumab and Rebif® Efficacy in
Multiple Sclerosis CARE-MS I and II studies —
two multinational, randomized, rater-blinded, Phase 3 studies of the safety and
effectiveness of the investigational drug alemtuzumab in participants with relapsing-remitting
multiple sclerosis (RRMS). You also will be able to review information from the
Phase 2 study that served as the rationale for the Phase 3 studies (below).
CARE-MS
Program Rationale
Clinical Experience
In a 3-year Phase 2 study, 334 treatment-naïve RRMS participants were randomized
1:1:1 to receive up to 3 annual cycles of 12 or 24 mg/day intravenous alemtuzumab
or 44 mcg subcutaneous Rebif 3 times per week. Alemtuzumab participants received
the drug once daily for 5 consecutive days at the beginning of the study, for 3
consecutive days at Month 12, and optionally for 3 consecutive days at Month 24.
Two hundred sixteen participants received alemtuzumab (108 received 12 mg and 108
received 24 mg), and 107 participants received Rebif.1 The 3-year efficacy results are based on the available clinical observations from 334 randomized patients.
Efficacy Results
Three-year results after initiation of treatment showed alemtuzumab was significantly
more effective than Rebif on the following co-primary endpoints.1
- Relapse rate: a 74% reduction in participants taking alemtuzumab compared to participants
treated with Rebif (P<0.001).
- Progression of clinically significant disability: a 71% reduction compared to participants
treated with Rebif (P<0.001).
Participants taking alemtuzumab experienced a statistically significant improvement
from baseline disability over 3 years compared to participants taking Rebif.1
Safety Results
Six of 216 (2.8%) participants taking alemtuzumab in the study were diagnosed with
immune thrombocytopenic purpura (ITP), which causes low platelet count that can
lead to bleeding. Though potentially life-threatening, ITP can be detected and monitored
and is usually treatable. A safety monitoring program was implemented in that study
(and is implemented in the CARE-MS studies) to monitor for the signs and symptoms
of ITP.
Among other side effects, patients who received alemtuzumab were more likely to
develop thyroid disease and mild to moderate infections (i.e., infections requiring
no specific medical intervention or requiring only oral medication). Thyroid problems
are reported to have been easily detected and treated. Patients who received Rebif
experienced injection site reactions, fatigue, flu-like illness, headache and abnormal
liver function tests.
Based on the results of this study, CARE-MS I and II were initiated to continue
the study of alemtuzumab in relapsing-remitting multiple sclerosis.
The objective of these studies is to compare the safety and efficacy of 2 annual
cycles of intravenous alemtuzumab to 3 times weekly subcutaneous injections of Rebif
in RRMS patients. CARE-MS I will compare 12 mg alemtuzumab to Rebif in treatment-naive
patients with recent disease activity. CARE-MS II will also study these dosing arms
in addition to a third arm, 24 mg alemtuzumab, in treated RRMS patients who have
relapsed on approved MS therapies.
Comparative evaluations between alemtuzumab and Rebif will include time to sustained
accumulation of disability and relapse rate. Additionally, the studies will compare
the side effects of the drugs and monitor for risks during treatment.
1 CAMMS223 Trial Investigators, Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran
S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early
multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801.