CARE-MS I

Alemtuzumab

CARE-MS I confirmed superior relapse control with two annual alemtuzumab courses versus subcutaneous interferon beta-1a in treatment-naïve early RRMS.

Phase
Phase III
Population
Treatment-naïve relapsing-remitting multiple sclerosis (RRMS)
Controlled period
Aug 2007 — Apr 2011

What was compared

RandomizedRater-blindedActive-controlledMulticenter
Intervention

Alemtuzumab

12 mg/day IV for 5 days at baseline and 3 days at month 12

n=386 randomized
Comparator

Interferon beta-1a

44 μg subcutaneously three times weekly

n=195 randomized
581 randomized; 563 in primary analyses24 months controlled phase

Primary endpoint

Prespecified outcome

Relapse and 6-month sustained disability accumulation

2 years

Outcome figure

Primary endpoint results

Intervention Comparator or reference

Participants with a relapse

Participants with relapse (%)

2 years
Alemtuzumab
22%
Interferon beta-1a
40%

6-month sustained disability accumulation

Participants with progression (%)

2 years
Alemtuzumab
8%
Interferon beta-1a
11%

Relapse rate was 54.9% lower (P<0.0001); disability accumulation did not differ significantly (HR 0.70; P=0.22).

Selected secondary outcomes

Relapse-free status

78% with alemtuzumab versus 59% with interferon beta-1a at 2 years.

Study population

Randomized
581 randomized; 563 in primary analyses
Age
Mean 33.1 years; eligible 18–50
Sex
365 women (65% of primary-analysis population)
Disability
EDSS 0–3.0
Disease definition
Treatment-naïve, early active relapsing-remitting MS

Who entered the trial

Key inclusion criteria

  • MS symptom onset within 5 years
  • At least two attacks in 2 years, including at least one in the prior year
  • No prior disease-modifying therapy and baseline EDSS 0–3.0

Key exclusion criteria

  • Any progressive form of MS
  • Prior MS therapy other than corticosteroids or prior immunosuppression
  • Significant autoimmune disease, cytopenia, bleeding disorder, or malignancy

Safety signal

  • Infusion-associated reactions occurred in 90% of alemtuzumab-treated participants; 3% were serious.
  • Infections and autoimmune thyroid events required structured long-term monitoring.

Why it mattered

CARE-MS I translated the CAMMS223 efficacy signal into a phase III first-line population and established a two-course induction regimen.

Important limitation

The trial met the relapse but not the disability coprimary endpoint, and rater blinding could not fully remove differences in treatment experience.

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